TopicNo SECTION-I Hrs.

1. Concept of Formulation Design: 5

a) Preformulation: Introduction, General consideration, Preliminary
evaluation & molecular optimization, Bulk characteristics, Solubility
analysis, Stability analysis.
b) Design of Dosage Form: Principles, Dosage form design,
Biopharmaceutical & Therapeutic aspects of dosage form design.
c) Study of excipients: Introduction, classification & selection
criteria

2. Stability studies:Concept of stability studies. 5

a) cGMP & ICH guidelines for Accelerated stability Testing.

b) Interaction of containers & closure Compatibility Testing

3. III. Solid Dosage Forms: A. Tablets: 20

Introduction, Advantages & Disadvantages, Types of tablets.

Formulation development: Preformulation of drugs & additives.

Introduction to tablet additives. Need of granulation. Mechanisms,
Manufacturing processes and Equipments for Wet granulation and
Dry granulation processes. Advanced granulation techniques –
Extrusion, spheronization, Pelletization, Spherical crystallization,
Fluidized bed granulation, Melt solidification & granulation.
Characterization and Evaluation of granules. Mechanism,
Manufacturing process and Equipments for Direct compression
technique. Physics of Tablet compression. Tablet compression
machines. Formulation and manufacture of Chewable tablets,
Effervescent tablets, Dispersible tablets, Mouth dissolving tablets,
Layered & Compression coated tablets.

Manufacturing problems & remedies thereof. Packaging & labeling-

strip, blister & bulk packaging. IPQC for tablets. Evaluation of tablets
as per
 IP, BP, USP

Tablet Coating: 4
Introduction and concept of tablet coating. Types of tablet coating
including Sugar, Film & Enteric coating. Material, processes
employed &

equipments for tablet coating. Manufacturing problems & remedies

during tablet coating. Evaluation of coated tablets.

Layout of tablet manufacturing section. 1

B. Capsules:a) Raw material for capsule shell: Manufacturing of 10

gelatin for capsule.
Introduction and concept of size selection of capsules. Selection
criteria

54

and size selection of capsules (with examples)

b) Hard gelatin capsules: Preparation of hard gelatin capsule shell,

standards & defects thereof. Formulation & development: Filling, processing
& capsule filling equipments. Problems in capsule filling & remedies thereof.
In process quality control & quality control parameters.

Soft gelatin capsules: formulation and development, manufacturing,

processing & equipment. In process quality control & quality control
parameters. Packaging & labeling of capsules: Strip, Blister & Bulk
Packaging.

SECTION- II

1. Disperse systems:Free energy consideration, thermodynamic v/s kinetic 2

stability. Classification
 of disperse system.

A) Suspensions: 10

Physicochemical principles. Theory of suspension: DLVO theory.

Wetting, Sedimentation, Flocculated & Deflocculated system. Structured

vehicle, particle size, particle charges & caking in suspensions. Importance
of changes in solubility because of changes in particle size, polymorphic
form, temp. Preformulation data. Formulation development, manufacturing,
packaging & equipments employed for the same. Rheology of suspensions.

Formulations of pharmaceutical suspensions (oral & topical), suspending

agents, wetting agents, dispersants, deflocculating & flocculating agents.
Evaluation of suspensions. Quality control standards.

B) Emulsions: 6

Physicochemical principles. Theory of emulsification. Creaming,

coalescence, cracking, destabilization kinetics, role of viscosity, energy

barriers to coalescence. Film barriers, steric stabilization. Emulsifier &
choice of emulsifier, HLB value & phase inversion temperature. Multiple
emulsions. Evaluation of emulsion, stress testing. Packaging of emulsions.

C) Suspension & emulsion manufacturing equipments: 2

Mechanical stirrers, homogenizers, colloid mill, foaming removal.

D) Layout and designing of manufacturing facility for suspension and 1

emulsion.

55
 2. Semisolids: 8
Properties of drugs, semisolid bases and additives, Selection of bases and

additives for ointment, cream, paste and gels. Percutaneous absorption.

Formulation and development, manufacturing of Ointment, Cream, Paste and
Gels. Processing equipments for ointment, cream, paste and gels. In process
quality control & quality control parameters, skin irritation test, packaging &
labeling.

3. III ) Cosmetics & Cosmeceuticals:

A) Cosmetics: 12
Cosmetics v/s drug formulation. Type of cosmetics. Formulation,

manufacturing & safety testing & quality control of following cosmetics.

Skin products: Moisturising, cleaning, cold, vanishing, face pack, anti
wrinkle, antiperspirants, deodorants, suntan,& sunscreen preparations. Hair
products: Shampoos, hair tonics, hair dyes, depilatories, shaving
preparations.

Eye products: Eye mascara, eye shadow, eye liner, eyebrow pencil.

Lip product: Lipstick.

Manicure products: Nail lacquer, Lacquer remover.

B) Cosmeceuticals: 4
Introduction, Definition and difference from cosmetics. History of

cosmeceuticals. Cosmeceutical Agents- Retinoids, hydroxyl acids, beta

hydroxyl acids, Antioxidants and others. Recent developments in
Cosmeceuticals.

3.1 PHARMACEUTICS-II

(Practical) 90 Hrs. (3 hrs/week)

I) Raw material testing of any 5 Experiments

II) Formulation, Preparation and Evaluation of the following dosage forms.

 1. Suspensions

o • Calamine lotion

o • Milk of Magnesia

o • Paracetamol Suspension

o • Antacid Suspension

Evaluation Parameters: Sedimentation volume, Organoleptic Properties, pH, Viscosity, Stability,

and assay of any one preparation

 2. Emulsions

o • Liquid paraffin oral Emulsion

o • Turpentine Liniment

o • Formulation of Emulsion (HLB Consideration)

Evaluation Parameters: Organoleptic Properties, pH, Globule size, wt/ml, and assay of any one
preparation

 3. Semisolids

o • Pain balm

56

o • Antifungal ointment/cream

o • Medicated Gel

o • Antiacne preparation

• Non staining Iodine ointment with Methyl Salicylate Evaluation Parameters: pH, Spreadability,
Organoleptic properties and assay of any one preparation

 4. Tablets

o • Aspirin – Using non aqueous binder solution

o • Paracetamol – By Wet granulation

o • Chewable, Dispersible, Effervescent Tablets

  Evaluation of granules- Angle of repose, Particle size, Densities and Carr’s

 Index

Evaluation of Tablets: Hardness, Friability, Weight variation, Tablet porosity, Dimensions,

Disintegration time, Dissolution time. Assay and Uniformity of content of any one preparation.

 5. Capsules

o • Ferrous Fumerate Capsules

o • Antibiotic Capsules

Evaluation of Empty and Filled Hard gelatin capsule shell. Evaluation of capsule- Weight
variation, dissolution time

 6. Tablet Coating (Demonstration)

 7. Cosmetics

o • Cold cream

o • Vanishing cream

o • Shampoo

o • Tooth Paste
 

o • Saving cream

o • Moisturising cream

o • Sunscreen cream/lotion

o • Lip stick

o • Eye shadow, Eye liner, Eye Mascara

o • After shave lotion

o • Nail lacquer

Evaluation Parameters: Organoleptic properties for all preparation. Foam test for shampoo and
shaving cream

 Film formation test for lipstick and eye preparation.

Recommended Books

1. Remington “The science and practice of pharmacy” 21 edition, Mack publishing company,
st

2005.

57
2. James J.Wells “ Pharmaceutical Preformulation : The physicochemical properties of drug
substances “ Ellis Horwood, Chichester, UK,1988

3. www.ich.org

4. H.C.Ansel; N.G.Poporich; L.V.Allen “Pharmaceutical dosage forms and Drug

Delivery systems” 9 edition, Wolters kluwer/ Lippincott Williams and wilkins,

th

2009.

5. L.Lachman; H.A.Liberman; J.L.Kanig “The Theory and Practice of Industrial Pharmacy” 3 rd

edition; Verghese publishing House, Mumbai 1991. / Special Indian edition, 2009.

6. M.E.Aulton “Pharmaceutics –The design and nanufacture of medicines” 3 edition; Churchil

rd

livingstone, 2007.

7. Bentley’s “Test book of Pharmaceutics” Bailliere Tindall; 8 edition; ELBS Publication, 1996.
th

8. G.S.banker, R.K.Chalmers “Pharmaceutics and Pharmacy Practice “J.B.Lippincott

Company, Philadelphia, PA, 1982.

9. J.Swarbrick; J.C.Boylan” Encyclopedia of pharmaceutical technology” Vol.1; Marcel

Dekker, 1998.

10. K.Ridgway “Hard Capsules Development and Technology” The Pharmaceutical

Press, London, UK, 1987.

11. H.A.Lieberman, L.Lachman and J.B.Schwart “Pharmaceutical dosage forms: Tablets”

Marcel Dekker, Vol. I, II, III 1998.

12. L. L. Augsberger, S. W. Hoag “Pharmaceutical Dosage Forms: Tablets” 3 edition, Informa

rd

Healthcare, Vol. I, II, III 2008.

13. Lieberman, Riser and Banker “Pharmaceutical Dosage forms and Disperse system” Marcel
Dekker; Vol. I, II, III 1988.

14. J.Knowlton and S.Rearce “ Handbook of cosmetic science and technology” 1 st

edition; Elsevier science publisher; oxford, UK, 1993

15. J.B.Wilkinson and R.J.Moore “Harry’s Cosmetology” 7 edition; Longman science and
th

technical, London 1982.

16. P. P. Sharma, “Cosmetic Formulation, Manufacturing and Quality Control” 7 th

edition, Vandana publication, 2001.

17. E.G.Thosmssen” Modern cosmetics Universal Publishing Corporation.

18. J. B. Wilkinson, R. J. Moore, “Harry’s Cosmetology”, 7 edition, Longman Scientific and

th

Technical, 1994

19. L.Appell “The formulation and preparation of cosmetics, fragrance and flavours” Micelle
press

20. W.A.Pocher” Poucher’s Perfumes, Cosmetics and Soaps” Vol.III; Chapman and Hall

21. Dr. Laba “Rheological properties of cosmetics and toiletries” Marcel Dekker.

22. “Indian Pharmacopoeia” 2007, Vol. I, II, III. Indian Pharmacopoeia Commision, Government
of India, Ministry of Health and Family Welfare.

23. “USP 30 NF 25 The United States Pharmacopoeia” 2007, Vol. I, II, III. National formulary
publication of US Pharmacopoeia.

24. “British Pharmacopoeia” 2005, Vol. I, II, III, IV. Stationary office on behalf of

Medicine and Healthcare Product Regulatory Agency (MHRA).

58
3.2 PHARMACEUTICAL BIOTECHNOLOGY

(Theory) 60 Hrs. (2 hrs per week)

TopicNo SECTION-I Hrs.

1. Introduction to Biotechnology, Scope, Potential & Achievements 1

2. Genetic Engineering : 4
2.1 Recombinant DNA technology :-

Gene cloning :- Introduction, enzymes acting on DNA (restriction

endonucleases, S nuclease, alkaline phosphatase, polymerase, ligase,

1

reverse transcriptase), types of cloning vectors, expression vectors

(expression vectors in brief), transformation & growth of cells,
Selection of clones ( screening methods).

Gene transfer: – Introduction & Types (Direct & Indirect 4

gene transfer methods) Ti & Ri plasmid mediated gene transfer.

2.2 Genetic Engineering techniques :- 8

Isolation of DNA, Genomic & cDNA libraries, Gel electrophoresis,

DNA Hybridization, Blotting techniques, polymerase chain reaction

(PCR) Site directed mutagenesis, Restriction Fragment Length
Polymorphism (RFLP), Human Gene therapy, DNA fingerprinting.
Gene synthesis & gene machine, Gene sequencing methods.

3. Plant Cell and Tissue Culture:- 8

3.1 Introduction to plant cell, media & laboratory requirements for
tissue culture

3.2 Types of cultures:- Callus, suspension, meristem, root-tip, hairy

 root, haploid cultures, anther cultures /Pollen grains (Introduction,
methodology & applications of above types)

3.3 Protoplast culture & protoplast fusion & application

Transgenic Plants introduction, Method, Application)

3.4 Germplasm storage & cryopreservation

4. Animal Cell Culture 5

4.1 Introduction, isolation of cells, preparing cells in culture,

established cell lines, culture media for animals, Role of blood plasma
& serum,

Preparation of chicken serum, mammalian serum & embryo extract.

4.2 Introduction to transgenic animals and their applications

SECTION- II

5. Immunotechnology 7
5.1 Vaccines Why vaccines? How it works? Traditional vaccine
approaches, Subculture and recombinant vaccines, Future directions,
Edible vaccines
5.2 Hybridoma technology, Preparation of Monoclonal Antibodies
and its

59

applications

5.3 Immunoassay by different techniques- Enzyme Linked Immuno Sorbant

Assay (ELISA), Radio Immuno Assay (RIA), Immunofluoroscence

6. Enzyme Technology 2

Introduction to enzyme, Immobilization of enzyme & its applications

7. Fermentation Technology 10
7.1 Study of methods at sterilization details & their applications to

Pharmaceutical Manufacturing

7. 2 Fermentation as a biochemical process – Fermenter, its material of

construction,
Accessory components and working, Down streaming Processing (Product
Recovery and Processing), Fermentation discharge and Effluent treatment

7.3 General Application of fermentation in Manufacturing of Antibiotics

(penicillin, Streptomycin, Tetracycline), Dextran, Vitamins (Vitamin B and 2

Vitamin B )12

8. Healthcare Biotechnology:- 6
8.1 Examples of Biotechnology derived Products:

Human insulin, Somatotropin, Interferons, Biogenetic drugs (Production and

uses)

8.2 Purification Toxicity studies in establishing safety and efficacy in

biotechnological Products.
8.3 Introduction to collection, processing, and storage of blood and blood
products

9. Biotechnology and Ethics :- 5

9.1 Social & ethical issue in Pharmacy, Agriculture, Energy & Environment.
9.2 Humans:-Artificial Insemination (Al), In-vitro Fertilization & embryo
Transplants, Surrogate motherhood, Freezing germ cells, Human Embryos
and Cloning (Facing Problems and finding solutions)

Total 60
Recommended Books:

1. Olive Kaiser ,Rainer Muller, Pharmaceutical Biotechnology: Drug Discovery and

Clinical Application, Wiley VCH publisher, 2004

2. Peter J. Russel, Genetics 5 Edition ,The Benjamin Cummins Publishing

th

California;1998

3. Watson WH Freeman and company N.Y. Recombinant DNA 2 edition Holtzbrinck nd

Publishers 1992

4. Gliek, Molecular biotechnology 3 edition ASM press Washington, USA 2003

rd

60

5. Vyas and Dixit Pharmaceutical Biotechnology, 1 CBS Publisher New Delhi, 1991
st

6. Dr. S. Iganacimuthu, Basic Biotechnology – Tata McGraw Hill Publishers

7. P. K. Gupta, Elements Of Biotechnology, Rastogi Publication, 10 edition, 2004 th

8. S.S. Purohit, Biotechnology Fundamentals and Applications Student edition Agrobios

 Publisher;2002

9. H. S. Chawala, Introduction of Plant Biotechnology, 2 edition, IBH Publishing Co.

nd

 Pvt.Ltd. New Delhi, 2002

10. M.H. Razdan, Introduction to Plant Biotechnology , 2 edition Oxford and IBH Publishing
nd

Co. Pvt. Ltd, New Delhi. 2003

11. K. Sambamurthy, Ashutosh Kar, Pharmaceutical Biotechnology, 2 edition New nd

 AGE International (LP) Limited, 2007.

3.3 MEDICINAL CHEMISTRY –I

(Theory) 90 Hrs. (3 hrs per week)

Sr. SECTION- I Hrs.

No

1 General considerations: Structure of biological membrane, 06

Selectedphysicochemical properties affecting drug action; solubility,
partition coefficient, Ferguson principle, stereo chemical aspects of drug
action, Bioisosterism, Drug absorption; distribution, metabolism and
elimination, Protein binding, Blood brain barrier.

2 Receptors: Types of receptors, Types of forces involved in drug 04

receptorinteraction; intracellular cyclic nucleotides and other mediators
of biological response, Transduction mechanism.

3 History and general aspects of the design & development of drugs

includingclassification, nomenclature, structure activity relationship
(SAR), mechanism of action, adverse effects, therapeutic uses, and recent
developments of following categories. Biochemical approaches in drug
designing wherever applicable should be discussed.

3.1 Cholinergic agonists and antimuscarinic agents: Neurotransmitters, 09

impulse,Biosynthesis of acetylcholine, its release and
metabolism.Cholinergic agonists: Receptor subtypes and their structural
features, Cholinergic antagonists, cholinesterase inhibitors,
Antimuscarinic agents:Ganglionic Blockers and neuromuscular blockers:
Ganglionic stimulants, Ganglionic transmission, Ganglionic blockers and
nicotinic receptors. Neuromuscular blockers

3.2 Adrenergic agonists and antagonists: Biosynthesis, release and 07

metabolism ofnoradrenaline, Receptor subtypes and their structural
features.

12
3.3 Cardiovascular drugsa. Cardiotonic drugs b. Antianginal agents

c. Antiarrhythemic agents d. Antihypertensive agents

e. Currently used Anti-lipedemic drugs

 3.4 Diuretic agents 05

61

SECTION- II

3.5 CNS Stimulant Drugsa. Analeptics and respiratory stimulants b. 04

Hallucinogens

06
3.6 CNS Depressant Drugsa. General anesthetic agents

b. Sedative & Hypnotic agents c. Anticonvulsants

3.7 Drugs used in Neurodegenerative diseasesa. Parkinson’s disease b. 05

Alzheimer’s disease

3.8 Psychotherapeutic agentsa. Antipsychotic agents b. Antidepressant agents 06

c. Anxiolytic agents

3.9 Local anesthetic agents 05

3.10 Anti-migraine agents 02

3.11 Diagnostic agents: Radio Opaque diagnostic agents, Agents for organ 03
functiontest, Miscellaneous diagnostic agent.

3.12 Oral hypoglycemic drugs ( including insulin) 05

3.13 Prodrugs, soft drugs and hard drugs 03

4 Scheme of synthesis of following drugs from various therapeutic 08

categories:Carbachol, dantrolene sodium, methyldopa, propranolol,
atenelol, salbutamol, thiopental sodium, lignocaine, prazocin,
guanethidine, terbutaline, captopril, amitryptiline, hydralazine,
imipramine, diazepam, chlorpromazine, haloperidol, trifluperazine,
phenytoin, sodium valproic acid, losartan, alprazolam, metazepine,
fluoxetine, clofibrate, sumatriptan, ondansetron, glyburide, rosiglitazone,
tolbutamide, furosemide, dicyclomine hydrochloride, chlorthiazide,
amiloride, donepezil

Total 90

3.3 (P) MEDICINAL CHEMISTRY –I

(Practical) (90Hrs. (3 hrs per batch)

1. Purification techniques of solvents/liquids by Fractional distillation and distillation under

vacuum

2. Determination of partition co-efficient, dissociation constant, molar refractivity and

 RM values of compounds for QSAR analysis.

3. Resolution of Recemic mixtures of any two APIs by any two methods

4. Demonstration of simple QSAR software (Hansch Analysis)

5. Demonstration of construction of stereo models of drugs (minimum two)

6. Preparation of acid salts of drugs and evaluation of its physical properties.

7. Two or more step synthesis of drugs and drug intermediates being studied in theory

 (any ten)

Recommended Books for Theory and Practicals

62

1 An Introduction to the Chemistry of Heterocyclic Compounds, by Acheson RN, Interscience

Publishers New York.

2 Bentely and Driver’s Textbook of Pharmaceutical Chemistry by Atherden LM, 8 th

edition Oxford University Press London.

3 Inorganic Medicinal and Pharmaceutical Chemistry by Block & Roche, 1 edition, Varghese
st

Publishing House.

4 A Textbook of Pharmaceutical Chemistry by Chatten LG, Vol I & II, Marcel Dekker

New York.
5 Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry by
Wilson and Gisvold, J. Lippincot Co. Philadelphia.

6 Stereochemistry of Carbon Compounds by Eliel EL, 32 reprint 2005, TATA McGraw Hill.
nd

7 The Organic Chemistry of Drug Synthesis, Vol. 1,2,3,4 by Lednicer Daniel, 1 st

edition, John Wiley & Sons INC..

8 Profiles in Drug Synthesis Vol 1 & 2 by Gogate.

9 Exploring QSAR Vol; I Fundamentals and Applications in Chemistry and Biology by

C Hansh and A Leo Vol. II: hydrophobic, Electronic and Steric Constants by C Hansh, A Leo
and D Hockman ACS Book Catalog.

10 Organic Chemistry by Finar IL, Vol. I & II, Pearson Education.

11 Foye’s Principles of Medicinal Chemistry by Foye, 6 edition, Lippincott William

th

Wilkins.

12 Comprehensive Medicinal Chemistry by Hansh C, Vol IV, Elsevier Pergamon.

13 Quantitative Drug Design- A Critical Introduction by Martin YC, Marcel Dekker Inc.

New York.

14 Medicinal Chemistry-A Biochemical Approach by Nogrady T, Oxford University

Press New York, Oxford.

15 Computer Aided Drug Design, by Pops and Perruns, Academic Press, NY

16 Burger’s Medicinal Chemistry by Wolff ME, John Wiley & Sons, New York.

17 Antibacterial Chemotherapeutic Agents by SL Dax, Blackie Academic and

Professional Publications, Chapman and Hall, 1997.

18 Principles of Medicinal Chemistry by Kadam SS, Mahadik KR, Bothara KG, Vol. I & II, 10 th

Edition, Nirali Prakashan.

19 Introduction to Medicinal Chemistry’ – How Drugs Act and Why by Alex Gringauz,

Willey-VCH Publication 1997.

rd
20 Drug Design by Bothara KG & Kulkarni VM, 3 edition, Nirali Prakashan.

21 An Introduction to Drug Design by SN Pandeya & IR Dimmock, 1 edition, New st

Age International Publishers.

22 Structure based Drug Design by Veerapandian, 1 edition, Taylor & Francis New st

York, London.

th
23 Pharmaceutical Substances by Kleeman & Engel, 4 edition, Thieme Publications.

24 Practical Pharmaceutical Chemistry by Beckett AH & Stenlake JB, Vol. I and II, 4 th

edition, CBS Publisher & Distributor.

25 Steric Constants by C Hansch, A Leo and D Hockman, ACS Book Catalog.

26 Textbook of Practical Organic Chemistry, The ELBS Longman, London.

27 Computer Software Application in Chemistry by Jurs PC, John Wiley & Sons, New

York.

28 Jenkins’s Quantitative Pharmaceutical Chemistry by Knevel AM and Digangi FE, McGraw

Hill Book Co. New York.

63

29 Practical Organic Chemistry by Mann FC & Saunders BC, The English Language

Book Society and Longman Group Limited, London.

30 Quantitative Drug Design – A Critical Introduction by Martin YC, Marcel Deckker

Inc. New York.

31 Vogel’s A Text book of Practical Organic Chemistry by Vogel, 3 edition, The rd

English language book society and Longman group limited, London.

32 Advanced practical Medicinal Chemistry by Ashutosh Kar, 1 edition, New Age st

International Publications.

33 Vogel’s Elementary Practical Organic Chemistry Small Scale Preparation by Arthur

I.,2 Edition, Part-I, CBS Publication.

nd

3.4 (T) PHARMACEUTICAL ANALYSIS-II

(Theory) 90 Hrs. (3 Hrs./week)

TopicNo SECTION-I Hrs.

1 Introduction to analytical methods, (Gravimetric methods, 4

Titrimetricmethods, Neutralization titrations and its applications,
Complexometric reactions and titrations), Advantages and
disadvantages of instrumental methods of analysis and respective
problems, Instruments for analysis.

2 Atomic Absorption Spectroscopy: Theory, Instrumentation line 4

broadening,Doppler effect, Flame types, different Interference and
their Corrections, Pharmaceutical applications

Flame Photometry: Principles, Instrumentation and 3

Pharmaceuticalapplications

3 Refractometry: Specific and molar refraction, Refractive index, 3

Measurementof RI (angle of refraction), Instrumentation and
 applications.

4 Electrophoresis – Principle, Instrumentation, Various types of 5

Developments

5 Polarography: – Introduction, Principle, Dropping Mercury Electrode 5

andOther Mercury Electrodes, Polarogram, half wave potential,
Linear Scan& Differential Pulse Polarography, applications covering
nonaqueous polarography

12
6 Fluorimetry and phosphorimetry: – Molecular luminescence,
measurement offluorescence, factors affecting fluorescence,
quantitative aspects of fluorescence, Excitation and emission spectra.
Instrumentation, advantages and disadvantages, applications,
synchronous fluorescence.

Spectrofluorometry Instrumentation, advantages and disadvantages,

applications, optical bleachers,

7 Chromatography: Introduction, Brief history, Chromatographic 15

selection ofmethod, classification. Paper Chromatography:
Technique, Development, application, Different types of paper, grain
direction, ascent number. Thin Layer Chromatography: Principle,
preparation, Adsorbents, Activity of Adsorbents, Development of
TLC, applications. Column Chromatography: Principle, Column
packing, techniques, application, theory, Efficiency of column, Van
Deemter Equation in detail, Capacity factor and other performance
parameters.

64

High Performance Thin Layer Chromatography (HPTLC):

Theory,Instrumentation and Applications, Automated Multiple
Development, Horizontal TLC and other development modes, Labeling of
TLC, Centrifugal TLC

SECTION-II

8 Electromagnetic spectrum, Interaction of Electromagnetic radiation 6

 withmatter, classification of analytical methods, molecular analysis,
elemental analysis, selecting an analytical method, classification of
instrumental methods.

9 Ultraviolet and Visible absorption spectroscopy:- origin and theory of 12

UVspectra, Fundamental laws of absorption, Instrumentation, Single beam
and double beam UV – Visible Spectrophotometer, Optimum conditions for
Spectrophotometric measurements, Derivative Spectrophotometry,
techniques for color comparison, Spectrophotometric titration, Applications
of UV- Visible spectrophotometry.

10 Coulometric Analysis: – Introduction, Coulorimetric methods, types 6

ofCoulometric analysis, Variations in Coulometric techniques, General
characteristics of Coulometric techniques. Coulorimetry at controlled
potential, apparatus and general techniques, applications.

11 Amperometry: – Principles, Amperometric titration apparatus, 4

generalprocedure, advantages and disadvantages, applications,
Biamperometric titrations and its applications. Rotating Disc, ring and
similar types of electrodes

12 Thermal Analysis: Differential Scanning Calorimetry (DSC) 7

Definition,Types, Instrumentation, Principle, applications.
Thermogravimetric Analysis (TGA): Introduction, Definition, Types,
Instrumentation, Principle, applications. Differential Thermal Analysis
(DTA): Introduction, Definition, Principle Instrumentation, applications.
Isothermal titration calorimetry

13 Nephelometry and Turbidometry: Introduction Principle, 4

Instrumentation,Applications.

3.4 (P) PHARMACEUTICAL ANALYSES-II (Practical) (75 Hrs. per batch)

1. Determination of refractive index by Abbe’s Refractometer Molar refraction

calculations, Use oils , fats and other similar samples also. Three exercises

2. UV spectrophotometric estimations of API and same from their formulations Four exercises

3. Flurometric estimation of few florescent compounds. Minimum Three exercises

4. Na , K Calcium and Lithium estimation from formulations by Flame Photometry,

+ +,

two exercises each for available filter

5. Nepheloturbidimetric estimation of few analytes containing ions, vitamins, alkaloids

Three exercises

6. Paper chromatography ascending, Radial Three exercises each

7. Thin Layer chromatography Three exercises

Recommended Books for Theory and Practicals

65

1 Practical Pharmaceutical Chemistry (Part I & Part II) by A.H. Beckett and J.B.

 th
Staenlake, 4 Edition, CBS Publisher & Distributor New Delhi.

2 A Textbook of Pharmaceutical Analysis by K.A. Conners, 3 edition, John Wiley and rd

 Sons.

3 Principles of Instrumental Analysis by Skoog, 5 edition, Thomson Brookslcole. th

4 A Textbook of Pharmaceutical Chemistry by L. K. Chatten, Vol I & II, Marcel

 Decker, New York.

5 Principles of Chromatography by KR Mahadik, KG Bothara, 1 edition, Nirali st

 Prakashan.

 6 Introduction to Chromatography (Theory and Practice) by VK Srivastav and KK

Shrivastav.

7 Pearson’s Analysis of Foods by Ronald Kiek and Ronald Sawyer (Longman).

8 Radio bioassays (Vol. I and II), by Faud S. Ashkar.

9 Vogel’s A Text book of Practical Organic Chemistry by Vogel, 3 edition, The rd

 English language book society and Longman group limited, London.

10 Macmillan Textbook of Physical Chemistry by Samuel Glasstone, 2 edition. nd

 11 Handbook of Instrumental Techniques for Analytical Chemistry by Frank Settle,

Practice Hall Publications.

 12 Instrumental Methods of Analysis by Willard Merit, Dean Settle, 7 edition, CBS th

Publisher & Distributor.

13 Analytical Chemistry by Gary D Christian, 5 edition, John Wiley & Sons th

 Publications.

14 Instrumental Methods of Chemical Analysis by BK Sharma, Goel Publishing House.

nd
15 Analytical Chemistry: Principles, 2 edition, John. H. Kennedy.

16 Remington The Science and Practice of Pharmacy, 20 edition, Lippincott Williams th

 & Wilkins.

 17 Practical Pharmaceutical Chemistry by Beckett AH & Stenlake JB, Vol. II, 4th
edition, CBS Publisher & Distributor and I.

18 Indian Pharmacopoeia. latest edition

19 British Pharmacopoeia. latest edition

20 United States Pharmacopoeia latest edition

21 High Performance Thin layer Chromatography, Quantitative Analysis of Pharmaceutical

Formulations by PD Sethi, CBS Publisher & Distributors, New Delhi First Edition, 2001.

22. A Textbook of Analytical Chemistry, Y. Anjaneyulu, K.Chandreshekhar, Valli

 Manickam, Pharma Med Press.

3.5 (T) PHARMACOLOGY

(Theory) 90 Hrs. (3 Hrs./week)

Sr. No SECTION- I Hrs.

Basic pharmacology (classification, mechanism of action, pharmacokinetics,

pharmacologicalactions, adverse effects, contraindications, therapeutic uses, drug
interaction, dosage, symptoms and treatment of poisoning) and Clinical Management of
diseases and drugs acting on following categories:

1. Autonomic Nervous System

a) Autonomic Nervous system-General Considerations

b) Cholinergic system and drugs

66

c) Anti-cholinergic drugs 20

d) Neuromuscular blocking agents e) Adrenergic system and drugs

f) Anti-adrenergic drugs

g) Ganglion stimulants and blockers

2. Drugs acting on Central Nervous System 25

 a) Aliphatic alcohol

 b) General anesthetics

c) Sedative and Hypnotics d) Antiepileptic drugs

 e) Anti-Parkinsonian drugs

 f) Drugs used in Mental illness (Psychopharmacological drugs)-

Antipsychotic, anti-anxiety, antidepressant, anti-mania drugs

g) Opioid analgesics and antagonists h) NSAIDs

 i) CNS stimulants and nootropic j) Drug dependence

 k) Introduction to Patient addiction rehabilitation Center and Principle

of rehabilitation of drug addicts- Alcohol, tobacco, opioids.

SECTION- II

3 Drugs acting on Respiratory tractDrugs for cough and bronchial asthma 04

4 Drugs acting on gastrointestinal tract 08

a) Drugs for peptic ulcers

b) Emetics and antiemetics

c) Drugs for constipation and diarrhea

5 Hormones and Hormones antagonists 25

a) Anterior and Posterior Pituitary hormones

b) Corticosteroids and corticosteroid antagonists

c) Thyroid and antithyroid drugs, parathyroid hormones, drugs regulating

calcium homeostasis, Vitamine D

d) Insulin, Oral hypoglycemic agents, glucagon

e) Gonadal hormones and Oral contraceptives, antifertility agents f) Oxytocin

and drugs acting on uterus.

6 Pharmacotherapy of gout, rheumatoid arthritis and osteoarthritis. 06

7 Local Anesthetics 02

3.5 PHARMACOLOGY- II

(Practical) (90 hrs: 3 hrs/week)

1. Introduction to commonly used instruments in experimental pharmacology.

2. Care and handling of common laboratory animals, animal welfare and introduction of

 CPCSEA and its guidelines, OECD guidelines.

 3. Introduction to animal physiology with their biochemical reference values in various

animal species.

4. Study of various anesthetics employed to anesthetize laboratory animals.

67

5. Study of various routes of drug administration

6. Study of physiological salt solutions, drug solution and use of molar solution in various animal
experiments.
7. Introduction to the techniques of Euthenesia, stunning and pithing
8. Study of various methods for collection of blood, body fluids and urine from experimental
animals.
9. Computer simulations of following experiments through computerized simulated software
programme using software such as X-Pharma, X-cology etc.

 a) Record and interpret the concentration response of acetylcholine/histamine using

suitable isolated tissues.

b) Study of synergism using isolated tissues.

c) Study of drug antagonism using isolated tissues.

d) Study of the miotic and mydriatic effect of drugs using rabbit eyes

e) To study effects of various cardiovascular drugs on following heart preparations.

10. Bioassay-Definition, Principle, types, advantages of various methods

11. Bioassay of Acetylcholine and histamine using suitable animal preparation

12. Behavioral pharmacology demonstrations using various instruments preferably by
simulations on computers (A small number of mice (3) to be used for each the following
experiments and the animals should not be sacrificed).

a) Study of analgesic activity of drugs using Eddy’s hot plate analgesiometer, tail immersion.

b) Study of locomotor activity of drug using actophotometer.

c) Study of anticonvulsant activity of drug using maximal electroshock/

 pentyleneterazol/ strychnine/INH method.

d) Study of muscle relaxant property of drug using rotarod.

e) Study of various drugs on sleeping time using suitable animals. f) Study of local anesthetic
effect of drugs using suitable animal.

g) Study of Haloperidol/ Clonidine/ Petazocin induced catalepsy using suitable animal.

Recommended Books

1. Barar, F.S.K., Essentials of Pharmacotherapeutics; S. Chand and Company, New

Delhi

2. A textbook of Pathophysiology, Bodhankar, SL and Vyawahare, NS, Nirali

Prakashan, Pune.

3. Craig, C.R. and Stitzel, B.E.; Modern Pharmacology, Little Brown and Co, Boston

4. Crossland, James and; Lewis,s Pharmacology Basis of Therapeutics, (Pergamon

Press, New York)

5. Das, M. M. and Dutta S. K. : R. Ghosh,s Modern Concepts on pharmacology and

Therapeutics, ( HILTON and Co. Calcutta )

6. Goodman and Gilman; Pharmacological Basis of Therapeutics, McGraw-Hill

7. Katzung, B.G; Basic and Clinical Pharmacology, Lange Medical Publisher, USA

8. Rang, H.P. and Dale, M.M.; Pharmacology, Churchill Livingston, UK

9. Satoskar , R.S. and Bhandarkar S.D. Pharmacology and Pharmacotherapeutics

(Popular Prakashan, Bombay).

10. Sharma H.L. Sharma K. K. General Pharmacology Basic Concepts. Paras Publication.

11. Tripathi K. D. Medical Pharmacology, Jaypee.

68

3.6 (T) PHARMACOGNOSY

(Theory) 90 Hrs. (3 Hrs./week)

Sr. SECTION- I Hrs.

No

Note: – Drugs mentioned in Bold must be studied in detail for their cultivation,
collection and extraction

1. Glycosides – Introduction, definition, occurrence, properties, 20

classification ,uses , general biogenetic pathway. General extraction and
isolation methods.
• Anthraquinones – Senna, Aloe, Rhubarb

• Cardioactive – Digitalis, Squill

• Saponins – Liquorice, dioscorea , shatavari

• Bitter- Quassia, Kalmegh, chirata

• Cynogenetic – Bitter almond

• Isothiocyanate – Black mustard

 • Flavonoid –Orange peels.

• Coumarin/ furocumarin – Psoralea

• Lactone – Artemesia

2. A) Terpenoids – Introduction, occurrence, properties, classification, 12

chemistry, uses, general biogenetic pathway.

B) Volatile Oils – Introduction, occurrence, properties, classification,

chemistry, uses, general methods of extraction and evaluation of volatile
oils.

Cardamom, cinnamon, cassia, lavender, caraway, dill, coriander,

eucalyptus, nutmeg, fennel, clove, tulsi.

3. Lipids – introduction, occurrence, properties, classification, uses, 8

methods ofextraction, adulteration, evaluation, general biogenetic
pathway.
Fixed Oils- Castor oil, olive oil, Linseed oil, Seasame oil, Cod liver oil,
Shark liver oil, soya oil.Fats – Cocoa butter, Kokum butter

Waxes – Bees wax, Wool fat, Carnauba wax

4. General methods to study the biogenetic pathways with special reference 5

toTracer Technique and its application in the biogenetic investigations
with suitable examples.

SECTION- II

5. Tannins – introduction, definition, classification, properties, uses, 8

chemicaltests and general method of extraction.
Ashoka , Arjuna ,Bahera, Amala, Myrobalon ,Pale catechu , Black
catechu

6. Resins and resins combinations – introduction, classification, 8

properties,chemical composition extraction, and uses.
Podophyllum, Asafoetida, Ginger, Turmeric, Capsicum, Benzoin,
Colophony, Shellac, Cannabis, Guggul
 7. Plant pesticides – Pyrethrum, Tobacco, Neem, Derris root. 3

8. Enzymes and proteins – Papain, gelatin, Bromelin, 3

Streptokinase,Serratiopeptidase, Urokinase .

9. Drugs of mineral origin – Shilajit, Bentonite, Kaolin, Calamine, Fullers 3

earth.

10. Extraction of Plant Material- Soxhlet extraction, Droplet-counter- 3

currentExtraction, Supercritical fluid extraction, Froth floating
technique, Evaluation

69

of herbal extract.

11. Applications of Medicinal Plant Tissue Culture in Pharmacognosy.• 12

Cultivation of Medicinal Plant Cells
• Production of Secondary Metabolites

• Bioconversions Using Plant Cells

• Plant Cell Immobilization

• Genetic manipulation: Mutation.Polyploidy, Hybridisation, Chemodemes,
Transgenic plants ,
• Conservation of Endangered species through micropropagation.

Recommended Books

1. Trease and Evans: Pharmacognosy, 15/ Ed., Saunders Company, London.

2. Tyler, Brady and Robbers: Pharmacognosy: CBS Publisher and Distributors, New Delhi

3. Wallis T. E. : Textbook of Pharmacognosy: CBS Publisher and Distributor

4. Kokate, Purohit, Gokhale: Pharmacognosy: Nirali Prakashan, Pune.

5. Rangari: Pharmacognosy: Career Publications

6. Chemistry of Organic Natural Products by O.P agrawal, Gowel Publication house

7. The Indian Pharmacopoeia, 1996 & 2007.

8. The British Pharmacopoeia.

9. M. A. Iyangar: Study of Crude Drug.

10. Martindale: The Extra Pharmacopoeia.

11. E. Ramstad: Modern Pharmacognosy: McGraw Hill Book Company, INC.

12. Kalia A. N: Indiustrial Pharmacognosy.

13. Mohammad Ali, Pharmacognosy/

14. Street H E, Tissue culture and plant science, Academic press, London.

15. Rainerat and Bajaj, plant tissue culture.

16. Satyanarayana “Biotechnology”,Books and Allieds Pvt Ltd.,

17. Razdan M.K.An Introduction to Plant Tissue Culture,Oxford publisher

18. T.M. Vasudevan & K.S. Laddha “Herbal Drug Microscopy” Yucca Publication..

19. M. A. Iyengar, S. G. K Nayak “Pharmacognosy Lab Manual”,Manipal Press. Manipal.

20. M.A. Iyengar, S.G.K Nayak “Anatomy of Crude Drugs” Manipal press, Manipal.

3.6 Pharmacognosy- II

(Practical) (90 hrs: 3 hrs/week)

1) Study of plant tissues, stomata, trichomes, starch grains and calcium oxalate crystals.

 2) Analytical study of morphological and microscopical characters, chemical and micro

chemical tests for following crude drugs in entire and in powdered form (including surface
preparation wherever required).
  • Leaf – Senna, digitalis, Eucalyptus (Comparitive study)

 • Bark- Cassia/ Cinnamon

 • Fruit- Fennel/ Caraway/ Dill/ Coriander/ Cardamom/ Capsicum.

 • Seed- Isapghula/ Linseed

 • Flower bud- Clove

 • Wood- Quassia

 • Stem – Kalmegh/ Chirata

 • Root and Rhizomes – Liquorice, Shatavari,Ginger. (Comparitive study)

70

3) Quantitative microscopy:

. Determination of Leaf constant- Stomatal number and Stomatal index, Palisade ratio, Vein-islet
no., Veinlet termination no.

. Determination of length, width and diameter of cellular material! cell contents.

 . Determination of % purity of crude drugs by lycopodium spore method

4) Experiments on – Sampling of crude drug for analysis. Determination of foreign matters,

Moisture cotent (Loss on drying! Toluene Distillation) Ash Values, Extractive values, Swelling
index, Foaming index, Crude fibre (by dutch method)
5) Estimation of Acid Value! Saponification value! Iodine Value
6) Identification of natural fibres by general chemical tests and microscopical examination.
7) A) Identification of crude drugs mentioned in theory syllabus from their morphological and
physical characters and preparation of herbarium for one medicinal plant.
B) Identification of unorganized drugs by physical characteristics and chemical Tests. Acacia,
Agar, aloe, Asafoetida, Catechu, Castor oil, Honey, Colophony, Guggul, Shellac, Benzoin,
Tragacanth
 Detection of adulteration in oils

9) Visit to a tissue Culture Laboratory.

Recommended Books

1. Kokate, Purohit, Gokhale, Pharmacognosy, Nirali Prakashan, Pune.

2. Rangari V D, Pharmacognosy & Phytochemistry, Vol I, II, Career.

3. Khandelwal K.R.Practical Pharmacognosy,Nirali Prakashan,Pune.

4. E Ramstad, Modern Pharmacognosy, Mc-graw hill Book Company. Pridham J B, Swain B,
Biosynthetic pathways in higher plants, Academic Press, New york.
5. Shah & Quadry, A text book of Pharmacognosy.

6. Chopra, Indigenous drugs of India.

7. Wealth of India

8. Materia Medica by Nadkami,

9. Ayurvedic Pharmacopoeia.

10. British Pharmacopoeia.

11. Martindale Extra Pharmacopoeia.

12. Cultivation and utilization of medicinal plants- Attal and Kapoor.

13. M. A. Iyengar, S. G. K Nayak “Pharmacognosy Lab Manual”, Manipal Press. Manipal.

14. M.A. Iyengar, S.G.K Nayak “Anatomy of Crude Drugs” Manipal press, Manipal.

71

3.7 (T) Pharmaceutical Business Management

(Theory) 60 Hrs. (2 Hrs./week)

Sr. SECTION- I Hrs.

No
1. 1. Fundamentals of management 3
i) Management basic Concepts efinition, Need for management,
Function of management, Management thoughts, Contribution of Taylor,
Fayol, Peter Drucker in modern management. Functions and
responsibilities of a manager.

ii) Planning: Nature and purpose of planning, important steps in 3

planning,types of planning, planning process, advantages and limitations.
Sales forecasting methods, analysis, advantages and limitations.

iii) Objectives: Types of objectives, Importance of objective, 2

Management byobjectives, Advantages and Limitations

iv) Organizing: Organizational structure, basic principals of 2

organization,Departmentalization, Delegation, Decentralization, Staffing,
Line & Staff organization.

v) Decision making: Types of strategies, Policies, Definition and 2

Importanceof decision making, Decision making process

vi) Controlling: Concepts and purpose of control techniques, Budgetary 3

andnon budgetary control, Management audit, Manage–ment information
system, Break even analysis, Network techniques (PERT & CPM), Profit
and loss account, Balance sheets

2. Pharmaceutical industry and operation managementi) Historical 1

perspective of pharmaceutical industry in India, Current status
and growth scenario.

ii) Operation management in Pharmaceutical Industry: Controlling 2

ofmanufacturing operation, Importance and function of Q.C and Q.A.

iii) R&D in Pharma industry, Drug discovery process, Drug 3

developmentprocess, Clinical research organization.

iv) Material management: Classification of materials, objectives 3

andprincipals of purchasing, inventory control.

3. 3. Industrial relations.Meaning, Scope, Causes of disputes, Tribunals, 5

Strikes, Lock outs. Labor law.
Trade unions, Job satisfaction, Personal counseling. Introduction to
Factories

Act,1948, Trade unions Act 1926 and Industrial Disputes Act 1947.

SECTION- II
 1. 1. Pharmaceutical Marketingi) Difference between marketing and 3
selling, Channels of distribution,
Wholesale, Retail, Departmental.

ii) Sales promotions, Objective, Principles & Techniques. Ethics of 3

sales,Advertising- Needs & Methods, Merchandising, Detailing

iii) Medical representative: Role & Qualities. 1

iv) Marketing research: Nature & Importance 2

v) Product management: Product life cycle, Launching a new product, 3

72

Branding, Packaging

vi) Price: Definition, Factors affecting , procedure for determination of 3

price,types of price

2. 2. Human Resource and Developmenti) Motivation: definition, concept, 4

Theory’s- Maslow’s Theory, Hertzberg’s
theory, Vroom’s theory, Expectancy theory, Reinforcement theory, Equity or
social comparison theory X & Y.

ii) Leadership: definition, importance, qualities of leadership, 3

leadershipstyles, trait theory, managerial grid

iii) Communication: importance, functions, communication process, formsof 2

communication, types of communication

iv) Interview techniques: – presentation skills 2

- group discussion

v) Performance appraisal: need and techniques, recruitment and training 2

3. 3. International market.Pharmaceutical export, procedure, documentation. 2

Export, registration
authorities, regulatory agencies

Recommended Books
1) Peter Drucker; The Practice of management, Harper and Row, New York, 1954.

2) Harold Koontz, Cyril O’Donnel & Heinz Weihrich; Management, 7 edition, th

1980.

3) P.C. Tripathi & P.N. Reddy; Principals of Management, Tata McGraw Hill publishing Co/
Ltd, 2 edition, New Delhi.
nd

4) Koontz H. & Weihrich H.; Essentials of Management, Tata McGraw Hill publishing Co/ Ltd,
5 edition, New Delhi, 1998.
th

5) Satya Saran Chatterjee; An Introduction to Management, The world Press Pvt. Ltd, 12 th

Edition, Calcutta, 1998.

6) G. Vidyasagar; Pharmaceutical Industrial Management, Pharma book Syndicate, Hyderabad,
2005.
7) Philip Kotler & Gary Armstrong; Principles of Marketing, Pearson Education Pvt. Ltd., 10 th

Edition, Singapore, 2005.

Mickey Smith; Principles of Pharmaceutical Marketing, CBS Publisher & Distributors, 3 rd

Edition, New Delhi, 2001.

9) J.C. Gandhi; Marketing A Managerial Intoduction, Tata McGraw Hill publishing Co/ Ltd, 8 th

Edition New Delhi, 1995.

10) Mickey Smith; Pharmaceutical Marketing in the 21 Century, Viva Books Pvt. Ltd., New
th

Delhi, 2001.

11) Horngren, Sundem & Stratton; Introduction to Management Accounting, Prentice

Hall of India Pvt. Ltd., 11 Edition, New Delhi, 2000.

th

12) Cost Accounting & Management Accounting: Everest Publication, New Delhi.

13) Principles and Methods of Pharmacy Management by Harry Smith.

14) Marketing Management by Philip Kotlar.

15) Marketing in New Millennium by Dr. M. J. Xavier, 1998.

16) Principles and Management: Koonz O’ Donnel.

73