ANNAMALAI UNIVERSITY

ANNAMALAI NAGAR

DEPARTMENT OF PHARMACY
FACULTY OF ENGINEERING AND
TECHNOLOGY

MASTER OF PHARMACY

HAND BOOK
2012 2013 onwards

DEPARTMENT OF PHARMACY
ANNAMALAI UNIVERSITY
CHOICE BASED CREDIT SYSTEM FOR M.PHARM. FULL-TIME
REGULATIONS
R1. CONDITION FOR ADMISSION
Candidates for admission to the M.Pharm Degree Programmes in all branches shall be required
to have passed the B.Pharm degree or Graduates of any other authority accepted by the syndicate
of this University as equivalent thereto. They shall satisfy the conditions regarding qualifying
marks and physical fitness as may be prescribed by the syndicate of the Annamalai University
from time to time.
R2. CREDITS
M.Pharm full-time programme will have duration of four semesters.
The number of credits per semester for the full-time programme shall be as follows :
First
Second semesters
Third Semester
Fourth Semester

:
:
:
:

20 credits
20 credits
12 credits
13 credits

The total credit for the entire programme will be 65. For the award of the degree, a student has to
earn a minimum of 65 credits.
R3. DURATION OF THE PROGRAMME
A student is normally expected to complete the full-time programme in four semesters but in any
case not more than four years from the time of admission.
R4. REGISTRATION FOR COURSES
A newly admitted student will automatically be registered for all the courses prescribed for the
first semester, without any option.
Every other student shall be submit a completed registration form indicating the list of courses
intended to be credited during the next semester. This registration will be done a week before the
last working day of the current semester. Late registration with the approval of the Dean on the
recommendation of the head of the department along with a late fee will be done up to the last
working day.
Registration for the thesis phase-I and phase-II shall be done at the appropriate semester.

R5. ASSESSMENT
i) The break-up of assessment and examination marks for theory subjects as follows.
First assessment ( I Mid Term Test)
: 10
Second assessment (II Mid Term Test)
: 10
Third assessment
: 05
End Semester Examination
: 75
ii) The break-up of assessment and examination marks for practical subjects as follows.
First assessment ( I Mid Term Test)
: 15
Second assessment (II Mid Term Test)
: 15
Third assessment
: 10
End Semester Examination
: 60
The thesis phase-I will be assessed for 40 marks by a committee consisting of the Head of the
department, the guide and minimum of two faulty members nominated by the Head of the
department. The Head of the department will be the Chairman. 60 marks are allotted for the
thesis work and viva voce examination at the end of the prefinal semester. The same procedure
will be adopted in the final semester also.
R6. COUNSELLOR
To help the students in planning their course of study and for general advice on the academic
programme, the Head of the department will attach a certain number of students to a member of
the faculty who shall function as counsellor for those students throughout their period of study.
Such counsellor shall advise the students, give preliminary approval for the courses to be taken
by the students during each semester and obtain the final approval of the Head of the department.
R7. CLASS COMMITTEE
For each semester, separate class committees will be constituted by the Head of Department.
The composition of the class committee for each semester except for the final semester shall be
as follows :

Teachers of the individual courses.

A thesis co-ordinator (in the prefinal and final semester committee only) who shall be
appointed by the Head of the department from among the thesis supervisors.

One Professor or Reader, preferably not teaching the concerned class, appointed as chairman
by the Head of the department.

The Head of the department may opt to be a member or the chairman.

All student counsellors of the class, the Head of the department (if not already a member)
and any staff member nominated by the Head of the Department may opt to be special
invitees.

The class committee shall meet four times during the semester.

The first meeting will be held within two weeks from the date of commencement of class to
decide the type of assessment like test, assignment etc. for the three assessments and dates of
completion of the assessments.

The second and third meetings will be held within a week after the completion of the first
and second assessments respectively to review the performance and for follow-up action.

The fourth meeting will be held after all the assessments except the examination are
completed for all the courses and at least one week before the commencement of the
examinations.

During this meeting the assessment on a maximum of 40 marks will be finalized for every
student and tabulated and submitted to the Head of the department for approval and
transmission to the Controller of examinations.

R8. WITHDRAWAL FROM A COURSE

A student can withdraw from a course at any time before a date fixed by the Head of the
department perior to the second assessment, with the approval of the Dean of the Faculty on the
recommendation of the Head of the department.
R9. TEMPORARY BREAK OF STUDY
A student can take a one time temporary break of study covering the current semester and / or the
next semester with the approval of the Dean on the recommendation of the Head of the
Department, not later than seven days after the completion of the mid-semester test. However,
the student must complete the entire programme within the maximum period of four years for
full-time.
R10. MOVEMENT TO THE PRE-FINAL SEMESTER
A maximum of 24 credits must be earned by the student to move to the prefinal semester. The
results of the final semester will be withheld until the student passes all the previous semester
examinations.
R11. SUBSTITUTE ASSESSEMETNS
A student who has missed, for genuine reasons accepted by the Head of the department, one or
more of the assessments of a course other than the end semester examination, may take a
substitute assessment for any one of the missed assessments. The substitute must be completed
before the date of the fourth meeting of the respective class committees.
A student who wishes to have a substitute assessment for a missed assessment must apply to the
Head of the department with a week from the date of the missed assessment.
R12. ATTENDANCE REQUIREMENTS
To be eligible to appear for the examination in a particular course, a student must put in a
minimum of 80% of attendance in that course. However, if the attendance is 75% or above but
less than 80% in any course, the authorities can permit the student to appear for the examination
in that course on payment of the prescribed condonation fee.

A student who withdraws from or does not meet the minimum attendance requirement in a
course must re-register for and repeat the course.
R13. PASSING AND DECLARATION OF EXAMINATION RESULTS
All assessments of all the courses on an absolute mark basis will be considered and passed by the
respective results passing boards in accordance with the rules of the University. The marks for
each course shall be converted to the corresponding letter grade as follows. Thereafter,
computation of the grade point average (GPA) and cumulative grade point average (CGPA), and
preparation of the grade cards shall be done.
90 to 100 marks
80 to 89 marks
70 to 79 marks
60 to 69 marks
55 to 59 marks
50 to 54 marks
Less than 50 marks
Insufficient attendance
Withdrawn from the course

:
:
:
:
:
:
:
:
:

Grade
Grade
Grade
Grade
Grade
Grade
Grade
Grade
Grade

S
A
B
C
D
E
F
I
W

In order to pass a subject the student has to get 30 marks out of 75 (end semester examination in
case of theory) 24 marks out of 60 (end semester examination in case of practical / thesis) and
50 marks out of 100 (total marks).
A student who earns a grade of S, A, B, C, D or E for a course is declared to have successfully
completed that course and earned the credits for that course. Such a course cannot be repeated by
the student.
A student who obtains letter grades I or W in a course must reregister for and repeat the course.
A student who obtains letter grade F in a course has to reappear for the examination in that
course.
A student who obtains letter grade I or W or F in thesis phase-I must reregister in the next
semester. Registration for thesis phase-II for such student can be done in the subsequent
semester.
The following grade points are associated with each letter grade for calculating the GPA and
CGPA.
S-10; A-9;

B-8;

C-7;

D-6;

E-5;

F-0

Courses with grade I and W are not considered for calculation of grade point average or
cumulative grade point average. F grade will be considered for computing GPA and CGPA.
A student can apply for retotaling of one or more of his/her examination answer papers within a
week from the date of issue of grade sheet to the student on payment of the prescribed fee per
paper. The application must be made to the Controller of Examinations with the recommendation
of the Head of the Department.

After the results are declared, grade cards will be issued to the students. The grade card will
contain the list of the courses registered during the semester, the grades scored and the grade
point average for the semester.
GPA is the sum of the products of the number of credits of a course with the grade point scored
in that course, taken over all the courses for the semester, divided by the sum of the number of
credits for all courses taken in that semester. CGPA is similarly calculated considering all the
courses taken from the time of admission.
The results of the final semester will be withheld until the student obtains passing grades in all
the subjects of all the earlier semesters.
After successful completion of the programme, the degree will be awarded with the following
classifications based on CGPA.
For first class with Distinction the student must earn a minimum of 65 credits with in four
semesters for full-time from the time of admission, pass all the courses in the first attempt and
obtain a CGPA of 8.25 or above.
For First class, the student must earn a minimum of 65 credits within two years and six months
for full time from the time of admission and obtain a CGPA of 6.75 or above.
For second class the student must earn a minimum of 65 credits within four years from the time
of admission.
R14. RANKING OF CANDIDATES
The candidates who are eligible to get the M.Pharm., degree in First Class with Distinction
and/or First Class with first attempt will be ranked together on the basis of CGPA for all the
subjects of study from I to IV Semester.
The candidates passing with First class and with out failing in any subjects from the time of
admission will be ranked next after those with distinction on the basis of CGPA for all the
courses of study from I to IV Semester of M.Pharm programmes
R15. ELECTIVES
Apart from the various elective courses offered in the curriculum of the branch of specialization,
a student can choose a maximum of two electives from any specialization under the faculty
during the entire period of study, with the approval of the Head of the Department and the Head
of the Department offering the course.
R16. TRANSITORY REGULATIONS
If a candidate studying M.Pharm under the old regulations who could not attend any of the
subjects in his/her courses, shall be permitted to attend equal number of subjects, under the new
regulation and will be examined in those subjects. The choice of subjects will be decided by the
concerned Head of the Department. However he/she will be permitted to submit the thesis as per
the old regulations. The results of such candidates will be passed as per old regulations.
The University shall have powers to revise or change or amend the regulations, the scheme of
examinations, the subjects of study and the syllabi from time to time.

M.PHARM. INDUSTRIAL PHARMACY

Courses of Study:
First Semester
MPIC 101: Instrumental methods of Analysis - Theory (Common to all Branches)
MPIC 102: Modern Analytical Techniques - Theory (Common to all Branches)
MPIC 103: Dosage Form Design Theory (Common with M.Pharm Quality Assurance and
M.Pharm Industrial Pharmacognosy)
MPIC 104: Modern Pharmaceutics- Theory (Common with M.Pharm Quality Assurance)
MPIC 105: Quality Assurance Management Theory (Common with M.Pharm Quality
Assurance)
MPIP 106: Pharmaceutical Analysis Practical (Common to all Branches)
MPIP 107: Industrial Pharmacy Practical (Common with M.Pharm Quality Assurance)
Second Semester
MPIC 201: Biopharmaceutics - Theory (Common with M. Pharm. Pharmacy Practice and
M.Pharm Pharmacology)
MPIC 202: Clinical Pharmacokinetics - Theory (Common with M. Pharm. Pharmacy Practice
and M.Pharm Pharmacology)
MPIC 203: Advances in Drug Delivery Systems Theory
MPIC 204: Advanced Pharmaceutics Theory
MPIC 205: Pharmaceutical Production Management Theory
MPIP 206: Biopharmaceutics Practical (Common with M. Pharm. Pharmacy Practice)
MPIP 207: Advanced Industrial Pharmacy Practical
Third Semester
MPIC 301: Research methodology and Pharmaceutical Statistics - Theory
MPIC 302: Elective:
1. MPIE 302(1) Advances in Industrial Pharmacy Theory
2. MPIE 302(2) Pharmaceutical Healthcare Theory
3. MPIE 302(3) Analytical method development Theory
4. MPIE 302 (4) Clinical pharmacology - Theory
5. MPIE 302(5) Strategy In Drug Synthesis - Theory
6. MPIE 302(6) Pharmacobiotechnology - Theory
MPIT 303: Thesis Phase I
Fourth Semester
MPIT 401: Thesis Phase II

Scheme of Examinations
M.Pharm. - Industrial Pharmacy
Subject

I-Semester
MPIC 101 Instrumental methods of
Analysis Theory
MPIC 102 Modern Analytical
Techniques Theory
MPIC 103 Dosage Form Design
Theory
MPIC 104 Modern PharmaceuticsTheory
MPIC 105 Quality Assurance
Management Theory
MPIP 106 Pharmaceutical Analysis
Practical
MPIP 107 Industrial Pharmacy
Practical
II-Semester
MPIC 201 Biopharmaceutics Theory
MPIC 202 Clinical
Pharmacokinetics Theory
MPIC 203 Advances in Drug
Delivery Systems Theory
MPIC 204: Advanced
Pharmaceutics Theory
MPIC 205 Pharmaceutical
Production Management Theory
MPIP 206 Biopharmaceutics
Practical
MPIP 207 Advanced Industrial
Pharmacy Practical
III -Semester
MPIC 301 Research Methodology &
Pharmaceutical Statistics
MPIE 302 Elective
MPIT 303 Thesis Phase I
IV- Semester
MPIT 401 Thesis Phase II

Hrs/Week
L
T P

Credits

Evaluation (Marks)
sessional Univ. Total
Exam

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

--

40

60

100

--

--

40

60

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

--

40

60

100

--

--

40

60

100

--

25

75

100

2
15

--

3
6

25
40

75
60

100
100

13

40

60

100

Syllabus
FIRST SEMESTER
MPIC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory) 35 Hrs.
1. UV-Visible Spectrophotometry: Theory Beer and Lamberts Law - Limitations of the
law, Design and working of single beam and double beam spectrophotometers.
Applications of UV absorptions spectrophotometry in qualitative analysis and
quantitative analysis.
2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence.
Chemical structure and fluorescence - factors affecting fluorescence intensity.
Instrumentation and Pharmaceutical applications of fluorimetry.
3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation
Types of interference and elimination of interference - Pharmaceutical applications
4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion
exchange chromatography and super critical fluid chromatography.
5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle,
Instruments and application. Chromatographic attributes: Capacity factor, resolution,
theoretical plates and symmetry factor
6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass
spectrometry
7. Introduction to Radio Immuno Assay
Books for Reference:
1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of
quantitative inorganic analysis, ELBS, London.
2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the
Athlone Press London.
3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry,
Saunders College publishing, New York.
4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college
publishing, New York.
5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
6. V.K. Srivastava and K.K.
S. Chand & Company, New Delhi.

Srivastav,

Introduction

to

Chromatography,

7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice
Hall London.
9

9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric

Identification of organic Compounds, John Wiley & Sons, New York.
10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New
Delhi.
11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.
12. Mofat, A.C (Ed). Clarkes Isolation and Identification of Drugs, The pharmaceutical
press, London.
13. Pharmacopoeia of India, Govt. of India, Ministry of Health.
14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.
15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.
16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea &
Febiger, Philadelphia.
MPIC 102: MODERN ANALYTICAL TECHNIQUES (Theory)

35 Hrs.

1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample

preparation - application of IR spectrophotometry in pharmacy. Introduction to FTIR
2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift,
magnetic equivalence spin-spin decoupling shift reagents, applications of NMR
spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple
organic compound as example)
3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron
bombardment, chemical ionization, field desorption, fast atom bombardment. Different
analysers. Interpretation of mass spectra, determination of molecular weight and
molecular formula and applications of mass spectrometry
4. Theory, instrumentation and applications of Differential Thermal Analysis and
Differential Scanning Calorimetry.
5. A preliminary study of principle, Instrument and applications of 13C NMR
6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins &
antibiotics
Books for reference:
1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the
Athlone Press London.
2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college
publishing, New York.
3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.

10

4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice
Hall London.
6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric
Identification of organic Compounds, John Wiley & Sons, New York.
7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New
Delhi.
8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.
9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.
10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
MPIC 103: DOSAGE FORM DESIGN (Theory)

35 Hrs.

1. Manufacturing and Quality control of solid dosage forms: Tablets and Capsules.
2. Manufacturing and Quality control of liquid dosage forms: orals and topicals.
3. a) Parenterals formulation development and evaluation
b) Aerosol Formulation Development and its Quality Control
4. Radio pharmaceuticals: Background information, dosage formulation, diagnostic and
therapeutic uses, production, quality assurance, storage and safety hazards.
5. Selection and evaluation of packaging materials, containers and closures, special
problems of container product interactions. Pharmacopoeial specifications, tests and
standards for packaging materials.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3 rd Edn,
Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Marcel Dekker, Inc., New
York, 1995
4. Lachman L, et al, Pharmaceutical Dosage Forms: Parenteral Medications, 2nd Edn., Vol I
& II, Marcel Dekker, New York, 1992.
5. Lachman L, et al, Pharmaceutical Dosage Forms: Tablets, 2 nd Edn., Vol I, II & III,
Marcel Dekker, New York, 1992.
6. Turco S and King R E, Sterile Dosage Forms, 3 rd Edn., Lea & Febiger, Philadelphia,
1987.
7. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Edn., Churchill Livingstone, New York, 1996.

11

MPIC 104: MODERN PHARMACEUTICS (Theory)

35 Hrs.
1. Stability testing of Pharmaceutical products: Physico-chemical factors affecting stability
of drugs, methods to find out degradation pathways, determination of shelf life by
accelerated stability testing.
2. Incompatibilities encountered in multi-component drug formulations, rationale for drug
combinations case studies.
3. Enzyme Technology-Production, Isolation and purification of Enzymes, applications in
pharmacy and Immobilised Enzymes and its future applications.
4. Sterile dosage forms: biologicals
5. Products of Biotechnology. Principles of Genetic Engineering.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3 rd Edn,
Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Mercel Dekker, Inc., New
York, 1995
4. Turco S and King R E, Sterile Dosage Forms, 3 rd Edn., Lea & Febiger, Philadelphia,
1987.
5. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Edn., Churchill Livingstone, New York, 1996.
6. Wiseman A, Principles of Bio-Technology, 2 nd Edn., Surrey Univ. Press, New York,
1988.
7. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery
Systems, 7th Edn., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
8. Wiseman A, Handbook of Enzyme Biotechnology, 2 nd Edn., Ellis Horwood Ltd., New
York, 1985.
MPIC 105: QUALITY ASSURANCE MANAGEMENT (Theory)

35 Hrs.

1. The origin and concept of GMP Schedule M of Drugs and cosmetics Act, WHO
specifications and US FDA guidelines. The study shall include special emphasis on
premises, personnel, sanitation, equipment, manufacturing operation and documentation.
GMP certification.
2. Regulatory affairs D&C act, DPCO
3. Ware housing Design, Construction, maintenance and sanitation for materials and
products good warehousing practices.
4. Finished product release, Quality review, Quality audits Batch release Distribution
and Distribution records Handling of returned goods. Recovered materials and
reprocessing.
5. Complaints and recalls, evaluation of complaints and recall procedures.

12

6. Documentation relating to product development, standard operating procedures, standard

test processes, cleaning methods, Quality control documents, batch release document,
distribution records, complaints and recalls records, retention of records.
7. Intellectual property rights and Patent Laws
Books for reference:
1.
2.
3.
4.
5.
6.

Theory and Practice of Industrial Pharmacy by Liberman and Lachman.

Remingtons Pharmaceutical Sciences.
GMP by Sidney H, Willing.
Quality Assurance Guide, Organization of Pharmaceutical Production of India.
Drugs and Cosmetics Act 1940 and Rules 1945
S.H. Willig., M.M.T. Tuckerman, W.S. Hitchings IV, Good Manufacturing Practices
for Pharmaceuticals, Marcel Dekker Inc, New York.
7. P.P. Sharma, How to Practice GMPs, Vandhana Publication, Agra.
8. Ira R. Berry and R.A Nash (eds), Pharmaceutical Process Validation, marcel Dekker
Inc., New York.
MPIP 106: PHARMACEUTLICAL ANALYSIS (Practical)

45 Hrs.

1. Experiments based on theory subjects Instrumental methods of analysis and Modern

Analytical techniques
2. Experiments would be selected illustrating the principles involved in estimation of raw
materials and finished products representing major categories of drug formulations from
pharmacopoeias.
MPIP 107: INDUSTRIAL PHARMACY (Practical)

70 Hrs.

1. Experiments based on Dosage Form Design and Modern Pharmaceutics theory papers
would be selected for the practical.
SECOND SEMESTER
MPIC 201: BIOPHARMACEUTICS (Theory)

35 Hrs.

1. Drug absorption and disposition: Mechanism of drug transport, factors affecting

absorption, distribution, bio- transformation and elimination.
2. First order process, rate constants, half-life; Zero order process
3. Open one compartment model: Description, volume of distribution, drug concentration in
plasma, kinetics of I.V. administration, short term constant rate I .V. infusion, absorption
rate and drug effects , continuous constant rate infusion, repetitive dosing- average
concentration of drug at steady state , loading dose , dosing interval.
4. Open two-compartment model; Kinetics of absorption, distribution and elimination.
Multiple dose administration. Limitation of multi- compartmental analysis.
13

5. Non-compartmental model; Area under first moment curve (AUMC), Apparent volume
of distribution, mean residence time (MRT), Drug absorption predicting steady state
concentration.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger,
Philadelphia, 1991.
3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker,
Inc., New York, 1987.
4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics A Treatise, 2nd
Edn., Vallabh Prakashan, New Delhi, 1998.
5. Swarbrick J, Current Concept in Phramaceutical Science: Bio Pharmaceutics, Lea &
Febiger, Philadelphia, 1970.
MPIC 202: CLINICAL PHARMACOKINETICS (Theory)

35 Hrs.

1. Clearance concepts- organ clearance, total clearance, renal clearance and excretion.
2. Hepatic clearance and elimination, other non renal clearance. Extraction ratio
3. Bio-availability and bio equivalency testing; Estimation methods, dissolution testing, in
vitro & in vivo correlation study , bio equivalency testing of dosage forms.
4. Pharmacokinetic variability; Body weight & size, obesity, age. Drug metabolism, Plasma
protein binding and renal excretion in newborn & children. Sex, pregnancy and genetic
factors. Poly morphic acetylation and oxidation.
5. Pharmcokinetic variability: Drug interactions
6. Effect of disease states on drug disposition, therapeutic drug monitoring and dosage
prediction of digoxin, gentamycin and anticonvulsants. Hypothesis of individualisation &
optimisation of drug therapy.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger,
Philadelphia, 1991.
3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker,
Inc., New York, 1987.
4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics, 2nd Edn., Vallabh
Prakashan, New Delhi, 1998.
5. Wagner J G, Bio- Pharmaceutics and relevant Pharmacokinetics, Drug Intelligence
Publications, Washington DC, 1971.
14

6. Rowland M and Tozer TN, Clinical Pharmacokinetics concepts and applications, 3 rd

Edn., Lea & Febiger, Philadelphia, 1995.
7. Shargel L and Yu AB, Applied Bio-Pharmaceutics and Pharmacokinetics, Appleton &
Lange, Norwalk, CT, 1993.
MPIC 203: ADVANCES IN DRUG DELIVERY SYSTEM (Theory) 35 Hrs.
1. Sustained Release Drug Delivery System Concept, drug properties relevant to sustained
release formulation, mechanisms, oral and parental sustained release dosage forms and
their Evaluation.
2. Targeted Drug Delivery System nanoparticles, liposomes, resealed erythrocytes,
immunologically based system antibodies for drug delivery, magnetic micro spheres.
3. Controlled Drug Delivery Modules (a) Insulin pump, Occusert, Oral osmotic pump
system, Modules for gastrointestinal tract, Implants, Intra vaginal & intra uterine drug
delivery systems (b) Transdermal drug delivery systems
4. Delivery of biotechnology products; Genetic material drug delivery, protein and peptide
drug delivery.
5. Regulatory considerations in controlled release medication requirements to demonstrate
safety and efficacy and controlled release nature, pharmacokinetic consideration and
bioavailability assurance. Feasibility of manufacture of sustained action drug delivery
systems.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Mercel Dekker, Inc., New
York, 1995
3. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Edn., Churchill Livingstone, New York, 1996.
4. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery
Systems, 7th Edn., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
5. Chien Y W, Novel Drug Delivery Systems, 2 nd Edn., Marcel Dekker, Inc., New York,
1992.
6. Robinson J R and Lee V H, Controlled Drug Delivery System Fundamentals and
apllications, 2 nd Edn., Marcel Dekker, Inc., New York, 1987.
7. Tyle P, Drug Delivery Devices, Fundamentals and Applications, Marcel dekker, Inc.,
New York, 1988.
MPIC 204: Advanced Pharmaceutics Theory

35 Hours

15

Fundamentals of drug nanoparticle: Nanoparticle size, nanoparticle surface, Nanoparticle

suspension and settling, production of nanoparticles, biological transport of nanoparticle. Types
of nanoparticular drug delivery system.
Manufacture of nanoparticle: Pearl / Ball milling, high pressure homogenisation,
spray drying, pellatisation techniques, super critical fluid technique, polymer
stabilised nanoparticle. Characterisation & evaluation of nanoparticles.
1. Bioequivalence testing : Methods for determining bioequivalence; Minimizing the
need for bioequivalence studies; Evaluation of bioequivalence data; Bioequivalence
assessment and data evaluation; Criteria for bioequivalence and statistical
requirements; Average or individual bioequivalence.
2. Plastic packaging materials: Types: Thermoplastics and Thermosets; commonly used
thermoplastics and thermosetting plastics and their applications including blister
packaging; Biological and physicochemical testing procedures; Regulatory aspects;
Recent trends.
3. Coating of pharmaceutical dosage forms: Objectives of coating; Film coating of solid
dosage forms film coating materials; Modified release film coatings- enteric and
sustained release coatings; Coating equipments; compresson coating; Recent trends
4. Statistical methods in dissolution studies: Biopharmaceutical Classification System
(BCS) of solid drugs; Application of BCS classification in oral drug delivery;
Dissolution profile comparisons; Statistical evaluation of dissolution similaritydifference factor(f1) and similarity factor (f2); Statistical properties of the dissolution
test.
5. (a) Drug release mechanisms and kinetics- Robinson Eriksen equation, Higuchi
equation in the design of modified release dosage form total dose calculation;
Korsemeyer-Peppas mathematical model and mode of drug release elucidation.
(b) Novel delivery of drugs through Nano/Micro-Electro Mechanical System (NEMS/
MEMS) and Gastro-retentive approach.
Reference Books
1. Gupta R.B., Kompella UB., Nonoparticle technology for drug delivery, Taylor &
Francis, New York, 2006 (Chapter 1)
2. Allen Jr. LV. Remington: The science and practice of pharmacy, 22nd Edn.
Lippincott Williams & Wilkins, Philadelphia, 2010.
3. Allen Jr. LV, Popovich NG, Ansel HC. Ansels Pharmaceutical dosage form and
drug delivery systems, 9th Edn., Lippincott Williams & Wilkins, Philadelphia, 2009.
4. Aulton ME. Aultons Pharmaceutics: The design and manufacture of medicines, 3rd
Edn, Churchill Livingstone, New York, 2007
5. Lachman L, Lieberman HH and Kanig, JL. The theory and practice of industrial
pharmacy, 3rd Edn., Lea & Febiger, Malvern, Pa, 1986

16

6. Guidance for Industry- Dissolution testing of immediate release solid oral dosage
form. FDA, US, Centre for Drug Evaluation and Research (CDER), Aug 1997.
7. Indian Pharmacopoeia-2007, the Indian Pharmacopoeia commission, Ghaziabad.
8. British Pharmacopoeia-2011, the Stationery office, London.
9. United States Pharmacopoeia-2008, USP 31, NF 26 the United States Pharmacopoeial
convention, 12601, Twin brook pathway, Rockvilli, MD 20852.
MPIC 205: PHARMACEUTICAL PRODUCTION MANAGEMENT (Theory)

35 Hrs.

1. Lay out of building, material management, Production planning and control, sales
forecasting.
2. New Product development Market research, Project identification, Management and
Production lunch.
3. ISO 9000 Salient features. Drug regulatory affairs Drugs and Cosmetics Act, Drugs
(Price Control) Order, Essential Commodities Act.
4. Safety and environment management.
5. Human resource management Supervisory skills and communication skills.
6. US-FDA regulatory affairs: US FDA review process for Investigational New Drug
(IND), New Drug (NDA). Hatch Waxman amendment, Abbreviated New Drug
Application (ANDA) for generic market - types of ANDA - Data presentation verification and grant by FDA - Common Technical Documentation (CTD), and review
process. Drug master File (DMF), Type - filing process - benefits. New product
exclusivity patent term restoration - exclusivity and orange book listings federal
register
7. GMP certification as per WHO: need and procedure for certification
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3 rd Edn,
Vergese Publishing House, Mumbai, 1991.
3. Drugs and Cosmetics Act, 1940 and the rules there under, 1945, Government of India.
4. Drugs Price Control Order, 1995, Ministry of Health, Govt. of India.
5. Sharma PP, How to Practice GMP, 1st Edn., New Delhi, 1998.
6. ISO Standards, Bureau of Indian Standard, New Delhi.
7. Pestomji, Text Book of Personal Management
8. Rao V Subba, Text Book on Personal Management, Panther, New Delhi, 1994.

17

MPIP 206: BIOPHARMACEUTICS (Practical)

45 Hrs.

1. Experiments based on Biopharmaceutics theory would be selected for the practical.

MPIP 207: ADVANCED INDUSTRIAL PHARMACY (Practical)

70 Hrs.

1. Experiments would be selected based on Pharmacokinetics, and Advanced Drug Delivery

system, theory courses
THIRD SEMESTER
MPIC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS
(Theory)
35 Hrs.
[Student should be familiar with pharmaceutical/chemical applications and use statistical tools,
by way of calculations, but not expected to derive and find proof.]
1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of
thesis and conventions adopted in writing; citing references; preparation of oral, poster
presentation. Accessing required information in a systematic manner from abstracts,
books journals, conference proceedings, thesis and dissertations, internet, CDROM etc.
Ethics, rights, permissions
2. The Population - The sample; measures describing the center of data distributions;
measurement of spread of data. Introduction to Probability - The Binomial and Normal
distributions - their significance.
3. Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t
tests, F tests, ANOVA [one way], Chi square test.
4. Linear regression and correlation.
5. Control charts Constructing control charts, between batch variation as a measure of
variability, quality control charts in research and development, quality control charts for
proportions.
6. Non parametric methods
7. Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed
rank test; Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for
randomness; Contingency tables.
References:
1. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series.
2. How to write and publish a scientific paper, 4th Ed., Robert A DayCambridge
University presses.
3. Fundamentals of Analytical Chemistry7th Ed., Skoog, West, Holler Saunders
College Publishing.
MPIE 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory) 35 Hrs
1. Pre formulation studies and new formulation development.

18

2. New drug development and approval process: Investigational New Drugs

(IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) ,
ICH requirements for registration of pharmaceuticals.
3. Validation techniques.
4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of
dissolution characteristics, bioavailability enhancers.
5. Pharmaceutical product stability testing- ICH guidelines.
6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer
solution, gel formation, coacervation, phase separation, microencapsulation, mechanical
properties, biomedical uses of polymers.
Books for Reference:
1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20th Ed.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3 rd Ed.,
Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3 rd Ed., Marcel Dekker, Inc., New
York, 1995.
4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1 st (International
Student) Ed., Churchill Livingstone, New York, 1996.
5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery Systems,
7th Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
6. FDA Code of Federal Regulations, Title 21, Part 300 314.
7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.
8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.
MPIE 302(2) PHARMACEUTICAL HEALTH CARE - THEORY

35 Hrs.

1.
2.
3.
4.
5.
6.

Concept and necessity of Pharmaceutical Health care.

A rational approach in paediatrics and geriatric care.
Therapeutic consideration with rational approach during pregnancy and lactation.
Evaluation of Immune system and its fuctions.
Rational use of antimicrobials.
Assessment and clinical significance of malnutrition, enteral and parentral nutrition,
Nutritional consideration in major organ failure.
7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus,
Peptic Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma.
8. Self care: Constipation, Common cold, cough, pain, and sun light protection.
REFERENCES :
19

1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical
Association, Washington.
2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569
3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.
4. Standard Treatment Guidelines
a) by WHO
b) by Government of India
c) by Various state governments
MPIE 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY

35 HRS.

1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision;

classification of errors, estimation of errors, sources of errors, minimization of errors, normal
distribution of errors. Significant figures in analytical chemistry rules and computations.
2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves external
standard methods, internal standard method, standard addition method [applications in HPLC
and GLC with calculations], linear regression of straight line calibration curvesusing the
regression equation[applications and calculations].
3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques
sampling techniquesrandom, stratified, systematic, cluster, for quality control. Sample
preparation reducing particle size, making solutions, separating analyte from interferants
extraction, automated extraction, solid phase extraction, solid phase micro extraction, super
critical fluid extraction and micro wave assisted extraction.
4. Validating the analytical method including bio-analytical method: Need for validation;
historical background; validation of analytical procedures-- methodologyguidelines of
ICH; FDA; USP. Understanding of the following concepts in validationaccuracy,
precision, specificity, limit of detection, limit of quantification, blind analysis of standard
sample, ruggedness testing, robustness testing, equivalency testing. Validating the method as
standard methodcollaborative testtwo sample collaborative testing, control charts.
5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column, Mobile
phase, Special additives. Method Development guiding tools: Separation factor, Selectivity
factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic phase, Aqueous
phase, Additional Variables: pH, Stationary Phase, Temperature. Column Conditions: Flow,
Column dimension, Particle diameter. Derivatisation.
6. System suitability tests as per Pharmacoepoeial specification.
7. Development of stability indicating analytical method
Books for References:
1. HPLC method development, Lunn. G(1996),John wiley & Interscience.
2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family
Welfare.

20

3. British Pharmacopeia (1993) London, Her Majestys Stationery Office.

4. ICH guide lines: validation of analytical procedures, methodology, November 1996.
5. Vogels text book of quantitative inorganic analysis 5th Ed.
6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series,
1993.
7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.
8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college
publishing.
MPIE 302(4): CLINICAL PHARMACOLOGY -THEORY

(35 Hrs)

1. (a) Definition and scope of clinical pharmacology, measurement of drug response

in man.
(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance
data analysis & presentation skills
(c) Pharmaco- epidemiology.
2

(a) Drug Drug interaction, Drug food interaction, and Drug disease
interaction in clinical pharmacology.
(b) Adverse drug reactions and ADR monitoring.

(a) Essential drug list, national drug policy

(b) Orphans drugs
(c ) Therapeutic drug monitoring, Pharmacists intervension in Therapeutic drug
monitoring in special situations such as pediatrics, geriatric and pregnant
cases.

Books for reference:

1. Goodman and Gillmans The Pharmacological Basis of Therapeutic 9 th Ed.
2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.
3. Remingtons Pharmaceutical Sciences 19th Ed.
4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach Vol 1.
and 2
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and
V.Austel
6. Practical approach in toxicity studies by pooley and leslie
7. Screeining methods in Pharmacology by R.A.Tuner
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett
9. Methods of clinical drug trials by Aln Sperit and Smion

21

10. Alternatives to animal experiments: Developing in-vitro methods and changing legislation.
TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22
12. Clinical drug trial and tribulations by Allan E.Cato (1980).
13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.Grehame-Smith
and J.K.Aronson.
14. International aspects of drug evaluation and usage by Jouhar and Grayson.

MPIE 302(5): STRATEGY IN DRUG SYNTHESIS Theory

1. Organic Name Reaction :

35 Hrs.

Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann

rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius
rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement,
Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction,
Reformatsky reaction, Scmidt rearrangement.
2. Introduction: Basic rules in disconnection.
3. Application of Synthon approach to drug synthesis: Case Studies.
a. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine.
b. Adrenergic agents: Stimulants, Epinephrine, Ephedrine.
c. Adrenergic blocking agents: Propranolol, Guanethidine.
d. Psychotropic agents: Chlorpromazine, Chloprothixene.
e. Antidepresants: Imipiramine.
f. CNS Stimulants: Amphetamine.
g. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.
Books for Reference:
1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.
2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.
3. Solomons Organic chemistry 5th Ed.
4. Organic Chemistry, I.L. Finar Vol. I, ELBS.
5. Modern Synthetic reaction, H.O.House.
6. Some Modern Method of Organic Synthesis, W. Carruthers.
7. Designing organic synthesis with work book a programmed introduction to the
synthon approach, Stuart Warren.
MPIE-302(6): PHARMACOBIOTECHNOLOGY (Theory)

35 Hrs.

22

1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process.

Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture,
Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial
growth, Down stream processing, Microbial products, Improvements in microbial strains.
Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid
and Penicillin.
2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic
nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes.
Methods of enzyme production. Profile of some important enzymes: Hyaluronidase,
Penicillinase, Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier
matrices, Materials and Methods of immobilization (Adsorption method, Covalent
bonding, Entrapment, Encapsulation). Advantages and disadvantages of immobilization.
Application of Enzymes and Immobilized enzymes.
3. Plant Tissue Culture Technology: Introduction and scope. Princple underlying plant
culture (totipotency). Nutrient media composition and preparation. Role of plant growth
regulators in Cell culture. Laboratory requirements for plant tissue culture. Aseptic
techniques and Maintenance of Aseptic environment. Basic steps in plant
tissue/cell/organ culture. Selection and preparation of explants. Surface sterilization of
explants.
4. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ
culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell
culture. Applications of plant tissue/cell culture: Micropropagation & Cloning,
Genetically modified plants, Medicinal plant improvement, Production of secondary
metabolites. Survey of phytochemicals produced through plant cell cultures.
5. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and
Methodologies for biotransformation. Cell immobilization, Advantages of cell
immobilization. Illustrations of biotransformations with special reference to steroids.
Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine,
Hydroxylation of beta methyl digitoxin, Arbutin).
6. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and
enzymes involved. Steps in engineering the Genes and the enzymes involved. Cloning
vectors. Introduction of rDNA into a host cell. Screening and selection of recombinants.
Typical examples of Recombinant DNA technology products (human insulin, human
growth hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).
Books for Reference:
1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi.
2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007,
Pharma Book Syndicate, Hyderabad.
3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age
International Publishers, New Delhi.
4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age
International Publishers Ltd., New Delhi.

23

5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004,

NIIR, New Delhi.
6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi.
7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.
MPIT 303: Thesis Phase I
Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to
be completed at the beginning of Third Semester. The candidate has to prepare an Orientation
Report.
FOURTH SEMESTER
MPIT 401: Thesis Phase II
THESIS
III and IV SEMESTERS
Phase-I
In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other
allied organizations to provide orientation & exposure. Simultaneously the student will carry out
a small project leading to a report at the end of that period. The faculty member of the
department and an expert from the respective organization jointly evaluate the report for 10
marks. The students are expected to identify a project towards their thesis and start working on it
and submit Phase I thesis during this stay. The students will come back to the Department to
appear for third semester examination. On completion of third semester examination the students
will return back to the industry/ Hospitals / other allied organizations where he was placed and
would continue the thesis work under the collective guidance of a faculty member and a guide
drawn from the collaborating organization.
Phase-II
The students would continue the thesis work in the fourth semester, in collaborating
organizations, under the supervision of two guides one from the Department and another from
collaborating organization allotted by the Head of the Department of Pharmacy.

24

M.PHARM. PHARMACY PRACTICE

Courses of Study:
First Semester
MPPC 101: Instrumental methods of Analysis - Theory (Common to all Branches)
MPPC 102: Modern Analytical Techniques - Theory (Common to all Branches)
MPPC 103: Pharmacotherapeutics including Pathophysiology I
MPPC 104: Hospital Pharmacy Theory
MPPC 105: Community Pharmacy Theory
MPPP 106: Pharmaceutical Analysis Practical (Common to all Branches)
MPPP 107: Pharmacotherapeutics including Pathophysiology I (Practical)
II Semester
MPPC 201: Biopharmaceutics - Theory (Common with M. Pharm. Industrial Pharmacy and
M.Pharm Pharmacology)
MPPC 202: Clinical Pharmacokinetics - Theory (Common with M. Pharm. Industrial Pharmacy
and M.Pharm Pharmacology)
MPPC 203: Pharmacotherapeutics including Pathophysiology II Theory
MPPC 204: Clinical Pharmacy - Theory
MPPC 205: Pharmacy Practice Theory
MPPP 206: Biopharmaceutics Practical (Common with M. Pharm. Industrial Pharmacy)
MPPP 207: Pharmacy Practice Practical
III - Semester
MPPC 301: Research methodology and Pharmaceutical Statistics Theory (Common to All
Branches)
MPPE 302: Electives:
1. MPPE 302(1) Advances in Industrial Pharmacy Theory
2. MPPE 302(2) Pharmaceutical Healthcare Theory
3. MPPE 302(3) Analytical Method Development Theory
4. MPPE 302(4) Clinical Pharmacology - Theory
5. MPPE 302(5) Strategy In Drug Synthesis
6. MPPE 302(6) Pharmacobiotechnology - Theory
MPPT 303: Thesis Phase I
IV Semester
MPPT 401 Thesis Phase II

25

Scheme of Examinations
M.Pharm.-Pharmacy Practice
Subject
I.Semester
MPPC 101 Instrumental
methods of Analysis
MPPC 102 Modern Analytical
Techniques
MPPC 103
Pharmacotherapeutics
including Pathophysiology I
MPPC 104 Hospital Pharmacy
MPPC 105 Community
Pharmacy
MPPP 106 Pharmaceutical
Analysis (Practical)
MPPP 107
Pharmacotherapeutics
including Pathophysiology I
(Practical)
II-Semester
MPPC 201 Biopharmaceutics
MPPC 202 Clinical
Pharmacokinetics
MPPC 203
Pharmacotherapeutics
including Pathophysiology II
MPPC 204 Clinical Pharmacy
MPPC 205 Pharmacy Practice
MPPP 206 Biopharmaceutics
(Practical)
MPPP 207 Pharmacy Practice
(Practical )
III Semester
MPPC 301 Research
Methodology and
Pharmaceutical Statistics
(Theory)
MPPE 302 Elective
MPPT 303 Thesis Phase I
IV Semester
MPPT 401 Thesis Phase II

Hrs/Week
L
T P

Credits

Evalutation (Marks)
Sessional Univ. Exam Total

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

--

40

60

100

--

--

40

60

100

--

25

75

100

--

25

75

100

--

25

75

100

2
2

1
1

---

3
3

25
25

75
75

100
100

--

--

40

60

100

--

--

40

60

100

--

25

75

100

2
15

--

3
6

25
40

75
60

100
100

13

40

60

100

26

Syllabus
I SEMESTER
MPPC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory)

35 Hrs.

1. UV-Visible Spectrophotometry: Theory Beer and Lamberts Law - Limitations of the

law, Design and working of single beam and double beam spectrophotometers.
Applications of UV absorptions spectrophotometry in qualitative analysis and
quantitative analysis.
2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence.
Chemical structure and fluorescence - factors affecting fluorescence intensity.
Instrumentation and Pharmaceutical applications of fluorimetry.
3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation
Types of interference and elimination of interference - Pharmaceutical applications
4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion
exchange chromatography and super critical fluid chromatography.
5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle,
Instruments and application. Chromatographic attributes: Capacity factor, resolution,
theoretical plates and symmetry factor
6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass
spectrometry
7. Introduction to Radio Immuno Assay
Books for Reference:
1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of
quantitative inorganic analysis, ELBS, London.
2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the
Athlone Press London.
3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry,
Saunders College publishing, New York.
4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college
publishing, New York.
5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
6. V.K. Srivastava and K.K.
S. Chand & Company, New Delhi.

Srivastav,

Introduction

to

Chromatography,

7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice
Hall London.

27

9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric

Identification of organic Compounds, John Wiley & Sons, New York.
10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New
Delhi.
11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.
12. Mofat, A.C (Ed). Clarkes Isolation and Identification of Drugs, The pharmaceutical
press, London.
13. Pharmacopoeia of India, Govt. of India, Ministry of Health.
14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.
15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.
16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea &
Febiger, Philadelphia.
MPPC 102: MODERN ANALYTICAL TECHNIQUES (Theory)

35 Hrs.

1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample

preparation - application of IR spectrophotometry in pharmacy. Introduction to FTIR
2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift,
magnetic equivalence spin-spin decoupling shift reagents, applications of NMR
spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple
organic compound as example)
3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron
bombardment, chemical ionization, field desorption, fast atom bombardment. Different
analysers. Interpretation of mass spectra, determination of molecular weight and
molecular formula and applications of mass spectrometry
4. Theory, instrumentation and applications of Differential Thermal Analysis and
Differential Scanning Calorimetry.
5. A preliminary study of principle, Instrument and applications of 13C NMR
6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins &
antibiotics
Books for reference:
1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the
Athlone Press London.
2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college
publishing, New York.
3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.

28

4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice
Hall London.
6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric
Identification of organic Compounds, John Wiley & Sons, New York.
7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New
Delhi.
8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.
9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.
10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
MPPC 103 PHARMACOTHERAPEUTICS INCLUDING PATHOPHYSIOLOGY 35 Hrs
Theory :
1. Pathophysiology and applied therapeutics of diseases associated with the following
systems/ diseases with special reference to the drugs of choice.
2. Cardiovascular System: Hypertension, Congestive cardiac failure, Ischaemic heart
diseases, Arrhythmias, Hyperlipidemias.
3. Respiratory System: Pulmonary function tests, Asthma, Chronic obstructive airways
disease, Drug induced pulmonary diseases.
4. Renal System: Acute renal failure, Chronic renal failure, Renal dialysis and
transplantation, Drug dosage in renal impairment, Drug induced renal diseases.
5. Haematological diseases: Anaemia, Thrombo-embolic disorders, Drug induced
haematological disorders.
6. Endocrine System: Diabetes, Thyroid diseases, Oral Contraceptives, Hormone
replacement therapy, Osteoporosis.
TEXT BOOKS:
1. Clinical Pharmacy and therapeutics-Roger and Walker, Churchill Livingstone
publication,2nd ed, 1999
2. Pharmacotherapy : A Patho-Physiological approach Joseph T.Dipiro et.al, Appleton
and Lange. 2nd ed, 1988
REFERENCE BOOKS :
1. Pathologic basis of diseases Robins SL.W.B.Saunders Pulication.
2. Pathology and therapeutics for pharmacist : a basis for Clinical Pharmacy Practice, Green
and Harris, Chapman and Hall Publication.
3. Clinical Pharmacy and Therapeutics Eric Herfindal, Willams and Wilkins Publication.

29

4. Applied Therapeutics : The clinical use of drugs, Llyod young and Koda-Kimble MA
{ISBN 0 333 65881 7}
5. Averys drug treatment, 4th Edn, 1997, Aids international Limited.
6. Relevant review articles from recent medical and pharmaceutical literature.
MPPC 104

HOSPITAL PHARMACY

35 Hrs

a) The role of hospital pharmacy department and its relationship to other hospital departments
and staff.
b) Hospital drug policy Drug Committee, formulary and guidelines , other hospital
committees such as infection control committee and research & ethics committee.
c) Hospital Pharmacy management Staff (Professional and non-professional), Materials
(drugs, non-drugs consumables), Financial (drug budget, cost centers, Planning
Infrastructure requirements (building, furniture and fitting, specialized equipments,
maintenance and repairs), Work load statistics, Hospital formulary.
d) Organisation of Hospital Pharmacy Services.
DRUG DISTRIBUTION
Purchasing, warehousing (Storage conditions, expiry date control, recycling of drugs, stock
taking, drug recalls), Drug distribution methods ( ward stock, individual patient dispensing, unit
doses ), specific requirements for inpatients, outpatients, casuality / emergency theatre,
ICU/ICCU, Drugs of dependence.
MANUFACTURING
Sterile and non sterile production, including total parentral nutrition, cytotoxics.
Radio-Pharmaceuticals, IV additive service, Pre-Packing and labeling, Quality control.
RESEARCH
Practice-based research, Research support including clinical trials, Laboratory-based research.
REFERENCES :
1.Hospital Pharmacy-Hassan WE, Lec and Febiger Publication., 1999
2.Text book of Hospital Pharmacy-Allowood MC and Blackwell., 1980, 1st ed
3.Averys Drug Treatment, 4th edition, Adis international limited.
4.Managing Drug Supply-2nd Edition, Management Sciences for Health, Kumarian press, 1997.

MPPC 105 COMMUNITY PHARMACY

35 Hrs

1. COMMUNITY PHARMACY
a) Introduction to the concept of Community Pharmacy its activities and professional
responsibilities.

30

b)
c)
d)
e)
f)
g)
h)

i)
j)

The role of the community pharmacy and its relationship to other health care providers.
Prescribed medication order-Interpretation and legal requirements.
Patient counselling in Community Pharmacy.
Over the counter (OTC) sales.
Health education and Community Pharmacy, Family Planning, First Aid, Immunization
programme, prevention,smoking cessation, screening programs.
Services to Nursing homes / Clinics.
Community Pharmacy Management, Financial, Material and staff management,
Infrastructure requirements, Drug information resources, Computers in Community
Pharmacy.
Code of ethics for Community Pharmacists.
Polypharmacy and its implications.

2. COMMUNICATION SKILLS
Principle and elements of communication skills, non-verbal communication in pharmacy,
barriers in communication, listening skills, questioning skills, explaining skills and ethics in
communication.
3. RESPONDING SYMPTOMS
Symptoms and causes of the following disorders.
Respiratory tract disorders, Gastro intestinal symptoms, Skin disorders, Headache, Eye
disorders.
4. Administration and mode of use of various drug delivery systems.
REFERENCES :
1.Hospital Pharmacy-Hassan WE, Lec and Febiger Publication. 1999, 4th Ed.
2.Text book of Hospital Pharmacy-Allowood MC and Blackwell. 1988, 1st Ed
3.Averys Drug Treatment, 4th edition, Adis international limited.
4.Managing Drug Supply-2nd Edition, Management Sciences for Health, Kumarian press, 1997.
MPPP 106 PHARMACEUTICAL ANALYSIS PRACTICAL
45Hrs
1. Experiments based on theory subjects Instrumental methods of analysis and Modern
Analytical techniques
2. Experiments would be selected illustrating the principles involved in estimation of raw
materials and finished products representing major categories of drug formulations from
pharmacopoeias.

MPPC 107 PHARMACOTHERAPEUTICS INCLUDING PATHOPHYSIOLOGY I

PRACTICAL
70 Hrs.

31

The students are required to be posted in various clinical wards for their exposure with
therapeutic management and other clinical aspects. They are expected to have experience and do
a tutorial as well as case presentation in the following clinical conditions.
1. Cardiology
a) Arrhythmias
b) Ischaemic heart diseases,
c) Congestive heart failure,
d) Myocardial infarction
e) Hypertension
f) Thrombo-embolic diseases,
g) Endocarditis
2. Gastroenterology
a) Diarrhoea, Contipation,
b) Acid peptic disease,
c) Hepatic diseases-Hepatitis, Cirrhosis & Drug induced hepatic disorders
d) Oseophageal reflux
e) Helicobactor pylori induced gastric disorders.
3. Rheumatology
a) Rheumatoid arthritis
b) Gout
c) Degenerative joint disease Temporal arthritis, Polymyalgia rheumatica etc.,
d) Systemic lupus erythematosus (SLE)
4. Respiratory Medicine
a) Asthma
b) Congestive obstructive airways disease (COAD),
c) Acute respiratory failure,
d) Respiratory tract infections,
e) Interstitial Lung disease,
f) Respiratory aids
5. Surgery
a) Prophylactic Antibiotics,
b) Anticoagulants Heparin, Warfarin,
c) Thrombolytics
d) Adjunctive therapy
e) Pre-operative medications
f) Analgesia
6. Geriatric Medicine
a) Postural hypotension
b) Dementia and Delirium
c) Compliance assessment
7. Paediatrics
a) Acute otitis media,
b) Tonsillitis
c) Paediatric asthma
d) Paediatric gastreoenteritis
e) Colic

32

f) Immunisation
g) Attention deficit disorder
h) Febrile neutropenia
8. Oncology
a) Breast Cancer
b) Lung cancer small cell, Non-small cell.
c) Gastric cancer,
d) Colon cancer,
e) Genitourinary tract cancer Bladder, Prostate, Testicular
f) Skin cancer
g) Radiation therapy
h) Adjunctive therapy Anti-emetics, Mouth care , Nutrition, Extravasations, Pain control
and Blood products
i) Colony stimulating factors
j) Infections disease in immuno compromised patients
k) Hypercalcemia
l) Cerebral edema
m) Maligant effusions.
9. Renal
a) Acute renal failure
b) Chronic renal failure
c) Drug induced renal diseases.
10. Haematology
a) Leukaemias,
b) Lymphomas Hodgkins, Non-Hodgkins
c) Multiple myeloma
d) Anaemia
e) Bleeding disorders.
11. Infections Disease
a) Respiratory tract infections
b) Tuberculosis
c) Urinary tract infections
d) Joint and bone infections
e) Skin and soft tissue infections
12. Critical Care
a) Haemodynamic monitoring
b) Parenteral and enteral nutrition,
c) Pharmacotherapy of ventilated patients
d) Shock Septic, Cardiogenic
13. Endocrinology
a) Diabetes
b) Osteoporosis
c) Thyroid disorders
d) Syndrome of inappropriate anti diuretic hormone secretion
e) Adrenal disorders
14. Dermatology

33

b) Psoriasis
c) Dermatitis
d) Drug induced skin disorders
15. Convulsive disorder
a) Parkinsons disease,
b) Neuro degenerative disorders
c) Stroke
d) TIAs
16. Psychiatry
a) Uni-polar and bipolar disorders
b) Anxiety
c) Psychosis
d) Alcohol abuse
e) Drug abuse
17. Opthalmology
a) Occular infections
b) Conjunctivitis
c) Glaucoma
d) Post-operative management
Books for References
1. Clinical Pharmacy and Therapeutics Roger and Walker, Churchill Livigstone, 5th Ed.
2. Pharmacotherapy: A pathophysiologic approach- Joseph, T. Dipiro et al. Appleton &
Lange, 8th Ed.
3. Pathologic basis for disease Robins S.L. 8 th Ed.
4. Pathology and Therapeutics for pharmacists: A basis for clinical pharmacy practice, 3rd Ed.
5. Clinical pharmacy and therapeutics, Eric T. Herfindal 5th Ed.
6. Applied therapeutics: The clinical use of drugs, Lloyd Young and Koda- Kimble MA.
7. Averis drug treatment, 4th Ed., Adis International Ltd.
8. Relevent review articles from recent medical and pharmaceutical literature.
Second Semester
MPPC 201: BIOPHARMACEUTICS (Theory)

35 Hrs.

1. Drug absorption and disposition: Mechanism of drug transport, factors affecting

absorption, distribution, bio- transformation and elimination.
2. First order process, rate constants, half-life; Zero order process
3. Open one compartment model: Description, volume of distribution, drug concentration in
plasma, kinetics of I.V. administration, short term constant rate I .V. infusion, absorption
rate and drug effects , continuous constant rate infusion, repetitive dosing- average
concentration of drug at steady state , loading dose , dosing interval.
4. Open two-compartment model; Kinetics of absorption, distribution and elimination.
Multiple dose administration. Limitation of multi- compartmental analysis.

34

5. Non-compartmental model; Area under first moment curve (AUMC), Apparent volume
of distribution, mean residence time (MRT), Drug absorption predicting steady state
concentration.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger,
Philadelphia, 1991.
3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker,
Inc., New York, 1987.
4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics A Treatise, 2nd
Edn., Vallabh Prakashan, New Delhi, 1998.
5. Swarbrick J, Current Concept in Phramaceutical Science: Bio Pharmaceutics, Lea &
Febiger, Philadelphia, 1970.
MPPC 202: CLINICAL PHARMACOKINETICS (Theory)

35 Hrs.

1. Clearance concepts- organ clearance, total clearance, renal clearance and excretion.
2. Hepatic clearance and elimination, other non renal clearance. Extraction ratio
3. Bio-availability and bio equivalency testing; Estimation methods, dissolution testing, in
vitro & in vivo correlation study , bio equivalency testing of dosage forms.
4. Pharmacokinetic variability; Body weight & size, obesity, age. Drug metabolism, Plasma
protein binding and renal excretion in newborn & children. Sex, pregnancy and genetic
factors. Poly morphic acetylation and oxidation.
5. Pharmcokinetic variability: Drug interactions
6. Effect of disease states on drug disposition, therapeutic drug monitoring and dosage
prediction of digoxin, gentamycin and anticonvulsants. Hypothesis of individualisation &
optimisation of drug therapy.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger,
Philadelphia, 1991.
3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker,
Inc., New York, 1987.
4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics, 2nd Edn., Vallabh
Prakashan, New Delhi, 1998.
5. Wagner J G, Bio- Pharmaceutics and relevant Pharmacokinetics, Drug Intelligence
Publications, Washington DC, 1971.
35

6. Rowland M and Tozer TN, Clinical Pharmacokinetics concepts and applications, 3 rd

Edn., Lea & Febiger, Philadelphia, 1995.
7. Shargel L and Yu AB, Applied Bio-Pharmaceutics and Pharmacokinetics, Appleton &
Lange, Norwalk, CT, 1993.

MPPC 203

PHARMACOTHERAPEUTICS INCLUDING PATHOPHYSIOLOGY II

35 Hrs.

Pathophysiology and applied therapeutics of diseases associated with following system/diseases

with special reference to the drugs of choice.
Nervous System : Epilepsy, Parkinsons disease, stroke and transient ischemic attacks, headache.
Psychiatric disorders: Schizophrenia, Depression, Anxiety disorders, Sleep disorders.
Gastro intestinal System: Ulcer diseases, inflammatory bowel diseases, Hepatitis, Jaundice, Drug
dosing in liver dysfunction, Diarrhoea and Constipation.
Rheumatic diseases: Rheumatoid arthritis, Osteoarthritis, Gout, Juvenile rheumatoid arthritis.
Infectious Diseases-Meningitis, Respiratory tract infections, Gastroenteritis, Pneumonia,
Bacterial endocarditis, Septicaemia, Otitis media, Urinary tract infections, Tuberculosis,
Leprosy, Protozoal infections and Helminthiasis, HIV and Opportunistic infections, Fungal
infections.
Skin and sexually transmitted disease-Psoriasis, Acne, Eczema and Scabies, Syphillis and
Gonorrhoea.
Oncology-General principles of cancer,chemotherapy, commonly used cytotoxic drugs and their
indications.
Ophthalmology: Glaucoma, Eye infections.
Pain management: Pain pathways, Analgesics and NSAIDs, opiates, Local anaesthetics,
neuralgia including post herpetic, trigeminal and glosso-pharyngeal neuralgias.
TEXTBOOKS
1. Clinical Pharmacy and therapeutics-Roger and Walker, Churchill Livingstone
publication.2nd ed, 1999
2. Pharmacotherapy. A Patho-physiological approach-Joseph T.Dipiro et.al. Appleton and
Lange. 2nd, 1997
REFERENCE BOOKS:
1. Pathologic basis of diseases-Robins SL. W.B. Saunders Publication.
2. Pathology and therapeutics for pharmacist; a basis for Clinical Pharmacy Practice Green
and Harris, Chapman and Hall publication.
3. Clinical Pharmacy and Therapeutics Eric Herfindal, Williams and Wilkins Publication. 4 th
ed., 1988

36

4. Applied Therapeutics: The clinical use of drugs, Lyod Young and Koda-Kimble
MA{ISBN-0-68881-7}
5. Averys drug treatment, 4th edn.1997,Aids international Limited.
6. Relevent review articles from recent medical and pharmaceutical literature.

MPPC 204

CLINICAL PHARMACY 35 Hrs.

Introduction to Clinical Pharmacy (Definition, Development and Scope)

Clinical laboratory tests used in the evaluation of disease states and interpretation of test results
Haematological tests, Liver function tests, Renal function tests, ests associated with cardiac
disorders, Fluid and electrolyte balance, common tests in Urine, Sputum, Faeces and CSF.
Sensitivity screening for common pathogenic microorganisms, its significance, resistance in
disease states and selection of appropriate anti-microbial regimens.
PATIENT DATA ANALYSIS :
The patients case history. its structure and use in evaluation of drug therapy. Patient medication
history review, Presentation of cases, teaching skills. Understanding common medical
abbreviations and terminology used in Clinical Practices.
DRUG & POISONS INFORMATION :
Introduction to information resource available,Design of literature searchers. Preparation of
written and verbal reports. Development of a drug and poison information database.
DRUG THERAPY MONITORING :
Medication chart review, clinical review, TDM, Pharmacist interventions, Ward round
participation, Adverse drug reaction management, Medication history and patient counselling.
Drug utilization evaluation (DUE) and review (DUR), Quality Assurance of Clinical Pharmacy
services.
EDUCATION AND TRAINING :
Training of technical staff, Training and continuing education for pharmacists, pharmacy
students, Medical staff and students, Nursing staff and students. Formal and informal meetings
and lectures, Drug and therapeutics newsletter.
CLINICAL TRIALS :
Various phases of clinical trails, design and execution of trails in different clinical settings.
REFERENCES :
1. Basic skills in interpreting laboratory data-Scott LT, American-society of health system
pharmacists Inc.
2. Practice, Standards and definitions-The Society of hospital Pharmacist of Australia.
ClinicalPpharmacokinetics-Rowland Tozer, Williams and Wilkins publication.
3. Biopharmaceutics and Applied Pharmacokinetics-Leon Shargel, prentice Hall publication.
4. Elevent review articles from recent medical and pharmaceutical journals.

37

1.
2.
3.
4.
5.
6.

MPPC 205
PHARMACY PRACTICE
Rational use of drugs
Essential drugs concept Pharmaceutical policy
Pharmacoeconomics
Therapeutics in practice decision making in drug therapy
Pharmacoepidemiology
Public health policy and Health care system.

35 Hrs.

REFERENCES :
1. Role of Pharmacist in the Health care system, WHO / PHARM / 94. 569
2. Remintons sciences and practice of Pharmacy; 20 th edition Lippin cott Williams and
Welkens.
3. Medicare scenario in India : Perception and perspectives Delhi society for promotion of
rational use of drugs.
MPPP 206

BIOPHARMACEUTICS - PRACTICAL

45 Hrs.

1. Experiments based on Biopharmaceutics theory would be selected for the practical.

MPPP 207:

PHARMACY PRACTICE - PRACTICAL

70 Hrs.

i) Patient medication history, interview, answering drug information questions, patient

medication counselling, participation in ward rounds. Case studies related to laboratory
investigations covering the topics dealt in theory classes.
ii) The students are required to be posted in various clinical wards for their exposure with
therapeutic management and other clinical aspects. There will be tutorial and case presentation in
various clinical conditions.
THIRD SEMESTER
MPPC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS
(Theory)
35 Hrs.
[Student should be familiar with pharmaceutical/chemical applications and use statistical tools,
by way of calculations, but not expected to derive and find proof.]
1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of thesis
and conventions adopted in writing; citing references; preparation of oral, poster
presentation. Accessing required information in a systematic manner from abstracts, books

38

2.

3.
4.
5.

6.
7.

journals, conference proceedings, thesis and dissertations, internet, CDROM etc. Ethics,
rights, permissions
The Population - The sample; measures describing the center of data distributions;
measurement of spread of data. Introduction to Probability - The Binomial and Normal
distributions - their significance.
Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t
tests, F tests, ANOVA [one way], Chi square test.
Linear regression and correlation.
Control charts Constructing control charts, between batch variation as a measure of
variability, quality control charts in research and development, quality control charts for
proportions.
Non parametric methods
Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed rank
test; Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for
randomness; Contingency tables.

References:
1. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series.
2. How to write and publish a scientific paper, 4 th Ed., Robert A DayCambridge University
presses.
3. Fundamentals of Analytical Chemistry7th Ed., Skoog, West, Holler Saunders College
Publishing.
MPPE 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory) 35 Hrs
1. Pre formulation studies and new formulation development.
2. New drug development and approval process: Investigational New Drugs
(IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) ,
ICH requirements for registration of pharmaceuticals.
3. Validation techniques.
4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of dissolution
characteristics, bioavailability enhancers.
5. Pharmaceutical product stability testing- ICH guidelines.
6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer solution,
gel formation, coacervation, phase separation, microencapsulation, mechanical properties,
biomedical uses of polymers.
Books for Reference:
1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20th Ed.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3 rd Ed.,
Vergese Publishing House, Mumbai, 1991.

39

3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3 rd Ed., Marcel Dekker, Inc., New
York, 1995.
4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1 st (International
Student) Ed., Churchill Livingstone, New York, 1996.
5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery Systems,
7th Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
6. FDA Code of Federal Regulations, Title 21, Part 300 314.
7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.
8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.
MPPE 302(2) PHARMACEUTICAL HEALTH CARE - THEORY

35 Hrs.

1.
2.
3.
4.
5.
6.

Concept and necessity of Pharmaceutical Health care.

A rational approach in paediatrics and geriatric care.
Therapeutic consideration with rational approach during pregnancy and lactation.
Evaluation of Immune system and its fuctions.
Rational use of antimicrobials.
Assessment and clinical significance of malnutrition, enteral and parentral nutrition,
Nutritional consideration in major organ failure.
7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus,
Peptic Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma.
8. Self care: Constipation, Common cold, cough, pain, and sun light protection.
REFERENCES :
1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical
Association, Washington.
2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569
3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.
4. Standard Treatment Guidelines
d) by WHO
e) by Government of India
f) by Various state governments

MPPE 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY

35 HRS.

1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision;

classification of errors, estimation of errors, sources of errors, minimization of errors, normal
distribution of errors. Significant figures in analytical chemistry rules and computations.
2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves external
standard methods, internal standard method, standard addition method [applications in HPLC
40

and GLC with calculations], linear regression of straight line calibration curvesusing the
regression equation[applications and calculations].
3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques
sampling techniquesrandom, stratified, systematic, cluster, for quality control. Sample
preparation reducing particle size, making solutions, separating analyte from interferants
extraction, automated extraction, solid phase extraction, solid phase micro extraction, super
critical fluid extraction and micro wave assisted extraction.
4. Validating the analytical method including bio-analytical method: Need for validation;
historical background; validation of analytical procedures-- methodologyguidelines of
ICH; FDA; USP. Understanding of the following concepts in validationaccuracy,
precision, specificity, limit of detection, limit of quantification, blind analysis of standard
sample, ruggedness testing, robustness testing, equivalency testing. Validating the method as
standard methodcollaborative testtwo sample collaborative testing, control charts.
5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column, Mobile
phase, Special additives. Method Development guiding tools: Separation factor, Selectivity
factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic phase, Aqueous
phase, Additional Variables: pH, Stationary Phase, Temperature. Column Conditions: Flow,
Column dimension, Particle diameter. Derivatisation.
6. System suitability tests as per Pharmacoepoeial specification.
7. Development of stability indicating analytical method
Books for References:
1. HPLC method development, Lunn. G(1996),John wiley & Interscience.
2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family
Welfare.
3. British Pharmacopeia (1993) London, Her Majestys Stationery Office.
4. ICH guide lines: validation of analytical procedures, methodology, November 1996.
5. Vogels text book of quantitative inorganic analysis 5th Ed.
6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series,
1993.
7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.
8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college
publishing.
MPPE 302(4): CLINICAL PHARMACOLOGY -THEORY

(35 Hrs)

1. (a) Definition and scope of clinical pharmacology, measurement of drug response

in man.
(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance
data analysis & presentation skills

41

(c) Pharmaco- epidemiology.

2

(a) Drug Drug interaction, Drug food interaction, and Drug disease
interaction in clinical pharmacology.
(b) Adverse drug reactions and ADR monitoring.

(a) Essential drug list, national drug policy

(b) Orphans drugs
(c ) Therapeutic drug monitoring, Pharmacists intervension in Therapeutic drug
monitoring in special situations such as pediatrics, geriatric and pregnant
cases.

Books for reference:

1. Goodman and Gillmans The Pharmacological Basis of Therapeutic 9 th Ed.
2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.
3. Remingtons Pharmaceutical Sciences 19th Ed.
4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach
Vol 1. and 2
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and
V.Austel
6. Practical approach in toxicity studies by pooley and leslie
7. Screeining methods in Pharmacology by R.A.Tuner
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett
9. Methods of clinical drug trials by Aln Sperit and Smion
10. Alternatives to animal experiments: Developing in-vitro methods and changing
legislation. TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22
12. Clinical drug trial and tribulations by Allan E.Cato (1980).
13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.GrehameSmith and J.K.Aronson.
14. International aspects of drug evaluation and usage by Jouhar and Grayson.
MPPE 302(5): STRATEGY IN DRUG SYNTHESIS Theory
1. Organic Name Reaction :

35 Hrs.

Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann

rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius
rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement,
Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction,
Reformatsky reaction, Scmidt rearrangement.
2. Introduction: Basic rules in disconnection.

42

3.
a.
b.
c.
d.
e.
f.
g.

Application of Synthon approach to drug synthesis: Case Studies.

Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine.
Adrenergic agents: Stimulants, Epinephrine, Ephedrine.
Adrenergic blocking agents: Propranolol, Guanethidine.
Psychotropic agents: Chlorpromazine, Chloprothixene.
Antidepresants: Imipiramine.
CNS Stimulants: Amphetamine.
Narcotic analgesics: Meperidine, Methadone, Propoxyphene.

Books for Reference:

1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.
2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.
3. Solomons Organic chemistry 5th Ed.
4. Organic Chemistry, I.L. Finar Vol. I, ELBS.
5. Modern Synthetic reaction, H.O.House.
6. Some Modern Method of Organic Synthesis, W. Carruthers.
7. Designing organic synthesis with work book a programmed introduction to the synthon
approach, Stuart Warren.
MPPE-302(6): PHARMACOBIOTECHNOLOGY (Theory)

35 Hrs.

1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process.

Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture,
Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial
growth, Down stream processing, Microbial products, Improvements in microbial strains.
Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid and
Penicillin.
2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic
nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes. Methods
of enzyme production. Profile of some important enzymes: Hyaluronidase, Penicillinase,
Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier matrices, Materials and
Methods of immobilization (Adsorption method, Covalent bonding, Entrapment,
Encapsulation). Advantages and disadvantages of immobilization. Application of Enzymes
and Immobilized enzymes.
3. Plant Tissue Culture Technology: Introduction and scope. Princple underlying plant culture
(totipotency). Nutrient media composition and preparation. Role of plant growth regulators in
Cell culture. Laboratory requirements for plant tissue culture. Aseptic techniques and
Maintenance of Aseptic environment. Basic steps in plant tissue/cell/organ culture. Selection
and preparation of explants. Surface sterilization of explants.

43

4. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ
culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell culture.
Applications of plant tissue/cell culture: Micropropagation & Cloning, Genetically modified
plants, Medicinal plant improvement, Production of secondary metabolites. Survey of
phytochemicals produced through plant cell cultures.
5. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and
Methodologies for biotransformation. Cell immobilization, Advantages of cell
immobilization. Illustrations of biotransformations with special reference to steroids.
Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine,
Hydroxylation of beta methyl digitoxin, Arbutin).
6. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and enzymes
involved. Steps in engineering the Genes and the enzymes involved. Cloning vectors.
Introduction of rDNA into a host cell. Screening and selection of recombinants. Typical
examples of Recombinant DNA technology products (human insulin, human growth
hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).
Books for Reference:
1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi.
2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007,
Pharma Book Syndicate, Hyderabad.
3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age
International Publishers, New Delhi.
4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age
International Publishers Ltd., New Delhi.
5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004,
NIIR, New Delhi.
6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi.
7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.
MPPT 303: Thesis Phase I
Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to
be completed at the beginning of Third Semester. The candidate has to prepare an Orientation
Report.
FOURTH SEMESTER
MPPT 401: Thesis Phase II
THESIS
III and IV SEMESTERS
Phase-I
In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other
allied organizations to provide orientation & exposure. Simultaneously the student will carry out
44

a small project leading to a report at the end of that period. The faculty member of the
department and an expert from the respective organization jointly evaluate the report for 10
marks. The students are expected to identify a project towards their thesis and start working on it
and submit Phase I thesis during this stay. The students will come back to the Department to
appear for third semester examination. On completion of third semester examination the students
will return back to the industry/ Hospitals / other allied organizations where he was placed and
would continue the thesis work under the collective guidance of a faculty member and a guide
drawn from the collaborating organization.
Phase-II
The students would continue the thesis work in the fourth semester, in collaborating
organizations, under the supervision of two guides one from the Department and another from
collaborating organization allotted by the Head of the Department of Pharmacy.

45

M.Pharm (Quality Assurance)

Subjects:
First Semester
MPQC 101 Instrumental methods of Analysis - Theory (Common to all Branches)
MPQC 102 Modern Analytical Techniques - Theory (Common to all Branches)
MPQC 103 Dosage form Design Theory (Common with M.Pharm Industrial Pharmacy)
MPQC 104 Modern Pharmaceutics-Theory (Common with M.Pharm Industrial Pharmacy)
MPQC 105 Quality Assurance Management Theory (Common with M.Pharm Industrial
Pharmacy)
MPQP 106 Pharmaceutical Analysis Practical (Common to all Branches)
MPQP 107 Industrial Pharmacy- Practical (Common with M.Pharm Industrial Pharmacy)
Second Semester
MPQC 201. Advanced Pharmaceutical Analysis - Theory
MPQC 202. Quality Assurance of Herbal Drugs Theory (Common with M.Pharm Industrial
Pharmacognosy)
MPQC 203. Pharmaceutical Regulatory affairs
MPQC 204 Quality Assurance Practice Theory
MPQC 205 Biological and Biochemical Analysis Theory (Common with M.Pharm
Pharmacology)
MPQP 206 Advanced Pharmaceutical Analysis Practical
MPQP 207. Quality control and Quality Assurance Practical
Third Semester
MPQC 301 Research methodology and Pharmaceutical statistics - Theory
MPQE 302 Elective
1. MPQE 302(1) Advances in Industrial Pharmacy Theory
2. MPQE 302(2) Pharmaceutical Healthcare theory
3. MPQE 302(3) Analytical method development Theory
4. MPQE 302(4) Clinical Pharmacology Theory
5. MPQE 302(5) Strategy In Drug Synthesis - Theory
6. MPQE 302(6) Pharmacobiotechnology - Theory
MPQT 303 Thesis Phase I
Fourth Semester
MPQT 401 Thesis Phase II

46

Scheme of Examinations
M.Pharm.- Quality Assurance
Subject

I.Semester
MPQC 101: Instrumental methods
of Analysis - Theory
MPQC 102: Modern Analytical
Techniques Theory
MPQC 103: Dosage form Design
Theory
MPQC 104: Modern
Pharmaceutics - Theory
MPQC 105: Quality Assurance
Management Theory
MPQP 106: Pharmaceutical
Analysis Practical
MPQP 107: Industrial Pharmacy
(Practical)
II-Semester
MPQC 201: Advanced
Pharmaceutical Analysis Theory
MPQC 202: Quality Assurance of
herbal drugs Theory
MPQC 203: Pharmaceutical
Regulatory affairs Theory
MPQC 204: Biological and
Biochemical Analysis Theory
MPQC 205: Quality Assurance
Practice Theory
MPQP 206: Advanced
Pharmaceutical Analysis
Practical
MPQP 207: Quality Control and
Quality Assurance Practical
III Semester
MPQC 301: Research
methodology and Pharmaceutical
statistics
MPQC 302: Elective
MPQT 303: Thesis Phase I
IV Semester
MPQT 401 Thesis Phase II

Hrs/Week
L
T P

Credits

Evalutation (Marks)
Sessional Univ. Total
exam

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

--

40

60

100

--

--

40

60

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

--

40

60

100

--

--

40

60

100

--

25

75

100

2
15

--

3
6

25
40

75
60

100
100

13

40

60

100

47

Syllabus
FIRST SEMESTER
MPQC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory) 35 Hrs.
1. UV-Visible Spectrophotometry: Theory Beer and Lamberts Law - Limitations of the
law, Design and working of single beam and double beam spectrophotometers.
Applications of UV absorptions spectrophotometry in qualitative analysis and quantitative
analysis.
2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence. Chemical
structure and fluorescence - factors affecting fluorescence intensity. Instrumentation and
Pharmaceutical applications of fluorimetry.
3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation
Types of interference and elimination of interference - Pharmaceutical applications
4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion
exchange chromatography and super critical fluid chromatography.
5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle,
Instruments and application. Chromatographic attributes: Capacity factor, resolution,
theoretical plates and symmetry factor
6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass
spectrometry
7. Introduction to Radio Immuno Assay
Books for Reference:
1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of
quantitative inorganic analysis, ELBS, London.
2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the
Athlone Press London.
3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry,
Saunders College publishing, New York.
4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college
publishing, New York.
5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
6. V.K. Srivastava and K.K.
S. Chand & Company, New Delhi.

Srivastav,

Introduction

to

Chromatography,

7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

48

8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice

Hall London.
9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric
Identification of organic Compounds, John Wiley & Sons, New York.
10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New
Delhi.
11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.
12. Mofat, A.C (Ed). Clarkes Isolation and Identification of Drugs, The pharmaceutical
press, London.
13. Pharmacopoeia of India, Govt. of India, Ministry of Health.
14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.
15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.
16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea &
Febiger, Philadelphia.
MPQC 102: MODERN ANALYTICAL TECHNIQUES (Theory)

35 Hrs.

1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample

preparation - application of IR spectrophotometry in pharmacy. Introduction to FTIR
2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift,
magnetic equivalence spin-spin decoupling shift reagents, applications of NMR
spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple
organic compound as example)
3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron
bombardment, chemical ionization, field desorption, fast atom bombardment. Different
analysers. Interpretation of mass spectra, determination of molecular weight and
molecular formula and applications of mass spectrometry
4. Theory, instrumentation and applications of Differential Thermal Analysis and
Differential Scanning Calorimetry.
5. A preliminary study of principle, Instrument and applications of 13C NMR
6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins &
antibiotics
Books for reference:
1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the
Athlone Press London.
2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college
publishing, New York.

49

3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.
5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice
Hall London.
6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric
Identification of organic Compounds, John Wiley & Sons, New York.
7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New
Delhi.
8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.
9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.
10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
MPQC 103: DOSAGE FORM DESIGN (Theory)

35 Hrs.

1. Manufacturing and Quality control of solid dosage forms: Tablets and Capsules.
2. Manufacturing and Quality control of liquid dosage forms: orals and topicals.
3. a) Parenterals formulation development and evaluation
b) Aerosol Formulation Development and its Quality Control
4. Radio pharmaceuticals: Background information, dosage formulation, diagnostic and
therapeutic uses, production, quality assurance, storage and safety hazards.
5. Selection and evaluation of packaging materials, containers and closures, special
problems of container product interactions. Pharmacopoeial specifications, tests and
standards for packaging materials.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3 rd Edn,
Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Marcel Dekker, Inc., New
York, 1995
4. Lachman L, et al, Pharmaceutical Dosage Forms: Parenteral Medications, 2nd Edn., Vol I
& II, Marcel Dekker, New York, 1992.
5. Lachman L, et al, Pharmaceutical Dosage Forms: Tablets, 2 nd Edn., Vol I, II & III,
Marcel Dekker, New York, 1992.
6. Turco S and King R E, Sterile Dosage Forms, 3 rd Edn., Lea & Febiger, Philadelphia,
1987.
7. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Edn., Churchill Livingstone, New York, 1996.
MPQC 104: MODERN PHARMACEUTICS (Theory)
35 Hrs.

50

1. Stability testing of Pharmaceutical products: Physico-chemical factors affecting stability

of drugs, methods to find out degradation pathways, determination of shelf life by
accelerated stability testing.
2. Incompatibilities encountered in multi-component drug formulations, rationale for drug
combinations case studies.
3. Enzyme Technology-Production, Isolation and purification of Enzymes, applications in
pharmacy and Immobilised Enzymes and its future applications.
4. Sterile dosage forms: biologicals
5. Products of Biotechnology. Principles of Genetic Engineering.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3 rd Edn,
Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Mercel Dekker, Inc., New
York, 1995
4. Turco S and King R E, Sterile Dosage Forms, 3 rd Edn., Lea & Febiger, Philadelphia,
1987.
5. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Edn., Churchill Livingstone, New York, 1996.
6. Wiseman A, Principles of Bio-Technology, 2 nd Edn., Surrey Univ. Press, New York,
1988.
7. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery
Systems, 7th Edn., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
8. Wiseman A, Handbook of Enzyme Biotechnology, 2 nd Edn., Ellis Horwood Ltd., New
York, 1985.
MPQC 105: QUALITY ASSURANCE MANAGEMENT (Theory)

35 Hrs.

1. The origin and concept of GMP Schedule M of Drugs and cosmetics Act, WHO
specifications and US FDA guidelines. The study shall include special emphasis on
premises, personnel, sanitation, equipment, manufacturing operation and documentation.
GMP certification.
2. Regulatory affairs D&C act, DPCO
3. Ware housing Design, Construction, maintenance and sanitation for materials and
products good warehousing practices.
4. Finished product release, Quality review, Quality audits Batch release Distribution
and Distribution records Handling of returned goods. Recovered materials and
reprocessing.
5. Complaints and recalls, evaluation of complaints and recall procedures.

51

6. Documentation relating to product development, standard operating procedures, standard

test processes, cleaning methods, Quality control documents, batch release document,
distribution records, complaints and recalls records, retention of records.
7. Intellectual property rights and Patent Laws
Books for reference:
1.
2.
3.
4.
5.
6.

Theory and Practice of Industrial Pharmacy by Liberman and Lachman.

Remingtons Pharmaceutical Sciences.
GMP by Sidney H, Willing.
Quality Assurance Guide, Organization of Pharmaceutical Production of India.
Drugs and Cosmetics Act 1940 and Rules 1945
S.H. Willig., M.M.T. Tuckerman, W.S. Hitchings IV, Good Manufacturing Practices for
Pharmaceuticals, Marcel Dekker Inc, New York.
7. P.P. Sharma, How to Practice GMPs, Vandhana Publication, Agra.
8. Ira R. Berry and R.A Nash (eds), Pharmaceutical Process Validation, marcel Dekker Inc.,
New York.
MPQP 106: PHARMACEUTLICAL ANALYSIS (Practical) 45 Hrs.
1. Experiments based on theory subjects Instrumental methods of analysis and Modern
Analytical techniques
2. Experiments would be selected illustrating the principles involved in estimation of raw
materials and finished products representing major categories of drug formulations from
pharmacopoeias.
MPQP 107: INDUSTRIAL PHARMACY (Practical)

70 Hrs.

1. Experiments based on Dosage Form Design and Modern Pharmaceutics theory papers
would be selected for the practical.

Second Semester
MPQC 201. Advanced Pharmaceutical Analysis Theory

35 Hrs.

1. Hyphenated techniques: LC-MS: theory ionization techniques (Electrospray, APCI and

APPI). Various modes of recording. Applications in drug development and research. LCMS/MS: basic principle and applications. GC-MS; interfaces, instrument outline, techniques
and applications
2. Capillary electrophoresis: Theory instrumentation. Techniques: capillary zone
electrophoresis, capillary gel electrophoresis, capillary isotachophoresis, and capillary
isoelectric focusing. Applications. Capillary electrochomatography
3. Chiral HPLC Analysis: Background, Principle of chiral recognition, Direct HPLC analysis,
Indirect HPLC analysis, Chiral Stationary phases (CSP): Pirkle CSPs, Polysaccharide CSPs,
Cavity CSPs, Protein CSPs. Application in drug development and research.
4. Near Infra red spectrophotometry: Theory, instrumentation and applications. Introduction to
Process Analytical Technology (PAT). Particle size measurement by light obscuration

52

5. Analytical methods based on Functional group analysis: Amino Group: Analytical methods
based on addition reaction, electrophilic & nucleophilic aromatic substitution, acyl transfer
and complex formation. Hydoxyl group: Analytical methods based on acyl transfer and
electrophilic aromatic substitution. Carbonyl group: Analytical methods based on acyl
transfer and nucleophilic aliphatic substitution. Carbonyl group: Analytical methods based on
addition to carbon oxygen double bond
Books:
1. Pharmaceutical Analysis Modern methods Part B., Ed. James W.Munson, Marcel Dekkar
Inc, New York. (Chapter 4 of Indian Reprint 2001).
2. Handbook of Instrumental Techniques for Analytical Chemistry, Frank Settle, Prentice Hall
PTR ,Pearson Education (Singapore) Pte.Ltd.(First Indian reprint 2004).
3. Principles of Instrumental Methods of Analysis, 5th edition Skoog, Holler and Nieman,
Saunders College Publishing.

MPQC 202 - Quality Assurance of Herbal Drugs

35 Hours

1) The significance of quality for efficacy and safety of herbal medicinal products. Typical
problems and challenges in quality control of herbal drugs. Factors affecting Herbal drug
quality. Classification of evaluation methods for plant drugs. Macro-morphological, Micromorphological evaluation of herbal raw materials. WHO guidelines for Sampling of plant
drugs.
2) Physicochemical standardization parameters for herbal drugs: Determination of Physical and
chemical constants such as extractive values, moisture content, alcohol content, volatile oil
content, ash values, bitterness values, foreign matter, and physical constants applicable to the
lipid containing drugs, swelling factor, foaming index, filth, insoluble matter etc.
3) Adulteration Introduction, Adulterants, types and methods of adulteration with illustrations
and their detection. Contamination of plant drugs, classification of contaminants and Need
for their detection. Detection and estimation of Arsenic and Heavy Metals Cadmium and
Lead. Determination of Pesticide residues. Microbial contamination, microbial load/counts
etc.
4) Rationale and concepts of metabolite profiling and fingerprinting in assessing the efficacy,
quality of phytomedicines and in general to plant drug analysis. Role of Molecular markers
in herbal drug quality assurance and associated pitfalls. A brief review of modern extraction
methods and sample-preparation techniques for the standardization and analysis of herbal
medicinal products.
5) Application of various analytical tools (including Hyphenated analytical technologies
[HAT]) in metabolite fingerprinting and profiling of plant drugs and its derivative products in
assessing their quality and efficacy. Some typical case studies (at least 3) from scientific
publications illustrating the current and modern approaches to plant drug quality assurance.

53

6) Guidelines proposed by regulatory bodies on quality of herbal medicinal products,

7) Herbal drug preparations and herbal medicinal products. Factors affecting stability of herbal
drugs and its formulations, the relevant ICH guidelines and methods of stability testing.
WHO guidelines on GMP for herbal medicines.
Books for Reference:
1. Quality Control Methods for Medicinal Plant Materials- WHO, Geneva.
2. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, 1993,
WHO, Regional Office for the Western Pacific, Manila.
3. Guidelines for the Assessment of Herbal Medicines, 1991, WHO, Geneva.
4. Good Manufacturing Practices: updated supplementary guidelines for the manufacture of
herbal medicines, WHO, July 2005.
5. Pharmacopoeia of India, Govt. of India, Ministry of Health,4th Edition,1996.
6. United States Pharmacopoeia, US pharmacopoeial Convention Inc. Rocville, USA,2000.
7. Evans, W.C., Trease and Evans Pharmacognosy, ELBS / Bailliere Tindall, London,15th
edition (Reprint 2006).
8. World Health Organization. Regulatory Situation of Herbal Medicine. World Wide Review.
Geneva, Switzerland: World Health Organization; 1998:1-5.
9. GMP for Botanicals : Regulatory and Quality Issues on Phytomedicines, edited by Pulok K.
Mukherjee and Robert Verpoorte. New Delhi, Business Horizons, 2003
10. Liang, Y.Z., Xie, P., and Chan, K., Quality control of herbal medicines, J Chromatogr B
Analyt Technol Biomed Life Sci. 2004, 812: 53-70. Review.
11. Quality Control on Herbal Drugs - Pulok K. Mukherjee, Eastern Publishers (Business
Horizons Ltd.) New Delhi 2002.
12. Pharmacognosy, Phytochemistry, Medicinal Plants by Jean Bruneton (1999)
MPQC 203 Pharmaceutical Regulatory affairs

35 Hours

1. US-FDA regulatory affairs: US FDA review process for Investigational New Drug (IND),
New Drug (NDA). Hatch Waxman amendment, Abbreviated New Drug Application
(ANDA) for generic market - types of ANDA - Data presentation - verification and grant by
FDA - Common Technical Documentation (CTD), and review process. Drug master File
(DMF), Type - filing process - benefits. New product exclusivity patent term restoration exclusivity and orange book listings federal register
2. European Commission regulatory affairs: Procedure for marketing authorization in European
Commission Countries mutual recognition process centralized procedure decision
making procedure
3. Organisation and functioning of ICH overview of various ICH guidelines. ICH quality
guidelines: Stability Testing of New Drug Substances and Products Stability Testing :

54

Photostability Testing of New Drug Substances and Products, Stability Testing for New
Dosage Forms, Bracketing and Matrixing Designs for Stability Testing of New Drug
Substances and Products, Evaluation of Stability Data, Impurities in New Drug Substances,
Impurities in New Drug Products, Impurities: Guideline for Residual Solvents,
4. GMP certification as per WHO: need and procedure for certification. ISO 9000 Salient
features
5. Good Clinical Practice : Basic rules to carry out clinical investigation of drugs in Phase I, II,
III, IV clinical trials - the subjects of clinical investigation - the documentation of studies ethical aspects of clinical investigations of drugs.
Reference:
1. US FDA CDER hand book, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research
2. ICH quality guidelines www.ich.org
3. "Good Manufacturing Practices for Pharmaceuticals", H. Willig, M.M.Tuckeman and
W.S.Hitchings, Drugs and Pharm. Sci. Series, Vol. 16, Marcel Dekker Inc., N.Y.
4. Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials,
Volume I & II, World Health Organisation, Pharma Book Syndicate, Hyderabad.
5. Notice to applicants volume 2a,, Procedure for Marketing Authorisation, European
commission Enterprise directorate-general single market : management & legislation for
consumer goods, Pharmaceuticals : regulatory framework.

MPQC 204 Biological and Biochemical Analysis Theory

35 Hrs.
1. Design and analysis of biological assay-precision, estimation of error, assay depending on
individual effective dose and measured effect on individual biological system. Assay
depending on quantal responses and combination of potency estimates. Bioassay of heparin,
oxytocin, vaopressin, insulin, digoxin and amylase.
2. Bio assay of the following products:
Vaccines : Diphtheria, Tetanus, Pertusis, Plague, Rabies, Smallpox and Typhoid Antitoxins : Diphtheria, Rabies anti serum and Tetanus antitoxin
3. Pyrogen test including Lal test Test for Histamine like substance, Freedom from undue
toxicity and living contaminants in vaccines.
4.
5.
6.
7.

Microbiological Assays of Vitamins and Antibiotics.

Immuno Assays including Radio Immuno Assays.
Affinity Chromatography
Sterility tests

Reference:
1. Pharmacopoeia of India, 4th Edition 1996.
2. British Pharmacopeia, 1993
3. Biological standardization Burn, Fininey and Godwin
4. Microbial Assays Barton J.Wright

55

5. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20 th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
MPQC 205: Quality Assurance Practice (Theory)

35 Hrs.

1. Validation: Process validation: Design, development and process validation methodsprotocols- methodology and interpretation of data for pharmaceutical operations involved in
the production of pharmaceutical products with special reference to tablets, suspensions.
Validation of process like mixing, granulation, drying, compression filling and water process
system.
2. Cleaning validation, Vendor validation, Vendor audit, Validation of service: Training,
maintenance and packing.
3. Equipment qualification: Installation qualification and operational qualification for
sterilization equipments like autoclave, oven and membrane filter.
4. US FDA guidelines for GLP for laboratories conducting non clinical animal testing. NABL
Accreditation. organisation and functioning of National Accreditation Board for Testing &
Calibration laboratories. Accreditation process, criteria for accreditation
5. In process Quality control: In process control during component manufacture- solid dosage
forms-Liquid Dosage forms-semi solid dosage forms-inhalations-sterile solutions-novel drug
delivery systems. Line clearance Change control
6. Quality control of primary packing materials: IP, BP & USP specifications for plastic
containers, glass containers, rubber closures
Books:
1. NABL 100 (Issue 1, 1996), National Accreditation Board for Testing & Calibration
laboratories., Department of Science & Technology, Ministry of Science & Technology,
Government of India.
2. "Pharmaceutical Process Validation", B.T.Loftus & R.A.Nash, Drugs and Pharm Sci.
Series, Vol. 23, Maarcel Dekker Inc., N.Y.
3. Pharmacopoeia of India,4th Edition(1996)Govt.of India,Ministry of Health.
4. British Pharmacopoeia(1993),London,Her Majestys Stationery Office.
5. United State Pharmacopeia(2000)US pharmacopeial convention Inc.Rocville,USA.

MPQP 206. Advanced Pharmaceutical Analysis Practical

70 Hrs.
a. Assay of multi drug formulations covering different techniques like UV, HPLC and
Spectrofluorimetry.
b. Quality Control test for cosmetics as per BIS Specifications.
c. Any other experiments to substantiate theory (2.1. Advanced Pharmaceutical Analysis
Theory and 2.3. Quality control of cosmetics theory)

56

MPQP 207Quality control and Quality Assurance Practical

70 Hrs.
1. Stability studies of marketed formulations as per ICH guidelines (The Experiment shall be
started at the beginning of the semester)
2. Experiments on process validation.
3. Calibration of spectrophotometer
4. Calibration of volumetric apparatus.
5. Chromatographic analysis of plant drugs for some phytoconstiuents such as alkaloids,
Anthracene glycosides, volatile oils.
6. Proximate analysis of plant-drugs to determine extractive values, ash values, insoluble matter
foreign matter, welling factor etc.
7. Determination of volatile oil content of plant drug.
8. Estimation of some phytoconstiuents.
9. Pharmacopoeial monograph of selected herbal drugs.
10. Any other experiments to substantiate theory
THIRD SEMESTER
MPQC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS
(Theory)
35 Hrs.
[Student should be familiar with pharmaceutical/chemical applications and use statistical tools,
by way of calculations, but not expected to derive and find proof.]
1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of thesis
and conventions adopted in writing; citing references; preparation of oral, poster
presentation. Accessing required information in a systematic manner from abstracts, books
journals, conference proceedings, thesis and dissertations, internet, CDROM etc. Ethics,
rights, permissions
2. The Population - The sample; measures describing the center of data distributions;
measurement of spread of data. Introduction to Probability - The Binomial and Normal
distributions - their significance.
3. Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t
tests, F tests, ANOVA [one way], Chi square test.
4. Linear regression and correlation.
5. Control charts Constructing control charts, between batch variation as a measure of
variability, quality control charts in research and development, quality control charts for
proportions.
6. Non parametric methods
7. Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed rank
test; Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for
randomness; Contingency tables.
References:
57

1. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series.

2. How to write and publish a scientific paper, 4 th Ed., Robert A DayCambridge University
presses.
3. Fundamentals of Analytical Chemistry7th Ed., Skoog, West, Holler Saunders College
Publishing.
MPQE 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory) 35 Hrs
1. Pre formulation studies and new formulation development.
2. New drug development and approval process: Investigational New Drugs
(IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) ,
ICH requirements for registration of pharmaceuticals.
3. Validation techniques.
4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of
dissolution characteristics, bioavailability enhancers.
5. Pharmaceutical product stability testing- ICH guidelines.
6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer
solution, gel formation, coacervation, phase separation, microencapsulation, mechanical
properties, biomedical uses of polymers.
Books for Reference:
1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20 th Ed.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3rd Ed.,
Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Ed., Marcel Dekker, Inc., New
York, 1995.
4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Ed., Churchill Livingstone, New York, 1996.
5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery
Systems, 7th Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
6. FDA Code of Federal Regulations, Title 21, Part 300 314.
7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.
8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.
MPQE 302(2) PHARMACEUTICAL HEALTH CARE - THEORY

1.
2.
3.
4.

35 Hrs.

Concept and necessity of Pharmaceutical Health care.

A rational approach in paediatrics and geriatric care.
Therapeutic consideration with rational approach during pregnancy and lactation.
Evaluation of Immune system and its fuctions.

58

5. Rational use of antimicrobials.

6. Assessment and clinical significance of malnutrition, enteral and parentral nutrition,
Nutritional consideration in major organ failure.
7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus,
Peptic Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma.
8. Self care: Constipation, Common cold, cough, pain, and sun light protection.
REFERENCES :
1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical
Association, Washington.
2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569
3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.
4. Standard Treatment Guidelines
g) by WHO
h) by Government of India
i) by Various state governments

MPQE 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY

35 HRS.

1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision;

classification of errors, estimation of errors, sources of errors, minimization of errors,
normal distribution of errors. Significant figures in analytical chemistry rules and
computations.
2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves
external standard methods, internal standard method, standard addition method
[applications in HPLC and GLC with calculations], linear regression of straight line
calibration curvesusing the regression equation[applications and calculations].
3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques
sampling techniquesrandom, stratified, systematic, cluster, for quality control. Sample
preparation reducing particle size, making solutions, separating analyte from
interferantsextraction, automated extraction, solid phase extraction, solid phase micro
extraction, super critical fluid extraction and micro wave assisted extraction.
4. Validating the analytical method including bio-analytical method: Need for validation;
historical background; validation of analytical procedures-- methodologyguidelines of
ICH; FDA; USP. Understanding of the following concepts in validationaccuracy,
precision, specificity, limit of detection, limit of quantification, blind analysis of standard
sample, ruggedness testing, robustness testing, equivalency testing. Validating the
method as standard methodcollaborative testtwo sample collaborative testing,
control charts.
5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column,
Mobile phase, Special additives. Method Development guiding tools: Separation factor,
Selectivity factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic

59

phase, Aqueous phase, Additional Variables: pH, Stationary Phase, Temperature. Column
Conditions: Flow, Column dimension, Particle diameter. Derivatisation.
6. System suitability tests as per Pharmacoepoeial specification.
7. Development of stability indicating analytical method
Books for References:
1. HPLC method development, Lunn. G(1996),John wiley & Interscience.
2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family
Welfare.
3. British Pharmacopeia (1993) London, Her Majestys Stationery Office.
4. ICH guide lines: validation of analytical procedures, methodology, November 1996.
5. Vogels text book of quantitative inorganic analysis 5th Ed.
6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series,
1993.
7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.
8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college
publishing.
MPQE 302(4): CLINICAL PHARMACOLOGY -THEORY

(35 Hrs)

1. (a) Definition and scope of clinical pharmacology, measurement of drug response

in man.
(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance
data analysis & presentation skills
(c) Pharmaco- epidemiology.
2

(a) Drug Drug interaction, Drug food interaction, and Drug disease
interaction in clinical pharmacology.
(b) Adverse drug reactions and ADR monitoring.

(a) Essential drug list, national drug policy

(b) Orphans drugs
(c ) Therapeutic drug monitoring, Pharmacists intervension in Therapeutic drug
monitoring in special situations such as pediatrics, geriatric and pregnant
cases.

Books for reference:

1. Goodman and Gillmans The Pharmacological Basis of Therapeutic 9 th Ed.
2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.
3. Remingtons Pharmaceutical Sciences 19th Ed.

60

4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach

Vol 1. and 2
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and
V.Austel
6. Practical approach in toxicity studies by pooley and leslie
7. Screeining methods in Pharmacology by R.A.Tuner
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett
9. Methods of clinical drug trials by Aln Sperit and Smion
10. Alternatives to animal experiments: Developing in-vitro methods and changing
legislation. TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22
12. Clinical drug trial and tribulations by Allan E.Cato (1980).
13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.GrehameSmith and J.K.Aronson.
14. International aspects of drug evaluation and usage by Jouhar and Grayson.

MPQE 302(5): STRATEGY IN DRUG SYNTHESIS Theory

35 Hrs.

1. Organic Name Reaction :

Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann
rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius
rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement,
Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction,
Reformatsky reaction, Scmidt rearrangement.
2. Introduction: Basic rules in disconnection.
3. Application of Synthon approach to drug synthesis: Case Studies.
h. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine.
i. Adrenergic agents: Stimulants, Epinephrine, Ephedrine.
j. Adrenergic blocking agents: Propranolol, Guanethidine.
k. Psychotropic agents: Chlorpromazine, Chloprothixene.
l. Antidepresants: Imipiramine.
m. CNS Stimulants: Amphetamine.
n. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.

Books for Reference:

61

1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.
2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.
3. Solomons Organic chemistry 5th Ed.
4. Organic Chemistry, I.L. Finar Vol. I, ELBS.
5. Modern Synthetic reaction, H.O.House.
6. Some Modern Method of Organic Synthesis, W. Carruthers.
7. Designing organic synthesis with work book a programmed introduction to the synthon
approach, Stuart Warren.
MPQE-302(6): PHARMACOBIOTECHNOLOGY (Theory)

35 Hrs.

1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process.

Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture,
Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial
growth, Down stream processing, Microbial products, Improvements in microbial strains.
Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid
and Penicillin.
2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic
nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes.
Methods of enzyme production. Profile of some important enzymes: Hyaluronidase,
Penicillinase, Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier
matrices, Materials and Methods of immobilization (Adsorption method, Covalent
bonding, Entrapment, Encapsulation). Advantages and disadvantages of immobilization.
Application of Enzymes and Immobilized enzymes.
3. Plant Tissue Culture Technology: Introduction and scope. Princple underlying plant
culture (totipotency). Nutrient media composition and preparation. Role of plant growth
regulators in Cell culture. Laboratory requirements for plant tissue culture. Aseptic
techniques and Maintenance of Aseptic environment. Basic steps in plant
tissue/cell/organ culture. Selection and preparation of explants. Surface sterilization of
explants.
4. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ
culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell
culture. Applications of plant tissue/cell culture: Micropropagation & Cloning,
Genetically modified plants, Medicinal plant improvement, Production of secondary
metabolites. Survey of phytochemicals produced through plant cell cultures.
5. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and
Methodologies for biotransformation. Cell immobilization, Advantages of cell
immobilization. Illustrations of biotransformations with special reference to steroids.
Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine,
Hydroxylation of beta methyl digitoxin, Arbutin).

62

6. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and

enzymes involved. Steps in engineering the Genes and the enzymes involved. Cloning
vectors. Introduction of rDNA into a host cell. Screening and selection of recombinants.
Typical examples of Recombinant DNA technology products (human insulin, human
growth hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).
Books for Reference:
1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi.
2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007,
Pharma Book Syndicate, Hyderabad.
3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age
International Publishers, New Delhi.
4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age
International Publishers Ltd., New Delhi.
5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004,
NIIR, New Delhi.
6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi.
7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.
MPQT 303: Thesis Phase I
Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to
be completed at the beginning of Third Semester. The candidate has to prepare an Orientation
Report.
FOURTH SEMESTER
MPQT 401: Thesis Phase II
THESIS
III and IV SEMESTERS
Phase-I
In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other
allied organizations to provide orientation & exposure. Simultaneously the student will carry out
a small project leading to a report at the end of that period. The faculty member of the
department and an expert from the respective organization jointly evaluate the report for 10
marks. The students are expected to identify a project towards their thesis and start working on it
and submit Phase I thesis during this stay. The students will come back to the Department to
appear for third semester examination. On completion of third semester examination the students
will return back to the industry/ Hospitals / other allied organizations where he was placed and
would continue the thesis work under the collective guidance of a faculty member and a guide
drawn from the collaborating organization.

63

Phase-II
The students would continue the thesis work in the fourth semester, in collaborating
organizations, under the supervision of two guides one from the Department and another from
collaborating organization allotted by the Head of the Department of Pharmacy.

64

M.PHARM. (PHARMACOLOGY)
COURSES OF STUDY
FIRST SEMESTER
MPOC 101: Instrumental methods of Analysis - (Common to all Branches)
MPOC 102: Modern Analytical Techniques - (Common to all Branches)
MPOC 103: Molecular And Biochemical Pharmacology (Common with M.Pharm.,
Pharmaceutical Chemistry)
MPOC 104: Systemic Pharmacology And Toxicology
MPOC 105: Pharmacological Screening methods (common with M.Pharm Pharmaceutical
chemistry and M.Pharm Industrial Pharmacognosy)
MPOP 106: Pharmaceutical Analysis Practical (Common to all Branches)
MPOP 107:Advanced pharmacology Practical I (Common with M.Pharm Industrial
Pharmacognosy)
SECOND SEMESTER
MPOC 201: Biopharmaceutics - (Common with M.Pharm Inustrial Pharmacy and M. Pharm.
Pharmacy Practice)
MPOC 202: Clinical Pharmacokinetics - (Common with M.Pharm Inustrial Pharmacy and M.
Pharm. Pharmacy Practice)
MPOC 203: Biological and Biochemical Analysis (Common with M.Pharm. Quality
Assurance)
MPOC 204: Advances in Drug Design(Common with M.Pharm Industrial Pharmacy)
MPOC 205: Advances in Pharmacology
MPOP 206: Biopharmaceutics Practical (Common with M. Pharm. Pharmacy Practice)
MPOP 207: Advanced Pharmacology Practical -II
THIRD SEMESTER
MPOC 301: Research methodology and Pharmaceutical Statistics
MPOE 302: Elective:
1. MPOE 302(1) Advances in Industrial Pharmacy
2. MPOE 302(2) Pharmaceutical Healthcare
3. MPOE 302(3) Analytical method development
4. MPOE 302(4) Clinical pharmacology
5. MPOE 302(5) Strategy in Drug Synthesis
6. MPOE 302(6) Pharmacobiotechnology - Theory
MPOT 303: Thesis Phase I

65

FOURTH SEMESTER
MPOT 401: Thesis Phase II
SCHEME OF EXAMINATIONS
Code
Subject

MPOC 101
MPOC 102
MPOC 103
MPOC 104
MPOC 105
MPOP 106
MPOP 107

MPOC 201
MPOC 202
MPOC 203
MPOC 204
MPOC 205
MPOP 206
MPOP 207

MPOC 301
MPOC 302
MPOT 303
MPOT 401

I-Semester
Instrumental methods of
Analysis
Modern Analytical
Techniques
Molecular And
Biochemical Pharmacology
Systemic Pharmacolgy
And Toxicology
Pharmacological Screening
methods
Pharmaceutical Analysis
Practical
Advanced Pharmacology
Practical I
II-Semester
Biopharmaceutics
Clinical Pharmacokinetics
Biological and
Biochemical Analysis
Advances in Drug Design
Recent Advances in
Pharmacology
Biopharmaceutics
Practical
Advanced Pharmacology
Practical II
III Semester
Research Methodology &
Pharmaceutical Statistics
Elective
Thesis Phase I
IV- Semester

Hrs/Week

Credit
points

Evaluation (Marks)
Univ.
Exam

Sessi
onal

Tota
l

75

25

100

--

75

25

100

--

75

25

100

--

75

25

100

--

75

25

100

--

--

60

40

100

--

--

60

40

100

--

75

25

100

--

75

25

100

--

75

25

100

--

75

25

100

--

75

25

100

--

--

60

40

100

--

--

60

40

100

--

2
15

--

3
6
13

75
75
60
60

25
25
40
40

--

100
100
100
100

66

Thesis Phase II
Syllabus
FIRST SEMESTER
MPOC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory) 35 Hrs.
1. UV-Visible Spectrophotometry: Theory Beer and Lamberts Law - Limitations of the
law, Design and working of single beam and double beam spectrophotometers. Applications
of UV absorptions spectrophotometry in qualitative analysis and quantitative analysis.
2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence. Chemical
structure and fluorescence - factors affecting fluorescence intensity. Instrumentation and
Pharmaceutical applications of fluorimetry.
3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation
Types of interference and elimination of interference - Pharmaceutical applications
4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion
exchange chromatography and super critical fluid chromatography.
5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle,
Instruments and application. Chromatographic attributes: Capacity factor, resolution,
theoretical plates and symmetry factor
6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass spectrometry
7. Introduction to Radio Immuno Assay
Books for Reference:
1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of quantitative
inorganic analysis, ELBS, London.
2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone
Press London.
3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry, Saunders
College publishing, New York.
4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college publishing,
New York.
5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
6. V.K.
Srivastava
and
K.K.
S. Chand & Company, New Delhi.

Srivastav,

Introduction

to

Chromatography,

7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall
London.

67

9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric

Identification of organic Compounds, John Wiley & Sons, New York.
10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.
11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.
12. Mofat, A.C (Ed). Clarkes Isolation and Identification of Drugs, The pharmaceutical press,
London.
13. Pharmacopoeia of India, Govt. of India, Ministry of Health.
14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.
15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.
16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea & Febiger,
Philadelphia.
MPOC 102: MODERN ANALYTICAL TECHNIQUES (Theory)

35 Hrs.

1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample preparation application of IR spectrophotometry in pharmacy. Introduction to FTIR
2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift,
magnetic equivalence spin-spin decoupling shift reagents, applications of NMR
spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple
organic compound as example)
3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron
bombardment, chemical ionization, field desorption, fast atom bombardment. Different
analysers. Interpretation of mass spectra, determination of molecular weight and molecular
formula and applications of mass spectrometry
4. Theory, instrumentation and applications of Differential Thermal Analysis and Differential
Scanning Calorimetry.
5. A preliminary study of principle, Instrument and applications of 13C NMR
6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins &
antibiotics
Books for reference:
1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone
Press London.
2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college publishing,
New York.
3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

68

5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall

London.
6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric
Identification of organic Compounds, John Wiley & Sons, New York.
7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.
8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.
9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.
10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
MPOC 103 . MOLECULAR AND BIOCHEMICAL PHARMACOLOGY (35 Hrs)
1. Receptor pharmacology
Receptor different types, Theories of receptor, G-protein coupled receptor, enzyme
inhibitor, Enzymes ligand gated, ion channel attached to receptor, (Sodium, Potassium,
Calcium, and Chloride channels) second messengers, NMDA channels, cAMP, cGMP,
InsP3, AA.
Neurohumoral transmission in central nervous systems, autonomic and somatic nervous
system- molecular basis, underlying the mechanism action of cholinergic, adrenergic
agonist and antagonist and neuromuscular blocking agents,
2. Chemotherapy
(a) Molecular & biochemical mechanism involved in the anti microbial effects of various
Chemotherapeutic agents (Anti bacterial, Anti fungal, Anti viral, and Anti cancer)
b) Gene therapy, recent advances made in the gene therapy of cancer diseases and other
chronic diseases.
3. a) Immuno pharmacology: Cellular mediators and their interactions during immune
response and Eicosanoids.
b) Autocoids, histamine, angiotensin, 5HT, and their antagonists.
c) Drugs inhibiting the transport of carrier systems.
Books for reference:
1. Goodman and Gilmans The Pharmacological Basis of Therapeutics (9th Ed.)
2. Pharmacology by H.P.Rang and M.M.Dale (3 rd end)
3. Basic and Clinical Pharmacology by BB.G.Katzung (7th Ed.)
4. Lippincotts illustrated reviews by R.A.Harvey and P.C.Champe
5. Clinical Pharmacology by D.R.Lawrence and P.N.Bennett
6. Drug Treatment by Averys

69

MPOC 104 SYSTEMIC PHARMACOLGY AND TOXICOLOGY

(35hrs)

1. Various CNS disorders and drugs acting on CNS,

2. a) Renal pharmacology Diuretics & Anti diuretics
b) Drugs used in the treatment of bronchial asthma (Patho physiological approach)
c) Drugs acting on G.I.T
d) Drugs used in peptic ulcer, patho physiology of peptic ulcer, anti diarrhoeal, emetics &
anti emetics
3

a) Drugs affecting uterine motility:

Oxytocine and other drugs
b) Endocrine pharmacology :
Drugs acting on pituitary, thyroids, antithyroids, insulin and oral antidiabetics,
Corticosteroids, and androgens, oestrogens and progesterone.

4 a) Cardiovascular Pharmacology, Cardiotonics, Antiarrhythmic, Anti anginals,

hypertensives And Hypolipedemic Agents.

Anti

b) Toxicology :
Acute poisoning, chronic poisoning, general principles of management of heavy metal
poisoning and chelating agents).

Reference Books:
1. Goodman and Gilmans The pharmacological Basis of therapeutics (9 th Ed.)
2. Basic and Clinical Pharmacology by BB.G.Katzung (7th Ed.)
3. Pharmacology by H.P.Rang and M.M.Dale (3 rdEd.)
4. AMA Drug Evaluation 6 th Ed.,
5. Drug Teatment by Averys
6. Annual review of Pharmacology and toxicology
7. Robbins Pathology
8. Davidsons Medicine

MPOC 105: PHARMACOLOGICAL SCREENING METHODS

- 35Hrs

1. (a)Basic principles of screening of drugs for pharmacological activities.

70

(b)Pre-clinical
screening

General
screening
procedure
for
CNS
activities, General
CNS profile- Study using pole climbing pattern, Rota rod,
Actophotometer and Jiggle cage experiments.
2. (a)Specific screening procedure for local anesthetics Rabbit cornea, lumbar plexus of
frog and Infiltration anesthesia on guinea pigs
(b) Screening for anti hypertensive agents:
How to do experimentally induced hypertension in albino rats, and using these animals
for screening of anti hypertensive, anaesthetized dog method etc.
(c) Screening for anti arrhythmic activity:
A study of aconitine or digoxin or isoprenaline induced arrhythmias in animals and use of
these animals to screen anti arrhythmic drugs. Studying various types of arrhythmiasis
based on ECG pattern recorded - Isolated rabbits heart and guinea pigs atrium for anti
arrhythmic screening and isolated frog heart.
(d) Screening for analgesic and anti-convulsent activities using, hot plate, tail flick and
tail clip methods (analgesic activity) MES seizures produced in albino rats and to study
the effects of anti convulsant (phenytoin), protection of electrically induced convulsion in
albino rats. Protection of cardiazol induced convulsion in rat by sodium valproate.
3. (a) Screening for anti depressant, anti psychiatric, anti parkinsonism and anti ulcer effect
(b) Screening for anti fertility activity and anti pyretic & anti inflammatory.
(c) Screening for skeletal muscle relaxants effect of drugs using nerve muscle
preparations, phrenic nerve diaphragm and frog rectus preparation.
4

(a) Toxicological studies:

Acute, sub acute, and chronic toxicological studies and calculation of median lethal
dosage for drugs

Books for reference:

1. Goodman and Gilmans, The pharmacological Basis of Therapeutic 9th Ed.
2. Pharmacology, by H.P.Rang
3. Remingtons Pharmaceutical Sciences 19th Ed.
4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bacharah Vol 1.
and 2.
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and
V.Austel.
6. Practical approach in toxicity studies by pooley and leslie.
7. Screeining methods in Pharmacology by R.A.Tuner.
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett.
9. Methods of clinical drug trails by Aln Sperit and Smith.

71

10. Alternatives to animal experiments: Developing in-vitro methods and changing

legislation. TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989), 16-22.
12. Clinical drug trial and tribulations by Allan E.cato (1980)
13. The Oxford text book of clinical Pharmacology and drug therapy by D.G.Grehame-Smith
and J.K.Aronson
14. International aspects of drug evaluation and usage by Jouhar and Grayson.
MPOP 106: PHARMACEUTICAL ANALYSIS (Practical)

45 Hrs.

1. Experiments based on theory subjects Instrumental methods of analysis and Modern

Analytical techniques
2. Experiments would be selected illustrating the principles involved in estimation of raw
materials and finished products representing major categories of drug formulations from
pharmacopoeias.
MPOP 107: ADVANCED PHARMACOLOGY PRACTICAL - 1
1.

Laboratory animals : Breeding, maintanance and handling

preparation of Physiological solution and drug solution

2.

Screening procedure for the following drugs:

70 Hrs.

Local anesthetics, antiepileptics, antidepressants, anti-inflammatory, antidiabetics,

antiulcer, analgesics and antimicrobial agents.
3.

a. Cardiac stimulants and depressants on frogs heart and rabbits or guinea pigs isolated
heart
b. Spasmogens and spasmolytics on rabbits intestine
c. Frogs rectus and rats phrenic nerve diaphragm preparation.

a. Effect of drugs on blood pressure, splenic volume, intestinal movements and

respiration in anesthetized dog (with software model)
b. Acute and sub acute toxicity studies and calculation of LD50
SECOND SEMESTER
MPOC 201: BIOPHARMACEUTICS (Theory)

35 Hrs.

1. Drug absorption and disposition: Mechanism of drug transport, factors affecting

absorption, distribution, bio- transformation and elimination.
2. First order process, rate constants, half-life; Zero order process

72

3. Open one compartment model: Description, volume of distribution, drug concentration in

plasma, kinetics of I.V. administration, short term constant rate I .V. infusion, absorption
rate and drug effects , continuous constant rate infusion, repetitive dosing- average
concentration of drug at steady state , loading dose , dosing interval.
4. Open two-compartment model; Kinetics of absorption, distribution and elimination.
Multiple dose administration. Limitation of multi- compartmental analysis.
5. Non-compartmental model; Area under first moment curve (AUMC), Apparent volume
of distribution, mean residence time (MRT), Drug absorption predicting steady state
concentration.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger,
Philadelphia, 1991.
3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker,
Inc., New York, 1987.
4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics A Treatise, 2nd
Edn., Vallabh Prakashan, New Delhi, 1998.
5. Swarbrick J, Current Concept in Phramaceutical Science: Bio Pharmaceutics, Lea &
Febiger, Philadelphia, 1970.
MPOC 202: CLINICAL PHARMACOKINETICS (Theory)

35 Hrs.

1. Clearance concepts- organ clearance, total clearance, renal clearance and excretion.
2. Hepatic clearance and elimination, other non renal clearance. Extraction ratio
3. Bio-availability and bio equivalency testing; Estimation methods, dissolution testing, in
vitro & in vivo correlation study , bio equivalency testing of dosage forms.
4. Pharmacokinetic variability; Body weight & size, obesity, age. Drug metabolism, Plasma
protein binding and renal excretion in newborn & children. Sex, pregnancy and genetic
factors. Poly morphic acetylation and oxidation.
5. Pharmcokinetic variability: Drug interactions
6. Effect of disease states on drug disposition, therapeutic drug monitoring and dosage
prediction of digoxin, gentamycin and anticonvulsants. Hypothesis of individualisation &
optimisation of drug therapy.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger,
Philadelphia, 1991.

73

3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker,

Inc., New York, 1987.
4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics, 2nd Edn., Vallabh
Prakashan, New Delhi, 1998.
5. Wagner J G, Bio- Pharmaceutics and relevant Pharmacokinetics, Drug Intelligence
Publications, Washington DC, 1971.
6. Rowland M and Tozer TN, Clinical Pharmacokinetics concepts and applications, 3 rd
Edn., Lea & Febiger, Philadelphia, 1995.
7. Shargel L and Yu AB, Applied Bio-Pharmaceutics and Pharmacokinetics, Appleton &
Lange, Norwalk, CT, 1993.
MPOC 203 Biological and Biochemical Analysis Theory

35 Hrs.

1. Design and analysis of biological assay-precision, estimation of error, assay depending

on individual effective dose and measured effect on individual biological system. Assay
depending on quantal responses and combination of potency estimates. Bioassay of
heparin, oxytocin, vaopressin, insulin, digoxin and amylase.
2. Bio assay of the following products:
Vaccines : Diphtheria, Tetanus, Pertusis, Plague, Rabies, Smallpox and Typhoid Antitoxins : Diphtheria, Rabies anti serum and Tetanus antitoxin
3. Pyrogen test including Lal test Test for Histamine like substance, Freedom from undue
toxicity and living contaminants in vaccines.
4.
5.
6.
7.

Microbiological Assays of Vitamins and Antibiotics.

Immuno Assays including Radio Immuno Assays.
Affinity Chromatography
Sterility tests

Reference:
1. Pharmacopoeia of India, 4th Edition 1996.
2. British Pharmacopeia, 1993
3. Biological standardization Burn, Fininey and Godwin
4. Microbial Assays Barton J.Wright
5. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
MPOC 204: ADVANCES IN DRUG DESIGNS

35 Hrs.

1. General approach to discovery of New Drugs: Lead discovery; Lead modification;

Structural modification-homologation-chain branching; Ring-chain transformation; Bio
isosterism; Quantitative structure activity relationship. Physicochemical Principles of
Drug Action: Partition coefficient & Drug Action; Chemical bonding & Drug Action;
Electronic Structure & Drug Action.
74

2. Receptor; Background; Forces of drug receptor interaction Theories of drug-receptor

interaction; Structure of Receptor and Drug-receptor interactions Ligand gated ion
channel, G-Protein coupled receptors, Tyrosine kinase/ enzyme coupled receptors, steroid
receptors. Receptor pharmacology and drug action.
3. Enzymes: Background;Theories of enzyme inhibition; Groups of drugs that work by
enzyme inhibition; Enzyme inhibition as a tool for drug development
4. Drug stereochemistry: basic concepts; Chirality & Drug action ;Influence of geometric
isomerism on drug action; Conformational flexibility and multiple mode of action;
current regulatory affairs on racemic drugs
5. Drug metabolism & Drug design: Drug metabolism; Introduction; Basic concepts;
Importance of biotransformation. Metabolites as independent drugs; necessity of
prodrugs; Bio transformation as a source of drug design; concept of hard drugs and soft
drugs
6. Design of new chemical entities (physicochemical approaches); Case Studies-Design of
H2 Receptors: histamine agonist; Design of Bronchodilators (salbutamol analogues);
Design of Antibiotics (Clavulanic acid); Design of anticancer drugs (alkylating agents)
Books for Reference:
1. William O Foye, Principles of Medicinal Chemistry, 4 th Ed., B I Waverly Pvt. Ltd., New
Delhi, 1995.
2. Wolff (Ed.), Burdgers Medicinal Chemistry and Drug Discovery, Vol 1-3, 5th Ed., Wily
Interscience, New York, 1995.
3. Martin Y.C, Quantitative Drug Design: A Critical Introduction, Marcel Dekker, Inc.,
New York, 1978.
4. Ariens(Ed), Drug Design, Vols 1-10, Academic Press, New York, 1971- 1980.
5. Physicians Desk Reference, 55th Ed., Medical Economics Company, Montvale, NJ, 2001
6. Smith H. J, Smith & Williams, Introduction to the Principles of Drug Design, 2 nd Ed.,
Wright, London, 1988.
7. Ganellin, Medicinal Chemistry.
MPOC 205: ADVANCES IN PHARMACOLOGY - 35 Hours
1.Recent advances in Pharmacotherapy of the following: (a) Neurological and psychiatric disorders, pain pathways and its management,
parkinsonism, Alzheimer disease, Schizophrenia.
(b) CNS disorders, Hypertension, angina pectoris, CCF, Arteriosclerosis and myocardial
infarction,
(c) GIT disorders, peptic ulcer and Diarrhoea
2. Recent advances in Pharmacotherapy of the following:(a)Respiratory disorders: Bronchial asthma and chronic obstructive pulmonary disorders
75

(b) Rheumatoid arthritis, gout and osteoporosis.

(c) Metabolic disorders: Diabetes mellitus
3. Recent advances in Pharmacotherapy of the following:(a) Infectious diseases: Upper and lower respiratory infection, UTI, STD, Tuberculosis &
Leprosy & HIV infections, mycotic infections
(b) Neoplastic disorders: Acute Leukemia, malignant lymphomas, breast cancer, GIT
cancer, lung cancers and prostate cancer
(c) Ocular disorders
Books for Reference:
1. Goodman and Gilmans, The pharmacological Basis of therapeutics (9th Ed.)
2. Pharmacology by H.P.Rang and M.M.Dale (3 rd Ed.)
3. Basic and Clinical Pharmacology by BB.G.Katzung (7th Ed.)
4. Lippincotts illustrated reviews by R.A.Harvey and P.C.Champe
5. Clinical Pharmacology by D.R.Lawrence and P.N.Bennett
6. Drug Treatment by Averys
MPOP 206: BIOPHARMACEUTICS- PRACTICAL

45 Hrs.

1. Experiments based on Bio pharmaceutics theory would be selected for the practical.
MPOP 207: ADVANCED PHARMACOLOGY- PRACTICAL- II 70 Hrs.
1. Recording of dose response curve for receptor agonist
2. Calculation of PA 2 value for antagonist using a suitable tissue
3. Bioassay of actlycholine using a suitable tissue by interpolation, matching, 3 point
and 4 point methods
4. Bioassay of histamine, oxytocin and d-tubacurarine

THIRD SEMESTER
MPOC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS
(Theory)
35 Hrs.
[Student should be familiar with pharmaceutical/chemical applications and use statistical tools,
by way of calculations, but not expected to derive and find proof.]

76

1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of

thesis and conventions adopted in writing; citing references; preparation of oral, poster
presentation. Accessing required information in a systematic manner from abstracts,
books journals, conference proceedings, thesis and dissertations, internet, CDROM etc.
Ethics, rights, permissions
2. The Population - The sample; measures describing the center of data distributions;
measurement of spread of data. Introduction to Probability - The Binomial and Normal
distributions - their significance.
3. Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t
tests, F tests, ANOVA [one way], Chi square test.
4. Linear regression and correlation.
5. Control charts Constructing control charts, between batch variation as a measure of
variability, quality control charts in research and development, quality control charts for
proportions.
6. Non parametric methods
7. Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed
rank test; Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for
randomness; Contingency tables.
References:
4. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series.
5. How to write and publish a scientific paper, 4 th Ed., Robert A DayCambridge
University presses.
6. Fundamentals of Analytical Chemistry7th Ed., Skoog, West, Holler Saunders
College Publishing.
MPOE 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory) 35 Hrs
1. Pre formulation studies and new formulation development.
2. New drug development and approval process: Investigational New Drugs
(IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) ,
ICH requirements for registration of pharmaceuticals.
3. Validation techniques.
4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of
dissolution characteristics, bioavailability enhancers.
5. Pharmaceutical product stability testing- ICH guidelines.
6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer
solution, gel formation, coacervation, phase separation, microencapsulation, mechanical
properties, biomedical uses of polymers.
Books for Reference:
1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20 th Ed.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3rd Ed.,
Vergese Publishing House, Mumbai, 1991.

77

3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Ed., Marcel Dekker, Inc., New
York, 1995.
4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Ed., Churchill Livingstone, New York, 1996.
5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery
Systems, 7th Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
6. FDA Code of Federal Regulations, Title 21, Part 300 314.
7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.
8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.
MPOE 302(2) PHARMACEUTICAL HEALTH CARE - THEORY

35 Hrs.

1.
2.
3.
4.
5.
6.

Concept and necessity of Pharmaceutical Health care.

A rational approach in paediatrics and geriatric care.
Therapeutic consideration with rational approach during pregnancy and lactation.
Evaluation of Immune system and its fuctions.
Rational use of antimicrobials.
Assessment and clinical significance of malnutrition, enteral and parentral nutrition,
Nutritional consideration in major organ failure.
7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus,
Peptic Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma.
8. Self care: Constipation, Common cold, cough, pain, and sun light protection.
REFERENCES :
1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical
Association, Washington.
2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569
3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.
4. Standard Treatment Guidelines
j) by WHO
k) by Government of India
l) by Various state governments

MPOE 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY

35 HRS.

1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision;

classification of errors, estimation of errors, sources of errors, minimization of errors, normal
distribution of errors. Significant figures in analytical chemistry rules and computations.
2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves external
standard methods, internal standard method, standard addition method [applications in HPLC

78

and GLC with calculations], linear regression of straight line calibration curvesusing the
regression equation[applications and calculations].
3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques
sampling techniquesrandom, stratified, systematic, cluster, for quality control. Sample
preparation reducing particle size, making solutions, separating analyte from interferants
extraction, automated extraction, solid phase extraction, solid phase micro extraction, super
critical fluid extraction and micro wave assisted extraction.
4. Validating the analytical method including bio-analytical method: Need for validation;
historical background; validation of analytical procedures-- methodologyguidelines of
ICH; FDA; USP. Understanding of the following concepts in validationaccuracy,
precision, specificity, limit of detection, limit of quantification, blind analysis of standard
sample, ruggedness testing, robustness testing, equivalency testing. Validating the method as
standard methodcollaborative testtwo sample collaborative testing, control charts.
5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column, Mobile
phase, Special additives. Method Development guiding tools: Separation factor, Selectivity
factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic phase, Aqueous
phase, Additional Variables: pH, Stationary Phase, Temperature. Column Conditions: Flow,
Column dimension, Particle diameter. Derivatisation.
6. System suitability tests as per Pharmacoepoeial specification.
7. Development of stability indicating analytical method
Books for References:
1. HPLC method development, Lunn. G(1996),John wiley & Interscience.
2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family
Welfare.
3. British Pharmacopeia (1993) London, Her Majestys Stationery Office.
4. ICH guide lines: validation of analytical procedures, methodology, November 1996.
5. Vogels text book of quantitative inorganic analysis 5th Ed.
6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series,
1993.
7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.
8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college
publishing.

MPOE 302(4): CLINICAL PHARMACOLOGY -THEORY

(35 Hrs)

1. (a) Definition and scope of clinical pharmacology, measurement of drug response

in man.
(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance
data analysis & presentation skills
79

(c) Pharmaco- epidemiology.

2

(a) Drug Drug interaction, Drug food interaction, and Drug disease
interaction in clinical pharmacology.
(b) Adverse drug reactions and ADR monitoring.

(a) Essential drug list, national drug policy

(b) Orphans drugs
(c ) Therapeutic drug monitoring, Pharmacists intervension in Therapeutic drug
monitoring in special situations such as pediatrics, geriatric and pregnant
cases.

Books for reference:

1. Goodman and Gillmans The Pharmacological Basis of Therapeutic 9 th Ed.
2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.
3. Remingtons Pharmaceutical Sciences 19th Ed.
4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach
Vol 1. and 2
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and
V.Austel
6. Practical approach in toxicity studies by pooley and leslie
7. Screeining methods in Pharmacology by R.A.Tuner
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett
9. Methods of clinical drug trials by Aln Sperit and Smion
10. Alternatives to animal experiments: Developing in-vitro methods and changing
legislation. TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22
12. Clinical drug trial and tribulations by Allan E.Cato (1980).
13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.GrehameSmith and J.K.Aronson.
14. International aspects of drug evaluation and usage by Jouhar and Grayson.

MPOE 302(5): STRATEGY IN DRUG SYNTHESIS Theory

35 Hrs.

1. Organic Name Reaction :

Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann
rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius
rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement,
80

Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction,

Reformatsky reaction, Scmidt rearrangement.
2. Introduction: Basic rules in disconnection.
3. Application of Synthon approach to drug synthesis: Case Studies.
o. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine.
p. Adrenergic agents: Stimulants, Epinephrine, Ephedrine.
q. Adrenergic blocking agents: Propranolol, Guanethidine.
r. Psychotropic agents: Chlorpromazine, Chloprothixene.
s. Antidepresants: Imipiramine.
t. CNS Stimulants: Amphetamine.
u. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.

Books for Reference:

1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.
2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.
3. Solomons Organic chemistry 5th Ed.
4. Organic Chemistry, I.L. Finar Vol. I, ELBS.
5. Modern Synthetic reaction, H.O.House.
6. Some Modern Method of Organic Synthesis, W. Carruthers.
7. Designing organic synthesis with work book a programmed introduction to the
synthon approach, Stuart Warren.
MPOE-302(6): PHARMACOBIOTECHNOLOGY (Theory)

35 Hrs.

1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process.

Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture,
Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial
growth, Down stream processing, Microbial products, Improvements in microbial strains.
Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid
and Penicillin.
2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic
nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes.
Methods of enzyme production. Profile of some important enzymes: Hyaluronidase,
Penicillinase, Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier
matrices, Materials and Methods of immobilization (Adsorption method, Covalent
bonding, Entrapment, Encapsulation). Advantages and disadvantages of immobilization.
Application of Enzymes and Immobilized enzymes.
3. Plant Tissue Culture Technology: Introduction and scope. Princple underlying plant
culture (totipotency). Nutrient media composition and preparation. Role of plant growth

81

regulators in Cell culture. Laboratory requirements for plant tissue culture. Aseptic
techniques and Maintenance of Aseptic environment. Basic steps in plant
tissue/cell/organ culture. Selection and preparation of explants. Surface sterilization of
explants.
4. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ
culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell
culture. Applications of plant tissue/cell culture: Micropropagation & Cloning,
Genetically modified plants, Medicinal plant improvement, Production of secondary
metabolites. Survey of phytochemicals produced through plant cell cultures.
5. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and
Methodologies for biotransformation. Cell immobilization, Advantages of cell
immobilization. Illustrations of biotransformations with special reference to steroids.
Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine,
Hydroxylation of beta methyl digitoxin, Arbutin).
6. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and
enzymes involved. Steps in engineering the Genes and the enzymes involved. Cloning
vectors. Introduction of rDNA into a host cell. Screening and selection of recombinants.
Typical examples of Recombinant DNA technology products (human insulin, human
growth hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).
Books for Reference:
1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi.
2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007,
Pharma Book Syndicate, Hyderabad.
3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age
International Publishers, New Delhi.
4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age
International Publishers Ltd., New Delhi.
5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004,
NIIR, New Delhi.
6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi.
7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.
MPOT 303: Thesis Phase I
Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to
be completed at the beginning of Third Semester. The candidate has to prepare an Orientation
Report.
FOURTH SEMESTER
MPOT 401: Thesis Phase II
THESIS

82

III and IV SEMESTERS

Phase-I
In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other
allied organizations to provide orientation & exposure. Simultaneously the student will carry out
a small project leading to a report at the end of that period. The faculty member of the
department and an expert from the respective organization jointly evaluate the report for 10
marks. The students are expected to identify a project towards their thesis and start working on it
and submit Phase I thesis during this stay. The students will come back to the Department to
appear for third semester examination. On completion of third semester examination the students
will return back to the industry/ Hospitals / other allied organizations where he was placed and
would continue the thesis work under the collective guidance of a faculty member and a guide
drawn from the collaborating organization.
Phase-II
The students would continue the thesis work in the fourth semester, in collaborating
organizations, under the supervision of two guides one from the Department and another from
collaborating organization allotted by the Head of the Department of Pharmacy.

83

M.PHARM. PHARMACEUTICAL CHEMISTRY

Courses of Study:
First Semester
MPMC 101: Instrumental methods of Analysis - Theory (Common to all Branches)
MPMC 102: Modern Analytical Techniques - Theory (Common to all Branches)
MPMC 103: Molecular and biochemical Pharmacology Theory (Common with M.Pharm
Pharmacology)
MPMC 104: Advanced organic chemistry I
MPMC 105: Pharmacological screening methods Theory (Common with M.Pharm Pharmacology)
MPMP 106: Pharmaceutical Analysis Practical (Common to all Branches)
MPMP 107: Advanced Organic chemistry Practical
Second Semester
MPMC 201: Advanced organic chemistry II Theory
MPMC 202: Medicinal Chemistry I Theory
MPMC 203: Medicinal Chemistry II Theory
MPMC 204: Natural Products Chemistry Theory (Common with M.Pharm Industrial
Pharmacognosy)
MPMC 205: Drug design and Drug action Theory
MPMP 206: Natural Products Chemistry Practical
MPMP 207: Medicinal Chemistry Practical
Third Semester
MPMC 301: Research methodology and Pharmaceutical Statistics Theory (Common to all
branches)
MPMC 302: Elective: (students have to choose any one among the following)
1. MPMC 302(1) Advances in Industrial Pharmacy Theory
2. MPMC 302(2) Pharmaceutical Healthcare Theory
3. MPMC 302(3) Analytical method development Theory
4. MPMC 302(4) Clinical Pharmacology Theory
5. MPMC 302(5) Strategy In Drug Synthesis Theory
6. MPME-302(6) Pharmacobiotechnology Theory
MPMT 303: Thesis Phase I
Fourth Semester
MPMT 401: Thesis Phase II

84

Scheme of Examinations
M.Pharm. Pharmaceutical Chemistry
Subject

I-Semester
MPMC 101 Instrumental methods of
Analysis Theory
MPMC 102 Modern Analytical
Techniques Theory
MPMC 103 Molecular and
biochemical Pharmacology Theory
MPMC 104 Advanced organic
chemistry I Theory
MPMC 105 Pharmacological
screening Methods Theory
MPMP 106 Pharmaceutical Analysis
Practical
MPMP 107 Advanced organic
chemistry- Practical
II-Semester
MPMC 201 Advanced organic
chemistry II Theory
MPMC 202 Medicinal chemistry ITheory
MPMC 203 Medicinal Chemistry II
Theory
MPMC 204 Natural Products
Chemistry Theory
MPMC 205 Drug design and Drug
action -Theory
MPMP 206 Natural Products
Chemistry Practical
MPMP 207 - Medicinal Chemistry
Practical
III -Semester
MPMC 301 Research Methodology
& Pharmaceutical Statistics
MPMC 302 Elective
MPMT 303 Thesis Phase I
IV- Semester
MPMT 401 Thesis Phase II

Hrs/Week

Credits

Evaluation
(Marks)
Sessio Univ. Total
-nal
Exam

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

--

40

60

100

--

--

40

60

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

25

75

100

--

--

40

60

100

--

--

40

60

100

--

25

75

100

2
15

--

3
6

25
40

75
60

100
100

13

40

60

100

85

Syllabus
FIRST SEMESTER
MPMC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory)

35 Hrs.

1. UV-Visible Spectrophotometry: Theory Beer and Lamberts Law - Limitations of the

law, Design and working of single beam and double beam spectrophotometers.
Applications of UV absorptions spectrophotometry in qualitative analysis and
quantitative analysis.
2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence.
Chemical structure and fluorescence - factors affecting fluorescence intensity.
Instrumentation and Pharmaceutical applications of fluorimetry.
3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation
Types of interference and elimination of interference - Pharmaceutical applications
4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion
exchange chromatography and super critical fluid chromatography.
5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle,
Instruments and application. Chromatographic attributes: Capacity factor, resolution,
theoretical plates and symmetry factor
6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass
spectrometry
7. Introduction to Radio Immuno Assay
Books for Reference:
1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of
quantitative inorganic analysis, ELBS, London.
2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the
Athlone Press London.
3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry,
Saunders College publishing, New York.
4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college
publishing, New York.
5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
6. V.K. Srivastava and K.K.
S. Chand & Company, New Delhi.

Srivastav,

Introduction

to

Chromatography,

7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

86

8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice

Hall London.
9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric
Identification of organic Compounds, John Wiley & Sons, New York.
10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New
Delhi.
11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.
12. Mofat, A.C (Ed). Clarkes Isolation and Identification of Drugs, The pharmaceutical
press, London.
13. Pharmacopoeia of India, Govt. of India, Ministry of Health.
14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.
15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.
16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea &
Febiger, Philadelphia.
MPMC 102: MODERN ANALYTICAL TECHNIQUES (Theory)

35 Hrs.

1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample

preparation - application of IR spectrophotometry in pharmacy. Introduction to FTIR
2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift,
magnetic equivalence spin-spin decoupling shift reagents, applications of NMR
spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple
organic compound as example)
3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron
bombardment, chemical ionization, field desorption, fast atom bombardment. Different
analysers. Interpretation of mass spectra, determination of molecular weight and
molecular formula and applications of mass spectrometry
4. Theory, instrumentation and applications of Differential Thermal Analysis and
Differential Scanning Calorimetry.
5. A preliminary study of principle, Instrument and applications of 13C NMR
6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins &
antibiotics
Books for reference:
1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the
Athlone Press London.
2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college
publishing, New York.

87

3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.
5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice
Hall London.
6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric
Identification of organic Compounds, John Wiley & Sons, New York.
7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New
Delhi.
8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.
9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.
10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
MPMC 103 . MOLECULAR AND BIOCHEMICAL PHARMACOLOGY (35 Hrs)
1. Receptor pharmacology
Receptor different types, Theories of receptor, G-protein coupled receptor, enzyme
inhibitor, Enzymes ligand gated, ion channel attached to receptor, (Sodium, Potassium,
Calcium, and Chloride channels) second messengers, NMDA channels, cAMP, cGMP,
InsP3, AA.
Neurohumoral transmission in central nervous systems, autonomic and somatic nervous
system- molecular basis, underlying the mechanism action of cholinergic, adrenergic
agonist and antagonist and neuromuscular blocking agents,
2. Chemotherapy
(a) Molecular & biochemical mechanism involved in the anti microbial effects of various
Chemotherapeutic agents (Anti bacterial, Anti fungal, Anti viral, and Anti cancer)
b) Gene therapy, recent advances made in the gene therapy of cancer diseases and other
chronic diseases.
3. a) Immuno pharmacology: Cellular mediators and their interactions during immune
response and Eicosanoids.
b) Autocoids, histamine, angiotensin, 5HT, and their antagonists.
c) Drugs inhibiting the transport of carrier systems.
Books for reference:
1. Goodman and Gilmans The Pharmacological Basis of Therapeutics (9th Ed.)
2. Pharmacology by H.P.Rang and M.M.Dale (3 rd end)
3. Basic and Clinical Pharmacology by BB.G.Katzung (7th Ed.)

88

4. Lippincotts illustrated reviews by R.A.Harvey and P.C.Champe

5. Clinical Pharmacology by D.R.Lawrence and P.N.Bennett
6. Drug Treatment by Averys
MPMC 104: ADVANCED ORGANIC CHEMISTRY I Theory

35 Hrs.

1. Bonding and electron distribution:

a) Localised chemical bonding: Covalent bonding, hybridization, inductive and field effects,
bond distance and bond angle, Lewis structure, curved arrow notation
b) Delocalised chemical bonding: Resonance effect, aromaticity, heterocyclic rings
exhibiting aromaticity (five membered and six membered)
c) Bonds weaker than covalent bond: Hydrogen bond, addition compounds, electron donoracceptor complexes, crown ethers, inclusion compounds and clathrate compounds
2. Stability and reactivity of reaction intermediates:
a) Ion stability, solvation and media effect
b) Ranking of stability and trends (structure, lone pair stabilization, pi- bond stabilization,
hyper conjugation)
c) Ranking of electron donor groups
d) Ranking of electron withdrawing groups
e) Carbanion stability and trends
f) pka rule
3.a) Classification of electron source: General ranking of electron sources, nonbonding
electrons, electron rich sigma bonds, electron rich pi- bonds and simple pi- bonds,
aromatic rings
3.b) Classification of electron acceptors: General ranking of electron acceptors, electron
deficient species, weak single bonds, polarised multiple bonds
3.c) Mechanism and methods of determining: Thermodynamic and kinetic requirements for
reaction methods of determining reaction mechanism.

4.a) Mechanism, reactivity and orientation of aliphatic nucleophilic substitution (SN1, SN2
and SNi reactions including effect of solvent, nucleophile and substrate on reactivity
and orientation with examples.
4.b) Mechanism, reactivity and orientation of free radical substitution reactions

5.a) Mechanism, reactivity and orientation of oxidation and reduction reactions. Birch reduction,
Meerwin pondroffs reduction, Oppeneaur oxidation, Wulf Kishner reduction, and catalytic
hydrogenation
5.b) Reagents in organic synthesis: Use of following reagents in organic synthesis and
functional group transformations Lithium Aluminium hydride, Periodic acid, NBromo succinamide.
Books for Reference:
89

1. Organic Chemistry, Morrison and Boyd, prentice hall Pvt. Ltd., New Delhi, 6th edition,1992,
New Delhi..
2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.
3. IUPAC Nomenclature of Organic Chemistry, Riguady, J. Klesney, S.P., Pergamon Press,
New York.
4. Principles of Organic synthesis, R.O.C. Norman, Science Paper Back Publishers, 3rd edition
1993.
5. Solomons Organic chemistry 5th edition,John wiley & sons, Newyork..
6. Stereochemistry of carbon compounds, Eliel
7. Stereochemistry , Potopov, 1979, MIR Publishers, Moscow.
8. Organic Chemistry, I.L. Finar Vol I & II , ELBS, 6th edition 1995..
9. Modern Synthetic reaction , H.O.House, 2nd edition, Sydney .
10. Some Modern Method of Organic Synthesis, W. Carruthers 3rd edition, 1993, New Delhi.
11. Electron flow in organic chemistry, Paul Schudler
12. Organic reaction mechanism, Ronald Breslow, 2 nd edition,Sydney.
13. Organic chemistry, Stanley.H.Pine, 5th edition, Mc.Graw.Hill.
14. Mechanism in organic chemistry, Peter Sykes, 1995, Longman Scientific &Technical,
England.

MPMC 105: PHARMACOLOGICAL SCREENING METHODS

- 35Hrs

1. (a)Basic principles of screening of drugs for pharmacological activities.

(b)Pre-clinical
screening

General
screening
procedure
for
CNS
activities, General
CNS profile- Study using pole climbing pattern, Rota rod,
Actophotometer and Jiggle cage experiments.
2. (a)Specific screening procedure for local anesthetics Rabbit cornea, lumbar plexus of frog
and Infiltration anesthesia on guinea pigs
(b) Screening for anti hypertensive agents:
How to do experimentally induced hypertension in albino rats, and using these animals for
screening of anti hypertensive, anaesthetized dog method etc.
(c) Screening for anti arrhythmic activity:
A study of aconitine or digoxin or isoprenaline induced arrhythmias in animals and use of
these animals to screen anti arrhythmic drugs. Studying various types of arrhythmiasis based
on ECG pattern recorded. Isolated rabbits heart and guinea pigs atrium for anti arrhythmic
screening and isolated frog heart.
(d) Screening for analgesic and anti-convulsent activities using, hot plate, tail flick and tail
clip methods (analgesic activity) MES seizures produced in albino rats and to study the

90

effects of anti convulsant (phenytoin), protection of electrically induced convulsion in albino

rats. Protection of cardiazol induced convulsion in rat by sodium valproate.
3. (a) Screening for anti depressant, anti psychiatric, anti parkinsonism and anti ulcer effect
(b) Screening for anti fertility activity and anti pyretic & anti inflammatory.
(c) Screening for skeletal muscle relaxants effect of drugs using nerve muscle preparations,
phrenic nerve diaphragm and frog rectus preparation.
4

(a) Toxicological studies:

Acute, sub acute, and chronic toxicological studies and calculation of median lethal dosage
for drugs

Books for reference:

1. Goodman and Gilmans, The pharmacological Basis of Therapeutic 9th Ed.
2. Pharmacology, by H.P.Rang
3. Remingtons Pharmaceutical Sciences 19th Ed.
4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bacharah Vol 1.
and 2.
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and
V.Austel.
6. Practical approach in toxicity studies by pooley and leslie.
7. Screeining methods in Pharmacology by R.A.Tuner.
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett.
9. Methods of clinical drug trails by Aln Sperit and Smith.
10. Alternatives to animal experiments: Developing in-vitro methods and changing
legislation. TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989), 16-22.
12. Clinical drug trial and tribulations by Allan E.cato (1980)
13. The Oxford text book of clinical Pharmacology and drug therapy by D.G.Grehame-Smith
and J.K.Aronson
14. International aspects of drug evaluation and usage by Jouhar and Grayson.
MPMP 106: PHARMACEUTLICAL ANALYSIS Practical

45 Hrs.

1. Experiments based on theory subjects Instrumental methods of analysis and Modern

Analytical techniques
2. Experiments would be selected illustrating the principles involved in estimation of raw
materials and finished products representing major categories of drug formulations from
pharmacopoeias.
Books for Reference:
91

1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of
quantitative inorganic analysis, ELBS, London.
2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II,
Athlone Press London.

the

3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry,
Saunders College publishing, New York.
4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college
publishing, New York.
5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of
Analysis, Wadsworth, New York.
6. V.K. Srivastava and K.K. Srivastav, Introduction to Chromatography, S. Chand &
Company, New Delhi.
7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-

Wisely, Boston

MPMP 107: ADVANCED ORGANIC CHEMISTRY Practical 70 Hrs

1. Qualitative analysis of mixture of organic compounds.
2.

a. Preparation of Benzanilide from Benzophenone (Beckmann rearrangement)

b. Preparation of 2- phenyl indole from acetaphenone. (Fischer Idolisation)
c. Preparation of antipyrine from ethylacetoacetate
d. Preparation of dibromo cinnamic acid from benzaldehyde (Perkin reaction)

3.

a. Workshop on spectral interpretation of organic compounds.

b. Workshop on synthetic reactions.

4. Quantitative analysis of
a. OCH3 group Zeisel method
b. Nitrogen estimation Kjeldhals Method
5. Any other exercise to substantiate theory
Books for Reference:
1. Elementary practical organic chemistry part I , II and III by A.I.Vogel
2. Practical Organic chemistry, Raj. K. Bansal, Wiley Eastern Ltd.
3. Text book of Practical organic chemistry by Dey and Seetharaman
4. Text book of Practical organic chemistry by Arther . I.Vogel, 2nd edition,
5. Quantitative organic analysis by A.I.Vogel
6. Experiments and Techniques in Organic Chemistry by D. Pasto,C Johnson and Miller 1992,
Prentic Hall, New Jersey.

92

SECOND SEMESTER
MPMC 201: ADVANCED ORGANIC CHEMISTRY II Theory

35 Hrs.

1.a)Mechanism, reactivity and orientation of elimination reaction including effect of solvent,

base and substrate on reactivity and orientation with examples.
1.b)Mechanism, reactivity and orientation of addition reactions of carbon - carbon multiple
bonds.
2.a)Mechanism, reactivity and orientation of electrophilic aromatic substitution reactions effect
of substituent on reactivity and orientation.
3.a) Mechanism, reactivity and orientation of aromatic nucleophillic substitution reactions.
3.b) IUPAC nomenclature of polycyclic aromatic system, fused ring system and heterocyclic
ring systems. Familiarity with naming of drugs from official books.
4. Stereochemical principles:
a) Symmetry elements: Axis of symmetry, Plane of symmetry, Rotation-reflection,
symmetry, Centre of symmetry, Reflection symmetry.
b) Introduction, Homomers, Isomers, Constitutional isomerism, stereoisomerism. Cis-trans
isomerism, Conformation, conformational changes and energy barriers, conformational
isomerism, Isomerism in biphenyls, Amine inversions.
c) Absolute configuration, R,S notation and Z,E notation
5. Application of stereochemical principles:
a. Conformations of saturated cyclic systems:
Introduction, cyclohexane, monosubstittued cyclohexanes, cyclopentane, small rings,
bridged rings (norboranes), fused rings (steroids)
b.Chiral compounds:
Molecules with one chiral centre, molecules with a chiral axis, molecules with a chiral
plane of symmetry, molecules with two or more chiral centers, characterization of
enantiomers by chiroptical methods: polarimetry, NMR, Calorimetry, Enzyme techniques.
Optical rotatory dispersion (ORD), Circular dichroism (CD), X-ray diffraction,
Configuration: relative and absolute, Resolution of enantiomers,
Reference Books
1. Organic Chemistry, Morrison and Boyd, prentice hall Pvt. Ltd., New Delhi.
2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.

93

3. IUPAC Nomenclature of Organic Chemistry, Riguady, J. Klesney, S.P., Pergamon Press,

New York.
4. Solomons Organic chemistry,5th edition, John wiley & Sons, New York.
5. Stereochemistry of carbon compounds, Eliel
6. Stereochemistry , Potopov, 1979, MIR Publishers, Moscow.
7. Organic Chemistry, I.L. Finar Vol I&II, ELBS,6th edition,1985.
8. Stereochemistry of Organic Compounds by D. Nasipur 1992,Wiley Eastern Ltd..
MPMC 202: MEDICINAL CHEMISTRY I Theory

35 Hrs.

1. Process of drug handling by the body I

Introduction, Absorption: Structure of cell membranes, modes of transfer across cell
membranes, passive diffusion, carrier-aided transfer, pinocytosis, persorption, filtration or
aqueous diffusion, diffusion of ions; routes of administration, enteral, parenteral.
Distribution: Fluid compartments, capillary structure, tissue perfusion; gradients of pH and
binding; pH, binding; partition into fat, active transport, Blood-brain barrier, placental
barrier.
2. Process of drug handling by the body II
Metabolism: Phase I metabolism, Oxidations, Reductions, Hydrolyses; Phase II metabolism:
Glucuronide formation, Sulphate formation, Methylation, Acylation; Glutathione
conjugation; Factors influencing metabolism: Stereoisomerism, Presystemic metabolism,
Dose-dependent metabolism, Inter-species variation, Intra-species variation, Age, Inhibition
of metabolism, Induction of metabolism; Excretion: Renal elimination of drugs; Glomerular
filtration, Active tubular secretion, Passive reabsorption, Renal clearance and half-life, Renal
elimination in diseases, Biliary elimination, Drugs in saliva, Drugs in milk, Drugs in expired
air, Elimination in other secretions.
3. Influence of formulation on drug availability
Introduction, Formulation aims: Physico-chemical factors influencing drug bioavailability;
Rates of solution, Complexation, Drug stability; Influence of route of administration and type
of dosage form; Formulation factors; Solutions, Emulsions, Soft gelatin capsules,
Suspensions, Hard gelatin capsules, Tablets, coated tablets: Sustained release dosage forms;
Bioequivalence.
4. Receptors
Structure, Forces involved in drug-receptor binding: Electrostatic interaction, Ion-dipole and
dipole-dipole interaction; Hydrogen bonding, Van der Waals Forces, Hydrophobic binding,
Ionisation, Determination of drug-receptor interaction; Drug-receptor theories: Occupancy
theory, Rate theory, Induced fit theory, Macromolecular perturbation theory, Activationaggregation theory

94

5. Metal complexation and salt formation in drug design

Metal complexes in drug action and biological systems: foreword, coordination complexes,
coordination number, chelating agents and chelation, Ligand selectivity, Medical
applications, Metal chelation in antibacterial activity, Chelation in anticancer activity, Iron
preparations, Metal-binding in enzyme action: Choice of anion (or cation) for salt formation:
Introduction, Factors affecting choice of anion (or cation)
Books for Reference
1. Smith, H.J. and Williams, H., Introduction to the Principles of Medicinal Chemistry, John
Wright & Sons, Bristol, 1983
2. Silverman, RB. The Organic Chemistry of Drug Design and Drug Action, Academic Press,
Inc., New York, 1992
3. Foye, W.O., Lemke, T, L. and Williams, D, A., Principles of Medicinal Chemistry, B.I.
Waverly Pvt. Ltd., New Delhi, 1995
4. Nogrady, J. Medicinal chemistry, A Biochemical Approach, New York, Oxford University
Press, 1985.
5. Roberts, S.M. and Prince, B.J. Medicinal chemistry, The Role of organic chemistry in
Research, New York, Academic Press, 1985.
6. Franke,R. Theoretical Drug Design Methods, Amsterdam, Elsevier, 1984.
7. Martin, Y.C. Quantitative Drug Design, New York, Marcel Dekker, 1978.
8. Yalkowsky, S.H, et.al., (Eds.), physical chemical properties of Drugs, New York, Marcel
Decker,1978.
9. James N. Delgado & William A.Remer (eds), Text Book of Organic Medicinal Chemistry.
9th edn., J.B.Lippincot Philadelphia,1991.
10. Wolff (ed), Burgers Medicinal Chemistry and Drug Discovery, Vols. 1-4, 5 th edn., New
York, Wiley-Interscience,1995
11. Keverling Buisman, J.A., Strategy in Drug Research, Vol.4, Elsveir Scientific Publication
Company Inc, 1982.
MPMC 203: MEDICINAL CHEMISTRY II Theory

35 Hrs.

Mode of discussion: Medicinal chemistry aspects to be covered, explain drug action on

molecular biochemical basis, discuss structure activity analysis, stereochemical consideration,
therapeutic utility (Excluding synthesis)
1. Antiviral agents: Viral diseases, viral replication and transformation of cells, anti viral
agents: drugs involved inhibition of stages of viral riplication, amantadine, interferon,
Zidovudin. Agents interfering with viral neuclic acid replication: acyclovir, iodoxuridin,
trifluorothymidine, vidaravin, cytaravin, rivaverin. Agents affecting translation of ribosomes.
Investigational antiviral agents.

95

2. Antineoplastic drugs: Nature of cancer occurrence, terminology, cell growth cycle.

Mechanism of tumour formation: Mutation, changed gene expression, viruses, chemicals,
and radiations. Chemotherapy: limitation, mode of action. Anti neoplastic drugs:
anyimetabolites, alkylating agents, DNA intercalating agents, antibiotics, and anymitotic
agents.
3. Antipsychotic agents: Classification, drugs used in treatment of psychosis: phenothiazines,
thiozanthenes, butyrophenones, dibenzazepines, dihydroindolones, benzamides, Rawolfia
alkaloids, benzoquinolines
4. Antihypertensive agents: Hypertension, centrally acting antihypertensive agents, adrenergic
neuron blockers, ganglion blockers, beta adrenergic blockers, drugs acting on renninangiotensin system, calcium channel blockers and vasodialators.
5. NSAID Classification of rheumatic diseases. Role of chemical mediator in inflammation.
Antipyretics and analgesics. Anilines and para amino phenols. Anti inflammatory agents:
salicylates, 3,5 pyrazolidine diones, arylalkanoic acid, aryl and hetero aryl propionic acid, N
arylanthranilic acid, and oxicams
6. Peptides and peptide hormones: Angiotensin, oxytocin, anti diuretic hormone, bradykinin,
and insulin. Design of drugs based on peptide hormone.
7. Prostaglandins and leucotrienes
Books for Reference:
1. Smith, H.J. and Williams, H., Introduction to the Principles of Medicinal Chemistry, John
Wright & Sons, Bristol, 1983
2. Silverman, RB. The Organic Chemistry of Drug Design and Drug Action, Academic Press,
Inc., New York, 1992
3. Foye, W.O., Lemke, T, L. and Williams, D, A., Principles of Medicinal Chemistry, B.I.
Waverly Pvt. Ltd., New Delhi, 1995
4. Nogrady, J. Medicinal chemistry, A Biochemical Approach, New York, Oxford University
Press, 1985.
5. Roberts, S.M. and Prince, B.J. Medicinal chemistry, The Role of organic chemistry in
Research, New York, Academic Press, 1985.
6. Franke,R. Theoretical Drug Design Methods, Amsterdam, Elsevier, 1984.
7. Martin, Y.C. Quantitative Drug Design, New York, Marcel Dekker, 1978.
8. Yalkowsky, S.H, et.al., (Eds.), physical chemical properties of Drugs, New York, Marcel
Decker,1978.
9. James N. Delgado & William A.Remer (eds), Text Book of Organic Medicinal Chemistry.
9th edn., J.B.Lippincot Philadelphia,1991.
10. Wolff (ed), Burgers Medicinal Chemistry and Drug Discovery, Vols. 1-4, 5 th edn., New
York, Wiley-Interscience,1995
96

11. Keverling Buisman, J.A., Strategy in Drug Research, Vol.4, Elsveir Scientific Publication
Company Inc, 1982.
MPMC 204: NATURAL PRODUCTS CHEMISTRY Theory

35 Hrs.

1. General methods of isolation and separation of plant constituents, Qualitative reactions

employed for the detection of plant constituents. Application of GLC, HPLC and counter
current distribution for separation and analysis of plant constituents. Application of IR,
H1NMR, mass spectroscopy to structural determination of natural products.
2. A general study of the chemistry of anti- bacterial antibiotics, anti-fungal antibiotics, anti-viral
antibiotics with detailed study of newer semi-synthetic Penicillins and Cephalosporin.
3. WHO Guidelines for evaluation of safety and efficacy of herbal medicine, quality
specifications of plant materials and toxicity studies of herbal medicines.
4. A detailed study of the following classes of natural products with special importantance to
occurrence, chemistry, biosynthesis, isolation, purification and estimation by physical,
chemical and biological methods.
a) Alkaloids Indole alkaloids (Reserpine, Vinblastine etc.), Morphine and related
alkaloids.
b) Vitamins Vitamin A, Folic acid, Vitamin B12 and Vitamin C
5. Steroids Detailed study of the structure and stereochemistry of steroid nucleus,
Transformation of Steroids by micro-organism and synthesis of the following Cholesterol,
Ergosterol (irradiation product), Oestrogen, Progesterone, and Testosterone
Method of isolation and estimation of the following natural products:
a. Diosgenin,
b. Quinine
c. Emetine
d. Penicillin and streptomycin
Books for Reference :
1. I. L .Finar,Organic chemistry Vol.-II 5th edition,ELBS.
2. S. William Pelletier Alkaloid chemical and biological perspective
3. Trease and Evans Pharmacognosy, 14 th edition, ELBS.
4. Tyler, V.E., Brady, L.R., Robbers, J.E., Pharmacognosy, 8th ed., Lea & Febiger, Philadelphia,
USA.
5. Asolkar, Diosgenin and other steroid drug precursor, CSIR
6. Weinsten. M.I, Wegman, G.H, Antibiotics, Isolation and separation.
7. Gorog.S.,Quantitative analysis of steroids

97

8. E.Vardemme, Biotechnology of Industrial antibiotics

9. Vapoorte, Swendson, Chromatography of Alkaloids.
10. Clerks Isolation and identification of Drugs by A.C. Mottal
11. Burgers Medicinal chemistry by Wolff .M.I., 4 th edition.
12. Wilson and Gisvolds Text Book of Oraganic Medicinal and Pharmaceutical Chemistry, 8th
edition.
13. Phytochemical methods of chemical analysis by Horborne.
14. The use of Pharmacological techniques for the evaluation of natural products by B.N.
Dhavan; R.C.Srimal, CDRI, Lucknow.
15. Weiss creger, Techniques in organic chemistry
16. Nakanishi Golo, Natural Product Chemistry
17. Bentley, The Alkaloids Part I and Part- II
18. Fischer and Fischer, Steroid.
19. Indian Pharmacopoeia, 1996.
20. Makin and Gower, Steroid analysis.
21. Bernard Fried and Sharma, Thin Layer Chromatography techniques and applications 2nd
edition.
22. N.S.Egorov, Antibiotics A Scientific Approach.
MPMC 205: DRUG DESIGN AND DRUG ACTION - THEORY

35 Hrs.

1. Drug Discovery, Design and Development

Drug discovery: Drug discovery without lead, Lead discovery: Random screening, Nonrandom screening, drug metabolism studies, clinical observations, Rational approach to lead
discovery. Drug Development: Lead modification: Identification of active moiety, Functional
groups modification, Structure-activity relationship. Structure modifications to increase
potency and therapeutic index: Homologation, Chain branching, Ring-chain transformations,
bio-isosterism, and Quantitative structure activity relationship (dealt under theoretical aspects
of drug design).
2. Theoretical Aspects of Drug Design
Introduction, Theoretic Approaches: Property-Activity Relationships, Intrinsic Activity and
Linear Free-Energy Relationships, Antibacterial Effect of Sulfonamides, Drug transport,
Quantitative structure-activity relationships; Quantitative Model Construction: Property-Based
Models, Structure-Based Models, Quantum Mechanics, Properties Calculated by MO Theory,
Molecular Conformation, Computer Graphics Simulations. Introduction to Combinatorial
chemistry
3. Drug Metabolism and Drug design
Pro-drugs: Design of pro-drugs to improve physical and biological properties of a drug:
98

Enzymes concerned in activation of pro-drugs, Modification leading to increased absorption of

a drug. Current research: Modification leading to elimination of unwanted physical properties
of a drug; Modification leading to restriction of a drug to a specific site in the body, Enhanced
enzyme activity, Differential pH. Modification leading to increased duration of action. Design
of more efficient drugs from knowledge of drug metabolism: Modification leading to shorter
action, Modification leading to longer action, steric hindrance of a vulnerable group,
Replacement of a vulnerable group, Design of soft drugs
4. Enzyme Inhibitors and Drug Design
Introduction, Basic concept, characteristics of potential drugs: Types of inhibitors; Reversible
inhibitors and irreversible inhibitors, kinetics of reversible and irreversible enzyme inhibition,
reversible and irreversible inhibitors as drugs:
Examples of reversible enzyme inhibitors (antimetabolites) used as drugs: Antibacterial
sulphonamides; Mode of action, Folic acid analogues in cancer chemotherapy, and bacterial
(and protozoal) chemotherapy, Purine and Pyrimidine analogues in cancer (and viral)
chemotherapy, Antihypertensive drugs
Examples of irreversible enzyme inhibitors used as drugs including affinity leveling agents and
mechanism based enzyme inhibitors such as Penicillin and Cephelosporin, Aspirin, Anticonvulsant drug, Anti-depressant drugs.
5. Drug Stereochemistry and Drug Design
Stereoisomerism in pharmaceuticals: Chirality: Impact of enantiomerism on the
pharmacokinetic, pharmacodynamic profile of chiral drugs, Development of enantiopure chiral
drugs, Enantioselective analysis and current regulatory affairs (US FDA, CDER) on the
development of chiral drugs. Conformational Isomerism: Influence on biological action, Cistrans isomerism: Impact on biological action.
Books for Reference:
1. Smith, H.J. and Williams, H., Introduction to the Principles of Medicinal Chemistry, John
Wright & Sons, Bristol, 1983
2. Silverman, RB. The Organic Chemistry of Drug Design and Drug Action, Academic Press,
Inc., New York, 1992
3. Foye, W.O., Lemke, T, L. and Williams, D, A., Principles of Medicinal Chemistry, B.I.
Waverly Pvt. Ltd., New Delhi, 1995
4. Nogrady, J. Medicinal chemistry, A Biochemical Approach, New York, Oxford University
Press, 1985.
5. Roberts, S.M. and Prince, B.J. Medicinal chemistry, The Role of organic chemistry in
Research, New York, Academic Press, 1985.
6. Franke,R. Theoretical Drug Design Methods, Amsterdam, Elsevier, 1984.
7. Martin, Y.C. Quantitative Drug Design, New York, Marcel Dekker, 1978.
8. Yalkowsky, S.H, et.al., (Eds.), physical chemical properties of Drugs, New York, Marcel
Decker,1978.

99

9. James N. Delgado & William A.Remer (eds), Text Book of Organic Medicinal Chemistry.
9th edn., J.B.Lippincot Philadelphia,1991.
10. Wolff (ed), Burgers Medicinal Chemistry and Drug Discovery, Vols. 1-4, 5 th edn., New
York, Wiley-Interscience,1995
11. Keverling Buisman, J.A., Strategy in Drug Research, Vol.4, Elsveir Scientific Publication
Company Inc, 1982.
MPMP 206: NATURAL PRODUCTS CHEMISTRY Practical
45 Hrs.
1. Screening of natural products for biological activities.
2. Estimation of elements and functional groups in natural products.
3. Exercise involving the extraction, isolation, separation and characterisation by modern
methods and quantitative estimation of therapeutically important phyto -constituents.
Reference Books
1. Phytochemical methods and chemical analysis by Horborne
2. The use of Pharmacological techniques for the evaluation of natural products by B.N.
Dhavan; R.C.Srimal, CDRI, Lucknow.
3. Techniques in organic chemistry by Weiss creger
4. Practical Pharmacognosy by Dr.C.K.Kokate,5th edition, Vallabh Prakashan.
5. Practical Pharmacognosy by Dr. P.K.Lala
6. Natural Product chemistry Nakanishi Golo
7. Natural Product chemistry A Laboratory Guide Raphaetkhan
8. Indian Pharmacopoeia 1996
9. British Pharmacopoeia 2001
10. Steroid analysis by Makin and Gower.
11. Clerks Isolation and Identification of Drugs by A.C.Mottal.
MPMP 207: MEDICINAL CHEMISTRY Practical
70 Hrs.
1. Carryout the organic synthesis to illustrate Esterification, Friedal Crafts reaction, Oppenaur
oxidation, Benzilic acid rearrangement, conversion of Cis isomer to trans isomer, Free
radical coupling reaction etc.,
2. Synthesis, purification and identification of the following compounds employing qualitative
analysis, Thin Layer Chromatography and FTIR
a) Sulphonamides
b) Benzocaine
c) Coumarin derivatives etc
3. Workshop on drug stereochemistry
4. Any other exercise to substantiate theory
Books for Reference:
1. Stereochemistry of Organic Compounds by D. Nasipur 1992,Wiley Eastern Ltd..
2. Reaction mechanism in Organic Chemistry by S, M.Mukherjee and S.P.Singh.
3. Guide Book to Organic Synthesis by R.K.Nakie and Smith
4. T.L.C techniques and Application, 2 nd edition ,by Bernard Fried and Sharma.
5. Spectrometric Identification of Organic compounds by Silverstein.

100

THIRD SEMESTER
MPMC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS
(Theory)
35 Hrs.
[Student should be familiar with pharmaceutical/chemical applications and use statistical tools,
by way of calculations, but not expected to derive and find proof.]
1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of thesis
and conventions adopted in writing; citing references; preparation of oral, poster
presentation. Accessing required information in a systematic manner from abstracts, books
journals, conference proceedings, thesis and dissertations, internet, CDROM etc. Ethics,
rights, permissions
2. The Population - The sample; measures describing the center of data distributions;
measurement of spread of data. Introduction to Probability - The Binomial and Normal
distributions - their significance.
3. Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t
tests, F tests, ANOVA [one way], Chi square test.
4. Linear regression and correlation.
5. Control charts Constructing control charts, between batch variation as a measure of
variability, quality control charts in research and development, quality control charts for
proportions.
6. Non parametric methods
7. Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed rank
test; Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for
randomness; Contingency tables.
References:
1. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series.
2. How to write and publish a scientific paper, 4 th Ed., Robert A DayCambridge University
presses.
3. Fundamentals of Analytical Chemistry7th Ed., Skoog, West, Holler Saunders College
Publishing.
MPME 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory)35 Hrs
1. Pre formulation studies and new formulation development.
2. New drug development and approval process: Investigational New Drugs
(IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) ,
ICH requirements for registration of pharmaceuticals.
3. Validation techniques.
4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of
dissolution characteristics, bioavailability enhancers.
5. Pharmaceutical product stability testing- ICH guidelines.

101

6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer

solution, gel formation, coacervation, phase separation, microencapsulation, mechanical
properties, biomedical uses of polymers.
Books for Reference:
1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20 th Ed.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3rd Ed.,
Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Ed., Marcel Dekker, Inc., New
York, 1995.
4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Ed., Churchill Livingstone, New York, 1996.
5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery
Systems, 7th Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
6. FDA Code of Federal Regulations, Title 21, Part 300 314.
7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.
8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.
MPME 302(2)

PHARMACEUTICAL HEALTH CARE - THEORY

35 Hrs.

1.
2.
3.
4.
5.
6.

Concept and necessity of Pharmaceutical Health care.

A rational approach in paediatrics and geriatric care.
Therapeutic consideration with rational approach during pregnancy and lactation.
Evaluation of Immune system and its fuctions.
Rational use of antimicrobials.
Assessment and clinical significance of malnutrition, enteral and parentral nutrition,
Nutritional consideration in major organ failure.
7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus,
Peptic Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma.
8. Self care: Constipation, Common cold, cough, pain, and sun light protection.
REFERENCES :
1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical
Association, Washington.
2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569
3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.
4. Standard Treatment Guidelines
m) by WHO
n) by Government of India
o) by Various state governments

102

MPME 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY

35 HRS.

1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision;

classification of errors, estimation of errors, sources of errors, minimization of errors, normal
distribution of errors. Significant figures in analytical chemistry rules and computations.
2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves external
standard methods, internal standard method, standard addition method [applications in HPLC
and GLC with calculations], linear regression of straight line calibration curvesusing the
regression equation[applications and calculations].
3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques
sampling techniquesrandom, stratified, systematic, cluster, for quality control. Sample
preparation reducing particle size, making solutions, separating analyte from interferants
extraction, automated extraction, solid phase extraction, solid phase micro extraction, super
critical fluid extraction and micro wave assisted extraction.
4. Validating the analytical method including bio-analytical method: Need for validation;
historical background; validation of analytical procedures-- methodologyguidelines of
ICH; FDA; USP. Understanding of the following concepts in validationaccuracy,
precision, specificity, limit of detection, limit of quantification, blind analysis of standard
sample, ruggedness testing, robustness testing, equivalency testing. Validating the method as
standard methodcollaborative testtwo sample collaborative testing, control charts.
5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column, Mobile
phase, Special additives. Method Development guiding tools: Separation factor, Selectivity
factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic phase, Aqueous
phase, Additional Variables: pH, Stationary Phase, Temperature. Column Conditions: Flow,
Column dimension, Particle diameter. Derivatisation.
6. System suitability tests as per Pharmacoepoeial specification.
7. Development of stability indicating analytical method
Books for References:
1. HPLC method development, Lunn. G(1996),John wiley & Interscience.
2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family
Welfare.
3. British Pharmacopeia (1993) London, Her Majestys Stationery Office.
4. ICH guide lines: validation of analytical procedures, methodology, November 1996.
5. Vogels text book of quantitative inorganic analysis 5th Ed.
6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series,
1993.
7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.

103

8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college
publishing.

MPME 302(4): CLINICAL PHARMACOLOGY -THEORY

(35 Hrs)

1. (a) Definition and scope of clinical pharmacology, measurement of drug response

in man.
(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance
data analysis & presentation skills
(c) Pharmaco- epidemiology.
2

(a) Drug Drug interaction, Drug food interaction, and Drug disease
interaction in clinical pharmacology.
(b) Adverse drug reactions and ADR monitoring.

(a) Essential drug list, national drug policy

(b) Orphans drugs
(c ) Therapeutic drug monitoring, Pharmacists intervension in Therapeutic drug
monitoring in special situations such as pediatrics, geriatric and pregnant
cases.

Books for reference:

1. Goodman and Gillmans The Pharmacological Basis of Therapeutic 9 th Ed.
2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.
3. Remingtons Pharmaceutical Sciences 19th Ed.
4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach
Vol 1. and 2
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and
V.Austel
6. Practical approach in toxicity studies by pooley and leslie
7. Screeining methods in Pharmacology by R.A.Tuner
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett
9. Methods of clinical drug trials by Aln Sperit and Smion
10. Alternatives to animal experiments: Developing in-vitro methods and changing
legislation. TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22
12. Clinical drug trial and tribulations by Allan E.Cato (1980).
13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.GrehameSmith and J.K.Aronson.

104

14. International aspects of drug evaluation and usage by Jouhar and Grayson.

MPME 302(5): STRATEGY IN DRUG SYNTHESIS Theory

35 Hrs.

1. Organic Name Reaction :

Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann
rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius
rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement,
Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction,
Reformatsky reaction, Scmidt rearrangement.
2. Introduction: Basic rules in disconnection.
3. Application of Synthon approach to drug synthesis: Case Studies.
a. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine.
b. Adrenergic agents: Stimulants, Epinephrine, Ephedrine.
c. Adrenergic blocking agents: Propranolol, Guanethidine.
d. Psychotropic agents: Chlorpromazine, Chloprothixene.
e. Antidepresants: Imipiramine.
f. CNS Stimulants: Amphetamine.
g. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.

Books for Reference:

1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.
2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.
3. Solomons Organic chemistry 5th Ed.
4. Organic Chemistry, I.L. Finar Vol. I, ELBS.
5. Modern Synthetic reaction, H.O.House.
6. Some Modern Method of Organic Synthesis, W. Carruthers.
7. Designing organic synthesis with work book a programmed introduction to the synthon
approach, Stuart Warren.
MPME-302(6): PHARMACOBIOTECHNOLOGY (Theory)

35 Hrs.

1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process.

Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture,
Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial
growth, Down stream processing, Microbial products, Improvements in microbial strains.

105

Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid and
Penicillin.
2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic
nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes. Methods
of enzyme production. Profile of some important enzymes: Hyaluronidase, Penicillinase,
Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier matrices, Materials and
Methods of immobilization (Adsorption method, Covalent bonding, Entrapment,
Encapsulation). Advantages and disadvantages of immobilization. Application of Enzymes
and Immobilized enzymes.
3. Plant Tissue Culture Technology: Introduction and scope. Princple underlying plant culture
(totipotency). Nutrient media composition and preparation. Role of plant growth regulators in
Cell culture. Laboratory requirements for plant tissue culture. Aseptic techniques and
Maintenance of Aseptic environment. Basic steps in plant tissue/cell/organ culture. Selection
and preparation of explants. Surface sterilization of explants.
4. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ
culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell culture.
Applications of plant tissue/cell culture: Micropropagation & Cloning, Genetically modified
plants, Medicinal plant improvement, Production of secondary metabolites. Survey of
phytochemicals produced through plant cell cultures.
5. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and
Methodologies for biotransformation. Cell immobilization, Advantages of cell
immobilization. Illustrations of biotransformations with special reference to steroids.
Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine,
Hydroxylation of beta methyl digitoxin, Arbutin).
6. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and enzymes
involved. Steps in engineering the Genes and the enzymes involved. Cloning vectors.
Introduction of rDNA into a host cell. Screening and selection of recombinants. Typical
examples of Recombinant DNA technology products (human insulin, human growth
hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).
Books for Reference:
1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi.
2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007,
Pharma Book Syndicate, Hyderabad.
3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age
International Publishers, New Delhi.
4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age
International Publishers Ltd., New Delhi.
5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004, NIIR,
New Delhi.
6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi.
7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.

106

MPMT 303: Thesis Phase I

Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to
be completed at the beginning of Third Semester. The candidate has to prepare an Orientation
Report.
FOURTH SEMESTER
MPMT 401: Thesis Phase II
THESIS
III and IV SEMESTERS
Phase-I
In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other
allied organizations to provide orientation & exposure. Simultaneously the student will carry out
a small project leading to a report at the end of that period. The faculty member of the
department and an expert from the respective organization jointly evaluate the report for 10
marks. The students are expected to identify a project towards their thesis and start working on it
and submit Phase I thesis during this stay. The students will come back to the Department to
appear for third semester examination. On completion of third semester examination the students
will return back to the industry/ Hospitals / other allied organizations where he was placed and
would continue the thesis work under the collective guidance of a faculty member and a guide
drawn from the collaborating organization.
Phase-II
The students would continue the thesis work in the fourth semester, in collaborating
organizations, under the supervision of two guides one from the Department and another from
collaborating organization allotted by the Head of the Department of Pharmacy.

107

M.Pharm (Industrial Pharmacognosy)

Subjects
First Semester
MPGC 101: Instrumental methods of Analysis Theory (Common to all Branches)
MPGC 102: Modern Analytical Techniques Theory (Common to all Branches)
MPGC 103: Dosage Form Design (Theory) (Common with M. Pharm. Industrial
Pharmacy)
MPGC 104: Advanced Pharmacognosy (Theory)
MPGC 105: Pharmacology and Screening Methods Theory (common with M.Pharm
Pharmacology, Pharmaceutical Chemistry)
MPGP 106: Pharmaceutical Analysis Practical (Common to all Branches)
MPGP 107: Advanced Pharmacology Practical (Common with M.Pharm Pharmacology)
Second Semester
MPGC 201: Herbal Drug Technology Theory
MPGC 202: Quality Assurance of Herbal Drugs Theory (Common with M.Pharm. Quality
Assurance)
MPGC 203: Industrial Pharmacognosy Theory
MPGC 204: Natural Products Chemistry Theory (Common with M.Pharm Pharm.
Chemistry)
MPGC 205: Pharmaceutical Production Management Theory (Common with M.Pharm
Industrial Pharmacy)
MPGP 206: Herbal Drug Technology Practical
MPGP 207: Quality Control of Herbal Drugs & Herbal Products Practical (Common with
M.Pharm. Quality Assurance)
Third Semester:
MPGC 301: Research methodology and Pharmaceutical Statistics Theory (Common to all
branches)
MPGE 302:
1.
2.
3.
4.
5.
6.

MPGE 302(1) Advances in Industrial pharmacy Theory

MPGE 302(2) Pharmaceutical Healthcare Theory
MPGE 302(3) Analytical Method Development- Theory
MPGE 302(4) Clinical Pharmacology- Theory
MPGE 302(5) Strategy in Drug Synthesis-Theory
MPGE 302(6) Pharmacobiotechnology- Theory

MPGT 303: Thesis Phase I

Fourth Semester
MPGT 401: Thesis Phase II
108

Scheme of Examinations
Subject

I-Semester
MPGC 101 Instrumental methods of
Analysis Theory
MPGC 102 Modern Analytical
Techniques Theory
MPGC 103 Dosage Form Design
Theory
MPGC 104 Advanced
Pharmacognosy- Theory
MPGC 105 Pharmacological
Screening Methods Theory
MPGP 106 Pharmaceutical Analysis
Practical
MPGP 107 Advanced Pharmacology
Practical
II-Semester
MPGC 201 Herbal Drug Technology
- Theory
MPGC 202 Quality Assurance of
Herbal Drugs Theory
MPGC 203 Industrial Pharmacognosy
Theory
MPGC 204 Natural Products
Chemistry Theory
MPGC 205 Pharmaceutical
Production Management Theory
MPGP 206 Herbal Drug Technology
Practical
MPGP 207 Quality Control of Herbal
Drugs & Herbal Products Practical
III -Semester
MPGC 301 Research Methodology &
Pharmaceutical Statistics
MPGC 302 Elective
MPGT 303 Thesis Phase I
IV- Semester
MPGT 401 Thesis Phase II

Hrs/Week

Credits

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

2
15

--

3
6
13

Evaluation
(Marks)
sessional Univ.
Exam
25

75

25

75

25

75

25

75

25

75

25

75

25

75

25

75

Total

100
100
100
100
100
100
100
100

25

75

25

75

25

75

25

75

25

75

25

75

25

75

100
100
100
100
100
100
100

25
25
25

75
75
75

100
100
100

109

Syllabus
FIRST SEMESTER
MPGC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory) 35 Hrs.
1. UV-Visible Spectrophotometry: Theory Beer and Lamberts Law - Limitations of the
law, Design and working of single beam and double beam spectrophotometers. Applications
of UV absorptions spectrophotometry in qualitative analysis and quantitative analysis.
2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence. Chemical
structure and fluorescence - factors affecting fluorescence intensity. Instrumentation and
Pharmaceutical applications of fluorimetry.
3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation
Types of interference and elimination of interference - Pharmaceutical applications
4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion
exchange chromatography and super critical fluid chromatography.
5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle,
Instruments and application. Chromatographic attributes: Capacity factor, resolution,
theoretical plates and symmetry factor
6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass spectrometry
7. Introduction to Radio Immuno Assay
Books for Reference:
1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of quantitative
inorganic analysis, ELBS, London.
2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone
Press London.
3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry, Saunders
College publishing, New York.
4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college publishing,
New York.
5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
6. V.K.
Srivastava
and
K.K.
S. Chand & Company, New Delhi.

Srivastav,

Introduction

to

Chromatography,

7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall
London.
9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric
Identification of organic Compounds, John Wiley & Sons, New York.

110

10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.
11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.
12. Mofat, A.C (Ed). Clarkes Isolation and Identification of Drugs, The pharmaceutical press,
London.
13. Pharmacopoeia of India, Govt. of India, Ministry of Health.
14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.
15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.
16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea & Febiger,
Philadelphia.
MPGC 102: MODERN ANALYTICAL TECHNIQUES (Theory)

35 Hrs.

1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample preparation application of IR spectrophotometry in pharmacy. Introduction to FTIR
2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift,
magnetic equivalence spin-spin decoupling shift reagents, applications of NMR
spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple
organic compound as example)
3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron
bombardment, chemical ionization, field desorption, fast atom bombardment. Different
analysers. Interpretation of mass spectra, determination of molecular weight and molecular
formula and applications of mass spectrometry
4. Theory, instrumentation and applications of Differential Thermal Analysis and Differential
Scanning Calorimetry.
5. A preliminary study of principle, Instrument and applications of 13C NMR
6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins &
antibiotics
Books for reference:
1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone
Press London.
2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college publishing,
New York.
3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis,
Wadsworth, New York.
4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.
5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall
London.

111

6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric

Identification of organic Compounds, John Wiley & Sons, New York.
7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.
8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.
9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.
10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
MPGC 103: DOSAGE FORM DESIGN (Theory)

35 Hrs.

1. Manufacturing and Quality control of solid dosage forms: Tablets and Capsules.
2. Manufacturing and Quality control of liquid dosage forms: orals and topicals.
3. a) Parenterals formulation development and evaluation
b) Aerosol Formulation Development and its Quality Control
4. Radio pharmaceuticals: Background information, dosage formulation, diagnostic and
therapeutic uses, production, quality assurance, storage and safety hazards.
5. Selection and evaluation of packaging materials, containers and closures, special problems of
container product interactions. Pharmacopoeial specifications, tests and standards for
packaging materials.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3 rd Edn,
Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Marcel Dekker, Inc., New
York, 1995
4. Lachman L, et al, Pharmaceutical Dosage Forms: Parenteral Medications, 2nd Edn., Vol I
& II, Marcel Dekker, New York, 1992.
5. Lachman L, et al, Pharmaceutical Dosage Forms: Tablets, 2 nd Edn., Vol I, II & III,
Marcel Dekker, New York, 1992.
6. Turco S and King R E, Sterile Dosage Forms, 3 rd Edn., Lea & Febiger, Philadelphia,
1987.
7. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Edn., Churchill Livingstone, New York, 1996.
MPGC-104: ADVANCED PHARMACOGNOSY (Theory)
35 Hrs
1. Plants as source of medicines. Survey of Plant derived modern drugs and their sources.
Drug development from Plants a Flowchart. Principles and procedures involved in
collection; identification, phytochemical screening of medicinal plants of research
interest. Good Practices for Medicinal plant and herbal raw material identification and
authentication. Sources of information on medicinal plants.

112

2. General aspects in the cultivation of medicinal and aromatic plants. Classification of

herbal drugs. Introduction to Chemotaxonomy. Status and Significance of
chemotaxonomy. Compounds useful in taxonomy of medicinal plants, Illustrations of
Chemotaxonomical significance of some important metabolite compounds.
3. Current status and scope of Marine Pharmacognosy. Bioactive agents from Marine
organisms, general methods of isolation and purification. Study of Cardiovascular,
Antimicrobial, Antibiotic, Anti-inflammatory, antispasmodic, Heparin-like substances
and Cytotoxic compounds from marine sources.
4. Review of Traditional System of Medicine (TSM). Role of Natural products in
Alternative System of Medicines like Ayurveda, Siddha, Unani, Chinse, Homeopathy and
Tribal Medicine. Study of different dosage forms and methods of preparation in TSM.
Standardization of Ayurvedic, Siddha Dosage forms and associated problems.
5. Study of major Phytoconstituents, Medicinal uses, Pharmacology, Adverse effects and
Herbal medicinal products of the following plant drugs: Andrographis paniculata herb,
Calendula officinalis flowers, Eucalyptus oil, Hypericum perforatum herb, Peppermint
oil, Ocimum sanctum herb, Silybum marianum fruits, Curcumae Longae rhizomes,
Centella asiatica herb, Bacopa monnieri, Echinaceae Purpureae, Panax ginseng root, Aloe
Vera Gel, Withania somnifera, Valeriana officinalis roots, Ginkgo biloba leaves,
Phyllanthus amarus, Terminalia arjuna.
6. Secondary metabolism: Origin and building blocks of secondary metabolites. Shikimic
acid pathway and Mevalonate pathway. Biosysnthesis of following metabolites: Geraniol,
Citronellol, Limonene, Cineole, Fenchone, Menthol. Ephedrine, Hyoscyamine, Cocaine,
Papaverine, Morphine, Ergotamine. Digitoxigenin, Capsaicin and Sennosides.
Books for Reference:
1. Paul M Dewick , Medicinal Natural Products Biosyntheric Approach, 2002, John Wiley
& Sons, Ltd. New York, Singapore.
2. William Charles Evans, Trease & Evans' Pharmacognosy, 15th Edition, 2001, Elsevier
Ltd., New York, Chennai.
3. Michael Heinrich, Joanne Barnes, Simon Gibbons and Elizabeth M. Williamson,
Fundamentals of Pharmacognosy and Phytotherapy, 2004, Elsevier Ltd., New York,
Chennai.
4. Ansari S.H., Essentials of Pharmacognosy, First Edition, 2006, Birla Publications Pvt.
Ltd., Delhi.
5. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Edition, 2006, New Age
International Publishers Ltd., New Delhi.
6. WHO, WHO Monographs on selected medicinal plants.Vol. 1., 1999, WHO
Publication, Geneva.
7. WHO, WHO Monographs on selected medicinal plants.Vol. 2., 2004, WHO
Publication, Geneva.
8. WHO, WHO Monographs on selected medicinal plants.Vol. 3., 2007, WHO
Publication, Geneva.

113

9. C. K. Kokate, A. P. Purohit, S. B. Gokhale, Pharmacognosy, 14th edition, 2008, Nirali

Prakashan.
10. Gunnar Samuelsson, Drugs of Natural Origin: A Textbook of Pharmacognosy, 5th
Edition, 2004, Swedish Pharmaceutic.
11. Jean Bruneton, Pharmacognosy, Phytochemistry, Medicinal Plants, 2nd edition, 1999,
Lavoisier.
12. A. P. Purohit, Modern Pharmacognosy, 2008, Alpha Science International Ltd., Oxford.
13. Partap Chauhan, Ayurvedic Pharmacognosy, 2007, Sonali Publications, by New Delhi.
14. Kaviraj Nagendra and Nath Sengupta, The Ayurvedic System of Medicine, 2 volumes,
1998.
15. Atal, C.K., and Kapur, B.M., Cultivation and utilization of Medicinal plants, RRL,
CSIR, Jammu.
16. J. B. Harborne and B. L. Turner, Plant Chemosystematics, 1984, Academic Press.

MPGC 105: PHARMACOLOGICAL SCREENING METHODS

- 35Hrs

1. (a)Basic principles of screening of drugs for pharmacological activities.

(b)Pre-clinical
screening

General
screening
procedure
for
CNS
activities, General
CNS profile- Study using pole climbing pattern, Rota rod,
Actophotometer and Jiggle cage experiments.
2. (a)Specific screening procedure for local anesthetics Rabbit cornea, lumbar plexus of
frog and Infiltration anesthesia on guinea pigs
(b) Screening for anti hypertensive agents:
How to do experimentally induced hypertension in albino rats, and using these animals
for screening of anti hypertensive, anaesthetized dog method etc.
(c) Screening for anti arrhythmic activity:
A study of aconitine or digoxin or isoprenaline induced arrhythmias in animals and use of
these animals to screen anti arrhythmic drugs. Studying various types of arrhythmiasis
based on ECG pattern recorded - Isolated rabbits heart and guinea pigs atrium for anti
arrhythmic screening and isolated frog heart.
(d) Screening for analgesic and anti-convulsent activities using, hot plate, tail flick and
tail clip methods (analgesic activity) MES seizures produced in albino rats and to study
the effects of anti convulsant (phenytoin), protection of electrically induced convulsion in
albino rats. Protection of cardiazol induced convulsion in rat by sodium valproate.
3. (a) Screening for anti depressant, anti psychiatric, anti parkinsonism and anti ulcer effect
(b) Screening for anti fertility activity and anti pyretic & anti inflammatory.
(c) Screening for skeletal muscle relaxants effect of drugs using nerve muscle
preparations, phrenic nerve diaphragm and frog rectus preparation.
4

(a) Toxicological studies:

114

Acute, sub acute, and chronic toxicological studies and calculation of median lethal
dosage for drugs
Books for reference:
1. Goodman and Gilmans, The pharmacological Basis of Therapeutic 9th Ed.
2. Pharmacology, by H.P.Rang
3. Remingtons Pharmaceutical Sciences 19th Ed.
4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bacharah Vol 1.
and 2.
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and
V.Austel.
6. Practical approach in toxicity studies by pooley and leslie.
7. Screeining methods in Pharmacology by R.A.Tuner.
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett.
9. Methods of clinical drug trails by Aln Sperit and Smith.
10. Alternatives to animal experiments: Developing in-vitro methods and changing
legislation. TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989), 16-22.
12. Clinical drug trial and tribulations by Allan E.cato (1980)
13. The Oxford text book of clinical Pharmacology and drug therapy by D.G.Grehame-Smith
and J.K.Aronson
14. International aspects of drug evaluation and usage by Jouhar and Grayson.
MPGP 106: PHARMACEUTLICAL ANALYSIS (Practical)

45 Hrs.

1. Experiments based on theory subjects Instrumental methods of analysis and Modern

Analytical techniques
2. Experiments would be selected illustrating the principles involved in estimation of raw
materials and finished products representing major categories of drug formulations from
pharmacopoeias.
MPGP 107: ADVANCED PHARMACOLOGY (Practical)
1.

Laboratory animals : Breeding, maintanance and handling

preparation of Physiological solution and drug solution

2.

Screening procedure for the following drugs:

70 Hrs.

Local anesthetics, antiepileptics, antidepressants, anti-inflammatory, antidiabetics,

antiulcer, analgesics and antimicrobial agents.

115

3.

a. Cardiac stimulants and depressants on frogs heart and rabbits or guinea pigs isolated
heart
b. Spasmogens and spasmolytics on rabbits intestine
c. Frogs rectus and rats phrenic nerve diaphragm preparation.

a. Effect of drugs on blood pressure, splenic volume, intestinal movements and

respiration in anesthetized dog (with software model)
b. Acute and sub acute toxicity studies and calculation of LD50

SECOND SEMESTER
MPGC-201 HERBAL DRUG TECHNOLOGY (Theory)

35 Hrs.

1. Essential Oil Technology: Basic Chemistry of Essential Oils. Uses of Essential oils in
food, cosmetics, perfumes and therapy. Industrial production of essential oils Technology, Methods, Equipment, Fractionation and rectification of essential oils.
Standardization, physical and chemical methods of analysis of essential oils. Production
of Mentha oil, Eucalyptus oil, Sandalwood oil, Rose oil, Jasmine oil, Clove oil.
2. Unit operations in Herbal Raw material processing: Principles and methods of extraction
including maceration, percolation, hot continuous extraction, Supercritical fluid
extraction, high pressure extraction technology and Microwave assisted extraction of
herbal raw materials. Their merits and demerits. Purification and Recovery of Solvents.
3. Herbal Drug Standardization: Factors affecting Variability and Quality in herbal raw
material and the need for standardization. Problems and prospects of standardization of
Herbal Medicinal Products. Physical, Chemical, Spectral and Chromatographic
Parameters in Standardization. Role of Bio-markers in herbal drug standardization.
4. Herbal Formulations: Types of Modern herbal dosage forms and Dosage forms in
traditional systems of medicine such as Ayurveda and Siddha. Methods involved in
monoherbal and polyherbal formulations with their merits and demerits. Excipients used
in herbal formulations. Formulation of powders, granules, capsules, tablets; liquid
formulations, gels, creams, ointments and other dosage forms. Evaluation of different
dosage forms. Stability studies of herbal formulations.
5. Herbal Cosmetics: Herbal raw materials used in cosmetics such as oils, extracts, waxes,
gums, hydrophilic colloids, preservatives and Anti-oxidants. Preparation Skin care
preparations (Creams and Lotions), Sunscreens and Sunburn applications, Hair care
preparations (Hair oils and Hair shampoos, Hair dyes and Hair gels) and Beautifying
preparations(Lipsticks, Face powders and Nail polish).
6. Nutraceuticals: Introduction and Classification, Health benefits of Nutraceuticals. Review
on plant derived nutraceuticals and thier benefits. Flavonoids as Nutraceuticals. General
extraction methods for nutraceuticals from plants with emphasis on Supercritical fluid
extraction. Marine Nutraceuticals such as Omega-3 Oils, Glucosamine Sources,
Applications, and Health Benefits.

116

BOOKS FOR REFERENCE:

1. William Charles Evans, Trease & Evans' Pharmacognosy, 15 edition, 2001, Bailliere
Tindall / Elsevier.
2. John Shi, Giuseppe Mazza, Marc Le Maguer, Functional Foods: Biochemical and
Processing Aspects, Volume II, 1 st Edition, 2002, CRC.
3. Colin Barrow and Fereidoon Shahidi, Marine nutraceuticals and functional foods, 2008,
CRC Press, Florida.
4. Guenther, E. The essential oils. Vol. 1-6, Second Edition, 1992., Robert E. Krieger Publ.
Co. Malabar, Florida.
5. Panda, H., Herbal Cosmetics Handbook, National Institute of Industrial Research, 2006,
New Delhi.
6. Chaudhari R. D., Herbal drug industry, 1st edition, 1996, Eastren publisher, New Delhi.
7. Martin M. Rieger, Harry's Cosmeticology, 8 th edition, 2000, CHS Press, San Francisco,
USA.
8. loyd V. Allen, jr, Nicholas G Popovich and Howard C. Ansel, Ansel's Pharmaceutical
Dosage Forms and Drug Delivery Systems, 8th edition, 2005, Lippincott Williams &
Wilkins, Baltimore.
9. Yoshioka, Sumie, Stella, Valentino J., Stability of Drugs and Dosage Forms, 2001,
Springer-Verlag.
10. Ram I Mahato, Pharmaceutical Dosage Forms and Drug Delivery, 2007, CRC Press,
Florida.
11. Yoshioka, Sumie, Stella, Valentino J., Stability of Drugs and Dosage Forms, 2001,
Springer-Verlag.
12. NIIR Board, Modern Technology Of Perfumes, Flavours And Essential Oils, 2nd edition,
2004, National Institute of Industrial Research, New Delhi.
13. P. K. Chattopadhyay, Herbal Cosmetics & Ayurvedic Medicines, 1998, National Institute
of Industrial Research (NIIR), New Delhi.
14. NIIR Board, Handbook on Herbal Products (Medicines, Cosmetics, Toiletries, Perfumes)
2 Vols., 2002, NIIR, New Delhi.
15. H. Panda, The Complete Technology Book on Herbal Perfumes & Cosmetics, 2003,
NIIR, New Delhi.
16. H. Panda, The Complete Technology Book on Herbal Beauty Products with Formulations
and Processes, 2005, NIIR, New Delhi.
17. H. Panda, Essential Oils Handbook, 2003, NIIR, New Delhi.
18. NIIR Project Consultancy Services (NPCS), Selected Formulary Handbook, 2007, NPCS,
New Delhi.
19. H. Panda, Medicinal Plants Cultivation & Their Uses, 2002, NIIR, New Delhi.
20. NIIR Board, Handbook On Herbs Cultivation And Processing, 2004, NIIR, New Delhi.
21. H. Panda, Aromatic Plants Cultivation, Processing And Uses, 2004, NIIR, New Delhi.
22. H. Panda, Handbook on Ayurvedic Medicines with Formulae, Processes and Their Uses,
2002, NIIR, New Delhi.

117

23. S.S. Agrawal and M. Paridhavi, Herbal Drug Technology, 2007, Universities Press,
Hyderabad.
MPGC-202: Quality Assurance of Herbal Drugs (Theory)

35 Hrs.

1. The significance of quality for efficacy and safety of herbal medicinal products. Typical
problems and challenges in quality control of herbal drugs. Factors affecting Herbal drug
quality. Classification of evaluation methods for plant drugs. Macro-morphological,
Micro-morphological evaluation of herbal raw materials. WHO guidelines for Sampling
of plant drugs.
2. Physicochemical standardization parameters for herbal drugs: Determination of Physical
and chemical constants such as extractive values, moisture content, alcohol content,
volatile oil content, ash values, bitterness values, foreign matter, and physical constants
applicable to the lipid containing drugs, swelling factor, foaming index, filth, insoluble
matter etc.
3. Adulteration Introduction, Adulterants, types and methods of adulteration with
illustrations and their detection. Contamination of plant drugs, classification of
contaminants and Need for their detection. Detection and estimation of Arsenic and
Heavy Metals Cadmium and Lead. Determination of Pesticide residues. Microbial
contamination, microbial load/counts etc.
4. Rationale and concepts of metabolite profiling and fingerprinting in assessing the
efficacy, quality of phytomedicines and in general to plant drug analysis. Role of
Molecular markers in herbal drug quality assurance and associated pitfalls. A brief
review of modern extraction methods and sample-preparation techniques for the
standardization and analysis of herbal medicinal products.
5. Application of various analytical tools (including Hyphenated analytical technologies
[HAT]) in metabolite fingerprinting and profiling of plant drugs and its derivative
products in assessing their quality and efficacy. Some typical case studies (at least 3)
from scientific publications illustrating the current and modern approaches to plant drug
quality assurance.
6. Guidelines proposed by regulatory bodies on quality of herbal medicinal products,
Guidance on specifications, test procedures and acceptance criteria for herbal materials,
herbal drug preparations and herbal medicinal products. Factors affecting stability of
herbal drugs and its formulations, the relevant ICH guidelines and methods of stability
testing. WHO guidelines on GMP for herbal medicines.
Books for Reference:
1. Quality Control Methods for Medicinal Plant Materials- WHO, Geneva.
2. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, 1993,
WHO, Regional Office for the Western Pacific, Manila.
3. Guidelines for the Assessment of Herbal Medicines, 1991, WHO, Geneva.
4. Good Manufacturing Practices: updated supplementary guidelines for the manufacture of
herbal medicines, WHO, July 2005.
5. Pharmacopoeia of India, Govt. of India, Ministry of Health.
118

6. United States Pharmacopoeia, US pharmacopoeial Convention Inc. Rocville, USA.

7. Evans, W.C., Trease and Evans Pharmacognosy, ELBS / Bailliere Tindall, London.
8. World Health Organization. Regulatory Situation of Herbal Medicine. World Wide
Review. Geneva, Switzerland: World Health Organization; 1998:1-5.
9. GMP for Botanicals : Regulatory and Quality Issues on Phytomedicines, edited by Pulok
K. Mukherjee and Robert Verpoorte. New Delhi, Business Horizons, 2003
10. Liang, Y.Z., Xie, P., and Chan, K., Quality control of herbal medicines, J Chromatogr B
Analyt Technol Biomed Life Sci. 2004, 812: 53-70. Review.
11. Quality Control on Herbal Drugs - Pulok K. Mukherjee, Eastern Publishers (Business
Horizons Ltd.) New Delhi 2002.
12. Pharmacognosy, Phytochemistry, Medicinal Plants by Jean Bruneton (1999)

MPGC-203: INDUSTRIAL PHARMACOGNOSY (Theory)

35 Hrs.
1. Status of Herbal drug industry. International trade in medicinal and aromatic plants.
Potential for MAPs based industry & herbal products. Problems and prospects of
Ayurvedic and Siddha products in International markets. Intellectual property protection
and management for medicinal and aromatic plants and their products. Exploratory
survey of some patents in herbal products.
2. Good Agricultural and Collection practices (in sourcing raw materials) for MAPs based
industry. Post-harvest technology such as garbling, drying, preservation, packing and
storage in the production of herbal raw materials from medicinal plants. Rationale and
Strategies for Conservation of Medicinal Plants for sustainable Herbal Drug Production.
3. Good Manufacturing Practices (GMP) in the Manufacture of Herbal Medicinal Products.
Salient features of WHO, NHPD and EMEA guidelines. GMP aspects under Schedule-T
for ASU medicines such as Infrastructural requirements, Standard Operating Procedure,
Health, Hygiene, Documentation and Records for manufacture herbal products.
4. Evidence for safety and efficacy of finished natural health products as per WHO and
NHPD Canada guidelines. Information needed to support clinical trial of herbal products
(WHO Operational guidance). Fundamentals of clinical trials. Guideline for clinical trial
protocols for herbal medicinal products.
5. International Regulatory Affairs on Herbal Medicinal Products. Common Terms and
Abbreviations used in relavance to Herbal drug Regulatory affairs. Salient features of
FDA Guidance to the industry on Botanical Drug Products, Australian regulatory
guidelines for complementary medicine (TGA), EMEA, NHPD Canada guidelines.
6. Good Laboratory Practices (GLP). Common GLP terms and definitions. GLP Principles.
Facilities, SOPs, Documentation. Total Quality Management (TQM) and Hazard
Analysis and Critical Control Points (HACCP). Pharmaceutical Processes validation in
the context of Herbal products.
Books for Reference:
1. Roy Upton, American Herbal Pharmacopoeia: Botanical Pharmacognosy-Microscopic
Characterization of Botanical Medicines, 1st Edition, 2009, CRC.
119

2. Praveen K. Saxena, Development of Plant-Based Medicines: Conservation, Efficacy and

Safety, 1 st Edition, 2001, Springer.
3. John Shi, Giuseppe Mazza, Marc Le Maguer, Functional Foods: Biochemical and
Processing Aspects, Volume II, 1 st Edition, 2002, CRC.
4. Philip W Grubb, Patents for Chemicals, Pharmaceuticals & Biotechnology, 4th Edition,
2004, Oxford University Press, New York.
5. Jurg P. Seiler, Good Lab Practicals The Why & the How, 2002, Springer, New York.
6. WHO, Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines,
1993, WHO, Geneva.
7. WHO, WHO guidelines on developing consumer information on proper use of
traditional,complementary and alternative medicine, 2004, WHO, Geneva.
8. WHO, WHO Guidelines on Good Agricultural and Collection Practices (GACP) for
Medicinal Plants, 2003, WHO, Geneva.
9. WHO, WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance
systems, 2004, WHO, Geneva.
10. WHO/IUCN/WWF Guidelines on the Conservation of Medicinal Plants, 1993, IUCN,
Switzerland.
11. WHO, General Guidelines for Methodologies on Research and Evaluation of Traditional
Medicine, 2000, WHO,Geneva.
12. WHO, Guidelines for the Appropriate use of Herbal Medicines, 1998, WHO, Geneva.
13. Chaudhari R. D., Herbal drug industry, 1st edition, 1996, Eastren publisher, New Delhi.
14. Robert Verpoorte, Pulok K Mukharjee, GMP for Botanicals - Regulatory and Quality
issues on Phytomedicine, 2003, Business Horizons, New Delhi.
15. Quality control of herbal drugs by Pulok K Mukarjee, 2002, Business Horizons
Pharmaceutical publishe, New Delhi.
16. Partap Chauhan, Ayurvedic Pharmacognosy, 2007, Sonali Publications, by New Delhi.
17. FDA, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements, Docket No. 1996N0417.
18. Natural Health Products Directorate (NHPD), Good Manufacturing Practices Guidance
Document, 2006, Canada.
19. TGA, Australian code of good manufacturing practice for medicinal products, 2002.
20. WHO, Good manufacturing practices: Supplementary guidelines for the manufacture of
herbal medicines, 2006, WHO Technical Report Series, No. 937, WHO, Geneva.
21. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and
Veterinary Use Draft Annex 7 Manufacture of Herbal Medicinal Products, 2006.
22. EMEA, Points to consider on good agricultural and collection practice for starting
materials of herbal origin, 2002, London.
23. WHO, WHO Guidelines on good agricultural and collection practices (GACP) for
medicinal plants, 2002, WHO, Geneva.
24. UNDP/World Bank/WHO, Handbook Good Laboratory Practice (GLP), Geneva.
25. OECD, OECD Principles of Good Laboratory Practice, 1988.

120

26. FAO, Food Quality and Safety Systems - A Training Manual on Food Hygiene and the
Hazard Analysis and Critical Control Point (HACCP) System, 1998, FAO, Rome.
27. Sara Mortimore, Carol Wallace, HACCP: A Practical Approach, 1998, Springer.
28. R.D. Chaudhri, Herbal Drugs Industry : A Practical Approach to Industrial
Pharmacognosy, 1996, Eastern Publishers, New Delhi.

MPGC 204: NATURAL PRODUCTS CHEMISTRY Theory

35 Hrs.

1. General methods of isolation and separation of plant constituents, Qualitative reactions

employed for the detection of plant constituents. Application of GLC, HPLC and counter
current distribution for separation and analysis of plant constituents. Application of IR,
H1NMR, mass spectroscopy to structural determination of natural products.
2. A general study of the chemistry of anti- bacterial antibiotics, anti-fungal antibiotics, anti-viral
antibiotics with detailed study of newer semi-synthetic Penicillins and Cephalosporin.
3. WHO Guidelines for evaluation of safety and efficacy of herbal medicine, quality
specifications of plant materials and toxicity studies of herbal medicines.
4. A detailed study of the following classes of natural products with special importantance to
occurrence, chemistry, biosynthesis, isolation, purification and estimation by physical,
chemical and biological methods.
c) Alkaloids Indole alkaloids (Reserpine, Vinblastine etc.), Morphine and related
alkaloids.
d) Vitamins Vitamin A, Folic acid, Vitamin B12 and Vitamin C
5. Steroids Detailed study of the structure and stereochemistry of steroid nucleus,
Transformation of Steroids by micro-organism and synthesis of the following Cholesterol,
Ergosterol (irradiation product), Oestrogen, Progesterone, and Testosterone
Method of isolation and estimation of the following natural products:
a. Diosgenin,
b. Quinine
c. Emetine
d. Penicillin and streptomycin
Books for Reference :
1. I. L .Finar,Organic chemistry Vol.-II 5th edition,ELBS.
2. S. William Pelletier Alkaloid chemical and biological perspective
3. Trease and Evans Pharmacognosy, 14 th edition, ELBS.
4. Tyler, V.E., Brady, L.R., Robbers, J.E., Pharmacognosy, 8th ed., Lea & Febiger, Philadelphia,
USA.

121

5. Asolkar, Diosgenin and other steroid drug precursor, CSIR

6. Weinsten. M.I, Wegman, G.H, Antibiotics, Isolation and separation.
7. Gorog.S.,Quantitative analysis of steroids
8. E.Vardemme, Biotechnology of Industrial antibiotics
9. Vapoorte, Swendson, Chromatography of Alkaloids.
10. Clerks Isolation and identification of Drugs by A.C. Mottal
11. Burgers Medicinal chemistry by Wolff .M.I., 4 th edition.
12. Wilson and Gisvolds Text Book of Oraganic Medicinal and Pharmaceutical Chemistry, 8th
edition.
13. Phytochemical methods of chemical analysis by Horborne.
14. The use of Pharmacological techniques for the evaluation of natural products by B.N.
Dhavan; R.C.Srimal, CDRI, Lucknow.
15. Weiss creger, Techniques in organic chemistry
16. Nakanishi Golo, Natural Product Chemistry
17. Bentley, The Alkaloids Part I and Part- II
18. Fischer and Fischer, Steroid.
19. Indian Pharmacopoeia, 1996.
20. Makin and Gower, Steroid analysis.
21. Bernard Fried and Sharma, Thin Layer Chromatography techniques and applications 2nd
edition.
22. N.S.Egorov, Antibiotics A Scientific Approach.
MPGC 205: PHARMACEUTICAL PRODUCTION MANAGEMENT (Theory)
35 Hrs.
1. Lay out of building, material management, Production planning and control, sales
forecasting.
2. New Product development Market research, Project identification, Management and
Production lunch.
3. ISO 9000 Salient features. Drug regulatory affairs Drugs and Cosmetics Act, Drugs
(Price Control) Order, Essential Commodities Act.
4. Safety and environment management.
5. Human resource management Supervisory skills and communication skills.
6. US-FDA regulatory affairs: US FDA review process for Investigational New Drug (IND),
New Drug (NDA). Hatch Waxman amendment, Abbreviated New Drug Application
(ANDA) for generic market - types of ANDA - Data presentation - verification and grant by
FDA - Common Technical Documentation (CTD), and review process. Drug master File

122

(DMF), Type - filing process - benefits. New product exclusivity patent term restoration exclusivity and orange book listings federal register
7. GMP certification as per WHO: need and procedure for certification
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20 th Edn.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3rd Edn,
Vergese Publishing House, Mumbai, 1991.
3. Drugs and Cosmetics Act, 1940 and the rules there under, 1945, Government of India.
4. Drugs Price Control Order, 1995, Ministry of Health, Govt. of India.
5. Sharma PP, How to Practice GMP, 1st Edn., New Delhi, 1998.
6. ISO Standards, Bureau of Indian Standard, New Delhi.
7. Pestomji, Text Book of Personal Management
8. Rao V Subba, Text Book on Personal Management, Panther, New Delhi, 1994.
MPGP-206: HERBAL DRUG TECHNOLOGY (PRACTICALS)

50 Hrs.

1. Isolation of Starch from Potato, Ginger Oleoresin from Ginger Rhizome, Capsicum
Oleoresin from Capsicum fruits, Podophyllotoxin from Podophyllum roots.
2. Preparation of few Herbal cosmetics covered in theory.
3. Preparation and Evaluation of few Herbal formulations of different types covered in theory.
4. Isolation of some plant derived nutraceuticals.
5. Extraction / Distillation of Essential oils from Aromatic raw materials.
6. Any other experiment(s) to substantiate topics covered in theory.
MPGP-207: QUALITY CONTROL OF HERBAL DRUGS & HERBAL PRODUCTS
(Practicals)
50 Hrs
a) Chromatographic analysis of plant drugs for some phytoconstiuents such as alkaloids,
Anthracene glycosides, volatile oils.
b) Proximate analysis of plant-drugs to determine extractive values, ash values, insoluble matter
foreign matter, welling factor etc.
c) Determination of volatile oil content of plant drug.
d) Estimation of some phytoconstiuents.
e) Evaluation of some parameters following as per pharmacopoeial monograph of selected
drugs.

123

THIRD SEMESTER
MPGC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS
(Theory)
35 Hrs.
[Student should be familiar with pharmaceutical/chemical applications and use statistical tools,
by way of calculations, but not expected to derive and find proof.]
1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of
thesis and conventions adopted in writing; citing references; preparation of oral, poster
presentation. Accessing required information in a systematic manner from abstracts,
books journals, conference proceedings, thesis and dissertations, internet, CDROM etc.
Ethics, rights, permissions
2. The Population - The sample; measures describing the center of data distributions;
measurement of spread of data. Introduction to Probability - The Binomial and Normal
distributions - their significance.
3. Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t
tests, F tests, ANOVA [one way], Chi square test.
4. Linear regression and correlation.
5. Control charts Constructing control charts, between batch variation as a measure of
variability, quality control charts in research and development, quality control charts for
proportions.
6. Non parametric methods
7. Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed
rank test; Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for
randomness; Contingency tables.
References:
1. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series.
2. How to write and publish a scientific paper, 4th Ed., Robert A DayCambridge
University presses.
3. Fundamentals of Analytical Chemistry7th Ed., Skoog, West, Holler Saunders
College Publishing.
MPGE 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory) 35 Hrs
1. Pre formulation studies and new formulation development.
2. New drug development and approval process: Investigational New Drugs
(IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) ,
ICH requirements for registration of pharmaceuticals.
3. Validation techniques.
4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of
dissolution characteristics, bioavailability enhancers.
5. Pharmaceutical product stability testing- ICH guidelines.
6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer
solution, gel formation, coacervation, phase separation, microencapsulation, mechanical
properties, biomedical uses of polymers.
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Books for Reference:

1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20 th Ed.,Vol I & II,
Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3rd Ed.,
Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Ed., Marcel Dekker, Inc., New
York, 1995.
4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International
Student) Ed., Churchill Livingstone, New York, 1996.
5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery
Systems, 7th Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
6. FDA Code of Federal Regulations, Title 21, Part 300 314.
7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.
8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.
MPGE 302(2) PHARMACEUTICAL HEALTH CARE - THEORY

35 Hrs.

1.
2.
3.
4.
5.
6.

Concept and necessity of Pharmaceutical Health care.

A rational approach in paediatrics and geriatric care.
Therapeutic consideration with rational approach during pregnancy and lactation.
Evaluation of Immune system and its fuctions.
Rational use of antimicrobials.
Assessment and clinical significance of malnutrition, enteral and parentral nutrition,
Nutritional consideration in major organ failure.
7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus,
Peptic Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma.
8. Self care: Constipation, Common cold, cough, pain, and sun light protection.
REFERENCES :
1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical
Association, Washington.
2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569
3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.
4. Standard Treatment Guidelines
a) by WHO
b) by Government of India
c) by Various state governments

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MPGE 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY

35 HRS.

1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision;

classification of errors, estimation of errors, sources of errors, minimization of errors, normal
distribution of errors. Significant figures in analytical chemistry rules and computations.
2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves external
standard methods, internal standard method, standard addition method [applications in HPLC
and GLC with calculations], linear regression of straight line calibration curvesusing the
regression equation[applications and calculations].
3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques
sampling techniquesrandom, stratified, systematic, cluster, for quality control. Sample
preparation reducing particle size, making solutions, separating analyte from interferants
extraction, automated extraction, solid phase extraction, solid phase micro extraction, super
critical fluid extraction and micro wave assisted extraction.
4. Validating the analytical method including bio-analytical method: Need for validation;
historical background; validation of analytical procedures-- methodologyguidelines of
ICH; FDA; USP. Understanding of the following concepts in validationaccuracy,
precision, specificity, limit of detection, limit of quantification, blind analysis of standard
sample, ruggedness testing, robustness testing, equivalency testing. Validating the method as
standard methodcollaborative testtwo sample collaborative testing, control charts.
5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column, Mobile
phase, Special additives. Method Development guiding tools: Separation factor, Selectivity
factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic phase, Aqueous
phase, Additional Variables: pH, Stationary Phase, Temperature. Column Conditions: Flow,
Column dimension, Particle diameter. Derivatisation.
6. System suitability tests as per Pharmacoepoeial specification.
7. Development of stability indicating analytical method
Books for References:
1. HPLC method development, Lunn. G(1996),John wiley & Interscience.
2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family
Welfare.
3. British Pharmacopeia (1993) London, Her Majestys Stationery Office.
4. ICH guide lines: validation of analytical procedures, methodology, November 1996.
5. Vogels text book of quantitative inorganic analysis 5th Ed.
6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series,
1993.
7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.
8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college
publishing.

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MPGE 302(4): CLINICAL PHARMACOLOGY -THEORY

(35 Hrs)

1. (a) Definition and scope of clinical pharmacology, measurement of drug response

in man.
(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance
data analysis & presentation skills
(c) Pharmaco- epidemiology.
2

(a) Drug Drug interaction, Drug food interaction, and Drug disease
interaction in clinical pharmacology.
(b) Adverse drug reactions and ADR monitoring.

(a) Essential drug list, national drug policy

(b) Orphans drugs
(c ) Therapeutic drug monitoring, Pharmacists intervension in Therapeutic drug
monitoring in special situations such as pediatrics, geriatric and pregnant
cases.

Books for reference:

1. Goodman and Gillmans The Pharmacological Basis of Therapeutic 9 th Ed.
2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.
3. Remingtons Pharmaceutical Sciences 19th Ed.
4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach
Vol 1. and 2
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and
V.Austel
6. Practical approach in toxicity studies by pooley and leslie
7. Screeining methods in Pharmacology by R.A.Tuner
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett
9. Methods of clinical drug trials by Aln Sperit and Smion
10. Alternatives to animal experiments: Developing in-vitro methods and changing
legislation. TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22
12. Clinical drug trial and tribulations by Allan E.Cato (1980).
13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.GrehameSmith and J.K.Aronson.
14. International aspects of drug evaluation and usage by Jouhar and Grayson.

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MPGE 302(5): STRATEGY IN DRUG SYNTHESIS Theory

1. Organic Name Reaction :

35 Hrs.

Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann

rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius
rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement,
Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction,
Reformatsky reaction, Scmidt rearrangement.
2. Introduction: Basic rules in disconnection.
3. Application of Synthon approach to drug synthesis: Case Studies.
a. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine.
b. Adrenergic agents: Stimulants, Epinephrine, Ephedrine.
c. Adrenergic blocking agents: Propranolol, Guanethidine.
d. Psychotropic agents: Chlorpromazine, Chloprothixene.
e. Antidepresants: Imipiramine.
f. CNS Stimulants: Amphetamine.
g. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.

Books for Reference:

1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.
2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.
3. Solomons Organic chemistry 5th Ed.
4. Organic Chemistry, I.L. Finar Vol. I, ELBS.
5. Modern Synthetic reaction, H.O.House.
6. Some Modern Method of Organic Synthesis, W. Carruthers.
7. Designing organic synthesis with work book a programmed introduction to the synthon
approach, Stuart Warren.
MPGE-302(6): PHARMACOBIOTECHNOLOGY (Theory)

35 Hrs.

1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process.

Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture,
Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial
growth, Down stream processing, Microbial products, Improvements in microbial strains.
Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid
and Penicillin.
2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic
nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes.
Methods of enzyme production. Profile of some important enzymes: Hyaluronidase,
Penicillinase, Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier

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matrices, Materials and Methods of immobilization (Adsorption method, Covalent

bonding, Entrapment, Encapsulation). Advantages and disadvantages of immobilization.
Application of Enzymes and Immobilized enzymes.
3.
4.
5. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ
culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell
culture. Applications of plant tissue/cell culture: Micropropagation & Cloning,
Genetically modified plants, Medicinal plant improvement, Production of secondary
metabolites. Survey of phytochemicals produced through plant cell cultures.
6. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and
Methodologies for biotransformation. Cell immobilization, Advantages of cell
immobilization. Illustrations of biotransformations with special reference to steroids.
Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine,
Hydroxylation of beta methyl digitoxin, Arbutin).
7. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and
enzymes involved. Steps in engineering the Genes and the enzymes involved. Cloning
vectors. Introduction of rDNA into a host cell. Screening and selection of recombinants.
Typical examples of Recombinant DNA technology products (human insulin, human
growth hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).
Books for Reference:
1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi.
2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007,
Pharma Book Syndicate, Hyderabad.
3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age
International Publishers, New Delhi.
4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age
International Publishers Ltd., New Delhi.
5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004,
NIIR, New Delhi.
6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi.
7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.
MPGT 303: Thesis Phase I
Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to
be completed at the beginning of Third Semester. The candidate has to prepare an Orientation
Report.
FOURTH SEMESTER
MPGT 401: Thesis Phase II

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THESIS
III and IV SEMESTERS
Phase-I
In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other
allied organizations to provide orientation & exposure. Simultaneously the student will carry out
a small project leading to a report at the end of that period. The faculty member of the
department and an expert from the respective organization jointly evaluate the report for 10
marks. The students are expected to identify a project towards their thesis and start working on it
and submit Phase I thesis during this stay. The students will come back to the Department to
appear for third semester examination. On completion of third semester examination the students
will return back to the industry/ Hospitals / other allied organizations where he was placed and
would continue the thesis work under the collective guidance of a faculty member and a guide
drawn from the collaborating organization.
Phase-II
The students would continue the thesis work in the fourth semester, in collaborating
organizations, under the supervision of two guides one from the Department and another from
collaborating organization allotted by the Head of the Department of Pharmacy.

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