Semester-V

PT 515. Industrial Pharmacy I (Theory)

45 Hours
Scope: 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.

Objectives: Upon completion of the course the student shall be able to

1. Know the various pharmaceutical dosage forms and their manufacturing
techniques.
2. Know various considerations in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality.

Course content:
3 hours/ week
UNIT-I 07 Hours
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties,
solubility profile (pKa, pH, partition coefficient), polymorphism
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization BCS
classification of drugs & its significant
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 incoating.
c. Quality control tests: In process and finished product tests

Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and
emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia

UNIT-III 08 Hours
Capsules:
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size of capsules,
Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing
defects. 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 minim/gram factors, production, in process and final product quality control tests.
Packing, storage and stability testing of soft gelatin capsules and their applications.
Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of
pellets

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, aseptic
processing
c. Formulation of injections, sterile powders, large volume parenterals and
lyophilized products.
d. Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids.
Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye 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 aerosol systems;
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.
PT 513B MEDICINAL CHEMISTRY – II (Theory)
45 Hours
Scope: 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.
Objectives: Upon completion of the course the student shall be able to
1. Understand the chemistry of drugs with respect to their pharmacological activity
2. Understand the drug metabolic pathways, adverse effect and therapeutic value of
drugs
3. Know the Structural Activity Relationship of different class of drugs

4. Study the chemical synthesis of selected drugs

Course Content:
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

Antihistaminic agents: Histamine, receptors and their distribution in the

humanbody
H1–antagonists: SAR of classical H1 antagonists, Diphenhydramine
hydrochloride*, Doxylamines cuccinate, Clemastine fumarate, Tripelenamine
hydrochloride, Meclizine hydrochloride, Buclizine hydrochloride,
Chlorpheniramine maleate, Triprolidine hydrochloride*, 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:
Alkylating agents: 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, Isosorbide
dinitrite*, Dipyridamole.
Calcium channel blockers: SAR of 1,4-dihydropyridines, Verapamil, Bepridil
hydrochloride, Diltiazem hydrochloride, Nifedipine, Amlodipine,
Felodipine, Nicardipine.

Diuretics:
Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide.
Thiazides: SAR of thiazide diuretics, Chlorthiazide*, Hydrochlorothiazide,
Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid. Potassium
sparing Diuretics: Spironolactone, Triamterene, Amiloride. Osmotic
Diuretics: Mannitol

Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril, 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, Amiodarone, Sotalol.

Anti-hyperlipidemic agents: Clofibrate, Lovastatin, Cholesteramine and Cholestipol

Coagulant & Anticoagulants: Acetomenadione, Warfarin*, Anisindione, clopidogrel

Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Tezosentan.

UNIT- IV 08 Hours

Drugs acting on Endocrine system

Nomenclature, Stereochemistry and metabolism of steroids

Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol, Diethyl

stilbestrol.
Drugs for erectile dysfunction: Sildenafil, Tadalafil.
Oral contraceptives: Mifepristone, levo-Norgestrel, Levonorgestrol
Corticosteroids: SAR of corticosteroids, Cortisone, Hydrocortisone,
Prednisolone, Betamethasone, Dexamethasone
Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine, Propylthiouracil,
Methimazole.

UNIT – V 07 Hours

Antidiabetic agents:
Insulin and its preparations
 Sulfonyl ureas: SAR of Sulfonyl ureas, Tolbutamide*, Chlorpropamide, Glipizide,
Glimepiride.

Biguanides: Metformin.
Thiazolidinediones: Pioglitazone, Rosiglitazone. Meglitinides:
Repaglinide, Nateglinide.
Glucosidase inhibitors: Acrabose, Voglibose.

Local Anesthetics: SAR of Local anesthetics

Benzoic Acid derivatives; Cocaine, Meprylcaine, Piperocaine.
Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*, Butacaine,
Propoxycaine, Tetracaine,
Anilide derivatives: Lignocaine (lidocaine), Mepivacaine, Ropivacaine.
Miscellaneous: Diperodon, Dibucaine.*

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.

PT 518 PHARMACOLOGY-II (Theory)

45 Hours

Scope: 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.

Objectives: Upon completion of this course the student should be able to

1. Understand the mechanism of drug action and its relevance in the treatment
of different diseases
2. Demonstrate isolation of different organs/tissues from the laboratory animals by
simulated experiments
3. Demonstrate the various receptor actions using isolated tissue preparation
4. Appreciate correlation of pharmacology with related medical sciences
Course Content:
UNIT-I
10hours
1. Pharmacology of drugs acting on cardio vascular system
 a. Introduction to hemodynamic and electrophysiology ofheart.
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
10hours
1. Pharmacology of drugs acting on cardio vascular system
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

10hours
3. 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 10 hours
5. Pharmacology of drugs acting on endocrine system
a. Basic concepts in endocrine pharmacology.
b. Anterior Pituitary hormones- analogues and their inhibitors.
c. Thyroid hormones- analogues and their inhibitors.
d. Hormones regulating plasma calcium level- Parathormone, Calcitonin and
Vitamin-D.
d. Insulin, Oral Hypoglycemic agents and glucagon.
e. ACTH and corticosteroids.

UNIT-V

05hours
5. Pharmacology of drugs acting on endocrine system
a. Androgens and Anabolic steroids.
b. Estrogens, progesterone and oral contraceptives.
c. Drugs acting on the uterus.
6. Bioassay
a. Principles and applications of bioassay. b.
 Types of bioassay
c. Bioassay of insulin, oxytocin, vasopressin

PT 598 PHARMACOLOGY-II (Practical)

4Hrs/Week

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 frogrectus
abdominis muscle and rat ileum respectively.
7. Bioassay of histamine using guinea pig ileum bymatching method.
8. Bioassay of oxytocin using rat uterine horn by interpolationmethod.
9. Bioassay of serotonin using rat fundus strip bythree 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 pigileum.
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. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology,
Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc
Graw-Hill.
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
4. 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.
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews-
Pharmacology.
6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert.
9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company,
Kolkata.
10. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan.
 PT 512 PHARMACOGNOSY AND PHYTOCHEMISTRY II (Theory)
45Hours
Scope: 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
Objectives: Upon completion of the course, the student shall be able
1. to know the modern extraction techniques, characterization and identification of the
herbal drugs and phytoconstituents
2. to understand the preparation and development of herbalformulation.
3. to understand the herbal drug interactions
4. to carryout isolation and identification of phytoconstituents

Course Content:
UNIT-I 9 Hours
Metabolic pathways in higher plants and their determination
a) Brief study of basic metabolic pathways and formation of different secondary metabolites
through these pathways- Shikimic acid pathway, mevalonic pathways.
b) Study of utilization of radioactive isotopes in the investigation of Biosynthetic studies.

UNIT-II 17 Hours
General introduction, composition, chemistry & chemical classes, biosources, therapeutic
uses and commercial applications of 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,
Tannins: Catechu, Pterocarpus
Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony
Glycosides: Senna, Aloes, Bitter Almond
Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids
UNIT-III 06 Hours
Isolation, Identification and Analysis of Phytoconstituents

a) Terpenoids: Menthol, Citral, Artemisin

b) Glycosides: Glycyrhetinic acid & Rutin
c) Alkaloids: Atropine, Quinine, Reserpine, Caffeine
d) Resins: Podophyllotoxin, Curcumin

UNIT IV 10 Hours
Basics of Phytochemistry
Modern methods of extraction, application of latest techniques like Spectroscopy,
chromatography and electrophoresis in the isolation, purification and identification of crude
drugs.
PT 516 Pharmaceutical Jurisprudence - Theory 4 Hours/week

45 Hours
Scope: This course is designed to impart basic knowledge on important legislations related to the
profession of pharmacy in India.

Objectives: Upon completion of the course, the student shall be able to understand:
1. The Pharmaceutical legislations and their implications in the development and marketing of
pharmaceuticals.
2. Various Indian pharmaceutical Acts and Laws
3. The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals 4.
The code of ethics during the pharmaceutical practice

Course Content:
UNIT-I 10 Hours
Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or
permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of
drugs for test, examination and analysis, manufacture of new drug, loan license and repacking
license.

UNIT-II 10 Hours
Drugs and Cosmetics Act, 1940 and its rules 1945. Detailed study of Schedule G, H and H1, M, N,
P,T,U, V, X, Y, Part XII B, Sch F
A) Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties
Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs and
cosmetics, List of permitted colors. Offences and penalties.
Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory,
Drugs Consultative Committee, Government drug analysts, Licensing authorities, controlling
authorities, Drugs Inspectors

UNIT-III 10 Hours

 Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its

constitution and functions, Education Regulations, State and Joint state pharmacy
councils; constitution and functions, Registration of Pharmacists, Offences and Penalties

 Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing,

Manufacture In bond and Outside bond, Export of alcoholic preparations, Manufacture
of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and Penalties.
  Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives,
Definitions, Authorities and Officers, Constitution and Functions of narcotic &
Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse,
Prohibition, Control andRegulation, Offences and Penalties
UNIT-IV 08 Hours
 Study of Salient Features of Drugs and Magic Remedies Act and its rules:
Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted
advertisements, Offences and Penalties
 Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional Animal
Ethics Committee, CPCSEA guidelines for Stocking of Animals, Performance of
Experiments, Records, Offences and Penalties
 National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)- 2013.
Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations, Retail
price and ceiling price of scheduled formulations, National List of Essential Medicines
(NLEM)
UNIT-V 07 Hours

 Pharmaceutical Legislations – A brief review of Health survey and development

committee, Brief note on Hathi committee and Mudaliar committee

 Code of Pharmaceutical ethics Definition, Pharmacist in relation to his job, trade,

medical profession and his profession, Pharmacist’s oath

 Medical Termination of Pregnancy Act – a brief review

 Introduction to Intellectual Property Rights (IPR) – a brief review

Recommended books: (Latest Edition)
1. Forensic Pharmacy by B. Suresh
2. Text book of Forensic Pharmacy by B.M. Mithal
3. Hand book of drug law-by M.L. Mehra
4. A text book of Forensic Pharmacy by N.K. Jain
5. Drugs and Cosmetics Act/Rules by Govt. of India publications.
6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.
7. Narcotic drugs and psychotropic substances act by Govt. of India publications
8. Drugs and Magic Remedies act by Govt. of India publication
9. Bare Acts of the said laws published by Government. Reference books (Theory)