Raghavendra Institute of Pharmaceutical Education and Research

(RIPER)
(Conferred Autonomous status from the academic year 2016-17)
Accorded under Sections 2 (f) and 12 (B) of UGC act 1956 and Accredited by National
Board of Accreditation (NBA) and National Assessment & Accreditation Council (NAAC)
Approved by PCI and AICTE, New Delhi

Academic regulations
Program structure
&
Syllabus
Effective from ACY 2018-2019

Master of Pharmacy

Pharmaceutics

(Applicable for the batch admitted from 2018 -2019)

: Awarding University:
Jawaharlal Nehru Technological University Anantapur (JNTUA)

KR Palli Cross, Near SKU University, Anantapuramu, Andhra Pradesh, India - 515 721
Phone: +91-8554 - 255646, 255548; FAX: +91-8554 - 255646
Website: www.riper.ac.in

1
Program Outcomes: M. Pharm (Pharmaceutics)

After successful completion of the program the graduate will be able to

1. Apply the principles of drug delivery system in the development of eco-friendly,
efficacious dosage forms.
2. Develop an ability to undertake multidisciplinary tasks in the pharmaceutical quality
system.
3. Analyze, criticize, organize, improvise and manage documents, data and information
related to pharmaceutical production process.
4. Imbibe ethical practices and moral values in personal and professional endeavours.
5. Execute team based research to implement innovative solutions in the area of
formulation, quality assurance and technology transfer.
6. Apply problem-based learning approach and analytical thinking in academic and
professional life.
7. Validate the knowledge and skills gained through education to gain recognition in
Pharmaceutical society and related field.
8. Set-up pharmaceutical production unit to design and formulate pharmaceutical dosage
form.

2
 Table – 1: Course of study for M. Pharm. (Pharmaceutics)

Course Credit Credit Hr/

Course Marks
Code Hours Points wk
Semester I
Modern Pharmaceutical
MPH101T 4 4 4 100
Analytical techniques

MPH102T Drug Delivery System 4 4 4 100

MPH103T Modern Pharmaceutics 4 4 4 100

MPH104T Regulatory Affairs 4 4 4 100

MPH105P Pharmaceutics Practical I 12 6 12 150

- Seminar/Assignment 7 4 7 100

Total 35 26 35 650

Semester II
Molecular Pharmaceutics (Nano Tech and
MPH201T Targeted 4 4 4 100
DDS)
Advanced Biopharmaceutics &
MPH202T 4 4 4 100
Pharmacokinetics
Computer Aided Drug
MPH203T 4 4 4 100
Delivery System
Cosmetic and
MPH204T 4 4 4 100
Cosmeceuticals
MPH205P Pharmaceutics Practical II 12 6 12 150

- Seminar/Assignment 7 4 7 100

Total 35 26 35 650

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 Table – 2: Course of study for M. Pharm. III Semester
(Common for All Specializations)

Course Course Credit Credit Points

Code Hours
MRM Research Methodology and 4 4
Biostatistics*
301T
- Journal club 1 1
- Discussion / Presentation
2 2
(Proposal Presentation)
- Research Work 28 14
Total 35 21
* Non University Exam

Table – 3: Course of study for M. Pharm. IV Semester

(Common for All Specializations)

Course Course Credit Credit Points

Code Hours
- Journal Club 1 1
- Research Work 31 16
- Discussion/Final 3 3
Presentation
Total 35 20

4
 Tables – 4: Schemes for internal assessments and end semester
(Pharmaceutics)

End
Internal Assessment Semester
Exams
Course Total
Course Continuous Sessional
Code Mark
Mode Exams Tota Marks Duration
s
Marks Duration l

SEMESTER I
MPH101T Modern
Pharmaceutical 10 15 1 Hr 25 75 3 Hrs 100

Analytical
techniques
MPH102T Drug Delivery
System 10 15 1 Hr 25 75 3Hrs 100
MPH103T Modern
Pharmaceutics 10 15 1 Hr 25 75 3 Hrs 100
MPH104T Regulatory Affairs
10 15 1 Hr 25 75 3Hrs 100
MPH105P Pharmaceutics
Practical I 20 30 6 Hrs 50 100 6Hrs 150
- Seminar - - - - - - 100
/Assignment
Total 650
SEMESTER II
MPH201T Molecular
Pharmaceutics (Nano 10 15 1 Hr 25 75 3Hrs 100
Tech and Targeted
DDS)
MPH202T Advanced
Biopharmaceutics & 10 15 1 Hr 25 75 3Hrs 100
Pharmacokinetics
MPH203T Computer Aided
Drug 10 15 1 Hr 25 75 3Hrs 100
Delivery System
MPH204T Cosmetic and
Cosmeceuticals 10 15 1 Hr 25 75 3Hrs 100
MPH205P Pharmaceutics
Practical II 20 30 6 Hrs 50 100 150
6Hrs
- Seminar
- - - - - - 100
/Assignment
Total 650

5
Tables – 5: Schemes for internal assessments and end semester examinations (Semester III&
IV)

Internal Assessment End Semester

Exams
Sessional Total
Course Conti
Course Exams Total Mark Duration Mark
Code nuou s
Mode Marks Duration s s

SEMESTER III
Research
MRM
Methodology 10 15 1 Hr 25 75 3 Hrs 100
30
and
1T Biostatistics*
- Journal - - - 25 - - 25
club
Discussion /
- Presentation - - - 50 - - 50
(Proposal
Presentation)
- Research - - - - 350 1 Hr 350
work*
Total 525

SEMESTER IV

- Journal club - - - 25 - - 25
Discussion /
- Presentation - - - 75 - - 75
(Proposal
Presentation)
Research
- - - - - 400 1 Hr 400
work and
Colloquium
Total 500
*Non University Examination

6
 MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES-Theory
(MPH 101T)
SCOPE
This subject deals with various advanced analytical instrumental techniques for identification,
characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer,
IR, HPLC, GC etc.
OBJECTIVES
After completion of course student is able to know about chemicals and excipients

• The analysis of various drugs in single and combination dosage forms

• Theoretical and practical skills of the instruments

THEORY 60 hours

1 a. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation 10hrs

associated with UV-Visible spectroscopy, Choice of solvents and solvent
effect and Applications of UV-Visible spectroscopy, Difference/ Derivative
spectroscopy.
b. IR spectroscopy: Theory, Modes of Molecular vibrations, Sample
handling, Instrumentation of Dispersive and Fourier - Transform IR
Spectrometer, Factors affecting vibrational frequencies and Applications of
IR spectroscopy, Data Interpretation.
c. Spectroflourimetry: Theory of Fluorescence, Factors affecting
fluorescence (Characterestics of drugs that can be analysed by flourimetry),
Quenchers, Instrumentation and Applications of fluorescence
spectrophotometer.
d. Flame emission spectroscopy and Atomic absorption spectroscopy:
Principle, Instrumentation, Interferences and Applications.
2 NMR spectroscopy: Quantum numbers and their role in NMR, Principle, 10 hrs
Instrumentation, Solvent requirement in NMR, Relaxation process, NMR
signals in various compounds, Chemical shift, Factors influencing chemical
shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double
resonance, Brief outline of principles of FT-NMR and 13C NMR.
Applications of NMR spectroscopy.
3 Mass Spectroscopy: Principle, Theory, Instrumentation of Mass 10hrs
Spectroscopy, Different types of ionization like electron impact, chemical,
field, FAB and MALDI, APCI, ESI, APPI Analyzers of Quadrupole and
Time of Flight, Mass fragmentation and its rules, Meta stable ions, Isotopic
peaks and Applications of Mass spectroscopy.
4 Chromatography: Principle, apparatus, instrumentation, chromatographic 10hrs
parameters, factors affecting resolution, isolation of drug from excipients,
data interpretation and applications of the following:
• Thin Layer chromatography
• High Performance Thin Layer Chromatography
• Ion exchange chromatography
• Column chromatography

7
 • Gas chromatography
• High Performance Liquid chromatography
• Ultra High Performance Liquid chromatography
• Affinity chromatography
• Gel Chromatography
5 a. Electrophoresis: Principle, Instrumentation, Working conditions, factors 10hrs
affecting separation and applications of the following:
a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis
d) Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric
focusing
b. X ray Crystallography: Production of X rays, Different X ray methods,
Bragg‘s law, Rotating crystal technique, X ray powder technique, Types of
crystals and applications of X-ray diffraction.
6 a. Potentiometry: Principle, working, Ion selective Electrodes and 10hrs
Application of potentiometry.
b. Thermal Techniques: Principle, thermal transitions and Instrumentation
(Heat flux and power-compensation and designs), Modulated DSC, Hyper
DSC, experimental parameters (sample preparation, experimental
conditions, calibration, heating and cooling rates, resolution, source of
errors) and their influence, advantage and disadvantages, pharmaceutical
applications. Differential Thermal Analysis (DTA): Principle,
instrumentation and advantage and disadvantages, pharmaceutical
applications,
derivative differential thermal analysis (DDTA). TGA: Principle,
instrumentation, factors affecting results, advantage and disadvantages,
pharmaceutical applications.

REFERENCES

1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition,

John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A.
Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS
Publishers, New Delhi, 1997.
5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd Edition,
CBS Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern Methods – Part B - J W Munson, Vol 11, Marcel.
Dekker Series
8. Spectroscopy of Organic Compounds, 2nd edn., P.S/Kalsi, Wiley estern Ltd., Delhi.

8
9. Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley & Sons,
1982.
10. Textbook of Pharmaceutical Analysis, KA.Connors, 3rd Edition, John Wiley & Sons,
1982.

9
 DRUG DELIVERY SYSTEMS-Theory
(MPH 102T)

SCOPE
This course is designed to impart knowledge on the area of advances in novel drug delivery
systems.

OBJECTIVES
Upon completion of the course, student shall be able to understand
• The various approaches for development of novel drug delivery systems.
• The criteria for selection of drugs and polymers for the development of delivering
system
• The formulation and evaluation of Novel drug delivery systems.

THEORY 60 hours

1 Sustained Release (SR) and Controlled Release (CR) formulations: 10hrs

Introduction & basic concepts, advantages/ disadvantages, factors influencing,
Physicochemical & biological approaches for SR/CR formulation, Mechanism of
Drug Delivery from SR/CR formulation. Polymers: introduction, definition,
classification, properties and application Dosage Forms for Personalized
Medicine. Introduction, Definition, Pharmacogenetics, Categories of
Patients for Personalized Medicines: Customized drug delivery systems,
Bioelectronic Medicines, 3D printing of pharmaceuticals, Telepharmacy.
2 Rate Controlled Drug Delivery Systems: Principles & Fundamentals, 10 hrs
Types, Activation; Modulated Drug Delivery Systems;Mechanically
activated, pH activated, Enzyme activated, and Osmotic activated Drug
Delivery Systems Feedback regulated Drug Delivery Systems; Principles &
Fundamentals
3 Gastro-Retentive Drug Delivery Systems: Principle, concepts advantages 10hrs
and disadvantages, Modulation of GI transit time approaches to extend GI
transit. Buccal Drug Delivery Systems: Principle of muco adhesion,
advantages and disadvantages, Mechanism of drug permeation, Methods of
formulation and its evaluations.
4 Occular Drug Delivery Systems: Barriers of drug permeation, Methods to 6 hrs
overcome barriers.
5 Transdermal Drug Delivery Systems: Structure of skin and barriers, 10hrs
Penetration enhancers, Transdermal Drug Delivery Systems, Formulation
and evaluation.
6 Protein and Peptide Delivery: Barriers for protein delivery. Formulation 8hrs
and Evaluation of delivery systems of proteins and other macromolecules.
7 Vaccine delivery systems: Vaccines, uptake of antigens, single shot 6hrs
vaccines, mucosal and transdermal delivery of vaccines.

10
REFERENCES

1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel
Dekker, Inc., New York, 1992.
2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker,Inc., New
York, 1992.
3. Encyclopedia of controlled delivery, Editor- Edith Mathiowitz, Published by
WileyInterscience Publication, John Wiley and Sons, Inc, New York! Chichester/Weinheim
4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New
Delhi, First edition 1997 (reprint in 2001).
5. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and advances, Vallabh
Prakashan, New Delhi, First edition 2002

JOURNALS
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian drugs (IDMA)3. Journal of controlled release (Elsevier Sciences) desirable
4. Drug Development and Industrial Pharmacy (Marcel & Decker) desirable

11
 MODERN PHARMACEUTICS-Theory
(MPH 103T)

SCOPE
Course designed to impart advanced knowledge and skills required to learn various aspects
and concepts at pharmaceutical industries

OBJECTIVES
Upon completion of the course, student shall be able to understand
• The elements of preformulation studies.
• The Active Pharmaceutical Ingredients and Generic drug Product development
• Industrial Management and GMP Considerations.
• Optimization Techniques & Pilot Plant Scale Up Techniques
• Stability Testing, sterilization process & packaging of dosage forms.

THEORY 60 hours

1 a. Preformation Concepts – Drug Excipient interactions - different 20hrs

methods, kinetics of stability, Stability testing. Theories of dispersion
and pharmaceutical Dispersion (Emulsion and Suspension,
SMEDDS)preparation and stability Large and small volume parental –
physiological and formulation consideration, Manufacturing and
evaluation.
b. Optimization techniques in Pharmaceutical Formulation: Concept and
parameters of optimization, Optimization techniques in pharmaceutical
formulation and processing. Statistical design, Response surface
method, Contour designs, Factorial designs and application in
formulation
2 Validation : Introduction to Pharmaceutical Validation, Scope & merits 10 hrs
of Validation, Validation and calibration of Master plan, ICH & WHO
guidelines for calibration and validation of equipments, Validation of
specific dosage form, Types of validation. Government regulation,
Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.
3 cGMP & Industrial Management: Objectives and policies of current 10hrs
good manufacturing practices, layout of buildings, services, equipments
and their maintenance Production management: Production
organization, materials management, handling and transportation,
inventory management and control, production and planning control,
Sales forecasting, budget and cost control, industrial and personal
relationship. Concept of Total Quality Management.
4 Compression and compaction: Physics of tablet compression, 10 hrs
compression, consolidation, effect of friction, distribution of forces,
compaction profiles. Solubility.
5 Study of consolidation parameters; Diffusion parameters, Dissolution 10hrs
parameters and Pharmacokinetic parameters, Heckel plots, Similarity
factors – f2 and f1, Higuchi and Peppas plot, Linearity Concept of
significance, Standard deviation , Chi square test, students T-test ,

12
 ANOVA test.

REFERENCES
1. Theory and Practice of Industrial Pharmacy By Lachmann and Libermann
2. Pharmaceutical dosage forms: Tablets Vol. 1-3 by Leon Lachmann.
3. Pharmaceutical Dosage forms: Disperse systems, Vol, 1-2; By Leon Lachmann.
4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1-2; By Leon Lachmann.
5. Modern Pharmaceutics; By Gillbert and S. Banker.
6. Remington’s Pharmaceutical Sciences.
7. Advances in Pharmaceutical Sciences Vol. 1-5; By H.S. Bean & A.H. Beckett.
8. Physical Pharmacy; By Alfred martin
9. Bentley’s Textbook of Pharmaceutics – by Rawlins.
10. Good manufacturing practices for Pharmaceuticals: A plan for total quality control,
Second edition; By Sidney H. Willig.
11. Quality Assurance Guide; By Organization of Pharmaceutical producers of India.
12. Drug formulation manual; By D.P.S. Kohli and D.H.Shah. Eastern publishers, New
Delhi.
13. How to practice GMPs; By P.P.Sharma. Vandhana Publications, Agra.
14. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash.
15. Pharmaceutical Preformulations; By J.J. Wells.
16. Applied production and operations management; By Evans, Anderson, Sweeney and
Williams.
17. Encyclopaedia of Pharmaceutical technology, Vol I – III.

13
 REGULATORY AFFAIRS-Theory
(MPH 104T)

SCOPE
Course designed to impart advanced knowledge and skills required to learn the concept of
generic drug and their development, various regulatory filings in different countries, different
phases of clinical trials and submitting regulatory documents: filing process of IND, NDA
and ANDA
• To know the approval process of
• To know the chemistry, manufacturing controls and their regulatory
• importance
• To learn the documentation requirements
• To learn the importance

OBJECTIVES
Upon completion of the course, it is expected that the students will be able understand
• The Concepts of innovator and generic drugs, drug development process
• The Regulatory guidance’s and guidelines for filing and approval process
• Preparation of Dossiers and their submission to regulatory agencies in different
countries
• Post approval regulatory requirements for actives and drug products
• Submission of global documents in CTD/ eCTD formats
• Clinical trials requirements for approvals for conducting clinical trial s
• Pharmacovigilence and process of monitoring in clinical trials.

THEORY 60 hours

1 a. Documentation in Pharmaceutical industry: Master formula record, 12hrs

DMF (Drug Master File), distribution records.
Generic drugs product development Introduction, HatchWaxman act
and amendments, CFR (CODE OF FEDERAL REGULATION),drug
product performance, in-vitro, ANDA regulatory approval process,
NDA approval process, BE and drug product assessment, in –vivo, scale
up process approval changes, post marketing surveillance, outsourcing
BA and BE to CRO.
b. Regulatory requirement for product approval: API, biologics, novel,
therapies obtaining NDA, ANDA for generic drugs ways and means of
US registration for foreign drugs
2 CMC, post approval regulatory affairs. Regulation for combination 12 hrs
products and medical devices.CTD and ECTD format, industry and
FDA liaison. ICH - Guidelines of ICH-Q, S E, M. Regulatory
requirements of EU, MHRA, TGA and ROW countries.
3 Non clinical drug development: Global submission of IND, NDA, 12hrs
ANDA. Investigation of medicinal products dossier, dossier (IMPD)and

14
 investigator brochure (IB).
4 Clinical trials: Developing clinical trial protocols. Institutional review 12 hrs
board/ independent ethics committee Formulation and working
procedures informed Consent process and procedures.
HIPAA- new, requirement to clinical study process, pharmacovigilance
safety monitoring in clinical trials.

REFERENCES
1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and
IsaderKaufer,Marcel Dekker series, Vol.143
2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert
P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185,
Informa Health care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino,
MD,5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley &
Sons.Inc.
5. FDA regulatory affairs: a guide for prescription drugs, medical devices, and
biologics/edited By Douglas J. Pisano, David Mantus.
6. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay
A.Rozovsky and Rodney K. Adams
7. www.ich.org/
8. www.fda.gov/
9. europa.eu/index_en.htm
10. https://www.tga.gov.au/tga-basics

15
 PHARMACEUTICS PRACTICALS – I (MPH 105P)

1. Analysis of pharmacopoeial compounds and their formulations by UV Vis

spectrophotometer
2. Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
3. Experiments based on HPLC
4. Experiments based on Gas Chromatography
5. Estimation of riboflavin/quinine sulphate by fluorimetry
6. Estimation of sodium/potassium by flame photometry
7. To perform In-vitro dissolution profile of CR/ SR marketed formulation
8. Formulation and evaluation of sustained release matrix tablets
9. Formulation and evaluation osmotically controlled DDS
10. Preparation and evaluation of Floating DDS- hydro dynamically balanced DDS
11. Formulation and evaluation of Muco adhesive tablets.
12. Formulation and evaluation of transdermal patches.
13. To carry out preformulation studies of tablets.
14. To study the effect of compressional force on tablets disintegration time.
15. To study Micromeritic properties of powders and granulation.
16. To study the effect of particle size on dissolution of a tablet.
17. To study the effect of binders on dissolution of a tablet.
18. To plot Heckal plot, Higuchi and peppas plot and determine similarity factors.

16
 MOLECULAR PHARMACEUTICS (NANO TECHNOLOGY & TARGETED DDS)
(NTDS) – THEORY (MPH 201T)

SCOPE
This course is designed to impart knowledge on the area of advances in novel drug delivery
systems.

OBJECTIVES
Upon completion of the course student shall be able to understand
• The various approaches for development of novel drug delivery systems.
• The criteria for selection of drugs and polymers for the development of NTDS
• The formulation and evaluation of novel drug delivery systems.

THEORY 60 hours

1 Targeted Drug Delivery Systems: Concepts, Events and biological 12hrs

process involved in drug targeting. Tumor targeting and Brain specific
delivery.
2 Targeting Methods: introduction preparation and evaluation. Nano 12 hrs
Particles & Liposomes: Types, preparation and evaluation.
3 Micro Capsules / Micro Spheres: Types, preparation and evaluation , 12hrs
Monoclonal Antibodies ; preparation and application, preparation and
application of Niosomes, Aquasomes, Phytosomes, Electrosomes
4 Pulmonary Drug Delivery Systems: Aerosols, propellents, 12 hrs
ContainersTypes, preparation and evaluation, Intra Nasal Route
Delivery systems; Types, preparation and evaluation.
5 Nucleic acid based therapeutic delivery system: Gene therapy, 12hrs
introduction (ex-vivo & in-vivo gene therapy). Potential target diseases
for gene therapy (inherited disorder and cancer). Gene expression
systems (viral and nonviral gene transfer). Liposomal gene delivery
systems. Biodistribution and Pharmacokinetics. knowledge of
therapeutic antisense molecules and aptamers as drugs of future.

REFERENCES

1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded,Marcel
Dekker, Inc., New York, 1992.
2. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and advances,
VallabhPrakashan, New Delhi, First edition 2002.
3. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors,
NewDelhi, First edition 1997 (reprint in 2001).

17
 ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS- THEORY
(MPH 202T)

SCOPE

This course is designed to impart knowledge and skills necessary for dose calculations, dose
adjustments and to apply biopharmaceutics theories in practical problem solving. Basic
theoretical discussions of the principles of biopharmaceutics and pharmacokinetics are
provided to help the students’ to clarify the concepts.

OBJECTIVES

Upon completion of this course it is expected that students will be able understand,
• The basic concepts in biopharmaceutics and pharmacokinetics.
• The use raw data and derive the pharmacokinetic models and parameters the best
describe the process of drug absorption, distribution, metabolism and elimination.
• The critical evaluation of biopharmaceutic studies involving drug product
equivalency.
• The design and evaluation of dosage regimens of the drugs using pharmacokinetic and
biopharmaceutic parameters.
• The potential clinical pharmacokinetic problems and application of basics of
pharmacokinetic
•
THEORY 60 hours

1 Drug Absorption from the Gastrointestinal Tract: Gastrointestinal tract, 12hrs

Mechanism of drug absorption, Factors affecting drug absorption, pH–
partition theory of drug absorption.
Formuulation and physicochemical factors: Dissolution rate,
Dissolution process, Noyes–Whitney equation and drug dissolution,
Factors affecting the dissolution rate. Gastrointestinal absorption: role
of the dosage form: Solution (elixir, syrup and solution)as a dosage
form ,Suspension as a dosage form, Capsule as a dosage form, Tablet
as a dosage form, Dissolution methods ,Formulation and processing
factors, Correlation of in vivo data with in vitro dissolution
data.Transport model: Permeability-Solubility-Charge State and the pH
Partition
Hypothesis, Properties of the Gastrointestinal Tract (GIT), pH
Microclimate Intracellular pH Environment, Tight-Junction Complex.
2 Biopharmaceutic considerations in drug product design and In Vitro 12 hrs
Drug Product Performance: Introduction, biopharmaceutic factors
affecting drug bioavailability, rate-limiting steps in drug absorption,
physicochemical nature of the drug formulation factors affecting drug
product performance, in vitro: dissolution and drug release testing,
compendial methods of dissolution, alternative methods of dissolution

18
 testing,meeting dissolution requirements,problems of variable control in
dissolution testingperformance of drug products. In vitro–in vivo
correlation, dissolution profile comparisons, drug product
stability,considerations in the design of a drug product.
3 Pharmacokinetics: Basic considerations, pharmacokinetic models, 12hrs
compartment modeling: one compartment model- IV bolus, IV infusion,
extra-vascular. Multi compartment model: two compartment - model in
brief, non-linear pharmacokinetics: cause of non-linearity, Michaelis –
Menten equation, estimation of k and v. Drug interactions: introduction,
the effect of proteinbinding interactions, the effect of tissue-binding
interactions, cytochrome p450-based drug interactions,drug interactions
linked to transporters.
4 Drug Product Performance, In Vivo: Bioavailability and 12 hrs
Bioequivalence: drug product performance, purpose of bioavailability
studies, relative and absolute availability. Methods for assessing
bioavailability, bioequivalence studies, design and evaluation of
bioequivalence studies, study designs, crossover study designs,
evaluation of the data, bioequivalence example, study submission and
drug review process. Biopharmaceutics classification system, methods.
Permeability: In-vitro, in-situ and In-vivo methods.generic biologics
(biosimilar drug products),clinical significance of bioequivalence
studies, special concerns in bioavailability and bioequivalence studies,
generic substitution.
5 Application of Pharmacokinetics: Modified-Release Drug Products, 12hrs
Targeted Drug Delivery Systems and Biotechnological Products.
Introduction to Pharmacokinetics and pharmacodynamic, drug
interactions. Pharmacokinetics and pharmacodynamics of
biotechnology drugs. Introduction, Proteins and peptides, Monoclonal
antibodies, Oligonucleotides, Vaccines (immunotherapy), Gene
therapies.

REFERENCES

Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4th edition,Philadelphia,

Lea and Febiger, 1991
2. Biopharmaceutics and Pharmacokinetics, A. Treatise, D .M. Brahmankar and Sunil B.
Jaiswal., VallabPrakashan, Pitampura, Delhi
3. Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land YuABC, 2 nd edition,
Connecticut Appleton Century Crofts, 1985
4. Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R. Hiremath,Prism
Book
5. Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel Dekker Inc.,New
York, 1982
6. Current Concepts in Pharmaceutical Sciences: Biopharmaceutics, Swarbrick. J, Leaand
Febiger, Philadelphia, 1970
7. Clinical Pharmacokinetics, Concepts and Applications 3rd edition by MalcolmRowland
and Thom~ N. Tozer, Lea and Febiger, Philadelphia, 1995
8. Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack PublishingCompany,
Pennsylvania 1989

19
9. Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4 th edition,revised and
expande by Robert. E. Notari, Marcel Dekker Inc, New York and Basel,1987.
10. Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and
M.Pemarowski, 1st edition, Drug Intelligence Publications, Hamilton, Illinois, 1971.
11. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.Boylan,
Marcel Dekker Inc, New York, 1996.
12. Basic Pharmacokinetics,1 st edition,Sunil S JambhekarandPhilip J Breen,pharmaceutical
press, RPS Publishing,2009.
13. Absorption and Drug Development- Solubility, Permeability, and Charge State, Alex
Avdeef, John Wiley & Sons, Inc,2003.

20
 COMPUTER AIDED DRUG DEVELOPMENT- THEORY
(MPH 203T)

SCOPE
This course is designed to impart knowledge and skills necessary for computer Applications
in pharmaceutical research and development who want to understand the application of
computers across the entire drug research and development process. Basic theoretical
discussions of the principles of more integrated and coherent use of computerized
information (informatics) in the drug development process are provided to help the students
to clarify the concepts.

OBJECTIVES
Upon completion of this course it is expected that students will be able to understand,
• History of Computers in Pharmaceutical Research and Development
• Computational Modeling of Drug Disposition
• Computers in Preclinical Development
• Optimization Techniques in Pharmaceutical Formulation
• Computers in Market Analysis
• Computers in Clinical Development
• Artificial Intelligence (AI)and Robotics
• Computational fluid dynamics(CFD)

THEORY 60 hours

1 Computers in Pharmaceutical Research and Development: A General 12hrs

Overview: History of Computers in Pharmaceutical Research and
Development. Statistical modeling in Pharmaceutical research and
development: Descriptive versus Mechanistic Modeling, Statistical
Parameters, Estimation, Confidence Regions, Nonlinearity at the
Optimum, Sensitivity Analysis, Optimal Design, Population Modeling
b. Quality-by-Design In Pharmaceutical Development: Introduction,
ICH Q8 guideline, Regulatory and industry views on QbD,
Scientifically based QbD - examples of application.
2 Computational Modeling Of Drug Disposition: Introduction, Modeling 12 hrs
Techniques: Drug Absorption, Solubility, Intestinal Permeation, Drug
Distribution ,Drug Excretion, Active Transport; P-gp, BCRP,
Nucleoside Transporters, hPEPT1, ASBT, OCT, OATP, BBB-Choline
Transporter.
3 Computer-aided formulation development: Concept of optimization, 12hrs
Optimization parameters, Factorial design, Optimization technology &
Screening design. Computers in Pharmaceutical Formulation:
Development of pharmaceutical emulsions, microemulsion drug carriers
Legal Protection of Innovative Uses of Computers in R&D, The Ethics
of Computing in Pharmaceutical Research, Computers in Market
analysis
4 a. Computer-aided biopharmaceutical characterization: Gastrointestinal 12 hrs
absorption simulation. Introduction, Theoretical background, Model
construction, Parameter sensitivity analysis, Virtual trial, Fed vs. fasted
state, In vitro dissolution and in vitroin vivo correlation, Biowaiver

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 considerations
b. Computer Simulations in Pharmacokinetics and Pharmacodynamics:
Introduction, Computer Simulation: Whole Organism, Isolated Tissues,
Organs, Cell, Proteins and Genes.
c. Computers in Clinical Development: Clinical Data Collection and
Management, Regulation of Computer Systems
5 Artificial Intelligence (AI), Robotics and Computational fluid 12hrs
dynamics: General overview, Pharmaceutical Automation,
Pharmaceutical applications, Advantages and Disadvantages. Current
Challenges and Future Directions.

REFERENCES
1. Computer Applications in Pharmaceutical Research and Development, Sean Ekins, 2006,
John Wiley & Sons.
2. Computer-Aided Applications in Pharmaceutical Technology, 1 Edition, Jelena Djuris,
Woodhead Publishing.
3. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.Boylan,
Marcel Dekker Inc, New York, 1996.

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 COSMETICS AND COSMECEUTICALS- THEORY
(MPH 204T)

SCOPE
This course is designed to impart knowledge and skills necessary forthefundamental need for
cosmetic and cosmeceutical products.

OBJECTIVES
Upon completion of the course, the students shall be able to understand
• Key ingredients used in cosmetics and cosmeceuticals.
• Key building blocks for various formulations.
• Current technologies in the market
• Various key ingredients and basic science to develop cosmetics and cosmeceuticals
• Scientific knowledge to develop cosmetics and cosmeceuticals with desired Safety,
stability, and efficacy.

THEORY 60 hours

1 Cosmetics – Regulatory : Definition of cosmetic products as per Indian 12hrs

regulation. Indian regulatory requirements for labeling of cosmetics
Regulatory provisions relating to import of cosmetics. Misbranded and
spurious cosmetics. Regulatory provisions relating to manufacture of
cosmetics – Conditions for obtaining license, prohibition of
manufacture and sale of certain cosmetics, loan license, offences and
penalties.
2 Cosmetics - Biological aspects : Structure of skin relating to problems 12 hrs
like dry skin, acne, pigmentation, prickly heat, wrinkles and body odor.
Structure of hair and hair growth cycle. Common problems associated
with oral cavity. Cleansing and care needs for face, eye lids, lips, hands,
feet, nail, scalp, neck, body and under-arm.
3 Formulation Building blocks: Building blocks for different product 12hrs
formulations of cosmetics/cosmeceuticals. Surfactants – Classification
and application. Emollients, rheological additives: classification and
application. Antimicrobial used as preservatives, their merits and
demerits. Factors affecting microbial preservative efficacy. Building
blocks for formulation of a moisturizing cream, vanishing cream, cold
cream, shampoo and toothpaste. Soaps and syndetbars.
Perfumes; Classification of perfumes. Perfume ingredients listed as
allergens in EU regulation. Controversial ingredients: Parabens,
formaldehyde liberators, dioxane.
4 Design of cosmeceutical products: Sun protection, sunscreens 12 hrs
classification and regulatory aspects. Addressing dry skin, acne, sun-
protection, pigmentation, prickly heat, wrinkles, body odor, dandruff,
dental cavities, bleeding gums, mouth odor and sensitive teeth through
cosmeceutical formulations.
5 Herbal Cosmetics : Herbal ingredients used in Hair care, skin care and 12hrs
oral care. Review of guidelines for herbal cosmetics by private bodies

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 like cosmos with respect to preservatives, emollients, foaming agents,
emulsifiers and rheology modifiers. Challenges in formulating herbal
cosmetics.

REFERENCES
1. Harry’s Cosmeticology. 8th edition.
2. Poucher’sperfumecosmeticsandSoaps,10th edition.
3. Cosmetics - Formulation, Manufacture and quality control, PP.Sharma,4th edition
4. Handbook of cosmetic science and Technology A.O.Barel, M.Paye and H.I. Maibach. 3 rd
edition
5. Cosmetic and Toiletries recent suppliers catalogue.
6. CTFA directory.

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 PHARMACEUTICS PRACTICALS - II
(MPH 205P)

1. To study the effect of temperature change, non solvent addition, incompatible polymer
addition in microcapsules preparation
2. Preparation and evaluation of Alginate beads
3. Formulation and evaluation of gelatin /albumin microspheres
4. Formulation and evaluation of liposomes/niosomes
5. Formulation and evaluation of spherules
6. Improvement of dissolution characteristics of slightly soluble drug by Solid dispersion
technique.
7. Comparison of dissolution of two different marketed products /brands
8. Protein binding studies of a highly protein bound drug & poorly protein bound drug
9. Bioavailability studies of Paracetamol in animals.
10. Pharmacokinetic and IVIVC data analysis by Winnoline software
11. In vitro cell studies for permeability and metabolism
12. DoE Using Design Expert® Software
13. Formulation data analysis Using Design Expert ® RSoftware
14. Quality-by-Design in Pharmaceutical Development
15. Computer Simulations in Pharmacokinetics and Pharmacodynamics
16. Computational Modeling Of Drug Disposition
17. To develop Clinical Data Collection manual
18. To carry out Sensitivity Analysis, and Population Modeling.
19. Development and evaluation of Creams
20. Development and evaluation of Shampoo and Toothpaste base
21. To incorporate herbal and chemical actives to develop products
22. To address Dry skin, acne, blemish, Wrinkles, bleeding gums and dandruff

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