B.PHARMACY 5TH SEMESTER SYLLABUS ;
According to PCI.
BP501T. MEDICINAL CHEMISTRY – II (Theory)
Scope:
This subject is designed to impart fundamental knowledge on the
structure,chemistry and therapeutic value of drugs. The subject emphasizes on
structure activityrelationships of drugs, importance of physicochemical
properties and metabolism ofdrugs. The syllabus also emphasizes on chemical
synthesis of important drugs under eachclass.
Objectives:
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
ofdrugs
Know the Structural Activity Relationship of different class of drugs
Study the chemical synthesis of selected drugs.
COURSE CONTENT Note:
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 Antihistaminic agents: Histamine, receptors and their distribution in the
Human body
H1–antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate,
Doxylamines cuccinate, 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:
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
Anti-anginal:
Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate,
Isosorbide
dinitrite*, Dipyridamole.
Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem
hydrochloride, 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
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
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
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.
UNIT – V Antidiabetic agents:
Insulin and its preparations
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, 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.*
Recommended Books (Latest Editions) 1. Wilson and Giswold‘s Organic medicinal and Pharmaceutical Chemistry.
Page 89 of 161
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
BP 502 T. Industrial Pharmacy I (Theory)
Scope:
Course enables the student to understand and appreciate the influence
ofpharmaceutical additives and various pharmaceutical dosage forms on the
performance ofthe drug product.
Objectives:
Upon completion of the course the student shall be able to
Know the various pharmaceutical dosage forms and their
manufacturingtechniques.
Know various considerations in development of pharmaceutical dosage forms
Formulate solid, liquid and semisolid dosage forms and evaluate them for
theirquality.
Course contents
UNIT-I 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 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 syrups and
elixirs
suspensions and emulsions; Filling and packaging; evaluation of liquid orals
official in pharmacopoeia
UNIT-III 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 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 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.
BP 506 P. Industrial Pharmacy I
(Practical) 1. Preformulation studies on paracetamol/asparin/or any other drug
2. Preparation and evaluation of Paracetamol tablets
3. Preparation and evaluation of Aspirin tablets
4. Coating of tablets- film coating of tables/granules
5. Preparation and evaluation of Tetracycline capsules
6. Preparation of Calcium Gluconate injection
7. Preparation of Ascorbic Acid injection
8. Quality control test of (as per IP) marketed tablets and capsules
9. Preparation of Eye drops/ and Eye ointments
10. Preparation of Creams (cold / vanishing cream)
11. Evaluation of Glass containers (as per IP).
Recommended 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
PharmaceuticalScience (RPS)
6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
BP503.T. PHARMACOLOGY-II
(Theory)
Scope: This subject is intended to impart the fundamental knowledge on various
aspects(classification, mechanism of action, therapeutic effects, clinical uses,
side effects andcontraindications) of drugs acting on different systems of body
and in addition,emphasison the basic concepts of bioassay.
Objectives:
Upon completion of this course the student should be able to
Understand the mechanism of drug action and its relevance in the treatment
ofdifferent diseases
Demonstrate isolation of different organs/tissues from the laboratory animals
bysimulated experiments
Demonstrate the various receptor actions using isolated tissue preparation
Appreciate correlation of pharmacology with related medical sciences.
COURSE CONTENTS UNIT-I 1. Pharmacology of drugs acting on cardio vascular system
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-hyper lipidemic drugs.
UNIT-II 2. 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
3. Pharmacology of drugs acting on urinary system
a. Diuretics
b. Anti-diuretics.
UNIT-III 4. 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 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 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, ACTH, d-tubocurarine, digitalis,
histamine
and 5-HT
BP 507 P. PHARMACOLOGY-II
(Practical)
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.
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 McGrawHill.
3. Goodman and Gilman‘s, The Pharmacological Basis of Therapeutics Page
97 of 161
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 PointLippincott 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
MedicalPublishers (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.
BP504 T. PHARMACOGNOSY AND
PHYTOCHEMISTRY II (Theory)
Scope: The main purpose of subject is to impart the students the knowledge of how
thesecondary metabolites are produced in the crude drugs, how to isolate and
identify andproduce them industrially. Also this subject involves the study of
producing the plants andphytochemicals through plant tissue culture, drug
interactions and basic principles oftraditional system of medicine
Objectives:
Upon completion of the course, the student shall be able to:
know the modern extraction techniques, characterization and identification of
theherbal drugs and phytoconstituents
understand the preparation and development of herbal formulation.
understand the herbal drug interactions
carryout isolation and identification of phytoconstituents.
Course content
UNIT-I
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, Acetate pathways and Amino
acid pathway.
b) Study of utilization of radioactive isotopes in the investigation of Biogenetic
studies.
UNIT-II
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
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
Industrial production, estimation and utilization of the following
phytoconstituents:
Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine,
Podophyllotoxin, Caffeine,
Taxol, Vincristine and Vinblastine
UNIT V
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.
BP 508 P. PHARMACOGNOSY AND PHYTOCHEMISTRY II
(Practical)
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 phytoconstitutents by TLC
6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii)
Colophony (iv) Aloes (v) Myrrh.
Recommended 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,
NewDelhi.
5. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications,
NewDelhi, 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.
BP 505 T. PHARMACEUTICAL JURISPRUDENCE
(Theory)
Scope:
This course is designed to impart basic knowledge on importantlegislations related to
the profession of pharmacy in India.
Objectives:
Upon completion of the course, the student shall be able to understand:
The Pharmaceutical legislations and their implications in the development
andmarketing of pharmaceuticals.
Various Indian pharmaceutical Acts and Laws
The regulatory authorities and agencies governing the manufacture and sale
ofpharmaceuticals
The code of ethics during the pharmaceutical practice.
Course contents UNIT-I 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 Drugs and Cosmetics Act, 1940 and its rules 1945.
Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F &
DMR (OA)
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 • 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 and Regulation, opium poppy cultivation and
production
of poppy straw, manufacture, sale and export of opium, Offences and
Penalties
UNIT-IV • Study of Salient Features of Drugs and Magic Remedies Act and
its rules: Objectives, Definitions, Prohibition of certain advertisem*nts,
Classes of
Exempted advertisem*nts, Offences and Penalties
• Prevention of Cruelty to animals Act-1960: Objectives, Definitions,
Institutional
Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of
Animals, Performance of Experiments, Transfer and acquisition of animals for
experiment, Records, Power to suspend or revoke registration, 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 • Pharmaceutical Legislations – A brief review, Introduction, Study of
drugs
enquiry
committee, Health survey and development committee, 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
• Right to Information Act
• Introduction to Intellectual Property Rights (IPR).
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-byM.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).
Written by VISHAL KUSHWAHA ; according to PCI.
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