SEMESTER IV

Pharmacy Council of India New Delhi

Rules & Syllabus for the Bachelor of Pharmacy (B. Pharm) Course

[Framed under Regulation 6, 7 & 8 of the Bachelor of Pharmacy (B. Pharm) course regulations]

BP401T. PHARMACEUTICAL ORGANIC CHEMISTRY –III (Theory)

Scope: This subject imparts knowledge on stereo-chemical aspects of organic compounds and organic reactions, important named reactions,
chemistry of important hetero cyclic compounds. It also emphasizes on medicinal and other uses of organic compounds.

Objectives: At the end of the course, the student shall be able to

1. understand the methods of preparation and properties of organic compounds

2. explain the stereo chemical aspects of organic compounds and stereo chemical reactions

3. know the medicinal uses and other applications of organic compounds

Course Content:

Note: To emphasize on definition, types, mechanisms, examples, uses/applications

UNIT-I 10 Hours

Stereo isomerism

Optical isomerism – Optical activity, enantiomerism, diastereoisomerism, meso compounds

Elements of symmetry, chiral and achiral molecules

DL system of nomenclature of optical isomers, sequence rules, RS system of nomenclature of optical isomers

Reactions of chiral molecules

Racemic modification and resolution of racemic mixture. Asymmetric synthesis: partial and absolute

UNIT-II 10 Hours

Geometrical isomerism

Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems)

Methods of determination of configuration of geometrical isomers.

Conformational isomerism in Ethane, n-Butane and Cyclohexane. Stereo isomerism in biphenyl compounds (Atropisomerism) and conditions for
optical activity. Stereospecific and stereoselective reactions

UNIT-III 10 Hours

Heterocyclic compounds: Nomenclature and classification Synthesis, reactions and medicinal uses of following compounds/derivatives Pyrrole,
Furan, and Thiophene
Relative aromaticity and reactivity of Pyrrole, Furan and Thiophene

UNIT-IV 8 Hours

Synthesis, reactions and medicinal uses of following compounds/derivatives Pyrazole, Imidazole, Oxazole and Thiazole. Pyridine, Quinoline,
Isoquinoline, Acridine and Indole. Basicity of pyridine

Synthesis and medicinal uses of Pyrimidine, Purine, azepines and their derivatives

UNIT-V 07 Hours

Reactions of synthetic importance

Metal hydride reduction (NaBH4 and LiAlH4), Clemmensen reduction, Birch reduction, Wolff Kishner reduction.

Oppenauer-oxidation and Dakin reaction.

Beckmanns rearrangement and Schmidt rearrangement.

Claisen-Schmidt condensation

Recommended Books (Latest Editions)

1. Organic chemistry by I.L. Finar, Volume-I & II. 2. A text book of organic chemistry – Arun Bahl, B.S. Bahl.

3. Heterocyclic Chemistry by Raj K. Bansal

4. Organic Chemistry by Morrison and Boyd

5. Heterocyclic Chemistry by T.L. Gilchrist

BP 502 T. Industrial Pharmacy I (Theory)

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:

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 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 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.

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BP 506 P. Industrial PharmacyI (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. Qulaity 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 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, 5thedition, 2005

9. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel Dekker Series, Vol 107.

BP 403 T. PHYSICAL PHARMACEUTICS-II (Theory)

Scope: The course deals with the various physica and physicochemical properties, and principles involved in dosage forms/formulations. Theory
and practical components of the subject help the student to get a better insight into various areas of formulation research and development,
and stability studies of pharmaceutical dosage forms.

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

1. Understand various physicochemical properties of drug molecules in the designing the dosage forms

2. Know the principles of chemical kinetics & to use them for stability testing nad determination of expiry date of formulations

3. Demonstrate use of physicochemical properties in the formulation development and evaluation of dosage forms.

Course Content:

UNIT-I 07 Hours

Colloidal dispersions: Classification of dispersed systems & their general characteristics, size & shapes of colloidal particles, classification of
colloids & comparative account of their general properties. Optical, kinetic & electrical properties.

Effect of electrolytes, coacervation, peptization & protective action.

UNIT-II 10 Hours

Rheology: Newtonian systems, law of flow, kinematic viscosity, effect of temperature, non-Newtonian systems, pseudoplastic, dilatant, plastic,
thixotropy, thixotropy in formulation, determination of viscosity, capillary, falling Sphere, rotational viscometers
Deformation of solids: Plastic and elastic deformation, Heckel equation, Stress, Strain, Elastic Modulus

UNIT-III 10 Hours

Coarse dispersion: Suspension, interfacial properties of suspended particles, settling in suspensions, formulation of flocculated and
deflocculated suspensions. Emulsions and theories of emulsification, microemulsion and multiple emulsions; Stability of emulsions,
preservation of emulsions, rheological properties of emulsions and emulsion formulation by HLB method.

UNIT-IV 10Hours

Micromeretics: Particle size and distribution, mean particle size, number and weight distribution, particle number, methods for determining
particle size by different methods, counting and separation method, particle shape, specific surface, methods for determining surface area,
permeability, adsorption, derived properties of powders, porosity, packing arrangement, densities, bulkiness & flow properties.

UNIT-V 10 Hours

Drug stability: Reaction kinetics: zero, pseudo-zero, first & second order, units of basic rate constants, determination of reaction order. Physical
and chemical factors influencing the chemical degradation of pharmaceutical product: temperature, solvent, ionic strength, dielectric constant,
specific & general acid base catalysis, Simple numerical problems.

Stabilization of medicinal agents against common reactions like hydrolysis & oxidation.

Accelerated stability testing in expiration dating of pharmaceutical dosage forms.

Photolytic degradation and its prevention

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BP 407P. PHYSICAL PHARMACEUTICS- II (Practical)

1. Determination of particle size, particle size distribution using sieving method

2. Determination of particle size, particle size distribution using Microscopic method

3. Determination of bulk density, true density and porosity

4. Determine the angle of repose and influence of lubricant on angle of repose

5. Determination of viscosity of liquid using Ostwald’s viscometer

6. Determination sedimentation volume with effect of different suspending agent

7. Determination sedimentation volume with effect of different concentration of single suspending agent

8. Determination of viscosity of semisolid by using Brookfield viscometer

9. Determination of reaction rate constant first order. 10. Determination of reaction rate constant second order

11. Accelerated stability studies

Recommended Books: (Latest Editions)

1. Physical Pharmacy by Alfred Martin, Sixth edition

2. Experimental pharmaceutics by Eugene, Parott.

3. Tutorial pharmacy by Cooper and Gunn.

4. Stocklosam J. Pharmaceutical calculations, Lea & Febiger, Philadelphia.

5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3, Marcel Dekkar Inc.
6. Liberman H.A, Lachman C, Pharmaceutical dosage forms. Disperse systems, volume 1, 2, 3. Marcel Dekkar Inc.

7. Physical Pharmaceutics by Ramasamy C, and Manavalan R.

BP 404 T. PHARMACOLOGY-I (Theory)

Scope: The main purpose of the subject is to understand what drugs do to the living organisms and how their effects can be applied to
therapeutics. The subject covers the information about the drugs like, mechanism of action, physiological and biochemical effects
(pharmacodynamics) as well as absorption, distribution, metabolism and excretion (pharmacokinetics) along with the adverse effects, clinical
uses, interactions, doses, contraindications and routes of administration of different classes of drugs.

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

1. Understand the pharmacological actions of different categories of drugs

2. Explain the mechanism of drug action at organ system/sub cellular/ macromolecular levels.

3. Apply the basic pharmacological knowledge in the prevention and treatment of various diseases.

4. Observe the effect of drugs on animals by simulated experiments

5. Appreciate correlation of pharmacology with other bio medical sciences

Course Content:

UNIT-I 08 hours

1. General Pharmacology

a. Introduction to Pharmacology- Definition, historical landmarks and scope of pharmacology, nature and source of drugs, essential drugs
concept and routes of drug administration, Agonists, antagonists( competitive and non competitive), spare receptors, addiction, tolerance,
dependence, tachyphylaxis, idiosyncrasy, allergy. b. Pharmacokinetics- Membrane transport, absorption, distribution, metabolism and
excretion of drugs .Enzyme induction, enzyme inhibition, kinetics of elimination

UNIT-II 12 Hours

General Pharmacology

a. Pharmacodynamics- Principles and mechanisms of drug action. Receptor theories and classification of receptors, regulation of receptors.
drug receptors interactions signal transduction mechanisms, G-protein–coupled receptors, ion channel receptor, transmembrane enzyme
linked receptors, transmembrane JAK-STAT binding receptor and receptors that regulate transcription factors, dose response relationship,
therapeutic index, combined effects of drugs and factors modifying drug action.

b. Adverse drug reactions.

c. Drug interactions (pharmacokinetic and pharmacodynamic)

d. Drug discovery and clinical evaluation of new drugs -Drug discovery phase, preclinical evaluation phase, clinical trial phase, phases of clinical
trials and pharmacovigilance.

UNIT-III 10 Hours

2. Pharmacology of drugs acting on peripheral nervous system

a. Organization and function of ANS.

b.Neurohumoral transmission,co-transmission and classification of neurotransmitters.

c. Parasympathomimetics, Parasympatholytics, Sympathomimetics, sympatholytics.

d. Neuromuscular blocking agents and skeletal muscle relaxants (peripheral).

e. Local anesthetic agents.

f. Drugs used in myasthenia gravis and glaucoma

UNIT-IV 08 Hours

3. Pharmacology of drugs acting on central nervous system

a. Neurohumoral transmission in the C.N.S.special emphasis on importance of various neurotransmitters like with GABA, Glutamate, Glycine,
serotonin, dopamine.

b. General anesthetics and pre-anesthetics.

c. Sedatives, hypnotics and centrally acting muscle relaxants.

d. Anti-epileptics

e. Alcohols and disulfiram

UNIT-V 07 Hours

3. Pharmacology of drugs acting on central nervous system

a. Psychopharmacological agents: Antipsychotics, antidepressants, anti-anxiety agents, anti-manics and hallucinogens.

b. Drugs used in Parkinsons disease and Alzheimer’s disease.

c. CNS stimulants and nootropics.

d. Opioid analgesics and antagonists

e. Drug addiction, drug abuse, tolerance and dependence.

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BP 408 P.PHARMACOLOGY-I (Practical)

1. Introduction to experimental pharmacology.

2. Commonly used instruments in experimental pharmacology.

3. Study of common laboratory animals.

4. Maintenance of laboratory animals as per CPCSEA guidelines.

5. Common laboratory techniques. Blood withdrawal, serum and plasma separation, anesthetics and euthanasia used for animal studies.

6. Study of different routes of drugs administration in mice/rats.

7. Study of effect of hepatic microsomal enzyme inducers on the phenobarbitone sleeping time in mimice

8. Effect of drugs on ciliary motility of frog oesophagus

9. Effect of drugs on rabbit eye.

10. Effects of skeletal muscle relaxants using rota-rod apparatus.

11. Effect of drugs on locomotor activity using actophotometer.

12. Anticonvulsant effect of drugs by MES and PTZ method.

13. Study of stereotype and anti-catatonic activity of drugs on rats/mice. 14. Study of anxiolytic activity of drugs using rats/mice. 15. Study of
local anesthetics by different 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. VallabhPrakashan.

BP 405 T.PHARMACOGNOSY AND PHYTOCHEMISTRY I (Theory)

Scope: The subject involves the fundamentals of Pharmacognosy like scope, classification of crude drugs, their identification and evaluation,
phytochemicals present in them and their medicinal properties.

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

1. to know the techniques in the cultivation and production of crude drugs

2. to know the crude drugs, their uses and chemical nature

3. know the evaluation techniques for the herbal drugs

4. to carry out the microscopic and morphological evaluation of crude drugs

Course Content:

UNIT-I 10 Hours

Introduction to Pharmacognosy:

(a) Definition, history, scope and development of Pharmacognosy

(b) Sources of Drugs – Plants, Animals, Marine & Tissue culture

(c) Organized drugs, unorganized drugs (dried latex, dried juices, dried extracts, gums and mucilages, oleoresins and oleo- gum -resins).
Classification of drugs:

Alphabetical, morphological, taxonomical, chemical, pharmacological, chemo and sero taxonomical classification of drugs

Quality control of Drugs of Natural Origin:

Adulteration of drugs of natural origin. Evaluation by organoleptic, microscopic, physical, chemical and biological methods and properties.
Quantitative microscopy of crude drugs including lycopodium spore method, leafconstants, camera lucida and diagrams of microscopic objects
to scale with camera lucida.

UNIT-II 10 Hours

Cultivation, Collection, Processing and storage of drugs of natural origin: Cultivation and Collection of drugs of natural origin
Factors influencing cultivation of medicinal plants. Plant hormones and their applications. Polyploidy, mutation and hybridization with
reference to medicinal plants Conservation of medicinal plants

UNIT-III 07 Hours

Plant tissue culture:

Historical development of plant tissue culture, types of cultures, Nutritional requirements, growth and their maintenance. Applications of plant
tissue culture in pharmacognosy. Edible vaccines

UNIT IV 10 Hours

Pharmacognosy in various systems of medicine:

Role of Pharmacognosy in allopathy and traditional systems of medicine namely, Ayurveda, Unani, Siddha, Homeopathy and Chinese systems of
medicine. Introduction to secondary metabolites:

Definition, classification, properties and test for identification of Alkaloids, Glycosides,

Flavonoids, Tannins, Volatile oil and Resins

08 Hours

Study of biological source, chemical nature and uses of drugs of natural origin containing following drugs

Plant Products:

Fibers - Cotton, Jute, Hemp

Hallucinogens, Teratogens, Natural allergens

Primary metabolites:

General introduction, detailed study with respect to chemistry, sources, preparation, evaluation, preservation, storage, therapeutic used and
commercial utility as Pharmaceutical Aids and/or Medicines for the following Primary metabolites:

Carbohydrates: Acacia, Agar, Tragacanth, Honey

Proteins and Enzymes : Gelatin, casein, proteolytic enzymes (Papain, bromelain, serratiopeptidase, urokinase, streptokinase, pepsin).
Lipids(Waxes, fats, fixed oils) : Castor oil, Chaulmoogra oil, Wool Fat, Bees Wax

Marine Drugs: Novel medicinal agents from marine sources

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BP408 P. PHARMACOGNOSY AND PHYTOCHEMISTRY I (Practical)

1. Analysis of crude drugs by chemical tests: (i)Tragaccanth (ii) Acacia (iii)Agar (iv) Gelatin (v) starch (vi) Honey (vii) Castor oil

2. Determination of stomatal number and index

3. Determination of vein islet number, vein islet termination and paliside ratio.

4. Determination of size of starch grains, calcium oxalate crystals by eye piece micrometer

5. Determination of Fiber length and width

6. Determination of number of starch grains by Lycopodium spore method

7. Determination of Ash value

8. Determination of Extractive values of crude drugs

9. Determination of moisture content of crude drugs

10. Determination of swelling index and foaming

Recommended Books: (Latest Editions)

1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co., London, 2009.

2. Tyler, V.E., Brady, L.R. and Robbers, J.E., Pharmacognosy, 9th Edn., Lea and Febiger, Philadelphia, 1988.

3. Text Book of Pharmacognosy by T.E. Wallis

4. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution, New Delhi.

5. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition, Nirali Prakashan, New Delhi.

6. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.

7. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New Delhi, 2007

8. Practical Pharmacognosy: C.K. Kokate, Purohit, Gokhlae

9. Anatomy of Crude Drugs by M.A. Iyengar