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R22 B.Pharmacy JNTUH

PS501: MEDICINAL CHEMISTRY – I

B. Pharm. III Year I Sem L T P C

3 1 0 4
Course Objectives: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasizes on structure activity relationships of
drugs, importance of physicochemical properties and metabolism of drugs. The syllabus also
emphasizes on chemical synthesis of important drugs under each class.

Course Outcomes: Upon completion of the course the student shall be able to
 understand the chemistry of drugs with respect to their pharmacological activity
 understand the drug metabolic pathways, adverse effect and therapeutic value of drugs
 know the Structural Activity Relationship (SAR) of different class of drugs
 write the chemical synthesis of some drugs

Study of the development of the following classes of drugs, Classification, mechanism of action,
uses of drugs mentioned in the course, Structure activity relationship of selective class of drugs
as specified in the course and synthesis of drugs superscripted (*)

UNIT – I 10 Hours
Introduction to Medicinal Chemistry
History and development of medicinal chemistry. Physicochemical properties in relation to biological
action (Ionization, Solubility, Partition Coefficient, Hydrogen bonding) Protein binding, Chelation,
Bioisosterism, significance of Isomerism in biological activity, Structural modifications in drug discovery.
Prodrugs: Basic concepts & application of prodrug design

UNIT – II 10 Hours
Drugs acting on Autonomic Nervous System
Adrenergic Neurotransmitters: Biosynthesis and catabolism of catecholamine. Adrenergic receptors
(Alpha & Beta) and their distribution.
Sympathomimetic agents: SAR of Sympathomimetic agents
Direct acting: Nor-epinephrine, Epinephrine, Phenylephrine*, Dopamine, Methyldopa, Clonidine,
Dobutamine, Isoproterenol, Terbutaline, Salbutamol*, Bitolterol, Naphazoline, Oxymetazoline and
Xylometazoline.
Indirect acting agents: Hydroxyamphetamine, Pseudoephedrine, Propylhexedrine.
Agents with mixed mechanism: Ephedrine, Metaraminol.
Adrenergic Antagonists:
Alpha adrenergic blockers: Tolazoline*, Phentolamine, Phenoxybenzamine, Prazosin,
Dihydroergotamine, Methysergide.
Beta adrenergic blockers: SAR of beta blockers, Propranolol*, Metibranolol, Atenolol, Betazolol,
Bisoprolol, Esmolol, Metoprolol, Labetolol, Carvedilol.

UNIT – III 10 Hours

Cholinergic neurotransmitters: Biosynthesis and catabolism of acetylcholine.
Cholinergic receptors (Muscarinic & Nicotinic) and their distribution.
Parasympathomimetic agents: SAR of Parasympathomimetic agents
Direct acting agents: Acetylcholine, Carbachol*, Bethanechol, Methacholine, Pilocarpine.
Indirect acting/ Cholinesterase inhibitors (Reversible & Irreversible): Physostigmine,
Neostigmine*, Pyridostigmine, Edrophonium chloride, Tacrine hydrochloride, Ambenonium chloride,
Isofluorphate, Echothiophate iodide, Parathione, Malathion.
Cholinesterase reactivator: Pralidoxime chloride.
Cholinergic Blocking agents: SAR of cholinolytic agents

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Solanaceous alkaloids and analogues: Atropine sulphate, Hyoscyaminesulphate, Scopolamine

hydrobromide, Homatropine hydrobromide, Ipratropium bromide*.
Synthetic cholinergic blocking agents: Tropicamide, Cyclopentolatehydrochloride, Clidinium
bromide, Dicyclomine hydrochloride*, Glycopyrrolate, Methantheline bromide, Propantheline bromide,
Benztropine mesylate, Orphenadrine citrate, Biperidine hydrochloride, Procyclidine hydrochloride*,
Tridihexethyl chloride, Isopropamide iodide, Ethopropazine hydrochloride.

UNIT – IV 08 Hours
Drugs acting on Central Nervous System
A. Sedatives and Hypnotics:
Benzodiazepines: SAR of Benzodiazepines, Chlordiazepoxide, Diazepam*, Oxazepam,
Chlorazepate, Lorazepam, Alprazolam, Zolpidem
Barbiturtes: SAR of barbiturates, Barbital*, Phenobarbital, Mephobarbital, Amobarbital, Butabarbital,
Pentobarbital, Secobarbital
Miscelleneous:
Amides & imides: Glutethmide.
Alcohol & their carbamate derivatives: Meprobomate, Ethchlorvynol.
Aldehyde & their derivatives: Triclofos sodium, Paraldehyde.

B. Antipsychotics
Phenothiazeines: SAR of Phenothiazeines Promazine hydrochloride, Chlorpromazine hydrochloride*,
Triflupromazine, Thioridazine hydrochloride, Piperacetazine hydrochloride, Prochlorperazine maleate,
Trifluoperazine hydrochloride.
Ring Analogues of Phenothiazeines: Chlorprothixene, Thiothixene, Loxapine succinate, Clozapine.
Fluro buterophenones: Haloperidol, Droperidol, Risperidone.
Beta amino ketones: Molindone hydrochloride.
Benzamides: Sulpieride.
C. Anticonvulsants: SAR of Anticonvulsants, mechanism of anticonvulsantaction
Barbiturates: Phenobarbitone, Methabarbital.
Hydantoins: Phenytoin, Mephenytoin, Ethotoin
Oxazolidine diones: Trimethadione, Paramethadione
Succinimides: Phensuximide, Methsuximide, Ethosuximide
Urea and monoacylureas: Phenacemide, Carbamazepine
Benzodiazepines: Clonazepam
Miscellaneous: Primidone, Valproic acid, Gabapentin, Felbamate

UNIT – V 07 Hours
Drugs acting on Central Nervous System
General anesthetics:
Inhalation anesthetics: Halothane*, Methoxyflurane, Enflurane, Sevoflurane, Isoflurane, Desflurane.
Ultra short acting barbitutrates: Methohexital sodium*, Thiamylalsodium, Thiopental sodium.
Dissociative anesthetics: Ketamine hydrochloride. *
Narcotic and non-narcotic analgesics
Morphine and related drugs: SAR of Morphine analogues, Morphinesulphate, Codeine, Meperidine
hydrochloride, Anilerdine hydrochloride, Diphenoxylate hydrochloride, Loperamide hydrochloride,
Fentanyl citrate*, Methadone hydrochloride*, Propoxyphene hydrochloride, Pentazocine, Levorphanol
tartarate.
Narcotic antagonists: Nalorphine hydrochloride, Levallorphan tartarate, Naloxone hydrochloride.
Anti-inflammatory agents: Sodium salicylate, Aspirin, Mefenamic acid*, Meclofenamate,
Indomethacin, Sulindac, Tolmetin, Zomepriac, Diclofenac, Ketorolac, Ibuprofen*, Naproxen, Piroxicam,
Phenacetin, Acetaminophen, Antipyrine, Phenylbutazone.

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R22 B.Pharmacy JNTUH

RECOMMENDED BOOKS (Latest Editions)

1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
9. Indian Pharmacopoeia.
10. Rama Rao Nadendla, Medicinal Chemistry, 2nd Revised Ed. Pharma Med Press

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R22 B.Pharmacy JNTUH

PS502: INDUSTRIAL PHARMACY - I

B.Pharm. III Year I Sem. L T P C

3 1 0 4
Course Objective: Course enables the student to understand and appreciate the influence of
pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug
product.

Course Outcomes: Upon completion of the course the student shall be able to
 Know the various pharmaceutical dosage forms and their manufacturing techniques.
 Know various considerations in development of pharmaceutical dosage forms
 Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality

UNIT - I 07 Hours
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (Crystalline and amorphous forms: Concepts of polymorphism
and its significance in industrial setup), particle size, shape, flow properties, solubility profile (pKa, pH,
partition coefficient).
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization BCS
classification of drugs
Application of preformulation considerations in the development of solid, liquid oral and parenteral
dosage forms and its impact on stability of dosage forms.

UNIT - II 10 Hours
Tablets:
a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of
tablets, granulation methods, compression and processing problems. Equipments and tablet
tooling.
b. Tablet coating: Types of coating, coating materials, formulation of coating composition,
methods of coating, equipment employed and defects in coating.
c. Quality control tests: In process and finished product tests
Liquid orals: Formulation and manufacturing consideration of solutions, suspensions and emulsions;
Filling and packaging; evaluation of liquid orals official in pharmacopoeia

UNIT – III 08 Hours

Capsules:
a. Hard gelatin capsules: Introduction, Extraction of gelatin and production of hard gelatin
capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard
gelatin capsules. In process and final product quality control tests for capsules.
b. Soft gelatin capsules: Nature of shell and capsule content, size of capsules, importance of
base adsorption and minimum/gram factors, production, in process and final product quality
control tests. Packing, storage and stability testing of soft gelatin capsules
Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of
pellets, Fluidised bed coater (FBC)/ extrusion spheronization technique.

UNIT – IV 10 Hours
Parenteral Products:
a. Definition, types, advantages and limitations. Preformulation factors and essential
requirements, vehicles, additives, importance of isotonicity
b. Production procedure, production facilities and controls.
c. Formulation of injections, sterile powders, emulsions, suspensions, large volume parenterals

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R22 B.Pharmacy JNTUH

and lyophilized products, Sterilization.

d. Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids.
Quality control tests.
Ophthalmic/Otic Preparations: Introduction, formulation considerations; formulation of eye drops, ear
drops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of
ophthalmic preparations

UNIT – V 10 Hours
Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos,
cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosolsystems;
formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors
influencing choice of containers, legal and official requirements for containers, stability aspects of
packaging materials, quality control tests.

TEXT BOOKS: (Latest Editions)

1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H. A. Liberman, Leon Lachman & J. B.
Schwartz
2. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman & Lachman
3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman
4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition
5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science
(RPS)
6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
7. Pharmaceutics- The science of dosage form design by M.E. Aulton, Churchill Livingstone,
Latest edition
8. Introduction to Pharmaceutical Dosage Forms by H. C. Ansel, Lea & Febiger, Philadelphia, 5th
edition, 2005
9. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel Dekker
Series, Vol 107.
10. Pharmaceutical Technology 1 &11 BY Gaurav Agarwal CBS Publishers
11. Pharmaceutics Basic principles and Formulations by D.K. Tripati Pharma med press
12. Semalty Ajay, Industrial Pharmacy ‐ I, Pharma med press

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R22 B.Pharmacy JNTUH

PS503: PHARMACOLOGY - II

B.Pharm. III Year I Sem. L T P C

3 1 0 4

Course Objective: This subject is intended to impart the fundamental knowledge on various aspects
(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on different systems of body and in addition, emphasis on the basic
concepts of bioassay.

Course Outcomes: Upon completion of this course the student should be able to
 Understand the mechanism of drug action and its relevance in the treatment of different
diseases
 Demonstrate isolation of different organs/tissues from the laboratory animals by simulated
experiments
 Demonstrate the various receptor actions using isolated tissue preparation
 Appreciate correlation of pharmacology with related medical sciences

UNIT – I 10 hours
Pharmacology of drugs acting on cardio vascular system - I
a. Introduction to hemodynamic and electrophysiology of heart.
b. Drugs used in congestive heart failure
c. Anti-hypertensive drugs.
d. Anti-anginal drugs.
e. Anti-arrhythmic drugs.
f. Anti-hyperlipidemic drugs.

UNIT – II 10 hours
1. Pharmacology of drugs acting on cardio vascular system - II
a. Drug used in the therapy of shock.
b. Hematinics, coagulants and anticoagulants.
c. Fibrinolytics and anti-platelet drugs
d. Plasma volume expanders
2. Pharmacology of drugs acting on urinary system
a. Diuretics
b. Anti-diuretics.

UNIT - III 10 hours

Autocoids and related drugs
a. Introduction to autacoids and classification
b. Histamine, 5-HT and their antagonists.
c. Prostaglandins, Thromboxanes and Leukotrienes.
d. Angiotensin, Bradykinin and Substance P.
e. Non-steroidal anti-inflammatory agents
f. Anti-gout drugs
g. Antirheumatic drugs

UNIT - IV 08 hours
Pharmacology of drugs acting on endocrine system - I
a. Basic concepts in endocrine pharmacology.
b. Anterior Pituitary hormones- analogues and their inhibitors.
c. Thyroid hormones- analogues and their inhibitors.

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R22 B.Pharmacy JNTUH

d. Hormones regulating plasma calcium level- Parathormone, Calcitonin and Vitamin-D.

e. Insulin, Oral Hypoglycemic agents and glucagon.
f. ACTH and corticosteroids.

UNIT - V 07 hours
1. Pharmacology of drugs acting on endocrine system - II
a. Androgens and Anabolic steroids.
b. Estrogens, progesterone and oral contraceptives.
c. Drugs acting on the uterus.
2. Bioassay
a. Principles and applications of bioassay.
b. Types of bioassay
c. Bioassay of insulin, oxytocin, vasopressin, ACTH, d-tubocurarine, digitalis, histamine

TEXT BOOKS (Latest Editions)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology,
2. Churchil Livingstone Elsevier
3. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc Graw-
Hill.
4. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
5. Basic Knowledge of Pharmacology BY Roland Seifert, Springer
6. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K., Bradley
R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott Williams & Wilkins.
7. Mycek M. J, Gelnet S. B and Perper M.M. Lippincott’s Illustrated Reviews-Pharmacology.
8. K. D. Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical Publishers (P)
Ltd, New Delhi.
9. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
10. Modern Pharmacology with clinical Applications, by Charles R. Craig& Robert.
11. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.
12. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan.

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R22 B.Pharmacy JNTUH

PS504: PHARMACOGNOSY AND PHYTOCHEMISTRY - II

B.Pharm. III Year I Sem. L T P C

3 1 0 4
Course Objective: The main purpose of subject is to impart the students the knowledge of how the
secondary metabolites are produced in the crude drugs, how to isolate and identify and produce them
industrially. Also this subject involves the study of producing the plants and phytochemicals through
plant tissue culture, drug interactions and basic principles of traditional system of medicine

Course Outcomes: Upon completion of the course, the student shall be able
 To know the modern extraction techniques, characterization and identification of the herbal
drugs and phytoconstituents
 To understand the preparation and development of herbal formulation.
 To understand the herbal drug interactions
 To carryout isolation and identification of phytoconstituents

UNIT - I 07 Hours
Metabolic pathways in higher plants and their determination
 Brief study of basic metabolic pathways and formation of different secondary metabolites
through these pathways- Shikimic acid pathway, Acetate pathways and Amino acid pathway.
 Study of utilization of radioactive isotopes in the investigation of Biogenetic studies.

UNIT - II 10 Hours
a. General introduction, general methods of extraction (Maceration, Percolatio, Chromatographic
methods) and isolation of alkaloids, glycosides, flavanoids and volatile oils.
b. Biological source, microscopical characters, composition, chemistry, analysis, therapeutic uses and
commercial applications of the following secondary metabolites:
Alkaloids: Vinca, Rauwolfia, Belladonna, Opium,
Phenylpropanoids and Flavonoids: Lignans, Tea, Ruta
Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea, Digitalis
Volatile oils: Mentha, Clove, Cinnamon, Fennel, Coriander,

UNIT - III 10 Hours

General introduction, composition, chemistry & chemical classes, general methods of extraction &
analysis, biological sources, therapeutic uses and commercial applications of following secondary
metabolites
Tannins: Catechu, Pterocarpus
Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony
Glycosides: Senna, Aloes, Bitter Almond
Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids

UNIT - IV 10 Hours
Isolation, Identification, analysis of phytoconstituents and commercial applications of following
a. Terpenoids: Menthol, Citral and Artemisin
b. Glycosides: Glycyrhetinic acid and Rutin
c. Alkaloids: atropine, Quinine, Reserpine and Caffeine
d. Resins: Podophyllotoxin and Curcumin

UNIT - V 08 Hours
a. Industrial production, estimation and utilization of the following phytoconstituents: Forskolin,
Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine, Podophyllotoxin, Caffeine, Taxol, Vincristine and
Vinblastine.

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R22 B.Pharmacy JNTUH

b. Modern methods of extraction (Super critical fluid extraction, counter current extraction, Microwave
assisted extraction, ultra sonication assisted extraction

TEXT BOOKS: (Latest Editions)

1. W. C. Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co., London,
2009.
2. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution, New
Delhi.
3. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition, Nirali
Prakashan, New Delhi.
4. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.
5. Essentials of Pharmacognosy, Dr. SH. Ansari, IInd edition, Birla publications, New Delhi, 2007
6. Herbal Cosmetics by H. Pande, Asia Pacific Business press, Inc, New Delhi.
7. A. N. Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, New Delhi, 2005.
8. R Endress, Plant cell Biotechnology, Springer-Verlag, Berlin, 1994.
9. Pharmacognosy & Pharmacobiotechnology. James Bobbers, Marilyn KS, VE Tylor.
10. The formulation and preparation of cosmetic, fragrances and flavours.
11. Remington’s Pharmaceutical sciences.
12. Text Boo of Biotechnology by Vyas and Dixit.
13. Text Book of Biotechnology by R. C. Dubey.
14. SL Deore, Pharmacognosy and Phytochemistry – II, Pharma Med Press
15. Kulkarni A. Vishaka, Pharmacognosy and Phytochemistry – II, Pharma Med Press

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PS505: GENERIC PRODUCT DEVELOPMENT (Open Elective - I)

B.Pharm. III Year I Sem. L T P C

3 1 0 4
Course Objectives: To learn the generic drug product development process, dosage form design and
development, analytical method development and dossier approval process.

Course Outcome: The knowledge of the students is enhanced with the clear information about the
generic product development.

UNIT - I
a. Concept of generic drug product development, Hatch-Waxman act and its amendments.
b. History of generic product development in US

UNIT - II
Design of dosage form to meet equivalence to reference listed drug, product development steps,
formula optimization, process optimization and packaging selection.

UNIT - III
Analytical method development for verification and validation for active ingredient and impurities, in-
process samples and finished dosage forms.

UNIT - IV
a. Stability studies on active ingredient and finished dosage forms, accelerated stability studies,
stability studies at different conditions, determination of expiration date.
b. Scale up studies to optimize manufacturing process and execution of exhibit batches.

UNIT - V
a. Bioequivalence studies, various designs of bioequivalence studies, bioequivalence criteria and
in-vitro tests to ensure bioequivalence of test product.
b. Introduction to electronic Common Technical Document (eCTD), various modules and the
important information in each module.
c. Drug product approval process in India and US.

REFERENCE BOOKS:
1. Generic Drug product Development: Solid oral dosage forms-Leon Shargel.
2. ICH guidelines.
3. Subba Rao Chaganti, Cracking the Generics code – Your Single-Source Success Manual for
Winning in Multi-Source Product Markets, Pharma Med Press

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PS506: GREEN CHEMISTRY (Open Elective - I)

B.Pharm. III Year I Sem. L T P C

3 1 0 4

Course Objectives: To familiarize students about environment benign chemical synthesis. To make
students familiarize with principles and importance of various green chemical synthesis. To provide
adequate knowledge regarding green reactions, green solvents and other alternative green
approaches. To impart adequate information regarding environment pollution, contributing factors and
the concerns.

Course Outcomes: Upon completion of this course, the students should be able to: Explain the
environment pollution factors. Understand the different greener approaches along with their principles.

UNIT – I
Introduction to green chemistry
Inception of green chemistry: history and development.
Principles of green chemistry: description with examples.
Synthetic approaches of green chemistry: in water, solvent less, microwave, ultrasonic, catalytic and
synthesis.

UNIT – II
In water and solvent less organic reactions
In water reactions: principle and process involved in the Michael reaction and Wartz synthesis
Solvent less organic synthesis:
Alternative solvents used in green chemistry strategies

UNIT – III
Microwave and ultrasonic mediated reactions
Microwave reactions: principles and process involved in the Fries rearrangement, Diels Alder reaction
and Metal halide reduction
Ultrasonic reaction: principle and process involved in the Strecker and Reformatsky reactions

UNIT – IV
Catalytic and solid supported reactions
Catalytic reactions: principle and process involved in the reactions catalyzed by metal catalysts, ionic
liquids (Knovenegel ondensatin) and bio catalysts (Villeger reaction)
Solid supported reactions: principles and process
Alternative reagents used in green chemistry strategies.

UNIT – V
Greener synthesis of pharmaceuticals: Principle and procedure of the following synthesis
Nicotinic acid, Ibuprofen, paracetamol, Aspirin
Future trends in Green chemistry

REFERENCE BOOKS
1. Paul T Anastas, John Charles Warmer. Green chemistry: theory and practice. Oxford university
Press, 1988
2. Alluwalia V. K, Green chemistry: environmentally benign reactions. 2nd edn, Ane Books Pvt Ltd,
New Delhi, 2012
3. Alluwalia V.K, M. Kidwai, New trends in green chemistry. 2nd edn, Anamaya Publishers, New
Delhi, 2004.

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PS507: CELL AND MOLECULAR BIOLOGY (Open Elective - I)

B.Pharm. III Year I Sem. L T P C

3 1 0 4

Course Objectives: Cell biology is a branch of biology that studies cells – their physiological properties,
their structure, the organelles they contain, interactions with their environment, their life cycle, division,
death and cell function. This is done both on a microscopic and molecular level.
Cell biology research encompasses both the great diversity of single-celled organisms like bacteria and
protozoa, as well as the many specialized cells in multi-cellular organisms such as humans, plants, and
sponges.

Course Outcomes: Upon completion of the subject student shall be able to:
 Summarize cell and molecular biology history.
 Summarize cellular functioning and composition.
 Describe the chemical foundations of cell biology.
 Summarize the DNA properties of cell biology.
 Describe protein structure and function.
 Describe cellular membrane structure and function.
 Describe basic molecular genetic mechanisms.
 Summarize the Cell Cycle

UNIT – I 10 Hours
a. Cell and Molecular Biology: Definitions theory and basics and Applications.
b. Cell and Molecular Biology: History and Summation.
c. Theory of the Cell? Properties of cells and cell membrane.
d. Prokaryotic versus Eukaryotic
e. Cellular Reproduction

UNIT – II 10 Hours
a. DNA and the Flow of Molecular Structure
b. DNA Functioning
c. DNA and RNA
d. Types of RNA
e. Transcription and Translation

UNIT – III 10 Hours

a. Proteins: Definition and Amino Acids
b. Protein Structure
c. Regularities in Protein Pathways
d. Cellular Processes
e. Positive Control and significance of Protein Synthesis

UNIT – IV 08 Hours
a. Science of Genetics
b. Transgenics and Genomic Analysis
c. Cell Cycle analysis
d. Mitosis and Meiosis
e. Cellular Activities and Checkpoints

UNIT – V 07 Hours
a. Cell Signals: Introduction

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R22 B.Pharmacy JNTUH

b. Receptors for Cell Signals

c. Signaling Pathways: Overview
d. Misregulation of Signaling Pathways
e. Protein-Kinases: Functioning

RECOMMENDED BOOKS (latest edition):

1. Ananthanarayana and Panikers, Text book of microbiology, 10th edition by universities press.
2. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific publications,
Oxford London.
3. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors, Delhi.
4. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
5. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
6. Rose: Industrial Microbiology.
7. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
8. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
9. Peppler: Microbial Technology.
10. Edward: Fundamentals of Microbiology.
11. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
12. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company
13. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications of
Recombinant DNA: ASM Press Washington D.C.
14. RA Goldshy et. al., Kuby Immunology.

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R22 B.Pharmacy JNTUH

PS508: COSMETIC SCIENCE (Open Elective - I)

B.Pharm. III Year I Sem. L T P C

3 1 0 4
Course Objective: This subject deals with cosmetic products, cosmetic excipients, skin care products
and their methods of preparation and evaluations.

Course Outcomes:
 Upon completion of the course the student shall be able to know the regulations pertaining to
cosmetics and cosmetic excipients.
 They will be knowing the preparations of various skin care products like creams, anti-
perspirants, deodorants, hair care products etc.
 They also know about the role of herbs in sunscreens.

UNIT – I 10 Hours
Classification of cosmetic and cosmeceutical products
Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients, preservatives.
Classification and application Skin: Basic structure and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Oral Cavity: Common problem associated with teeth and gums.

UNIT – II 10 Hours
Principles of formulation and building blocks of skin care products:
Face wash,
Moisturizing cream, Cold Cream, Vanishing cream their relative skin sensory, advantages and
disadvantages. Application of these products in formulation of cosmeceuticals.
Principles of formulation and building blocks of Hair care products:
Conditioning shampoo, Hair conditioners, antidandruff shampoo.
Hair oils.
Chemistry and formulation of Para-phylene diamine based hair dye. Principles of formulation and
building blocks of oral care products: Toothpaste for bleeding gums, sensitive teeth. Teeth whitening,
Mouthwash.

UNIT – III 10 Hours

Sun protection, Classification of Sunscreens and SPF.
Role of herbs in cosmetics:
Skin Care: Aloe and turmeric
Hair care: Henna and amla.
Oral care: Neem and clove
Analytical cosmetics: BIS specification and analytical methods for shampoo, skin-cream and
toothpaste.

UNIT – IV 08 Hours
Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics,
cosmetics as quasi and OTC drugs.
Principles of Cosmetic Evaluation: Principles of sebumeter, corneometer. Measurement of TEWL, Skin
Color, Hair tensile strength, Hair combing properties Soaps, and syndet bars. Evolution and skin
benefits.

UNIT – V 07 Hours
Oily and dry skin, causes leading to dry skin, skin moisturization. Basic understanding of the terms
Comedogenic, dermatitis.

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Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall causes Cosmetic problems
associated with skin: blemishes, wrinkles, acne, prickly heat and body odor.
Antiperspirants and Deodorants- Introduction, classification and mechanism of action

REFERENCE BOOKS:
1. Harry’s Cosmeticology, Wilkinson, Moore, Seventh Edition, George Godwin.
2. Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4 th Edition,
Vandana Publications Pvt. Ltd., Delhi.
3. Textbook of Cosmetics by Rajesh Kumar Nema, Kamal Singh Rathore and BK Dubey
4. Textbook of Cosmetics by M. Vimaladevi
5. Rao Madhusudan, Cosmeceuticals, Pharma Med Press
6. Vinita kale, Textbook of Cosmetic science and technology, Pharma Med Press

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R22 B.Pharmacy JNTUH

PC509: MEDICINAL CHEMISTRY – I LAB

B. Pharm. III Year I Sem L T P C

0 0 4 2
List of Experiments:
I. Preparation of drugs/ intermediates
1 1,3-pyrazole
2 1,3-oxazole
3 Benzimidazole
4 Benztriazole
5 2,3- diphenyl quinoxaline
6 Phenothiazine
7 Barbiturate

II Assay of drugs
1 Chlorpromazine
2 Phenobarbitone
3 Atropine
4 Ibuprofen
5 Aspirin
6 Furosemide

III Determination of Partition coefficient for any two drugs

RECOMMENDED BOOKS (Latest Editions)

1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. rganic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- A.I. Vogel
11. Raghuprasad, et al., Advanced Medicinal Chemistry – A Laboratory Guide, Pharma Med Press

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R22 B.Pharmacy JNTUH

PS510: INDUSTRIAL PHARMACY LAB

B. Pharm. III Year I Sem L T P C

0 0 4 2

List of Experiments:
1. Preformulation study for prepared granules
2. Preparation and evaluation of Paracetamol tablets
3. Preparation and evaluation of Aspirin tablets
4. Coating of tablets
5. Preparation and evaluation of Tetracycline capsules
6. Preparation of Calcium Gluconate injection
7. Preparation of Ascorbic Acid injection
8. Preparation of Paracetamol Syrup
9. Preparation of Eye drops
10. Preparation of Pellets by extrusion spheronization technique
11. Preparation of Creams (cold / vanishing cream)
12. Evaluation of Glass containers (As per IP)

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R22 B.Pharmacy JNTUH

PS511: PHARMACOLOGY - II LAB

B. Pharm. III Year I Sem L T P C

0 0 4 2
List of Experiments:
1. Introduction to in-vitro pharmacology and physiological salt solutions.
2. Effect of drugs on isolated frog heart.
3. Effect of drugs on blood pressure and heart rate of dog.
4. Study of diuretic activity of drugs using rats/mice.
5. DRC of acetylcholine using frog rectus abdominis muscle.
6. Effect of physostigmine and atropine on DRC of acetylcholine using frog rectus abdominis
muscle and rat ileum respectively.
7. Bioassay of histamine using guinea pig ileum by matching method.
8. Bioassay of oxytocin using rat uterine horn by interpolation method.
9. Bioassay of serotonin using rat fundus strip by three point bioassay.
10. Bioassay of acetylcholine using rat ileum/colon by four point bioassay.
11. Determination of PA2 value of prazosin using rat anococcygeus muscle (by Schilds plot
method).
12. Determination of PD2 value using guinea pig ileum.
13. Effect of spasmogens and spasmolytics using rabbit jejunum.
14. Anti-inflammatory activity of drugs using carrageenan induced paw-edema model.
15. Analgesic activity of drug using central and peripheral methods

Note: All laboratory techniques and animal experiments are demonstrated by simulated experiments by
softwares and videos

RECOMMENDED BOOKS (Latest Editions)

1. A Practical book of Pharmacology by Dr. Ramesh Alluri
2. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.
3. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan.

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R22 B.Pharmacy JNTUH

PS512: PHARMACOGNOSY AND PHYTOCHEMISTRY II LAB

B. Pharm. III Year I Sem L T P C

0 0 4 2

List of Experiments:
(1) Morphology, histology and powder characteristics & extraction & detection of: Cinchona,
Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander
(2) Exercise involving isolation & detection of active principles
a. Caffeine - from tea dust.
b. Diosgenin from Dioscorea
c. Atropine from Belladonna
d. Sennosides from Senna
(3) Separation of sugars by Paper chromatography
(4) TLC of herbal extract
(5) Distillation of volatile oils and detection of phytoconstituents by TLC
(6) Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii) Colophony (iv) Aloes
(v) Myrrh

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R22 B.Pharmacy JNTUH

*MC500: ENVIRONMENTAL SCIENCES

B. Pharm. III Year I Sem L T P C

1 0 0 0

Course Objectives: Environmental Sciences is the scientific study of the environmental system and
the status of its inherent or induced changes on organisms. It includes not only the study of physical
and biological characters of the environment but also the social and cultural factors and the impact of
man on environment.

Course Outcomes: Upon completion of the course the student shall be able to:
 Create the awareness about environmental problems among learners.
 Impart basic knowledge about the environment and its allied problems.
 Develop an attitude of concern for the environment.
 Motivate learner to participate in environment protection and environment improvement.
 Acquire skills to help the concerned individuals in identifying and solving environmental
problems.
 Strive to attain harmony with Nature.

UNIT – I
The Multidisciplinary nature of environmental studies
Natural Resources
Renewable and non-renewable resources:
Natural resources and associated problems
a) Forest resources; b) Water resources; c) Mineral resources; d) Food resources; e) Energy
resources; f) Land resources: Role of an individual in conservation of natural resources.

UNIT – II
Ecosystems
Concept of an ecosystem.
Structure and function of an ecosystem.
Introduction, types, characteristic features, structure and function of the ecosystems: Forest ecosystem;
Grassland ecosystem; Desert ecosystem; Aquatic ecosystems (ponds, streams, lakes, rivers, oceans,
estuaries)

UNIT – III
Biodiversity and Biotic Resources: Introduction, Definition, genetic, species and ecosystem diversity.
Value of biodiversity; consumptive use, productive use, social, ethical, aesthetic and optional values.
India as a mega diversity nation, Hot spots of biodiversity. Field visit. Threats to biodiversity: habitat
loss, poaching of wildlife, man-wildlife conflicts; conservation of biodiversity: In-Situ and Ex-situ
conservation. National Biodiversity act.

UNIT – IV
Environmental Pollution: Air pollution; Water pollution; Soil pollution, Noise Pollution

UNIT – V
Environmental Policy, Legislation & EIA: Environmental Protection act, Legal aspects Air Act- 1981,
Water Act, Forest Act, Wild life Act.
Towards Sustainable Future: Concept of Sustainable Development, Population and its explosion,
Crazy Consumerism, Environmental Education, Urban Sprawl, Human health, Environmental Ethics,
Concept of Green Building, Ecological Foot Print, Life Cycle assessment (LCA), Low carbon life style.

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RECOMMENDED BOOKS (Latest edition):

1. Y.K. Sing, Environmental Science, New Age International Pvt, Publishers, Bangalore
2. Agarwal, K.C. 2001 Environmental Biology, Nidi Publ. Ltd. Bikaner.
3. Bharucha Erach, The Biodiversity of India, Mapin Publishing Pvt. Ltd., Ahmedabad – 380 013,
India,
4. Text book of environmental science and technology, Dr. M. Anji Reddy.
5. Brunner R.C., 1989, Hazardous Waste Incineration, McGraw Hill Inc. 480p
6. Clark R.S., Marine Pollution, Clanderson Press Oxford
7. Cunningham, W.P. Cooper, T. H. Gorhani, E & Hepworth, M.T. 2001, Environmental
Encyclopedia, Jaico Publ. House, Mumbai, 1196p
8. De A.K., Environmental Chemistry, Wiley Eastern Ltd.
9. Down of Earth, Centre for Science and Environment
10. Manoharachary C. Principles of Environmental Studies, Pharma Med Press

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R22 B.Pharmacy JNTUH

PS601: MEDICINAL CHEMISTRY – II

B. Pharm. III Year II Sem L T P C

3 1 0 4

Course Objectives: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasis on modern techniques of rational drug
design like quantitative structure activity relationship (QSAR), Prodrug concept, combinatorial chemistry
and Computer aided drug design (CADD). The subject also emphasizes on the chemistry, mechanism
of action, metabolism, adverse effects, Structure Activity Relationships (SAR), therapeutic uses and
synthesis of important drugs.

Course Outcomes: Upon completion of the course student shall be able to

 Understand the importance of drug design and different techniques of drug design.
 Understand the chemistry of drugs with respect to their biological activity.
 Know the metabolism, adverse effects and therapeutic value of drugs.
 Know the importance of SAR of drugs.

Study of the development of the following classes of drugs, Classification, mechanism of action,
uses of drugs mentioned in the course, Structure activity relationship of selective class of drugs
as specified in the course and synthesis of drugs superscripted by (*)

UNIT- I 10 Hours
Antihistaminic agents: Histamine, receptors and their distribution in the human body
H1–antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate, Doxylamines succinate,
Clemastine fumarate, Diphenylphyraline hydrochloride, Tripelenamine hydrochloride, Chlorcyclizine
hydrochloride, Meclizine hydrochloride, Buclizine hydrochloride, Chlorpheniramine maleate,
Triprolidine hydrochloride*, Phenidamine tartarate, Promethazine hydrochloride*, Trimeprazine tartrate,
Cyproheptadine hydrochloride, Azatidine maleate, Astemizole, Loratadine, Cetirizine, Levocetrazine
Cromolyn sodium
H2-antagonists: Cimetidine*, Famotidine, Ranitidin.
Gastric Proton pump inhibitors: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole
Anti-neoplastic agents:
Alkylatingagents: Meclorethamine*, Cyclophosphamide, Melphalan, Chlorambucil, Busulfan,
Thiotepa
Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine, Cytarabine, Methotrexate*,
Azathioprine
Antibiotics: Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin
Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate
Miscellaneous: Cisplatin, Mitotane.

UNIT – II 10 Hours
Anti-anginal:
Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate, Isosorbidedinitrite*, Dipyridamole.
Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazemhydrochloride, Nifedipine,
Amlodipine, Felodipine, Nicardipine, Nimodipine.
Diuretics:
Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide, Dichlorphenamide.
Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide, Cyclothiazide,
Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid.
Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride.
Osmotic Diuretics: Mannitol

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R22 B.Pharmacy JNTUH

Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril, Benazepril hydrochloride, Quinapril

hydrochloride, Methyldopate hydrochloride,* Clonidine hydrochloride, Guanethidine monosulphate,
Guanabenz acetate, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine, Hydralazine hydrochloride.

UNIT - III 10 Hours

Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide hydrochloride, Disopyramide phosphate*,
Phenytoin sodium, Lidocaine hydrochloride, Tocainide hydrochloride, Mexiletine hydrochloride,
Lorcainide hydrochloride, Amiodarone, Sotalol.
Anti-hyperlipidemic agents: Clofibrate, Lovastatin, Cholesteramine and Cholestipol
Coagulant & Anticoagulants: Menadione, Acetomenadione, Warfarin*, Anisindione, clopidogrel
Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Nesiritide Bosentan, Tezosentan.

UNIT - IV 08 Hours
Antidiabetic agents:
Insulin and its preparations
Sulfonyl ureas: Tolbutamide*, Chlorpropamide, Glipizide, Glimepiride.
Biguanides: Metformin.
Thiazolidinediones: Pioglitazone, Rosiglitazone.
Meglitinides: Repaglinide, Nateglinide.
Glucosidase inhibitors: Acarbose, Voglibose.
Local Anesthetics: SAR of Local anesthetics
Benzoic Acid derivatives; Cocaine, Hexylcaine, Meprylcaine, Cyclomethycaine, Piperocaine.
Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*, Butacaine, Propoxycaine,
Tetracaine, Benoxinate.
Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine, Etidocaine.
Miscellaneous: Phenacaine, Diperodon, Dibucaine.*

UNIT – V 07 Hours
Introduction to Drug Design:
Introduction to molecular modeling tools, molecular representations, file formats, parameters used in
QSAR, QSAR methods, Pharmacophore modeling, Docking studies.
Combinatorial Chemistry: Concept and applications of combinatorial chemistry: solid phase and
solution phase synthesis.

RECOMMENDED BOOKS (Latest Editions)

1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1to 5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- A. I. Vogel.
11. Jenkins, The Chemistry of Organic Medicinal Products, Pharma Med Press.

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R22 B.Pharmacy JNTUH

PS602; PHARMACOLOGY - III

B.Pharm. III Year II Sem. L T P C

3 1 0 4

Course Objectives: This subject is intended to impart the fundamental knowledge on various aspects
(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on respiratory and gastrointestinal system, infectious diseases,
immuno-pharmacology and in addition, emphasis on the principles of toxicology and
chronopharmacology.

Course Outcomes: Upon completion of this course the student should be able to:
 Understand the mechanism of drug action and its relevance in the treatment of different
infectious diseases
 Comprehend the principles of toxicology and treatment of various poisonings and appreciate
correlation of pharmacology with related medical sciences.

UNIT- I 10 hours
1. Pharmacology of drugs acting on Respiratory system
a. Anti -asthmatic drugs
b. Drugs used in the management of COPD
c. Expectorants and antitussives
d. Nasal decongestants
e. Respiratory stimulants
2. Pharmacology of drugs acting on the Gastrointestinal Tract
a. Antiulcer agents.
b. Drugs for constipation and diarrhoea.
c. Appetite stimulants and suppressants.
d. Digestants and carminatives.
e. Emetics and anti-emetics.

UNIT – II 10 hours
Antimicrobial agents
a. General principles of chemotherapy.
b. Sulfonamides and cotrimoxazole.
c. Antibiotics - Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and
fluoroquinolins, tetracycline and aminoglycosides

UNIT – III 10 hours

Chemotherapy
a. Antitubercular agents
b. Antifungal agents
c. Antiviral drugs

d. Antileprotic agents
e. Anthelmintics
f. Antimalarial drugs
g. Antiamoebic agents
h. Urinary tract infections and sexually transmitted diseases.

UNIT – IV 08 hours
1. Antimalignancy & Immunotherapy

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R22 B.Pharmacy JNTUH

Types of malignancy.
Chemotherapy of cancer.
2. Immunopharmacology
a. Immunostimulants
b. Immunosuppressant
c. Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars

UNIT – V 07 hours
Principles of toxicology
a. Definition and basic knowledge of acute, subacute and chronic toxicity.
b. Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity and mutagenicity
c. General principles of treatment of poisoning
d. Clinical symptoms and management of barbiturates, morphine, organ ophosphosphorus
compound and lead, mercury and arsenic poisoning.

RECOMMENDED BOOKS (Latest Editions)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology,
2. Churchill Livingstone Elsevier
3. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc Graw-Hill
4. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
5. Basic Knowledge of Pharmacology BY Roland Seifert, Springer
6. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K., Bradley
R.W., Applied Therapeutics, The Clinical use of Drugs. The Point Lippincott Williams & Wilkins
7. Mycek M. J, Gelnet S. B and Perper M.M. Lippincott’s Illustrated Reviews-Pharmacology
8. K. D. Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical Publishers (P)
Ltd, New Delhi.
9. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher Modern
Pharmacology with clinical Applications, by Charles R. Craig& Robert,
10. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata,
11. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan,
12. N. Udupa and P.D. Gupta, Concepts in Chronopharmacology.
13. Essentials of Experimental Pharmacology, General Concepts by Sunil Bothra, Pharmamed
Press.

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PS603: HERBAL DRUG TECHNOLOGY

B.Pharm. III Year II Sem. L T P C

3 1 0 4

Course Objectives: This subject gives the student the knowledge of basic understanding of herbal
drug industry, the quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics, natural
sweeteners, nutraceutical etc. The subject also emphasizes on Good Manufacturing Practices (GMP),
patenting and regulatory issues of herbal drugs

Course Outcomes: Upon completion of this course the student should be able to:
 understand raw material as source of herbal drugs from cultivation to herbal drug product
 know the WHO and ICH guidelines for evaluation of herbal drugs
 know the herbal cosmetics, natural sweeteners, nutraceuticals
 appreciate patenting of herbal drugs, GMP.

UNIT – I 6 Hours
1. Herbs as raw materials
Definition of herb, herbal medicine, herbal drug preparation
Source of Herbs
Selection, identification and authentication of herbal materials
Processing of herbal raw material
2. Good Agricultural Practices
Good agricultural practices in cultivation of medicinal plants including Organic farming.
Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.
3. General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions/ research organizations involved in
production and research on medicinal and aromatic plants in India.

UNIT – II 7 Hours
1. Nutraceuticals
General aspects, Market, growth, scope and types of products available in the market. Health
benefits and role of Nutraceuticals in ailments like Diabetes, Cancer, Irritable bowel syndrome and
various Gastro intestinal diseases, obesity.
Study of following herbs as health food: Ginger, Fenugreek, Garlic, Honey, Amla, Ginseng,
Ashwagandha, Spirulina, Tinospora cordifolia, Linseed.
2. Herbal-Drug and Herb-Food Interactions: General introduction to interaction and classification.
Study of following drugs and their possible side effects and interactions: Hypercium, Ginkobiloba,
Ginseng, Garlic, Pepper.

UNIT - III 10 Hours

1. Herbal Cosmetics
Principles and preparation of herbal cosmetics formulations- Shampoos, Dyes, face creams,
perfumes, tooth pastes and Bleaching agents.
2. Herbal excipients:
Herbal Excipients – Significance of substances of natural origin as excipients – colorants,
sweeteners, binders, diluents, viscosity builders, disintegrants, flavors.
3. Herbal formulations:
Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms like
phytosomes
4. Introduction to herbal pharmacopeia

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UNIT – IV 10 Hours
1. Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs Stability testing
of herbal drugs.
2. Patenting and Regulatory requirements of natural products:
a. Introduction to Herbal Pharmacopeia
b. Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and
Biopiracy
c. Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma
& Neem.
3. Regulatory Issues - Regulations in India (ASU DTAB – Ayurvedic Sidda Unani Drugs technical
advisory board, ASU DCC - Ayurvedic Sidda Unani drugs Consultative Committee), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.

UNIT – V 07 Hours
Schedule T– Good Manufacturing Practice for herbal drug industry
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipment, standard
operating procedures, health and hygiene, documentation and records.

RECOMMENDED BOOKS: (Latest Editions)

1. Textbook of Pharmacognosy by Trease & Evans.
2. Textbook of Pharmacognosy by Tyler, Brady & Robber.
3. Pharmacognosy by Kokate, Purohit and Gokhale
4. Essential of Pharmacognosy by Dr. S.H. Ansari
5. Pharmacognosy & Phytochemistry by V.D. Rangari
6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine
& Homeopathy)
7. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals.
Business Horizons Publishers, New Delhi, India, 2002.
8. Herbal drug Technology. By SS Agrawal and M Paridhavi
9. Indian Medicinal Plants A compendium of 500 species Vol 1, 11, 111, 1V & V By Arya vaidys
sala, Universities Press
10. SL Deore, Herbal Drug Technology, Pharma Med Press

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R22 B.Pharmacy JNTUH

PS604: BIOPHARMACEUTICS AND PHARMACOKINETICS

B.Pharm. III Year II Sem. L T P C

3 1 0 4

Course Objectives: This subject 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.

Course Outcomes: Upon completion of the course student shall be able to:
 Understand the basic concepts in biopharmaceutics and pharmacokinetics.
 Use plasma data and derive the pharmacokinetic parameters to describe the process of drug
absorption, distribution, metabolism and elimination.
 Critically evaluate biopharmaceutic studies involving drug product equivalency
 Design and evaluate dosage regimens of the drugs using pharmacokinetic and
biopharmaceutic parameters.
 Detect potential clinical pharmacokinetic problems and apply basic pharmacokinetic principles
to solve them

UNIT – I 10 Hours
Introduction to Biopharmaceutics
Absorption: Mechanisms of drug absorption through GIT, factors influencing drug absorption though
GIT, absorption of drug from extra-vascular routes(Transmucosal & Transdermal), Distribution:
Distribution of drugs Tissue permeability of drugs, binding of drugs, apparent, volume of drug
distribution, protein binding of drugs, factors affecting protein-drug binding. Kinetics of protein binding,
Clinical significance of protein binding of drugs

UNIT – II 10 Hours
Metabolism & Excretion: Drug metabolism and basic understanding of metabolic pathways. Renal
excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non renal routes of drug
excretion of drugs
Bioavailability and Bioequivalence: Objectives of bioavailability studies, absolute and relative
bioavailability, measurement of bioavailability, in-vitro drug dissolution models, bioequivalence studies.

UNIT – III 10 Hours

Pharmacokinetics:
Introduction to Pharmacokinetics models, Compartment models, Non-compartment models,
physiological models, One compartment open model. a. Intravenous Injection (Bolus) b. Intravenous
infusion, extra vascular administrations, calculations of Ka, KE. From plasma and urinary excretion data

UNIT – IV 08 Hours
Multicompartment models: Two compartment open model. IV bolus
Multiple – Dosage Regimens: Repititive Intravenous injections – One Compartment Open Model

UNIT – V 07 Hours
Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity. c. Michaelis-menton
method of estimating parameters, Biotransformation of drugs

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R22 B.Pharmacy JNTUH

RECOMMENDED BOOKS: (Latest Editions)

1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.
2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B. C. YU 4th
edition, Prentice-Hall International edition. USA
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil B.
Jaiswal, Vallabh Prakashan Pitampura, Delhi
5. Venkateswarlu V. Biopharmaceutics and Pharmacokinetics, Pharma Med Press
6. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
7. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS Health
Science Press.
8. Biopharmaceutics; By Swarbrick
9. Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and
10. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
11. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing Company,
Pennsylvania 1989.
12. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and
expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
13. Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvania.
14. Experimental approaches to Biopharmaceutics and Pharmacokinetics by Suresh Banari,
Pharmamed Press
15. Textbook of Biopharmaceutics and Clinical Pharmacokinetics by Sarfaraz Niazi, Pharmamed
Press.

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R22 B.Pharmacy JNTUH

PS605: PHARMACEUTICAL QUALITY ASSURANCE (Open Elective - II)

B.Pharm. III Year II Sem. LT P C

3 1 0 4

Course Objectives: This course deals with the various aspects of quality control and quality assurance
aspects of pharmaceutical industries. It covers the important aspects like cGMP, QC tests,
documentation, quality certifications and regulatory affairs.

Course Outcomes: Upon completion of the course student shall be able to:
 Understand the cGMP aspects in a pharmaceutical industry
 Appreciate the importance of documentation
 Understand the scope of quality certifications applicable to pharmaceutical industries
 Understand the responsibilities of QA & QC departments

UNIT – I 10 Hours
1. Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
2. Total Quality Management (TQM): Definition, elements, philosophies
3. ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with
special emphasis on Q-series guidelines.
4. Quality by design (QbD): Definition, overview, elements of QbD program
5. ISO 9000 & ISO14000: Overview, Benefits, Elements
6. NABL accreditation: Brief introduction and Principles

UNIT – II 10 Hours
1. Organization and personnel: Personnel responsibilities, training, hygiene and personal records.
Premises: Design, construction and plant layout, maintenance, sanitation, environmental control,
utilities and maintenance of sterile areas, control of contamination.
2. Equipments and raw materials: Equipments selection, purchase specifications, maintenance,
purchase specifications and maintenance of stores for raw materials.

UNIT – III 10 Hours

Quality Control: Quality control test for containers (Glass & Plastic) and rubber closures
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities.

UNIT – IV 08 Hours
1. Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and waste
disposal.
2. Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula.
Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents,
distribution records.

UNIT – V 07 Hours
1. Calibration and Validation: Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan.
Calibration of pH meter and UV-Visible spectrophotometer.
2. Warehousing: Good warehousing practices.

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R22 B.Pharmacy JNTUH

RECOMMENDED BOOKS: (Latest Edition)

1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and related materials Vol
I WHO Publications.
4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMP’s – P P Sharma.
6. ISO 9000 and Total Quality Management – Sadhank G Ghosh
7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality
specification for Pharmaceutical Substances, Excipients and Dosage forms
8. Good laboratory Practices – Marcel Deckker Series
9. ICH guidelines, ISO 9000 and 14000 guidelines
10. Pharmaceutical Quality Assurance by Dr. Sohan Chiltlange
11. Chowdary KPR, A Textbook of Pharmaceutical Quality Assurance, Pharma Med Press
12. Pharmaceutical Quality Assurance and Management by K. P. Bhusari, Pharma Med Press

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R22 B.Pharmacy JNTUH

PS606: PHARMACEUTICAL BIOTECHNOLOGY (Open Elective - II)

B.Pharm. III Year II Sem. LT P C

3 1 0 4
Course Objectives:
 Biotechnology has a long promise to revolutionize the biological sciences and technology.
 Scientific application of biotechnology in the field of genetic engineering, medicine and
fermentation technology makes the subject interesting.
 Biotechnology is leading to new biological revolutions in diagnosis, prevention and cure of
diseases, new and cheaper pharmaceutical drugs.
 Biotechnology has already produced transgenic crops and animals and the future promises lot
more.
 It is basically a research-based subject.
Course Outcomes: Upon completion of the subject student shall be able to;
 Understanding the importance of Immobilized enzymes in Pharmaceutical Industries
 Genetic engineering applications in relation to production of pharmaceuticals
 Importance of Monoclonal antibodies in Industries
 Appreciate the use of microorganisms in fermentation technology

UNIT – I 10 Hours
a. Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.
b. Enzyme Biotechnology- Methods of enzyme immobilization and applications.
c. Biosensors- Working and applications of biosensors in Pharmaceutical Industries.
d. Brief introduction to Protein Engineering.
e. Use of microbes in industry. Production of Enzymes- General consideration - Amylase,
Catalase, Peroxidase, Lipase, Protease, Penicillinase.
f. Basic principles of genetic engineering.

UNIT – II 10 Hours
a. Study of cloning vectors, restriction endonucleases and DNA ligase.
b. Recombinant DNA technology. Application of genetic engineering in medicine.
c. Application of r DNA technology and genetic engineering in the products:
d. a) Interferon b) Vaccines- hepatitis- B c) Hormones- Insulin.
e. Brief introduction to PCR

UNIT – III 10 Hours

a. Structure of Immunoglobulins
b. Structure and Function of MHC (Major Histocompa
c. Types of immunity- humoral immunity, cellular immunity
d. Hypersensitivity reactions, Immune stimulation and Immune suppressions.
e. General method of the preparation of bacterial vaccines, toxoids, viral vaccine, antitoxins,
serum-immune blood derivatives and other products relative to immunity.
f. Storage conditions and stability of official vaccines
g. Hybridoma technology- Production, Purification and Applications

UNIT – IV 08 Hours
a. Immuno blotting techniques- ELISA, Western blotting, Southern blotting.
b. Genetic organization of Eukaryotes and Prokaryotes
c. Microbial genetics including transformation, transduction, conjugation, plasmids and
transposons.
d. Introduction to Microbial biotransformation and applications.
e. Mutation.

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UNIT – V 07 Hours
a. Types of mutation/mutants
b. Fermentation methods and general requirements, study of media, equipments, sterilization
methods, aeration process, stirring.
c. Large scale production fermenter design and its various controls.
d. Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid, Griseofulvin,

RECOMMENDED BOOKS (Latest edition):

1. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications
2. of Recombinant DNA: ASM Press Washington D.C.
3. RA Goldshy et. al., Kuby Immunology.
4. J. W. Goding: Monoclonal Antibodies.
5. J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal Society of
Chemistry.
6. Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.
7. S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell Scientific Publication.
8. Stanbury F., P., Whitakar A., and Hall J., S., Principles of fermentation technology, 2nd edition,
Aditya books Ltd., New Delhi
9. Nagori, Foundations in Pharmaceutical Biotechnology, Rev. Ed. Pharma Med Press
10. Pharmaceutical Biotechnology by Ravi Kumar Maddali, Pharma Med Press

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R22 B.Pharmacy JNTUH

PS607: BIOINFORMATICS (Open Elective - II)

B.Pharm. III Year II Sem. L T P C

3 1 0 4

Course Objective: This subject is design to impart fundamental knowledge on the principles of
bioinformatics

Course Outcomes: Upon completion of the course the student able to understand
 Foundation of bioinformatics
 Sequence comparisons methods
 Genomic applications
 Proteomic and metabolic applications.

UNIT – I
Foundations of bioinformatics
1.1 Bioinformatics- a historical perspective
1.2 Bioinformatics data- nucleic acid sequence, protein sequence, protein structure, genome variation
data, gene expression data, proteomic data, metabolic pathways and networks
1.3 Bioinformatics tools and resources- free online tolls, downloadable free tools, software pakags,
bioinformatics web portals
1.4 Role of internet in Bioinformatics.

UNIT - II
Sequence comparison methods
2.1 Basics of sequence alignment: Match, mismatch, gaps, scoring an alignment (gap penalties (linear
& affine gap penalties), sequence relationships (sequence identity, similarity, homology, orthologs,
paralogs & xenologs)
2.2 DNA Vs protein sequence alignment (permissible replacement, similarity score, scoring matrices
(PAM & BLOSUM)
2.3 multiple-sequence alignment (MSA): significance of MSA

UNIT – III
Genomic Applications:
3.1 Bioinformatics for genome sequencing, first and next generation methods of genome sequencing,
de-novo and reference based genome sequencing, genome assembly (reads, contigs &scaffolds)
3.2 Transcript- profiling: expression microarrays (gene array& oligo array), transcriptome sequencing
and RNA- seq analysis small RNA sequencing and analysis

UNIT – IV
4.1 Genome maps an markers: identification of molecular makers (SSR, STS & SNP markers), linkage
Vs physical maps, displaying genome annotation using genome browsers
4.2 Medical application of bioinformatics –understanding diseases and identification of disease genes,
disease diagnostics, overview of drug discovery, pharmacogenomics.

UNIT – V
Proteomic and metabolomic applications:
5.1 Protein profiling (2D gels, protein fingerprinting & identification), protein structure analysis
5.2 Protein structure: structure visualization
5.3 Protein: secondary and tertiary structure prediction (homology modelling)

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RECOMMENDED BOOKS (Latest edition):

1. Bioinformatics by B. G. Gurran, R. J. Walker, S.C. Bhatia. CBS Publishers.
2. Bioinformatics: Skills & applications by Rastogi, CBS Publishers
3. Bioinformatics: Sequence & genome analysis by mount, CBS Publishers
4. Bioinformatics and bioprogramming by CN Chaveli
5. Bioinformatics (Basics, alogerthmas and applications by Ruchi singh and Richa Sharma
6. Essential Bioinformatics Jinxiong
7. Durai Ananda Kumar T. Elementary Pharmacoinformatics, Pharma Med Press
8. Khan Imtiyaz Alam, Elementary Bioinformatics, Pharma Med Press

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R22 B.Pharmacy JNTUH

PS608: SCREENING METHODS IN PHARMACOLOGY (Open Elective - II)

B.Pharm. III Year II Sem. LT P C

3 1 0 4

Course Objectives: The student is going to study about various techniques involved in screening of
drugs for various pharmacological activities and guidelines for handling animals

Course Outcomes: This subject is designed to impart the knowledge on preclinical evaluation of drugs
and recent experimental techniques in the drug discovery and development. The subject content helps
the student to understand the maintenance of laboratory animals as per the guidelines. The expected
outcome are – the students will know how to handle animals and know about various techniques for
screening of drugs for different pharmacological activities and guidelines for regulations involved in
screening of new drug molecules on animals.

UNIT – I
Care, handling and breeding technique of laboratory animals. Regulations for laboratory animals,
CPSCEA guidelines, alternative to animal studies.

UNIT – II
Toxiciy test: OECD guidelines, determination of LD50, acute, sub-acute and chronic toxicity studies.

UNIT – III
Organization of screening for pharmacological activity of new substances with emphasis on the
evaluation of antipsychotics, antiepileptics and antidepressants.

UNIT – IV
Screening methods for anti-diabetic, antiulcer, CHF and anti-hypertensive drugs.

UNIT – V
Screening methods for anti-inflammatory, analgesics and antipyretic drugs.

RECOMMENDED BOOKS (Latest edition):

1. Biological standardization by J.H. Burn D.J. Finney and I.G. Goodwin.
2. Screening methods in Pharmacology by Robert Turner. A.
3. Methods in Pharmacology by Arnold Schwartz.
4. Pharmacological screening methods and Toxicology by A Srinivasa Rao and N. Bhagya
Lakshmi
5. Fundamentals of experimental Pharmacology by M.N. Ghosh.
6. Experimental Pharmacology for undergraduates by M C Prabhakara.
7. Drug discovery and Evaluation by Vogel H.G.
8. Experimental Pharmacology by R.K. Goyal.
9. Preclinical evaluation of new drugs by S.K. Gupta.
10. Pharmacological Screening methods and Toxicology by A. Srinivasa Rao
11. Handbook of Experimental Pharmacology, SK. Kulkarni.
12. Practical Pharmacology and Clinical Pharmacy, SK. Kulkarni, 3rd Edition.
13. Screening Methods in Pharmacology, Robert A. Turner.
14. Bodakhe H. Surendra, Guidelines and Screening Methods of Pharmacology, Pharma Med
Press

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R22 B.Pharmacy JNTUH

PS609: MEDICINAL CHEMISTRY- II LAB

B.Pharm. III Year II Sem. L T P C

0 0 4 2

1. Preparation of drugs and intermediates

a. Benzocaine
b. Sulphanilamide
c. 7-Hydroxy, 4-methyl coumarin
d. Triphenyl imidazole
e. Tolbutamide
f. Phenytoin Sodium
g. Diphenhydramine HCl
h. 6-methyl Uracil
i. Procaine
j. Promethazine HCl

2. Assay of drugs
a. Isonicotinic acid hydrazide
b. Metronidazole
c. Chlorpheniramine maleate
d. Quinidine Sulphate
e. Acetazolamide
f. Omeprazole

3. Preparation of medicinally important compounds or intermediates by Microwave irradiation

technique
4. Drawing structures and reactions using chem draw®
5. Determination of physicochemical properties such as logP, clogP, MR, Molecular weight, Hydrogen
bond donors and acceptors for class of drugs course content using drug design software Drug
likeliness screening (Lipinskies RO5)

RECOMMENDED BOOKS (Latest Editions)

1. Indian Pharmacopoeia.
2. Text book of practical organic chemistry- A.I. Vogel.
3. Durai Ananda Kumar T. Experimental Organic and Medicinal Chemistry Principles & Practice,
Pharma Med Press.

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R22 B.Pharmacy JNTUH

PS610: PHARMACOLOGY - III LAB

B.Pharm. III Year II Sem. L T P C

0 0 4 2

List of Experiments:
1. Dose calculation in pharmacological experiments
2. Antiallergic activity by mast cell stabilization assay
3. Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and NSAIDS induced
ulcer model.
4. Study of effect of drugs on gastrointestinal motility
5. Effect of agonist and antagonists on guinea pig ileum
6. Estimation of serum biochemical parameters by using semi- autoanalyser
7. Effect of saline purgative on frog intestine
8. Insulin hypoglycemic effect in rabbit
9. Test for pyrogens (rabbit method)
10. Determination of acute oral toxicity (LD50) of a drug from a given data
11. Determination of acute skin irritation / corrosion of a test substance
12. Determination of acute eye irritation / corrosion of a test substance
13. Calculation of pharmacokinetic parameters from a given data
14. Biostatistics methods in experimental pharmacology (student’s t test, ANOVA)
15. Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon Signed Rank
test)

*Experiments are demonstrated by simulated experiments/videos

RECOMMENDED BOOKS (Latest Editions)

1. A Practical book of Pharmacology by Dr. Ramesh Alluri
2. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata,
3. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan,

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R22 B.Pharmacy JNTUH

PS611: HERBAL DRUG TECHNOLOGY LAB

B.Pharm. III Year II Sem. L T P C

0 0 4 2

List of Experiments:
1. To perform preliminary phytochemical screening of crude drugs.
2. Evaluation of excipients of natural origin
3. Incorporation of prepared and standardized extract in cosmetics formulations like creams,
lotions, Shampoos and their evaluation.
4. Incorporation of prepared and standardized extract in cosmetics formulations like Syrups,
Mixtures and tablets and their evaluations as per pharmacopoeial requirements
5. Monograph analysis of herbal drugs from recent Pharmacopoeias
6. Determination of Aldehyde content
7. Determination of phenolic content
8. Determination of total alkaloids

RECOMMENDED BOOKS: (Latest Editions)

1. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals.
Business Horizons Publishers, New Delhi, India, 2002.
2. Mandal Vivekananda, Quick Review on Herbal Drug Technology, Pharma Med Press

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R22 B.Pharmacy JNTUH

PS612: BIOPHARMACEUTICS AND PHARMACOKINETICS LAB

B.Pharm. III Year II Sem. L T P C

0 0 4 2

List of Experiments:
1. Dissolution experimental study of influence of disintegration
2. Drug release from semisolids (Agar diffusion using petri dishes, Salicylic acid release from
semisolid dosage form
3. Study of permeability of drugs using dialysis tubes/Sac
4. Drug permeation across membranes using diffusion cells (franz diffusion cells)
5. Calculation of all Pharmacokinetic parameters following the below rate of administration
a) IV bolus/Plasma
b) IV bolus/Urine
c) Extravascular/Plasma
d) Extravascular/Urine
e) Non compartment Pharmacokinetics Extravascular/Plasma

Reference Books
1) Experimental approaches to Biopharmaceutics and Pharmacokinetics by Bandari Suresh
2) Biopharmaceutics and Pharmacokinetics lab manual, by Dachinamurthy

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R22 B.Pharmacy JNTUH

*MC600: HUMAN VALUES AND PROFESSIONAL ETHICS

B.Pharm. III Year II Sem. L T P C

1 0 0 0

Course Objective: To enable the students to imbibe and internalize the Values and Ethical Behavior
in the personal and Professional lives.

Course Outcome: The students will understand the importance of Values and Ethics in their personal
lives and professional careers. The students will learn the rights and responsibilities as an employee,
team member and a global citizen.

UNIT - I
Introduction to Professional Ethics: Basic Concepts, Governing Ethics, Personal & Professional
Ethics, Ethical Dilemmas, Life Skills, Emotional Intelligence, Thoughts of Ethics, Value Education,
Dimensions of Ethics, Profession and professionalism, Professional Associations, Professional Risks,
Professional Accountabilities, Professional Success, Ethics and Profession.

UNIT – II
Basic Theories: Basic Ethical Principles, Moral Developments, Deontology, Utilitarianism, Virtue
Theory, Rights Theory, Casuist Theory, Moral Absolution, Moral Rationalism, Moral Pluralism, Ethical
Egoism, Feminist Consequentialism, Moral Issues, Moral Dilemmas, Moral Autonomy.

UNIT – III
Professional ethics in pharmacy: general introduction to code of pharmaceutical ethics, objectives,
pharmacists in relation to his job, his trade, to his profession and relation to medicinal professions.
Pharmacists’ oath.

UNIT – IV
Work Place Rights & Responsibilities, Ethics in changing domains of Research, Engineers and
Managers; Organizational Complaint Procedure, difference of Professional Judgment within the
Nuclear Regulatory Commission (NRC), the Hanford Nuclear Reservation.
Ethics in changing domains of research - The US government wide definition of research misconduct,
research misconduct distinguished from mistakes and errors, recent history of attention to research
misconduct, the emerging emphasis on understanding and fostering responsible conduct, responsible
authorship, reviewing & editing.

UNIT – V
Global issues in Professional Ethics: Introduction – Current Scenario, Technology Globalization of
MNCs, International Trade, World Summits, Issues, Business Ethics and Corporate Governance,
Sustainable Development Ecosystem, Energy Concerns, Ozone Deflection, Pollution, Ethics in
Manufacturing and Marketing, Media Ethics; War Ethics; Bio Ethics, Intellectual Property Rights.

TEXT BOOKS:
1. Professional Ethics: R. Subramanian, Oxford University Press, 2015.
2. Ethics in Engineering Practice & Research, Caroline Whitbeck, 2e, Cambridge University Press
2015.
3. Indian Culture Values and Professional Ethics by P. S. R. Murty, BS Publications

REFERENCE BOOKS:
1. Engineering Ethics, Concepts Cases: Charles E Harris Jr., Michael S Pritchard, Michael J
Rabins, 4e , Cengage learning, 2015.
2. Business Ethics concepts & Cases: Manuel G Velasquez, 6e, PHI, 2008.
3. Forensic Pharmacy by Dr. Kokate
4. Forensic Pharmacy by Bhaskar Chaurasia

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R22 B.Pharmacy JNTUH

PS701: INSTRUMENTAL METHODS OF ANALYSIS

B.Pharm. IV Year I Sem. LT P C

3 1 0 4
Course Objectives: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart a fundamental knowledge on the
principles and instrumentation of spectroscopic and chromatographic technique. This also emphasizes
on theoretical and practical knowledge on modern analytical instruments that are used for drug testing.

Course Outcomes: Upon completion of the course the student shall be able to:
• Understand the interaction of matter with electromagnetic radiations and its applications in drug
analysis
• Understand the chromatographic separation and analysis of drugs.
• Perform quantitative & qualitative analysis of drugs using various analytical instruments.

UNIT – I 10 Hours
1. UV Visible spectroscopy
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on absorption
spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectors-Photo tube,
Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.
Applications - Spectrophotometric titrations, Single component and multi component analysis
2. Fluorimetry
Theory, Concepts of singlet, doublet and triplet electronic states, internal and external conversions,
factors affecting fluorescence, quenching, instrumentation and applications

UNIT – II 10 Hours
1. IR spectroscopy
Introduction, fundamental modes of vibrations in poly atomic molecules, sample handling, factors
affecting vibrations
Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell, Bolometer,
Thermocouple, Thermistor, Pyroelectric detector and applications
2. Flame Photometry - Principle, interferences, instrumentation and applications
3. Atomic absorption spectroscopy - Principle, interferences, instrumentation and applications
4. Nepheloturbidometry - Principle, instrumentation and applications

UNIT – III 10 Hours

Introduction to chromatography
1. Adsorption and partition column chromatography- Methodology, advantages, disadvantages
and applications.
2. Thin layer chromatography- Introduction, Principle, Methodology, Rf values, advantages,
disadvantages and applications.
3. Paper chromatography- Introduction, methodology, development techniques, advantages,
disadvantages and applications
4. Electrophoresis– Introduction, factors affecting electrophoretic mobility, Techniques of paper, gel,
capillary electrophoresis, applications

UNIT – IV 08 Hours
1. Gas chromatography - Introduction, theory, instrumentation, derivatization, temperature
programming, advantages, disadvantages and applications
2. High performance liquid chromatography (HPLC) - Introduction, theory, instrumentation,
advantages and applications.

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R22 B.Pharmacy JNTUH

UNIT – V 07 Hours
1. Ion exchange chromatography - Introduction, classification, ion exchange resins, properties,
mechanism of ion exchange process, factors affecting ion exchange, methodology and applications
2. Gel chromatography - Introduction, theory, instrumentation and applications
3. Affinity chromatography - Introduction, theory, instrumentation and applications

RECOMMENDED BOOKS (Latest Editions):

1. Instrumental Methods of Chemical Analysis by B. K Sharma
2. Organic spectroscopy by Y. R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein
11. Vidya Sagar, Instrumental Methods of Drug Analysis, Pharma Med Press

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R22 B.Pharmacy JNTUH

PS702: INDUSTRIAL PHARMACY - II

B.Pharm. IV Year I Sem. LT P C

3 1 0 4

Course Objectives: This course is designed to impart fundamental knowledge on pharmaceutical

product Commercialization from laboratory to market

Course Outcomes: Upon completion of the course, the student shall be able to:
• Know the process of pilot plant and scale up of pharmaceutical dosage forms
• Understand the process of technology transfer from lab scale to commercial batch
• Know different laws and acts that regulate pharmaceutical industry in India and US
• Understand the approval process and regulatory requirements for drug products

UNIT – I 10 Hours
Pilot plant scale up techniques: General considerations - including significance of personnel
requirements, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid
orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to Platform technology
Plant location, industrial hazards and plant safety: Plant Layout, utilities and services, Mechanical
hazards, Chemical hazards, Fire hazards, explosive hazards and their safety.
Materials of pharmaceutical plant construction, Corrosion and its prevention: Factors affecting
during materials selected for Pharmaceutical plant construction, Theories of corrosion, types of
corrosion and there prevention. Ferrous and nonferrous metals, inorganic and organic non metals.
Material handling systems: Objectives & applications of Material handling systems, different types of
conveyors such as belt, screw and pneumatic conveyors.

UNIT – II 10 Hours
Technology development and transfer: WHO guidelines for Technology Transfer: Terminologies,
Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process,
packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packing
materials) Documentation, Premises and equipments, qualification and validation, quality control,
analytical method transfer, Approved regulatory bodies and agencies, Commercialization - practical
aspects and problems (case studies), TOT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; Technology of Transfer (TOT) related documentation - confidentiality agreements, licensing,
MoUs, legal issues

UNIT – III 10 Hours

1. Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities,
Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals
2. Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical Drug
Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of
Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application
(NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical
Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.

UNIT – IV 08 Hours
Quality management systems: Quality management & Certifications: Concept of Quality, Total
Quality Management, Quality by design, Six Sigma concept, Out of Specifications (OOS), Change
control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP

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R22 B.Pharmacy JNTUH

UNIT – V 07 Hours
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State
Licensing Authority: Organization, Responsibilities, Common Technical Document (CTD), Certificate of
Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.

RECOMMENDED BOOKS: (Latest Editions)

1. International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php
2. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for
Prescription Drugs, Medical Devices, and Biologics’ 2nd Edition.
3. Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm.
4. Industrial Pharmacy by Roopa K Khar, S. P Vyas, Farhan J Ahmed, Gaurav K Jain, 4th Edition
5. Industrial Pharmacy: A Comprehensive Approach by Tripathi DK, Pharmamed Press

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R22 B.Pharmacy JNTUH

PS703: PHARMACY PRACTICE

B.Pharm. IV Year I Sem. L T P C

3 1 0 4

Course Objectives: In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution, drug
information, and therapeutic drug monitoring for improved patient care. In community pharmacy,
students will be learning various skills such as dispensing safe medication and patient counselling.

Course Outcomes: Upon completion of the course, the student shall be able to:
• Know various drug distribution methods in a hospital
• Appreciate the pharmacy stores management and inventory control
• Monitor drug therapy of patient through medication chart review and clinical review
• Know pharmaceutical care services
• do patient counselling in community pharmacy

UNIT – I 10 Hours
1. Hospital and it’s organization
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals, Classification
based on clinical and non- clinical basis, Organization Structure of a Hospital, and Medical staffs
involved in the hospital and their functions.
2. Hospital pharmacy and its organization
Definition, functions of hospital pharmacy, Organization structure, Location, Layout and staff
requirements, and Responsibilities and functions of hospital pharmacists.
3. Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legal requirements
for establishment and maintenance of a drug store, Dispensing of proprietary products,
maintenance of records of retail and wholesale drug store.

UNIT – II 10 Hours
1. Drug distribution system in a hospital
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy and labelling,
dispensing of drugs to ambulatory patients, and Dispensing of controlled drugs.
2. Therapeutic drug monitoring
Need for Therapeutic Drug Monitoring, Factors to be considered during the Therapeutic Drug
Monitoring, and Indian scenario for Therapeutic Drug Monitoring.
3. Community pharmacy management
Financial, materials, staff, and infrastructure requirements.

UNIT – III 10 Hours

1. Drug information services
Drug and Poison information centre, Sources of drug information, Computerized services, and
storage and retrieval of information.
2. Patient counselling
Definition of patient counselling; steps involved in patient counseling, and Special cases that require
the pharmacist
3. Education and training program in the hospital
Role of pharmacist in the education and training program, Internal and external training program,
Services to the nursing homes/clinics, Code of ethics for community pharmacy, and Role of
pharmacist in the interdepartmental communication and community health education.

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R22 B.Pharmacy JNTUH

UNIT – IV 08 Hours
1. Clinical Pharmacy
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and responsibilities of
clinical pharmacist, Drug therapy monitoring - medication chart review, clinical review, pharmacist
intervention, Ward round participation, Medication history and Pharmaceutical care.
2. Over the counter (OTC) sales
Introduction and sale of over the counter, and Rational use of common over the counter
medications.

UNIT – V 07 Hours
Drug store management and inventory control
Organization of drug store, types of materials stocked and storage conditions, Purchase and inventory
control: principles, purchase procedure, purchase order, procurement and stocking, Economic order
quantity, Reorder quantity level, and Methods used for the analysis of the drug expenditure

RECOMMENDED BOOKS (Latest Edition):

1. Merchant S. H. and Dr. J. S. Quadry. A textbook of hospital pharmacy, 4th ed. Ahmadabad: B.S.
Shah Prakakshan; 2001.
2. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of Clinical Pharmacy
Practice- essential concepts and skills, 1st ed. Chennai: Orient Longman Private Limited; 2004.
3. William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger; 1986.
4. Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.
5. Scott LT. Basic skills in interpreting laboratory data, 4th ed. American Society of Health System
Pharmacists Inc; 2009.
6. Parmar N. S. Health Education and Community Pharmacy, 18th ed. India: CBS Publishers &
Distributers; 2008.
7. Balasubramanian, Pharmacy Practice, Pharma Med Press
8. Bari B. Sanjay, Pharmacy Practice: Essentials of Hospital, Clinical and Community Pharmacy,
Pharma Med Press
9. Patient Assessment in Pharmacy, by Yolanda M H
10. Patient Communication for Pharmacy: A Case-Study Approach on Theory and Practice, Min
Liu, Lakesha M. Butler
11. Fundamental Skills for Patient Care in Pharmacy Practice by Colleen Doherty Lauster, Sneha
Baxi Srivastava

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R22 B.Pharmacy JNTUH

PS704: MEDICINAL CHEMISTRY – III

B.Pharm. IV Year I Sem. LT P C

3 1 0 4

Course Objectives: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasis on modern techniques of rational drug
design like quantitative structure activity relationship (QSAR), Prodrug concept, combinatorial chemistry
and Computer aided drug design (CADD). The subject also emphasizes on the chemistry, mechanism
of action, metabolism, adverse effects, Structure Activity Relationships (SAR), therapeutic uses and
synthesis of important drugs.

Course Outcomes: Upon completion of the course student shall be able to

 Understand the importance of drug design and different techniques of drug design.
 Understand the chemistry of drugs with respect to their biological activity.
 Know the metabolism, adverse effects and therapeutic value of drugs.
 Know the importance of SAR of drugs.

Study of the development of the following classes of drugs, Classification, mechanism of action,
uses of drugs mentioned in the course, Structure activity relationship of selective class of drugs
as specified in the course and synthesis of drugs superscripted by (*)

UNIT – I 10 Hours
Antibiotics I:
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical
degradation classification and important products of the following classes.
Beta-Lactam antibiotics: Penicillin, Cephalosporins, Beta-Lactamase inhibitors, Monobactams
Aminoglycosides: Streptomycin, Neomycin, Kanamycin
Tetracyclines: Tetracycline, Oxytetracycline, Chlortetracycline, Minocycline, Doxycycline

UNIT – II 10 Hours
Antibiotics II:
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical
degradation, classification and important products of the following classes.
Macrolide: Erythromycin Clarithromycin, Azithromycin.
Miscellaneous: Chloramphenicol*, Clindamycin.
Antimalarials: Etiology of malaria.
Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine, Primaquine phosphate, Pamaquine*,
Quinacrine hydrochloride, Mefloquine.
Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquone.

UNIT – III 10 Hours

Anti-tubercular Agents
Synthetic anti tubercular agents: Isoniazid*, Ethionamide, Ethambutol, Pyrazinamide, Para amino
salicylic acid.*
Anti-tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine Streptomycine, Capreomycin sulphate.
Urinary tract anti-infective agents
Quinolones: SAR of quinolones, Nalidixic Acid, Norfloxacin, Enoxacin,
Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin, Moxifloxacin
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.
Antiviral agents: Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine trifluoride,

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R22 B.Pharmacy JNTUH

Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine, Lamivudine, Loviride, Delavirding,

Ribavirin, Saquinavir, Indinavir, Ritonavir.

UNIT – IV 08 Hours
Antifungal agents:
Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin, Griseofulvin.
Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole, Oxiconazole Tioconozole,
Miconazole*, Ketoconazole, Terconazole, Itraconazole, Fluconazole, Naftifine hydrochloride,
Tolnaftate*.
Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole, Diloxanide, Iodoquinol, Pentamidine
Isethionate, Atovaquone, Eflornithine.
Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole, Mebendazole*, Albendazole,
Niclosamide, Oxamniquine, Praziquantal, Ivermectin.
Sulphonamides and Sulfones
Historical development, chemistry, classification and SAR of Sulfonamides:
Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*, Sulphapyridine, Sulfamethoxaole*,
Sulphadiazine, Mefenide acetate, Sulfasalazine.
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.
Sulfones: Dapsone*.

UNIT – V 07 Hours
Drugs acting on Endocrine system
Nomenclature, Stereochemistry and metabolism of steroids
Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol, Oestrione, Diethyl
stilbestrol.
Drugs for erectile dysfunction: Sildenafil, Tadalafil.
Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol
Corticosteroids: Cortisone, Hydrocortisone, Prednisolone, Betamethasone, Dexamethasone
Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine, Propylthiouracil, Methimazole.

RECOMMENDED BOOKS (Latest Editions)

1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- A.I. Vogel.
11. S. P. Vyas and R. K. Khar, Controlled Drug Delivery - concepts and advances, Vallabh
Prakashan, New Delhi, 1st edition 2002.
12. Durai Ananda Kumar T. Experimental Organic and Medicinal Chemistry Principles & Practice,
Pharma Med Press

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R22 B.Pharmacy JNTUH

PS705: PHARMACEUTICAL MARKETING (Open Elective - III)

B.Pharm. IV Year I Sem. LTPC

3104

Course Objectives: The pharmaceutical industry not only needs highly qualified researchers, chemist,
technical people but also requires skilled managers who can take the industry forward by managing
and taking the complex decisions which are imperative for the growth of the industry. Sales & Marketing
which grooms the people for taking a challenging role in Sales and Product management.

Course Outcome: Provide an understanding of marketing concepts and techniques and the application
of the same in the pharmaceutical industry.

UNIT – I 10 Hours
Marketing: Definition, general concepts, and scope of marketing; Distinction between marketing &
selling; Marketing environment; Industry and competitive analysis; Analyzing consumer buying
behavior; industrial buying behavior.
Pharmaceutical market: Quantitative and qualitative aspects; size and composition of the market;
demographic descriptions and socio-psychological characteristics of the consumer; market
segmentation& targeting. Consumer profile; Motivation and prescribing habits of the physician; patients'
choice of physician and retail pharmacist. Analyzing the Market; Role of market research.

UNIT – II 10 Hours
Product decision: Meaning, Classification, product line and product mix decisions, product life cycle,
product portfolio analysis; product positioning; New product decisions; Product branding, packaging
and labeling decisions, Product management in pharmaceutical industry.

UNIT – III 10 Hours

Promotion: Meaning and methods, determinants of promotional mix, promotional budget; An overview
of personal selling, advertising, direct mail, journals, sampling, retailing, medical exhibition, public
relations, online promotional techniques for OTC Products.

UNIT – IV 10 Hours
Pharmaceutical marketing channels: Designing channel, channel members, selecting the
appropriate channel, conflict in channels, physical distribution management: Strategic importance,
tasks in physical distribution management.
Professional sales representative (PSR): Duties of PSR, purpose of detailing, selection and training,
supervising, norms for customer calls, motivating, evaluating, compensation and future prospects of the
PSR.

UNIT – V 10 Hours
Pricing: Meaning, importance, objectives, determinants of price; pricing methods and strategies, issues
in price management in pharmaceutical industry. An overview of DPCO (Drug Price Control Order) and
NPPA (National Pharmaceutical Pricing Authority).
Emerging concepts in marketing: Vertical & Horizontal Marketing; Rural Marketing; Consumerism;
Industrial Marketing; Global Marketing.

RECOMMENDED BOOKS: (Latest Editions)

1. Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India, New Delhi
2. Walker, Boyd and Larreche: Marketing Strategy- Planning and Implementation, Tata McGraw
Hill, New Delhi.
3. Subba Rao Changanti, Pharmaceutical Marketing in India, Pharma Med Press

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R22 B.Pharmacy JNTUH

4. Dhruv Grewal and Michael Levy: Marketing, Tata McGraw Hill

5. Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India
6. Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition)
7. Ramaswamy, U.S & Nanakamari, S: Marketing Management: Global Perspective, Indian
Context, Macmillan India, New Delhi.
8. Shanker, Ravi: Service Marketing, Excell Books, New Delhi
9. Smarta Raja B. Strategic Pharmaceutical Marketing, Pharma Med Press

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R22 B.Pharmacy JNTUH

PS706: PHARMACEUTICAL REGULATORY SCIENCE (Open Elective - III)

B.Pharm. IV Year I Sem. LT P C

3 1 0 4

Course Objectives: This course is designed to impart the fundamental knowledge on the regulatory
requirements for approval of new drugs, drug products in regulated countries like US, EU, Japan,
Australia and Canada. It prepares the students to learn in detail on the regulatory requirements,
documentation requirements, and registration procedures for marketing the drug products in regulated
countries.

Course Outcomes: Upon completion of the subject student shall be able to:
• Know about the process of drug discovery and development
• Know the regulatory authorities and agencies governing the manufacture and sale of
pharmaceuticals
• Know the regulatory approval process and their registration in Indian and international markets

UNIT – I 10 Hours
New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical
studies, Innovator and generics, Concept of generics, Generic drug product development.

UNIT – II 10 Hours
Regulatory Approval Process: Approval processes and timelines involved in Investigational New
Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA) in US. Changes
to an approved NDA / ANDA.
Regulatory authorities and agencies: Overview of regulatory authorities of United States, European
Union, Australia, Japan, Canada (Organization structure and types of applications)

UNIT – III 10 Hours

Registration of Indian drug product in overseas market: Procedure for export of pharmaceutical
products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD),
electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD)
research.

UNIT – IV 08 Hours
Clinical trials: Developing clinical trial protocols, Institutional Review Board / Independent Ethics
committee - formation and working procedures, Informed consent process and procedures, GCP
obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials,
Pharmacovigilance - safety monitoring in clinical trials

UNIT – V 07 Hours
Regulatory Concepts: Basic terminologies, guidance, guidelines, regulations, laws and acts, Orange
book, Federal Register, Code of Federal Regulatory, Purple book

RECOMMENDED BOOKS (Latest edition):

1. Drug Regulatory Affairs by Sachin Itkar, Dr. N. S. Vyawahare, Nirali Prakashan.
2. The Pharmaceutical Regulatory Process, 2nd 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, 5 th
edition, Drugs and the Pharmaceutical Sciences, Vol. 190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.

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R22 B.Pharmacy JNTUH

5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited
by Douglas J. Pisano, David Mantus.
6. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer,
Marcel Dekker series, Vol.143
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance by Fay A.
Rozovsky and Rodney K. Adams
8. Principles and Practices of Clinical Research, 2nd Edition Edited by John I. Gallin and Frederick
P. Ognibene
9. Drugs: From Discovery to Approval, 2nd Edition by Rick N
10. Clinical Research: Principles, Practices, Perspective, by Bikash Medhi, Pharmamed Press

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PS707: PHARMACOVIGILANCE (Open Elective - III)

B.Pharm. IV Year I Sem. LT P C

3 1 0 4

Course Objective: This paper will provide an opportunity for the student to learn about development
of pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario of
Pharmacovigilance, train students on establishing pharmacovigilance programme in an organization,
various methods that can be used to generate safety data and signal detection.

Course Outcomes: At completion of this paper it is expected that students will be able to (know, do,
and appreciate):
 Why drug safety monitoring is important?
 History and development of pharmacovigilance
 National and international scenario of pharmacovigilance
 International standards for classification of diseases and drugs
 Adverse drug reaction reporting systems and communication in pharmacovigilance
 Data during pre-clinical, clinical and post approval.
 Pharmacovigilance Program of India (PvPI)
 ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning

UNIT - I 10 Hours
Introduction to Pharmacovigilance:
a) History and development of Pharmacovigilance
b) Importance of safety monitoring of Medicine
c) WHO international drug monitoring programme
d) Pharmacovigilance Program of India (PvPI)
Introduction to adverse drug reactions:
a) Definitions and classification of ADRs
b) Detection and reporting
c) Methods in Causality assessment
d) Severity and seriousness assessment
e) Predictability and preventability assessment
Basic terminologies used in pharmacovigilance:
a) Terminologies of adverse medication related events
b) Regulatory terminologies

UNIT – II 10 hours
Drug and disease classification:
a) Anatomical, therapeutic and chemical classification of drugs
b) International classification of diseases
c) Daily defined doses
Drug dictionaries and coding in pharmacovigilance:
a) WHO adverse reaction terminologies
b) MedDRA and Standardized MedDRA queries
c) WHO drug dictionary
Information resources in pharmacovigilance:
a) Basic drug information resources
Establishing pharmacovigilance programme:
a) Establishing in a hospital
b) Establishment & operation of drug safety department in industry
c) Contract Research Organizations (CROs)

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R22 B.Pharmacy JNTUH

UNIT – III 10 Hours

Vaccine safety surveillance:
a) Vaccine Pharmacovigilance
b) Vaccination failure
c) Adverse events following immunization
Pharmacovigilance methods:
a) Passive surveillance – Spontaneous reports and case series
b) Stimulated reporting
c) Active surveillance – Sentinel sites, drug event monitoring and registries
d) Comparative observational studies – Cross sectional study, case control study and cohort study
e) Targeted clinical investigations

UNIT – IV 08 Hours
Statistical methods for evaluating medication safety data
Safety data generation:
a) Pre-clinical phase
b) Clinical phase
c) Post approval phase
ICH Guidelines for Pharmacovigilance:
a) Organization and objectives of ICH
b) Expedited reporting
c) Individual case safety reports
d) Periodic safety update reports
e) Post approval expedited reporting
f) Pharmacovigilance planning
g) Good clinical practice in pharmacovigilance studies

UNIT – V 07 hours
Pharmacogenomics of adverse drug reactions:
Drug safety evaluation in special population
a) Pediatrics
b) Pregnancy and lactation
c) Geriatrics

RECOMMENDED BOOKS (Latest edition):

1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
3. Mann's Pharmacovigilance: Elizabeth B. Andrews, Nicholas, Wiley Publishers.
4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley
Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller, Wiley Publishers.
6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert, Jones& Bartlett
Publishers.

7. Textbook of Pharmacoepidemiology edited by Brian L. Strom, Stephen E Kimmel, Sean

Hennessy, Wiley Publishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills: G. Parthasarathi,
Karin Nyfort Hansen, Milap C. Nahata
9. National Formulary of India
10. Text Book of Medicine by Yashpal Munjal

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R22 B.Pharmacy JNTUH

11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna,
Pharmamed Press.
12. A Textbook of Clinical Research and Pharmacovigilance, KPR Chowdary, Pharmamed Press.
13. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn3=7297
14. http://www.ich.org/
15. http://www.cioms.ch/
16. http://cdsco.nic.in/
17. http://www.who.int/vaccine_safety/en/
18. http://www.ipc.gov.in/PvPI/pv_home.html

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R22 B.Pharmacy JNTUH

PS708: QUALITY CONTROL AND STANDARDIZATION OF HERBALS (Open Elective - III)

B.Pharm. IV Year I Sem. LT P C

3 1 0 4

Course Objective: In this subject the student learns about the various methods and guidelines for
evaluation and standardization of herbs and herbal drugs. The subject also provides an opportunity for
the student to learn cGMP, GAP and GLP in traditional system of medicines.

Course Outcomes: Upon completion of the subject student shall be able to:
• Know WHO guidelines for quality control of herbal drugs
• Know Quality assurance in herbal drug industry
• Know the regulatory approval process and their registration in Indian and international markets
• Appreciate EU and ICH guidelines for quality control of herbal drugs

UNIT – I 10 hours
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage forms.
WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude drugs intended for
use

UNIT – II 10 hours
Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in traditional system of
medicine. WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines
WHO Guidelines on GACP for Medicinal Plants.

UNIT – III 10 hours

EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

UNIT – IV 08 hours
Stability testing of herbal medicines. Application of various chromatographic techniques in
standardization of herbal products.
Preparation of documents for new drug application and export registration GMP requirements and
Drugs & Cosmetics Act provisions.

UNIT – V 07 hours
Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems Comparison
of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal products

RECOMMENDED BOOKS: (Latest Editions)

1. Pharmacognosy by Trease and Evans
2. Pharmacognosy by Kokate, Purohit and Gokhale
3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006.
4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal Products,
6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals.
Business Horizons Publishers, New Delhi, India, 2002.
7. Shinde M. V., Dhalwal K., Potdar K., Mahadik K. Application of quality control principles to
herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-.

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8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health Organization,
Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal Medicines. WHO Regional
Publications, Western Pacific Series No 3, WHO Regional office for the Western Pacific, Manila,
1998.
9. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn. World Health
Organization, Geneva, 1981. WHO. Quality Control Methods for Medicinal Plant Materials.
World Health Organization, Geneva, 1999.
10. WHO. WHO Global Atlas of Traditional, Complementary and Alternative Medicine. 2 vol. set.
Vol. 1 contains text and Vol. 2, maps. World Health Organization, Geneva, 2005.
11. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants.
World Health Organization, Geneva, 2004.
12. Deore S L, Quality Control of Herbal Drugs, Pharma Med Press

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PS709: INSTRUMENTAL METHODS OF ANALYSIS LAB

B.Pharm. IV Year I Sem. L T P C

0 0 4 2
List of Experiments:
1. Determination of absorption maxima and effect of solvents on absorption maxima of organic
compounds
2. Estimation of dextrose by colorimetry
3. Estimation of sulfanilamide by colorimetry
4. Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy
5. Assay of paracetamol by UV- Spectrophotometry
6. Estimation of quinine sulfate by fluorimetry
7. Study of quenching of fluorescence
8. Determination of sodium by flame photometry
9. Determination of potassium by flame photometry
10. Determination of chlorides and sulphates by nephelo turbidometry
11. Separation of amino acids by paper chromatography
12. Separation of sugars by thin layer chromatography
13. Separation of plant pigments by column chromatography
14. Demonstration experiment on HPLC
15. Demonstration experiment on Gas Chromatography

RECOMMENDED BOOKS (Latest Editions):

1. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
2. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
3. Quantitative Analysis of Drugs by D. C. Garrett
4. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi

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R22 B.Pharmacy JNTUH

PS710: PRACTICE SCHOOL

B.Pharm. IV Year I Sem. L T P C

0 0 4 2

Course Objectives: Practice school is an educational innovation seeking to link industry/hospital/

pharmacy experience with university instruction. The student will:
• Meet the rapidly changing needs and challenges of a professional work place.
• Acquire knowledge and skills.
• Bear an economic relevance to the society.

Course Outcome: Institutionalized linkage between university/college and industry. Student’s

involvement in real life projects continues internal evaluation and monitoring the faculty help by student
to understand the practical issues. After successful completion of 150 hrs, the students will submit the
detailed report in the following field.

Note: Any domains relevant to pharmacy can be given to students. Following domains for for
reference

Industry oriented PS:

It comprises industry visits and interactions with executives to facilitate the process of learning by
observations and discussions duly aided by the check list. It promotes learning by doing in various
departments like production quality control and assurance, R&D etc. Taking one issue and working on
it for prescribed hours and submit the report.

Hospital oriented PS:

The student is asked to visit the hospitals and work on some case studies like cardiovascular, diabetics,
gastrointestinal, gynaecological, pulmonary paediatric etc. related cases of some 5 to 6 to be studied
and detailed data to be submitted.

Retail pharmacy-oriented PS:

The students have to visit different pharmacy shops and collect the data related to the most prescribed
medicines in that area, prescription patterns, medical audit etc and submit the report.

Election of medicinal plants orientated PS:

The students have to visit medicinal plant gardens and collect some medicinal plants those are useful
to various disorders and submit the report in detail about the plants they come across during their study
period

Regulatory affairs: collect and analyse the regulatory affairs. Some important cases filed by drug
control officers to be analysed and reported.

National poison centre: visit the local poison centre and write the relevant matter

Formulation aspects: Formulations using any equipments which otherwise are not usually used for
regular practicals

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R22 B.Pharmacy JNTUH

PS801: BIOSTATISTICS AND RESEARCH METHODOLOGY

B.Pharm. IV Year II Sem. L T P C

3 1 0 4

Course Objectives: To understand the applications of Biostatics in Pharmacy. This subject deals with
descriptive statistics, Graphics, Correlation, Regression, ANOVA, Introduction to Design of
Experiments, Phases of Clinical trials and Observational and Experimental studies.

Course Outcomes: Upon completion of the course the student shall be able to
• Know the operation of M.S. Excel, SPSS, R and MINITAB®, DoE (Design of Experiment)
• Know the various statistical techniques to solve statistical problems
• Appreciate statistical techniques in solving the problems.

UNIT – I 10 Hours
Introduction: Statistics, Biostatistics, Frequency distribution
Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples
Measures of dispersion: Dispersion, Range, standard deviation, Pharmaceutical problems
Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple correlation -Pharmaceuticals
examples

UNIT – II 10 Hours
Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and x = a + by,
Multiple regression, standard error of regression– Pharmaceutical Examples.
Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis, sampling,
essence of sampling, types of sampling, Error-I type, Error-II type, Standard error of mean (SEM) -
Pharmaceutical examples
Parametric test: t-test (Sample, Pooled or Unpaired and Paired), ANOVA, (One way and Two way),
Least Significance difference

UNIT – III 10 Hours

Non-Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-Wallis test, Friedman
Test
Introduction to Research: Need for research, Need for design of Experiments, Experiential Design
Technique, plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graph.
Designing the methodology: Sample size determination and Power of a study, Report writing and
presentation of data, Protocol, Cohorts studies, Observational studies, Experimental studies, Designing
clinical trial, various phases.

UNIT – IV 8 Hours
Introduction to Practical components of Industrial and Clinical Trials Problems: Statistical
Analysis Using Excel, SPSS, MINITAB®, DESIGN OF EXPERIMENTS, R - Online Statistical Software’s
to Industrial and Clinical trial approach

UNIT – V 7 Hours
Design and Analysis of experiments:
Factorial Design: Definition, 22, 23 design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical design, Optimization
Techniques

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RECOMMENDED BOOKS (Latest edition):

1. Pharmaceutical Statistics - Practical and clinical applications, Sanford Bolton, Publisher Marcel
Dekker Inc. New York.
2. Fundamental of Statistics – Himalaya Publishing House- S. C. Guptha
3. Design and Analysis of Experiments – PHI Learning Private Limited, R. Pannerselvam,
4. Design and Analysis of Experiments – Wiley Students Edition, Douglas and C. Montgomery
5. Bayya Subba Rao, Pharmaceutical Research Methodology and Bio-Statistics: Theory &
Practice, Pharma Med Press
6. Chowdary KPR, A Textbook of Research Methodologies and Biostatistics for Pharmacy
Students, Pharma Med Press

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PS802: SOCIAL AND PREVENTIVE PHARMACY

B.Pharm. IV Year II Sem. LTPC

310 4

Course Objectives: The purpose of this course is to introduce to students a number of health issues
and their challenges. This course also introduced a number of national health programmes. The roles
of the pharmacist in these contexts are also discussed.

Course Outcomes: After the successful completion of this course, the student shall be able to:
• Acquire high consciousness/realization of current issues related to health and pharmaceutical
problems within the country and worldwide.
• Have a critical way of thinking based on current healthcare development.
• Evaluate alternative ways of solving problems related to health and pharmaceutical issues

UNIT – I 10 Hours
Concept of health and disease: Definition, concepts and evaluation of public health. Understanding
the concept of prevention and control of disease, social causes of diseases and social problems of the
sick.
Social and health education: Food in relation to nutrition and health, Balanced diet, Nutritional
deficiencies, Vitamin deficiencies, Malnutrition and its prevention.
Sociology and health: Socio cultural factors related to health and disease, Impact of urbanization on
health and disease, Poverty and health
Hygiene and health: personal hygiene and health care; avoidable habits

UNIT – II 10 Hours
Preventive medicine: General principles of prevention and control of diseases such as cholera, SARS,
Ebola virus, influenza, acute respiratory infections, malaria, chicken guinea, dengue, lymphatic
filariasis, pneumonia, hypertension, diabetes mellitus, cancer, drug addiction-drug substance abuse

UNIT – III 10 Hours

National health programs, its objectives, functioning and outcome of the following: HIV and AIDS
control programme, TB, Integrated disease surveillance program (IDSP), National leprosy control
programme, National mental health program, National
programme for prevention and control of deafness, Universal immunization programme, National
programme for control of blindness, Pulse polio programme.

UNIT – IV 08 Hours
National health intervention programme for mother and child, national family welfare programme,
national tobacco control programme, national malaria prevention program, national programme for the
health care for the elderly, social health programme; role of *who in indian national program

UNIT – V 07 Hours
Community services in rural, urban and school health: Functions of PHC, Improvement in rural
sanitation, national urban health mission, Health promotion and education in school.

RECOMMENDED BOOKS (Latest edition):

1. Short Textbook of Preventive and Social Medicine, Prabhakara G N, 2nd Edition, 2010, ISBN:
9789380704104, JAYPEE Publications
2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by Roy Rabindra
Nath, Saha Indranil, 4th Edition, 2013, ISBN: 9789350901878, JAYPEE Publications

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3. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6 th Edition, 2014,
ISBN: 9789351522331, JAYPEE Publications
4. Essentials of Community Medicine - A Practical Approach, Hiremath Lalita D, Hiremath
Dhananjaya A, 2nd Edition, 2012, ISBN: 9789350250440, JAYPEE Publications
5. Park Textbook of Preventive and Social Medicine, K Park, 21st Edition, 2011, ISBN-14:
9788190128285, Banarsidas Bhanot Publishers.
6. Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad
7. K. Ravi Shankar, Social and Preventive Pharmacy, Pharma Med Press.

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R22 B.Pharmacy JNTUH

PS803: NOVEL DRUG DELIVERY SYSTEMS

B.Pharm. IV Year II Sem. LT P C

3 1 0 4

Course Objectives: This subject is designed to impart basic knowledge on the area of novel drug
delivery systems.

Course Outcomes: Upon completion of the course student shall be able:

• To understand various approaches for development of novel drug delivery systems.
• To understand the criteria for selection of drugs and polymers for the development of Novel
drug delivery systems, their formulation and evaluation

UNIT – I 10 Hours
1. Controlled drug delivery systems: Introduction, terminology/definitions and rationale,
advantages, disadvantages, selection of drug candidates. Approaches to design-controlled release
formulations based on diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations
2. Polymers: Introduction, classification, properties, advantages and application of polymers in
formulation of controlled release drug delivery systems.

UNIT – II 10 Hours
1. Microencapsulation: Definition, advantages and disadvantages, microspheres /microcapsules,
microparticles, methods of microencapsulation, applications
2. Mucosal Drug Delivery system: Introduction, Principles of bioadhesion / mucoadhesion,
concepts, advantages and disadvantages, transmucosal permeability and formulation
considerations of buccal delivery systems
3. Implantable Drug Delivery Systems: Introduction, advantages and disadvantages, concept of
implants and osmotic pump

UNIT – III 10 Hours

1. Transdermal Drug Delivery Systems: Introduction, Permeation through skin, factors affecting
permeation, permeation enhancers, basic components of TDDS, formulation approaches
2. Gastroretentive drug delivery systems: Introduction, advantages, disadvantages, approaches
for GRDDS – Floating, high-density systems, inflatable and gastroadhesive systems and their
applications
3. Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary routes of drug
delivery, Formulation of Inhalers (dry powder and metered dose), nasal sprays, nebulizers

UNIT – IV 08 Hours
Nanotechnology and its Concepts: Concepts and approaches for targeted drug delivery systems,
advantages and disadvantages, introduction to liposomes, niosomes, nanoparticles, monoclonal
antibodies and their applications

UNIT – V 07 Hours
1. Ocular Drug Delivery Systems: Introduction, intra ocular barriers and methods to overcome –
Preliminary study, ocular formulations and ocuserts
2. Intrauterine Drug Delivery Systems: Introduction, advantages and disadvantages, development
of intra uterine devices (IUDs) and applications

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RECOMMENDED BOOKS: (Latest Editions)

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. Edith Mathiowitz, Published by Wiley Interscience
Publication, John Wiley and Sons, Inc, New York. Chichester/Weinheim
4. N. K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New Delhi, 1st
edition 1997 (reprint in 2001).
5. Tripathi Dulal Krishna, Novel Drug Delivery Systems, Pharma Med Press

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PS804: COMPUTER AIDED DRUG DESIGN (Open Elective - IV)

B.Pharm. IV Year II Sem. L T P C

3 1 0 4

Course Objectives: This subject is designed to provide detailed knowledge of rational drug design
process and various techniques used in rational drug design process.

Course Outcomes: Upon completion of the course, the student shall be able to understand:
• Design and discovery of lead molecules
• The role of drug design in drug discovery process
• The concept of QSAR and docking
• Various strategies to develop new drug like molecules.
• The design of new drug molecules using molecular modelling software

UNIT – I 10 Hours
Introduction to Drug Discovery and Development: Stages of drug discovery and development
Lead discovery and Analog Based Drug Design
Rational approaches to lead discovery based on traditional medicine, Random screening, Non-random
screening, serendipitous drug discovery, lead discovery based on drug metabolism, lead discovery
based on clinical observation.
Analog Based Drug Design: Bioisosterism, Classification, Bioisosteric replacement. Any three case
studies

UNIT – II 10 Hours
Quantitative Structure Activity Relationship (QSAR): SAR versus QSAR, History and development
of QSAR, Types of physicochemical parameters, experimental and theoretical approaches for the
determination of physicochemical parameters such as Partition coefficient, Hammet’s substituent
constant and Tafts steric constant. Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like
COMFA and COMSIA.

UNIT – III 10 Hours

Molecular Modeling and virtual screening techniques
Virtual Screening techniques: Drug likeness screening, Concept of pharmacophore mapping and
pharmacophore-based Screening
Molecular docking: Rigid docking, flexible docking, manual docking, Docking based screening. De
novo drug design.

UNIT – IV 08 Hours
Informatics & Methods in drug design: Introduction to Bioinformatics, chemoinformatics. ADME
databases, chemical, biochemical and pharmaceutical databases.

UNIT – V 07 Hours
Molecular Modelling: Introduction to molecular mechanics and quantum mechanics. Energy
Minimization methods and Conformational Analysis, global conformational minima determination.

RECOMMENDED BOOKS (Latest Editions):

1. Robert GCK, ed., “Drug Action at the Molecular Level” University Prak Press Baltimore.
2. Martin YC. “Quantitative Drug Design” Dekker, New York.
3. Delgado JN, Remers WA eds “Wilson & Gisvolds’s Text Book of Organic Medicinal &
Pharmaceutical Chemistry” Lippincott, New York.
4. Foye WO “Principles of Medicinal chemistry ‘Lea & Febiger.

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5. Koro lkovas A, Burckhalter JH. “Essentials of Medicinal Chemistry” Wiley Interscience.

6. Wolf ME, ed “The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry” John Wiley &
Sons, New York.
7. Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University Press.
8. Smith HJ, Williams H, eds, “Introduction to the principles of Drug Design” Wright Boston.
9. Silverman R.B. “The organic Chemistry of Drug Design and Drug Action” Academic Press New
York.
10. Durai Ananda Kumar T. Current Concepts in Drug Design. Pharma Med Press

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R22 B.Pharmacy JNTUH

PS805: NANO TECHNOLOGY (Open Elective - IV)

B.Pharm. IV Year II Sem. L T P C

3 1 0 4

Course Objectives: To develop expertise regarding suitability and evaluation of nanomaterials, able
to apply the properties to the fabrication of nano pharmaceutical, evaluate the intensity of dosage forms
and availability for targeting and controlled delivery.

Course Outcomes: The students should be able to select the right kind of materials, able to develop
nano formulations with appropriate technologies, evaluate the product related test and for identified
diseases

UNIT – I
Introduction to Nanotechnology
a. Definition of nanotechnology
b. History of nanotechnology
c. Unique properties of nanomaterials
d. Classification of nanomaterials
.
UNIT – II
Synthesis of Nanomaterials
Methods for synthesis of:
a. Gold nanoparticles
b. Magnetic nanoparticles
c. Polymeric nanoparticles
d. Self – assembly structures such as liposomes, Niosomes, micelles, aquasomes and
nanoemulsions

UNIT – III
Biomedical applications of Nanotechnology
a. Nanotechnology products used for in vitro diagnostics
b. Applications in imaging and targeting.

UNIT – IV
Design of nanomaterials for drug delivery, pulmonary, nasal drug delivery, cardiovascular diseases and
localized drug delivery systems.

UNIT – V
Characterization, drug release and stability studies of nanomaterials

RECOMMENDED BOOKS (Latest Editions):

1. Nanomedicine and Nanoproducts: Applications, Disposition and Toxicology in the Human body,
Eiki Igarashi, CRC press. 2015
2. Nanotechnology and Drug Delivery Volume one and two: Nanoplatforms in Drug Delivery, Jose
L. Arias, CRC press
3. Nano: The Essentials: Understanding Nanosicence and Nanotechnology, T. Pradeep, Tata
McGraw-Hill Publishing Company Limited, New Delhi, 2008.
4. Nanocrystals: Synthesis, Properties and Applications, C. N. R. Rao, P.J. Thomas and G.U.
Kulakarni, Springer (2007)
5. Nanostructures and Nanomaterials: Synthesis, Properties and Application, Guozhong Gao,
Imperial College Press (2004)

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R22 B.Pharmacy JNTUH

6. Nano chemistry: A Classical Approach to Nanomaterials – Royal Society for Chemistry,

Cambridge, UK (2005)
7. Nanocomposite science and technology, pulickel M. Ajayan, Linda S. Schadler, paul V. Braun,
Wiley-VCH Verlag, Weiheim (2003)
8. Nanoscale materials in chemistry, Edited by Kenneth J. Klabunde, John Wiley & Sons, 2009
9. Nanoparticles as Drug carriers, Vladimir P Torchiling, Imperial College Press, USA, 2006
10. Introduction to Nano Science and Technologies, Ankaneyulu Yerramilli, BS Publications. 2016
11. Anjaneyulu Y. Introduction to Nano-Science and Technologies, Pharma Med Press.

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R22 B.Pharmacy JNTUH

PS806: EXPERIMENTAL PHARMACOLOGY (Open Elective - IV)

B.Pharm. IV Year II Sem. L T P C

3 1 0 4

Course Objectives: This subject is designed to impart the knowledge on preclinical evaluation of drugs
and recent experimental techniques in the drug discovery and development. The subject content helps
the student to understand the maintenance of laboratory animals as per the guidelines.

Course Outcomes: Upon completion of the course the student shall be able to,
• Appraise the regulations and ethical requirement for the usage of experimental animals.
• Describe the various animals and newer screening methods used in the drug discovery
• Understand the Research methodology to be followed Bio-statistical data interpretation of the
assays

UNIT – I
Laboratory Animals: Description and applications of different species and strains of animals. Popular
transgenic and mutant animals. Techniques for collection of blood and common routes of drug
administration in laboratory animals, Techniques of blood collection and euthanasia

UNIT – II
Preclinical screening models: Dose selection, calculation and conversions, preparation of drug
solution/suspensions, grouping of animals and importance of sham negative and positive control groups

UNIT - III
Preclinical screening models: for ANS activity, sympathomimetics, sympatholytics,
parasympathomimetics, parasympatholytics and skeletal muscle relaxants.

UNIT - IV
Preclinical screening models for diuretics, anticoagulants and anticancer activities

UNIT – V
Research methodology and Bio-statistics, Selection of research topic, review of literature, research
hypothesis and study design, Interpretation using Student’t’ test and One-way ANOVA. Graphical
representation of data.

RECOMMENDED BOOKS (Latest Editions):

1. Biological standardization by J.H. Burn D.J. Finney and I.G. Goodwin.
2. Screening methods in Pharmacology by Robert Turner. A.
3. Methods in Pharmacology by Arnold Schwartz.
4. Pharmacological screening methods and Toxicology by A Srinivasa Rao and N. Bhagya
Lakshmi
5. Fundamentals of experimental Pharmacology by M. N. Ghosh.
6. Experimental Pharmacology for undergraduates by M C Prabhakara.
7. Drug discovery and Evaluation by Vogel H. G.
8. Experimental Pharmacology by R. K. Goyal.
9. Preclinical evaluation of new drugs by S.K. Gupta.
10. Handbook of Experimental Pharmacology, S K. Kulkarni.
11. Practical Pharmacology and Clinical Pharmacy, S K. Kulkarni, 3rd Edition.
12. Screening Methods in Pharmacology, Robert A. Turner.
13. Guidelines and Screening Methods of Pharmacology, Surendra H. Bodakhe, Pharmamed
Press.

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R22 B.Pharmacy JNTUH

PS807: ADVANCED INSTRUMENTATION TECHNIQUES (Open Elective - IV)

B.Pharm. IV Year II Sem. L T P C

3 1 0 4

Course Objectives: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart advanced knowledge on the principles
and instrumentation of spectroscopic and chromatographic hyphenated techniques. This also
emphasizes on theoretical and practical knowledge on modern analytical instruments that are used for
drug testing.

Course Outcomes: Upon completion of the course the student shall be able to:
• Understand the advanced instruments used and its applications in drug analysis
• Understand the chromatographic separation and analysis of drugs.
• Understand the calibration of various analytical instruments
• Know analysis of drugs using various analytical instruments.

UNIT – I 10 Hours
Nuclear Magnetic Resonance spectroscopy
Principles of H-NMR and C-NMR, chemical shift, factors affecting chemical shift, coupling constant,
Spin - spin coupling, relaxation, instrumentation and applications
Mass Spectrometry - Principles, Fragmentation, Ionization techniques - Electron impact, chemical
ionization, instrumentation and applications.

UNIT - II 10 Hours
Thermal Methods of Analysis: Principles, instrumentation and applications of Thermogravimetric
Analysis (TGA), Differential Thermal Analysis (DTA), Differential Scanning Calorimetry (DSC)
X-Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals, X-ray Crystallography, rotating
crystal technique, single crystal diffraction, powder diffraction and applications.

UNIT - III 10 Hours

Calibration and validation-as per ICH and USFDA guidelines
Calibration of following Instruments
Electronic balance, UV-Visible spectrophotometer, IR spectrophotometer, Fluorimeter, Flame
Photometer, HPLC and GC

UNIT – IV 08 Hours
Radio immune assay: Importance, various components, Principle, different methods, Limitation and
Applications of Radio immuno assay
Extraction Techniques: General principle and procedure involved in the solid phase extraction and
liquid-liquid extraction

UNIT – V 07 Hours
Hyphenated techniques - LC-MS/MS, GC-MS/MS, HPTLC-MS.

RECOMMENDED BOOKS (Latest Editions):

1. Instrumental Methods of Chemical Analysis by B. K Sharma
2. Organic spectroscopy by Y. R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar

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R22 B.Pharmacy JNTUH

7. Organic spectroscopy by William Kemp

8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein
11. Liptak, Analytical Instrumentation, T&F

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R22 B.Pharmacy JNTUH

PS808: NOVEL DRUG DELIVERY SYSTEMS LAB

B.Pharm. IV Year II Sem. L T P C

0 0 4 2
1. Study on diffusion of drugs through various polymeric membranes
2. Study on polymeric properties
3. Preparation and Evaluation of Microencapsules by different methods
4. Preparation and Evaluation of Mucosal Drug Delivery Systems
5. Preparation and Evaluation of Transdermal Drug Delivery Systems
6. Preparation and Evaluation of Gastroretentive Drug Delivery Systems
7. Preparation and Evaluation of Buccal Drug Delivery Systems
8. Preparation and Evaluation of Osmotic Drug Delivery Systems
9. Preparation and Evaluation of Liposomes, Niosomes and Nanoparticles

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R22 B.Pharmacy JNTUH

PROJECT WORK

The student should select a project work from the following areas and should work in respective
industries/departments to complete project. The project work done has to be presented as a report. The
student should present the findings of the project work in the college for final evaluation.
1. Formulation Development
2. Analytical Development
3. Chemical synthesis/Natural products
4. Pharmacological / toxicological screening
5. Pharmacovigilance
6. Herbal drugs, formulations and Analysis
7. Regulatory Affairs
8. Bioavailability, Bioequivalence, clinical students
9. Intellectual property management
10. Hospital Pharmacy
11. Community Pharmacy
12. Any project work related to Pharmacy profession

Reference Books
1) Tripathi Dulal Krishna, Novel Drug Delivery Systems, Pharma Med Press

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