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M.SC. IN OF PHARMACY SYLLABUS
Subject Code : interpretation
1. First Digit Indicates Semester Number e.g.
1 for 1st Semester, 2 for 2nd Semester, 3 for 3rd Semester, 4 for 4th Semester
2. Second Digit Indicates Paper Number e.g. 1,2 and 3
3. Alphabets A, B, C, D Indicates Subject
A.
Quality Assurance (QA)
B.
Pharmacognosy (CG).
C. Clinical Pharmacy (CP)
D.
Pharmaceutical Chemistry (PC)
E.
Dosage formdesign and BioPharmaceutics (DB)
F.
Pharmaceutics & Pharmaceutical Technology (PT)
G.
Pharmacology (CL)
Semester - I
Subject
Code
Disciplines
Subject Name
Distribution of
Grand
Marks
Total
Theory Practical
11 (All) QA,CG,CP,PC,DB,PT,CL
Modern Analytical
Techniques
100
100
200
12 (All) QA,CG,CP,PC,DB,PT,CL
Advance in
Pharmaceutical Sciences
100
-
100
13A
QA
Pharmaceutical Quality
Assurance
100
100
200
13B
CG
Chemistry of Medical
Natural Product
100
100
200
13C
CP
Pathophysiology and
Pharmacotherapeutics - I
100
100
200
13D
PC
Organic Chemistry
100
100
200
13E
DB
Pharmaceutical
Formulation Design and
Development
100
100
200
13F
PT
Pharmacokinetic and
Formulation Design
100
100
200
13G
CL
Cellular and Molecular
Pharmacology
100
100
200
300
200
500
Total Marks for each Discipline
Semester - II
Subject
Code
Disciplines
Subject Name
Distribution of
Grand
Marks
Total
Theory Practical
21A
QA,
Standardization and Stabilization
Method of Drugs
100
100
200
21B
CG,
Standardization and Stabilization
Method of Herbal Formulation
100
100
200
21C/21E
CP, DB
Biopharmaceutics and
Pharmacokinetics
100
100
200
21D
PC
Organic Chemistry - II
100
100
200
21F
PT
Advance in Pharmaceutical
Technology
100
100
200
21G
CL
Advance Systemic Pharmacology
100
100
200
22A
QA
Special Techniques in Drug
Analysis
100
100
200
22B
CG
Evaluation of Herbal Drugs and
Formulations
100
100
200
22C
CP
Pathophysiology and
Pharmacotherapeutics - II
100
100
200
22D
PC
Pharmaceutical Chemistry - I
100
100
200
22E/22F
DB, PT
Design & Development of Novel
Drug Delivery System
100
100
200
22G
CL
Pharmacometrics and Evaluation
of Drugs
100
100
200
23A/23E/23F
QA, DB,
PT
Validation & c-GMP
100
-
100
23B
CG
Biotechnology and Cultivation of
Medicinal Plants
100
-
100
23C
CP
Clinical Research and Approval of
New Drugs
100
-
100
23D
PC
Pharmaceutics Chemistry - II
100
-
100
23G
CL
Clinical Pharmacotherapeutics and
100
-
100
Toxicology
Total Marks for each Discipline
300
200
500
Semester - III
Subject
Code
Disciplines
Subject Name
31
Seminar of Recent
QA,CG,CP,PC,DB,PT,CL Subject in Pharmaceutical
Sciences.
32
QA,CG,CP,PC,DB,PT,CL
Seminar on Dissertation
(Introduction)
Total Marks for each Discipline
Distribution of
Grand
Marks
Total
Theory Practical
-
100
100
-
100
100
-
200
200
Semester - IV
Subject
Code
41
Disciplines
Subject Name
QA,CG,CP,PC,DB,PT,CL Thesis and Viva
Total Marks for each Discipline
Distribution of
Grand
Marks
Total
Theory Practical
-
200
200
-
200
200
11(ALL) : MODERN ANALYTICAL TECHNIQUE
THEORY
1. Theory of UV, IR, derivative spectroscopy, FT-IR, NIR, ATR and their
applications to structural elucidation.
2. Theory, instrumentation and application of flourimetry.
3. Theory, instrumentation and application of atomic absorption and atomic
emission spectroscopy.
4. Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR
(Magnetic properties of nuclei: applied field & precession: absorption & transition
frequency), chemical shift concept, factors affecting chemical shift, isotopic
nuclei, reference standards; proton magnetic spectra, their characteristics,
presentation, terms used in describing spectra & their interpretation (signal no,
position, intensity), brief outline of instrumental arrangements & some practical
details, signal multiplicity phenomena in high resolution PMR; Spin spin coupling
application of signal splitting & coupling constant data to interpretation of
spectra, proton exchange reaction, decoupling & shift reagent methods.
 Brief outline of principles of FT-NMR with reference to 13 C NMR:

Spin-spin & spin- lattice relaxation phenomena, free induction decay (FID),
proton noise decoupling, signal averaging time domain & frequency domain
signals, nuclear overhauser enhancement; 13C NMR spectra; their presentation,
characteristics, interpretation, examples & applications.
 Brief indication of application of magnetic response spectral data of other nuclei
by modern NMR instruments, introduction to 2-D NMR techniques
5. Mass Spectrometry: Basic principles & brief outline of instrumentation, ion
formation & types; molecular ions, meta stable ions, fragmentation processes,
fragmentation patterns & fragment characteristic in relation to parent structure &
functional groups, relative abundances of isotopes & their contribution to
characteristic peaks mass spectrum; its characteristic, presentation &
interpretation chemical ionization, Fast atom bombardment mass spectroscopy.
6. Basic principle, applications and recent trends in chromatography.
o
HPLC, LCMS
o
GC, GCMS
o
HPTLC
o
Ion exchange chromatography
o
Ion pair chromatography
o
Size exclusion chromatography
o
Affinity chromatography
o
Electro kinetic chromatography
o
Supercritical Fluid Chromatography
PRACTICAL
The practical syllabus comprises of the exercises formulated based on the topics
mentioned in the Theory syllabus.
BOOKS RECOMMENDED:
1. Munson Janues W. “Pharmaceutical Analysis” Marcel Dekker.
2. Willard “Instrumental Method of Analysis” 7th edition CBS publication.
3. SkoogPrinciples of Instrumental Analysis” 5th edition Thomson.
4. Kenneth A. Conor “A textbook of Pharmaceutical Analysis, 3rd edition, John
Wiley & sons.
5. Robert M. Silverstein, “Spectrometric identification of organic compound”.
6. B. K. Sharma Instrumental methods of chemical analysis, Goel Publication, 23rd
edition.
12(ALL) : ADVANCES IN PHARMACEUTICAL SCIENCES
THEORY
Biostatistics
The application of the following topics in Pharmacy shall be covered:
Mean, Median and Mode, Standard Deviation and Coefficient of variation, Students ttest, One way NOVA, Chi-square test, Probability, Frequency distribution, Regression
analysis, Bioavailability – Cross-over study, Wilcoxon signed rank test, Introduction to
control charts.
Pharmainformatics
Introduction to information resources available on Internet for the various subjects in
Pharmacy (Pharmaceutical Technology, Pharmaceutical Chemistry, Quality Assurance,
Pharmacology and Pharmacognosy).
Experimental Designs
Introduction to Full and Fractional Factorial Designs, central composite designs,
Evolution of full and reduced mathematical models in experimental designs, Applications
of the experimental designs for the subjects mentioned under Pharmainformatics,
Introduction to contour plots.
Patents
Definition, Need for patenting, Types of Patents, Conditions to be satisfied by an
invention to be patentable, Introduction to patent search.
The essential elements of patent; Guidelines for preparation of laboratory note book,
Non-obviousness in Patent, Drafting of Patent claims, Important Patent related web-sites.
Brief introduction to Trademark protection and WO Patents.
Introduction to “The Patents Act 1970” and “The Patents Rules 2003”’ with special
emphasis on the forms to be submitted along with a patent application.
Biotechnology in Drug Discovery
Cloning of DNA, Expression of cloned DNA, Manipulation of DNA sequence
information, New Biological Targets for Drug Development. Novel Drug Screening
Strategies, Novel Biological Agents, Antibodies, Antisense oligonucleotide Therapy,
Gene Therapy
Quality assurance and regulatory affairs
1.
Basic Concept of quality assurance & requirement of cGMP (WHO, USFDA,
MHRA).
2.
ISO & ICH requirements of quality.
3.
GLP Guidelines.
Registration of new drugs for importing and manufacturing in India.
Introduction to IND, NDA, ANDA for registration in USA.
BOOKS RECOMMENDED:
1. Web Resources in Pharmacy, InPharma Publication, Bangalore
2. Basic Statistics and Pharmaceutical Statistical Applications by James E. De
Muth, Marcel Dekker Inc.
3. Method in Biostatistics by B.K.Mahajan, JayPee Brothers, New Delhi.
4. Statistical Methods in Biological & Health Sciences by J.Susan Milton, Tata Mc
GrawHill Int. Edition.
5. Pharmaceutical Statistics by Standards Bolton, Marcel Dekker Inc.
6. Pharmaceutical Experimental Design by G.A.Lewis, D.Mathiea, Roger PhanTan-Luu, Marcel Dekker Inc.
7. Pharmaceutical Experimental Design and Interpretation by N.A.Armstrong
L.K.C. James, Taylor & Francis.
8. Current Patent Acts of Various countries.
9. Sanford Bolton, “Pharmaceutical Statistics” 3rd edition, Drug & Pharmaceutical
Sciences series Vol: 80, Marcel Dekker Inc.
10. James E. Demath “ Basic Statistics and Pharmaceutical Statistical Application
Marcel Dekker Inc.
11. Mueen Ahmed K.K. “Web Resources in Pharmacy” Gareth A. Lewis, Didier
Mathieu, Roger Phan – Tan-Luu, “Pharmaceutical Experimental Design”, Vol-92,
Marcel Dekker Inc.
13A : PHARMACEUTICAL QUALITY ASSURANCE
THEORY:
1. A critical review of pharmacopoeia and other advanced methods used for
qualitative and quantitative estimation of drugs and their formulations.
2. An approach to the development of analytical methods for drugs in bulk and in
their formulations, recovery studies.
3. Methods of analysis of common excipients/ additives in formulations.
Determination of active constituents in presence of these excipients.
4. Analysis of drugs/metabolites in biological fluids like urine, blood and tissues,
enzymatic analysis.
5. Biochemical analysis of drugs, estimation of enzymes and other endogenous
materials.
6. Microbiological assay of antibiotics and vitamins. Immunological assays : ELISA, immunoblotting , immunoflorescence, immunoaffility.
7. Reference and working standard: source, preparation, characterization, usage,
storage and records.
PRACTICAL
Laboratory examination including oral and practical examination in
general course illustrative of theory section in the syllabus.
BOOKS RECOMMENDED:
1. IP, BP & USP
2. Enzymes – Biochemistry, Biotechnology, Clinical Chemistry
3. Michael E. Swartz, Analytical method development & validation.
4. S.Suzanne Nielsen, “Introduction to the Chemical analysis of foods”.
D.C.Garratt “The quantitative analysis of drugs” 2nd edition.
13B : CHEMISTRY OF MEDICINAL NATURAL PRODUCTS (CG)
THEORY
1. Classification of medicinally active constituents. General methods of Extraction
procedures, Isolation, Purification and Identification of Natural Products such as
Alkaloids, Glycosides, Tannins and other Phenolics, Volatile oils and Terpenoids,
Fixed oils, Carbohydrates, Acetogenins and Marine products.
2. Study of Biogenetic pathways of therapeutically important active constituents of
plant origins. Techniques to investigate biogenetic pathways.
3. Study of sources, isolation, purification, identification and analysis and structure
illucidation of plant constituents of economical and medicinal importance such as
Atropine, Ergometrine, Vincristine, Disosgenin, Sennosides, Glycyrrhetanic acid,
Guggulipids, Boswellic acids, Rutin, Psoralen, Digoxin, Podophyllotoxin,
Quinine, Reserpine, Echimic acid, Andrographolide, Withanolides and
Withanoferins, Ginkolide, Silymarin, Picroside, Artimisin, Gymnemic acids,
Curcuminoids, Embelin, Opium alkaloids, Menthol, Thymol, Citrrl, Taxol.
4. Review of recent literatures appearing on Phytopharmaceuticals used as
antiallergic, antimicribials, anti-inflammatory, anticancer, antidiabetic,
antihepatotoxic and immunomodulators.
PRACTICAL
The practical syllabus comprises of the exercises formulated based on the topics
mentioned in the Theory syllabus.
BOOKS RECOMMENDED:
1. Manske- The Alkaloid- Chemistry and Physiology.
2. Sim - Medicinal Plant Glycosides.
3. Sim - Medicinal Plant Alkaloids.
4. IUPAC - Chemistry of Natural Products - International symposium.
5. Zechmeister - Progress in the Chemistry of Organic Natural Products.
6. Reinhold - Liwschitz - Progress in Phytochemistry.
7. Wagner - Wolf- New Natural Products and Plant Drugs with Pharmacological,
Biological or Therapeutic Activity
8. Finar- Organic Chemistry.
9. Peach - Tracey - Modern Methods of Plant Analysis.
10. Geissman - Modem Methods of Plant Analysis.
11. Garatt - The Quantitative Analysis of Drugs.
12. Backett - Stenlake - Practical Pharmaceutical Chemistry,
13. Arthur-Symposium on Phytochemistry.
14. Pridham - Swain - Biosynthetic Pathways in Higher Plants.
15. Greenbury - Metabolic Pathways.
16. Margaret - Brain - Secondary Plant Metabolism.
17. Wagner - Horhammer - Pharmacognosy and Phytochemistry
18. Harborne - Comparative Biochemistry of Flavonoids.
19. Lehninger - Principles of Biochemistry,
20. Bonner - Plant Biochemistry.
21. Harborne - Phytochemical Methods.
22. Rosenthaler - The Chemical Investigation of Plants.
23. Cheronis - Organic Functional Group Analysis.
24. Nakanishi -Natural Products Chemistry, Vol. 1 & Vol. 2
13C : PATHOPHYSIOLOGY AND PHARMACOTHERAPEUTICS – I
(CP)
THEORY
1. Basic Concepts of Pathophysiology and Pharmacotherapeutics
2. Recording of medication history, self-medication, non-prescription drug usage,
improving patient compliance and providing patient counselling,
communication skills – behavioral and interpersonal with patients and other
professionals.
3. Principles of pharmacovigilance and pharmacoeconomics.
4. Drug interactions
i. Prescription monitoring, documentation and other methods for minimizing
clinically relevant drug interactions.
5. Drugs induced diseases, adverse drug reactions and the role of clinical pharmacist in
their monitoring and prevention.
6. Interpretation of clinical laboratory tests
i. Hematological, pathological and biochemical investigations as markers of major
organ damage and their effect on drug therapy decisions.
7. Concept of essential drugs and rational drug use.
8. Concept of therapeutic drug monitoring.
9. General principles of clinical toxicology
10. Drug treatment during infancy and in the elderly (pediatric and geriatric
considerations)
11. Drug treatment during pregnancy and treatment of women including
dysmenorrhoea, fertility control and hormone replacement therapy.
PRACTICAL
Practical exercises will be based on theory syllabus (i.e. pertaining to hospital based
Haematological, Bio-chemical, Pathological and Diagnostic Tests).
Hospital visits, ward rounds, medication history and prescription analysis, etc.
BOOKS RECOMMENDED
1. British National Formulary (Current Edition) – BMA/RPSGB
2. Medicines, Ethics & Practice. The Pharmaceutical Press
3. Oxford Text Book of Clinical Pharmacology and Drug Therapy, 3rd edition,
Graham-Smith D. and Aronson J., Oxford University Press
4. Hand Book of Pharmacy Health Care. The Pharmaceutical Press
5. Drug Interactions. Stockley I.H. (1996). The Pharmaceutical Press
6. Katzung. B.B., Basic and Clinical Pharmacology. Prentice Hall, International.
7. Harrisons Principles of Internal Medicine. Medical Toxicology (Ellen Horns)
8. Davidson’s Principle and Practice of Medicine, Eds. Christopher R. W., Edwards &
Ian A.D. Boucher ELBS with Cdnorchill Living stone. Edinburgh.
Latest Edition.
9. Oxford Text Book of Medicine, 4th edition, David A. Warrell, Timothy M. Cox,
John D. Firth.
10. CRC desk reference of Clinical Pharmacology, Manuchair Ebadi.
11. Oxford Text Book of Pharmaceutical Medicine, 4th edition, John P. Griffin, John
O’Grady.
12. Principles of Pharmacology, the Pathophysiological Basis of Drug Therapy,
Lippincott, Williams & Wilkins.
13. Drug Interaction Facts, 2003. David S. Tatro.
14. Emergency Toxicology, 2nd edition. Peter Viccellio.
15. Toxicology - The basic science of poisons, international edition, Curtis D.Klaassen,
6th edition.
16. Toxicology – Principles and Applications, Raymond J.M.Niesink, John de.Vries,
Mannfred A. Hollinger.
17. Clinical Pharmacy and Therapeutics. Roger Walker and Clive Edwards, Churchill
Livingstone Edinburg/ London.
18. Pathology & Therapeutics for Pharmacists. Russel. J. Greene and Normal F.Harris.
Chapman & Hall, London/ Glasgow/ Madras.
19. Text Book of Therapeutics: Drug and Disease Management. 7th Edition. Editors:
Eric T. Herfindal and Dick R. Gourley, Williams and Wilkins, 2000.]
20. Davidson’s Principles and Practice of Medicine, Eds. Christopher R.W.Edwards
and Lan A.D.Bouchier ELBS with Churchill Livingstone, Edinburgh. Latest
Edition.
21. Applied Therapeutics: The Clinical Use or Drugs Eds. Brian S.Katcher, Lioyd Yee
Young, Marry Anne Koda-Kimble, Applied Therapeutics Inc.
Spokane. Latest Edition.
22. Pathology & Therapeutics for Pharmacists. Greene, R.J & Harris, N.D. (1993). The
Pharmaceutical Press.
23. De Gruchi’s Clinical Haemotology in Medical Practice. Frank Firkin, Bryan Rush,
David Penington, Colin Chesterman. Blactwell Scientific Publication. 5th
edition.
24. Robbins Pathologic Basis of Disease. Cartran, Kumar, Collins, W.B.Saunders. 6th
edition.
25. Textbook of Medical laboratory Technology. Praful B. Godkar, Darshan P.Godkar,
Bhalani Publication House, Mumbai. 2nd edition.
26. Manual of basis techniques for a health laboratory, 2nd edition, World Health
Organization, Geneva.
13D : ORGANIC CHEMISTRY-I (PC)
THEORY
1. Chemical Bonding and Structure
Chemical bonding, Bond energies, Orbital theory, Orbital Hybridization Reson
Electronegativity, Polarity, Hyperconjugation.
2. Chemical Reactivity and Molecular Structure
Kinetics, Resonance, Stearic, Inductive and electrostatic effect on reactivity, Acids
and Bases
3. Various Reaction mechanisms
a) Substitution Reaction: Nucleophilic substitution reaction in aliphatic systemsSN1, SN2, Hydride transfer reaction, Cram’s rule, Participation of
neighboring group in nucleophilic substitution-reactions and
rearrangements.Aromaticity, electrophonic and nucleophilic substitution in aromatic
systems Reactivate orientation in electrophilic substitution.
b) Elimination Reaction: Beta elimination reactions, E1, E2 & E1cb mechanisms
Hoffman Saytzeff’s elimination.
c) Addition Reactions: Nucleophilic additions, Markonikov’s rule
d) Rearrangement reactions: Transannular rearrangement, Pinacol and related
rearranger Beckman rearrangement, Hofmann rearrangement.
e) Free radical reactions: Formation – Detection – Reactions, Homolysis and free
displacements – additions and rearrangements of free radicals.
4. Reactions of carboxylic acids and esters
BAC2, AAC2, BAL2, BAL1, AAL1. Claisen condensation, decarboxylation,
cabanions enolis keto-enol equilibria
5. Stereochemistry
Molecular asymmetry, compounds with one, two or more unequal asymmetric
carbon racemic modifications, Configurations – absolute, relative, synthesis
of optically active compounds cyclohexane, six membered heterocyclic rings –
stereoisomerism of compounds with asymmetric plane – allenes and related
compounds – stereoselective synthesis.
PRACTICAL
The practical syllabus comprises of the exercises based on the topics mentioned in the
Theory syllabus.
BOOKS RECOMMENDED
1. J. March , Advanced Organic Chemistry, Reaction Mechanisms and Structure,
(John Wiley and Sons, N.Y).
2. E.S.Gould, Hold Rinchart and Winston,, Mechanisms and structure in Organic
Chemistry, New York.
3. Thomas N. Serrell, Organic Chemistry, 1st edition, (Viva Books Pvt. Ltd.)
4. A. Carey, Organic Chemistry, 5th edition, (Tata Mcgraw - Hill Pub. Comp. Ltd.)
5. R.A. Sheldon, Chirotechnology, (Marcell Dekker Inc., New York, 1993).
6. R.A. Aitken and S.M. Kilengi, Asymmetric Synthesis, , Ed., (Blackie Academic
and Professional, London, 1992).
7. Finar Vol-1 & 2, Organic Chemistry.
13E : PHARMACEUTICAL FORMULATION DESIGN AND
DEVELOPMENT (DB)
THEORY
1. Preformulation studies - Perspective and concepts: Detailed study of parameters
like solubility, paratition coefficient, dissolution,
crystal morphology, crystal optics, polymorphism and purity studies: drug
excipient compatibility study.
2. Dissolution Study:
- Importance, objectives, equipments
- Biological classification system (BCS); its significance on dissolution study and
application in dosage form development.
- Selection of dissolution medium and conditions.
- Comparison of dissolution profile by model independent (similarity and
dissimilarity factor) and dependent method.
3. Stability studies:
- Basic concept and objectives of stability study.
- Order of reaction and their applications in predicting shelf life and half-life of
Pharmaceutical formulations.
- Importance of accelerated stability study.
- Effect of various environmental / processing on stability of the formulation and
techniques for stabilization of products against the same.
- Regulatory requirements related to stability testing with emphasis on
matrixing/bracketing techniques, climatic zone, impurities in stability study
photostability testing etc.
- Application of microcolorimetry in stability study.
4. Polymers - Classification. General methods of synthesis, properties,
characterization and evaluation: Biodegradable polymers - Classification - Mechanism
of biodegradation in the body: Polymer processing with respect to novel
formulation design: Applications of polymers in novel drug delivery systems,
Medical prosthetics and packaging.
5. In-vitro In-vivo Correlation (IVIVC)
Methods of establishing IVIVC
Factors effecting IVIVC
6. A Brief study on formulation and evaluation of specialized pharmaceutical dosage
form Dry syrup, Topical gel,, Microemulsion, dry powder, Parenteral
emulsion and suspension, occuserts, Clear shampoo, hair cream, Face wash,
Sunscreen Lotion, Antiwrinkle cream, Face wash
PRACTICAL
The practical syllabus comprises of the exercises formulated based on the topics
mentioned in the Theory syllabus.
BOOKS RECOMMENDED
1. Milo Gibaldi and Donald Perrier, "Pharmacokinetics", Drugs and Pharm. Sci.
Series, VoL 15., Marcel Dekker Inc., N.Y.
2. J.C. Wagner, "Fundamentals of Clinical Pharmacokinetics", Drug Intelligence
Publications, Hamilton, 1975.
3. Bert N. LaDu, "Fundamentals of Drug Metabolism & Disposition", Waverley Press
Inc., Baltimore, 1972.
4. T.Z.Laaky, "Intestinal Absorption & Malabsorption", Raven Press, N.Y., 1975.
5. J.T.Carstensen, "Theory of Pharm. Systems", Vols. 1-3, Academic Press, N.Y.
6. U.S. Beans, A.K.Beckett and J.E.Caraless, “Advances in Pharm.Sci.”, Vol. 1 to 4.
7. J.T.Carstensen, "Drug Stability: Principles and Practices", Drugs and Pharm. Sci.
Series, Vol. 43, Marcel Dekker Inc., N.Y.
8. Lisbeth lliun & Stanley S. Davis: "Polymers in Controlled Drug Delivery", Wright,
Bristol (1987).
9. Pharmaceutics “The Science of Dosage form design” by Aulton.
10. Encyclopedia of Pharmaceutical technology Volumes: 1 to 19.
11. Remingtons Pharmaceutical Sciences 19th edition.
12. Pharmaceutical dissolution testing by Banaker.
13. Pharmacokinetics by Welling and Tse.
14. Modern Pharmaceutics by G.S.Banker
15. Clinical Pharmacokinetics, Concepts and applications, by Rowland and Tozer.
16. Biopharmaceutics and Pharmacokinetics – An introduction by Notari.
Techniques of Solubilization of Drugs by Yalkowsky
13 F : PHARMACOKINETICS AND FORMULATION DESIGN (PT)
THEORY
1. Nonlinear Pharmacokinetics: Michaelis-Menten Kinetics, Estimation of Km and
Vm Clearance, half life and volume of distribution, steady state, Bioavailability
etc., Urinary excretion process and other nonlinear elimination process, some
problems in quantifying nonlinear pharmacokinetics.
2. Physiological Pharmacokinetic Models: Compartment models, Blood flow rate limited models - blood clearance, lung clearance, apparent volume of distribution,
nonlinear dispositions, Membrane limited models.
3. Noncompartment Analysis : based on statistical moment theory : statistical
moments, Bioavailibility, clearance, Half life, Absorption kinetics, apparent
volume of distribution etc., Steady state.
4. In-vitro In-vivo Correlation (IVIVC)
Methods of establishing IVIVC
Factors effecting IVIVC
5. Computer modeling of dissolution & pharmacokinetic data.
6. Preformulation studies - Perspective and concepts: Detailed study of parameaters
like solubility, partition coefficient, dissolution, crystal morphology, crystal
optics, polymorphism and purity studies: drug excipient compatibility study.
7. Stability studies:
- Basic concept and objectives of stability study.
- Order of reaction and their applications in predicting shelf life and half-life of
pharmaceutical formulations.
- Importance of accelerated stability study.
- Effect of various environmental / processing on stability of the formulation
and techniques for stabilization of products against the same.
- Regulatory requirements related to stability testing with emphasis on
matrixing/bracketing techniques, climatic zone, impurities in stability study
photostability testing etc.
- Application of microcolorimetry in stability study.
8.
Polymers - Classification. General methods of synthesis, properties,
characterization and evaluation: Biodegradable polymers - Classification - Mechanism
of biodegradation in the body: Polymer processing with respect to novel
formulation design: Applications of polymers in novel drug delivery systems,
Medical prosthetics and packaging.
9. Dissolution Study:
- Importance, objectives, equipments
- Biological classification system (BCS); its significance on dissolution study
and application in dosage form development
- Selection of dissolution medium and conditions.
- Comparison of dissolution profile by model independent (similarity and
dissimilarity factor) and dependent method.
PRACTICAL
The practical syllabus comprises of the exercises formulated based on the topics
mentioned in the Theory syllabus.
BOOKS RECOMMENDED
1. Milo Gibaldi and Donald Perrier, "Pharmacokinetics", Drugs and Pharm. Sci.
Series, VoL 15., Marcel Dekker Inc., N.Y.
2. J.C. Wagner, "Fundamentals of Clinical Pharmacokinetics", Drug Intelligence
Publications, Hamilton, 1975.
3. Bert N. LaDu, "Fundamentals of Drug Metabolism & Disposition", Waverley Press
Inc., Baltimore, 1972.
4. T.Z.Laaky, "Intestinal Absorption & Malabsorption", Raven Press, N.Y., 1975.
5. J.T.Carstensen, "Theory of Pharm. Systems", Vols. 1-3, Academic Press, N.Y.
6. U.S. Beans, A.K.Beckett and J.E.Caraless, “Advances in Pharm.Sci.”, Vol. 1 to 4.
7. J.T.Carstensen, "Drug Stability : Principles and Practices", Drugs and Pharm. Sci.
Series, Vol. 43, Marcel Dekker Inc., N.Y.
8. Lisbeth lliun & Stanley S. Davis : "Polymers in Controlled Drug Delivery",
Wright, Bristol (1987).
9. Pharmaceutics “The Science of Dosage form design” by Aulton.
10. Encyclopedia of Pharmaceutical technology Volumes: 1 to 19.
11. Remingtons Pharmaceutical Sciences 19th edition.
12. Pharmaceutical dissolution testing by Banaker.
13. Pharmacokinetics by Welling and Tse.
14. Modern Pharmaceutics by G.S.Banker
15. Clinical Pharmacokinetics, Concepts and applications, by Rowland and Tozer.
16. Biopharmaceutics and Pharmacokinetics – An introduction by Notari.
17. Techniques of Solubilization of Drugs by Yalkowsky.
18. Applied biopharmaceutics & Pharmacokinetics, Leon shargel
13G : CELLULAR AND MOLECULAR PHARMACOLOGY (CL)
THEORY
1. Molecular structure of biological membrane and transport mechanism across cell
membrane.
2. Factors influencing drug absorption.
3. Drug distribution - protein binding, tissue binding - blood brain, barrier, placental
barrier, Volume of Distribution.
4. Biotransformation of drugs - microsomal, non-microsomal metabolism, factors
influencing, enzyme induction and inhibition, pharmacogenetics.
5. Drug excretion - renal and non renal, factors influencing renal clearance,
biological half life.
6. Pharmacokinetics - single and multiple dose therapy, single and multiply
compartment models, bioavailability
7. Physicochemical basis of drug action including quantitative structure activity
relationship.
8. Theories of drug receptors and drug receptor interactions.
9. Drug antagonism
10. Cellular and molecular basis of drug action.
11. Neurotransmitters and neuropeptides in CNS disorders.
12. Electrophysiotogy of heart - pathophysiology of cardiac disorders
13. Molecular structure and functions of ion channels.
14. Physiology of renal functions - electrolyte metabolism, acid - base equilibrium,
renin angiotensin system.
15. Vitamins.
16. Hematinics.
17. Gene expression and regulation
18. Gene cloning with respect to action of drugs.
19. Pharmacogenomics.
20. Autacoids.
21. Immunopharmacology
PRACTICALS
1. Calculation of PA2, PD2 values using isolated tissue preparations - Rat fundus
strip, rat uterus, guineapig tracheal chain, rabbit aortic strip, I leal preparation,
mammalian heart - etc.
2. Simple Bioavailability studies
3. Exercise in Molecular Pharmacology.
21A: STANDARDIZATION AND STABILIZATION METHODS (QA)
THEORY
1. General methods
i.
WHO guide lines of the standardization of Herbal raw
materials and finished products.
ii.
Morphological, microscopical, cytomorphological and
chemical examinations of raw materials and finished products.
iii.
Determination of Physical and chemical constants such as
extractive values, moisture content, alcohol content, volatile oil content,
ash values, bitterness values, foreign matters, and physical constants
applicable to the lipid containing drugs.
iv.
Microbial counts, bioburden and Pharmacopoeial microbial
assays.
2. Standardization
i.
Standardization of food products. Concepts of nutritional
requirements at different age, sex, and in different conditions like normal,
pregnancy and diseases like diabetes, hypertension and atherosclerosis,
jaundice etc. Different types of additives used and analysis of these
ingredients in ethical and non ethical foods.
ii.
Standardization of cosmetics. Information on ingredients
used in various cosmetics such as creams, powders, lotions, hair products
nail polishes, lipstick, depilatories, toiletries etc. and their analysis.
iii.
Standardization of Herbal products. Physicochemical
characterization in whole form, separation and identification of active
principles, excipients and their estimation by different techniques.
3. Stability
i.
Factors affecting stability of a formulation, ICH guidelines,
Methods of stabilizations and Methods of stability testing. Concept of
development of stability indicating analytical methods.
PRACTICAL
The practical syllabus comprises of the exercises based on the topics mentioned in the
Theory
syllabus.
BOOKS
RECOMMENDED
1.
Food
additiveR.
J.
Taylor
2. Antimicrobial in food- Alfred larry branen. P Michael division publishing
corporation
3.
Method
of
protein
analysis
by
istran
kerese.
4. Cosmetic analysis- selective methods and techniques by P. Borc
5.
Henry,s
cosmeticologyMartin
M.
Rieger.
6.
Cosmaceuticals
Drug
vs
Cosmetics
7.
Herbal
cosmetics.
Beuty
through
HerbsDr.
Urjita
jain.
8. Morris B. Jacobs. The chemical analysis of foods and food products.
9. S. Suzanne Neilson. “ Introduction to chemical analysis of foods.’
10. Jemns T Cartenson. Drug stability- Principles and Practices. 2nd edition, Marsel
deckker.
11.
Applied
Microbiology.
Vinitakale
Kishor
Bhusari.
12. Michael J. Pelezar/ Chan/ Kricg. “ Microbiology. 5th edition,
13. Tortora, Funke, Case.” Microbiology”- An introduction. 8th edition.
14. P.P.Sharma.- Cosmetics Formulation, Manufacturing and Quality control.
15. WHO Guide line for the quality control of herbal plant material.
16. The practical evaluation of phytopharmaceutical by brain & turner
17. Indian herbal pharmacopoea- Vol-I & II
21C/21E : BIOPHARMACEUTICS AND PHARMACOKINETICS (CP, DB)
THEORY
1. Drug Absorption
Relevant anatomy & Physiology of organs involved in drug absorptions; factors
affecting drug absorption following oral, parenteral, topical, Buccal, rectal,
vaginal, urethral and nasal administration of drugs; methods of studying drug
absorption following different routes of administration; kinetics of drug
absorption.
2. Drug Distribution
Distribution in the blood, beyond the blood compartment tissue localization;
volumes of distribution.
3. Drug Biotransformation
Sties of drug biotransformation; kinetics of drug biotransformation, Phase-l and
Phase-II biotransformation reactions; mechanisms of microsomal
oxidation; mechanisms of glucuronide formation; factors affecting
biotransformation; methods of studying biotransformation of drugs; usefulness of
biotransformation study in drug design and dosage forms.
4. Drug Excretion
Excretion in urine, biliary excretion, excretion in expired air, excretion in the
stomach; excretion in the intestine, saliva, breast-milk, genital secretions, sweat.
5. Bioavailability and Bioequivalence Testing
6. Pharmacokinetic Models
Instantaneous distribution models; delay distribution equilibrium models; nonlinear
pharmacokinetic models; pharmacological pharmacokinetic models.
7. Clinical Applications of Pharmacokinetic Parameters
Blood level curves; continuous blood and tissue levels in therapy; dosage
regimensaccumulation during repetitive dosing; adjustment of dosage regimen in
renal failure; distribution dependent dosage adjustment; pharmacokinetic drug
interactions. Applications in TDM and patient care specific drugs and disease
states, effects of age and concomitant drug administration.
8. Pharmacokinetic Basis of Controlled Drug Delivery
9. Statistical treatment of data, test for significance, t-test, analysis of variance
repression analysis, standard deviation, standard error, fiducial limits, hypothesis
testing,randomization etc.
10 Application of computer in clinical research.
PRACTICAL
Practical exercises will be based on theory syllabus
BOOKS RECOMMENDED
1. Modern Pharmaceutics by Banker & Rhodes.
2. Pharmacokinetics, Milo Gibaldi and Donald Perrier
3. Pharmacokinetics and Drug Metabolism by Testa – Jhenner
4. Rowland M. and Tozer T.N. Clinical Pharmacokinetics, Lea & d Febiger, NY.
5. Winter M.E., Basic Clinical Pharmacokinetics, Applied Therapeutics, Inc. San
Fransisco
6. Welling Peter G. and Tse Francis L.S., Pharmacokinetics, Marcel Dekker Inc. N.Y.
7. Wirth N. Systematic Programming – An Introduction Prentice Hall Englewood
Cliff’s New Jersey.
8. S. Bolton – Pharmaceutical Statistics
9. Lectures on Biostatistics by D.Colquhoun
21D: ORGANIC CHEMISTRY-II (PC)
THEORY
1. Study of individual reactions
Allylic rearrangement – Arndt Eister synthesis – Baeyer Villiger reaction BakerVenkatraman reaction - Benzidine rearrangement - Benzilic acid
rearrangement-Carrol reaction-Curtius rearrangement- Dimorth rearrangement Favorskii rearrangement - Lossen-Schmidt rearrangement - Pinner reaction
- Reformatsky reaction - Robinson Annelation reaction - Witting reaction - DielsAlder reaction, Birch reduction, Mannich reaction.
2. Use of diazonium salt-diazomethane and peracids in synthesis
3. Y-lides of phosphorous-sulphur-nitrogen
4. Photochemistry
Theory-energy transfer-characteristics of photoreactions – typical photo reaction
5. Concerted pericyclic reactions
Electrocyclic reaction – sigmatropic rearrangem cycloaddition reactions.
6. Heterocyclic chemistry
Introduction-nomenclature-properties-synthesis and reactions involved in five
membered and six membered heterocycles. Heterocycles with one, two or
more hetero atoms . Biological importance of heterocycles.
PRACTICAL
The practical syllabus comprises of the exercises based on the topics mentioned in the
Theory syllabus.
BOOKS RECOMMENDED
1. J. March , Advanced Organic Chemistry, Reaction Mechanisms and Structure,
(John Wiley and Sons, N.Y).
2. E.S.Gould, Hold Rinchart and Winston,, Mechanisms and structure in Organic
Chemistry, New York.
3. Bernard Miller , Advanced Organic Chemistry, Reaction Mechanisms, 2nd edition,
(Pearson education Ptc. Ltd. Singapore).
4. Thomas Lane & Andreas Plagens, Named Organic Reactions, 2nd edition, (John
Wiley and Sons, N.Y).
5. Maya Shankar singh, Advanced Organic Chemistry, Reaction Mechanisms 1st
edition, (Pearson education Ptc. Ltd. Singapore).
6. Finar Vol-1 & 2, Organic Chemistry.
21F : ADVANCE IN PHARMACEUTICAL TECHNOLOGY (PT)
THEORY
I. Production Management, Production Planning, Fundamentals of production,
organization, economic policy, manufacturing economics, production
capacities,production lines, and job balancing.
II. Consideration for design of large scale manufacturing unit including intricate
design criteria for units to manufacture of sterile and nonsterile products with
special reference to tablets, capsules and injections. As per Schedule M.
III. Design and development of packaging units including recent advances in
packaging techniques for various types of sterile and non sterile dosage
forms.Stability aspects of packaging, regulatory aspects of packaging.
IV. Process automation in Pharmaceutical manufacturing.
V. Pilot plant, scale up technique, introduction to SUPAC guidelines.
VI. A Brief study on formulation and evaluation of specialized pharmaceutical dosage
form Dry syrup, Topical gel,, Microemulsion, dry powder, Parenteral
emulsion and suspension, occuserts, Clear shampoo, hair cream, Face wash,
Sunscreen Lotion, Antiwrinkle cream, Face wash etc
PRACTICAL
The practical syllabus comprises of the exercises formulated bases on the topics
mentioned in the Theory syllabus
BOOKS RECOMMENDED
1. H.A. Libermen & L. Lachman, Pharmaceutical Dosage Forms: Tablets, Vol. I to
III, Marcel Dekker Inc., N.Y.
2. K.E.Avis, Pharmaceutical Dosage Forms: Parental Medication, Vol. I Marcel
Dekker Inc., N.Y.
3. S. Turco and R.E. King, Sterile Dosage Forms, 2nd edition.
4. Pharmaceutics “The Science of Dosage form design” by Aulton.
5. Encyclopedia of Pharmaceutical technology Volumes: 1 to 19.
6. Remingtons Pharmaceutical Sciences 19th edition
21G : ADVANCED SYSTEMIC PHARMACOLOGY (CL)
THEORY
1. Parasympathomimetics.
2. Parasympathetic blocking agents
3. Sympathomimetics.
4. Sympathetic blocking agents
5. Ganglion stimulants and blockers
6. Neuromuscular stimulants and blockers
7. General and local anaesthetics
8. Sedatives and Hypnotics.
9. Antiepileptics.
10. Psychopharmacological agents
11. Analgesics
12. Anti-inflammatory agents
13. Drugs used in Alzeimer's disease
14. Drugs used in Migraine
15. Anti-Parkinson's drugs
16. CNS Stimulants
17. Cardiotonics
18. Anti-Hypertensive drugs
19. Anti-Arrhythmic drugs
20. Drugs used in Ischaemic Heart Disease
21. Drugs used in Atherosclerosis
22. Diuretics
23. Drugs used in Gastro-intestinal disorders
24. Drugs used in Respiratory
disorders
25. Drugs used in Urino-genital disorders
26. Drugs used in Diabetes
27. Drugs used in Endocrine disorders
PRACTICAL
Practicals related to above mentioned syllabus for Paper-II
BOOKS RECOMMENDED
Latest editions of
1. Goodmann & Gilmann’s The Pharmacological basis of therapeutics –
J.G.Hardman & L.E.Limbird
2. Pharmacology by H.P.Rang & M.M.Dale
3. Pharmacology & Pharmacotherapeutics by R.S.Satoskar & S.D.Bhandarkar
4. Essential of Medical Pharmacology, By K D Tripathi
5. Textbook of Pharmacology, By S. D. Seth
6. Principle of Internal Medicine Vol I & II by Braunwald, Harrison et al.
7. Essential of Pharmacotherapeutics By F. S. K. Barar
8. Textbook of Therapeutics, Drug and Disease Management, By Fric T. Herfindal,
Dick R. Gourley
9. Principles of Pharmacology A Tropical Approach, By D T Okpako, M Thomas, M
A Oriowo
10. Medical Pharmacology Principles and Concepts, By Andres Goth and Elliot S
Vessell
11. Pharmacology By Mary J Mycek et al.
12. Principles of Pharmacology Basic Concepts and Clinical Applications By Paul L.
Munson et al.
13. Essential of Pharmacology for Health Occupations by Ruth Woodrow
22A: SPECIAL TECHNIQUES IN DRUG ANALYSIS (QA)
THEORY
1.
Ion Selective Electrodes: Classification, instrumentation and applications
in drug analysis.
2.
Voltametry : Theory and Principles, AC pulse polarography and Square
wave polarography.
3.
Chemiluminescence; Principle, instrumentation and applications.
4.
Electron spin Resonance - Principle, Instrumentation, interpretation of
spectra, applications.
5.
Emission Methods - Spark emission and Plasma emission, instrumentation
and application.
6.
Flow injection Analysis.
7.
Radiochemical Analysis - Instruments used - analytical and screening
instruments, Isotopic dilution, neutron activation, and Positron Emission
Topography (PET).
8.
Photoacoustic spectroscopy; Principle, instrumentation and applications.
9.
Laser: Basic principles, Classification, instrumentation and applications.
10.
Raman Spectroscopy; Principle, Instrumentation & applications,
Interpretation of Raman Spectra.
11.
Electrophoresis. Moving boundary electrophoresis,
zone electrophoresis isotachphoresis isoelectric focousing continuous
electrophoresis (preparative)
12.
Principals and procedure involved in using the following reagents in
pharmaceuticals analysis: - 2, 6 – dichloro qunone chlorimide, 1, 2nappthaquinone –4- sulfate, 2,3,5-triphenyltetrazolium salt, 3- methyl-1, 2benzothiazoline hydrazone hydrochloride (MBTH), Folium ciocalteu reagent, pdimethylamino benzaldehyde/ cinnamaldehyde (PDAB), (PDMAC), ninhydrine
reagent.
13.
X-ray diffraction methods: - Introduction, generation of X- ray,
elementary crystallography, milier indices, X-ray, diffraction Bragg’s low X-ray
power diffraction, X-ray power diffractometer, obtaining and interpretation of Xray power diffraction data.
14.
Thermal method of analysis: - Introduction TCA, DTA, and DSC theory,
instrumentation of thermographs and application.
PRACTICAL
The practical syllabus comprises of the exercises based on the topics mentioned in the
Theory syllabus.
BOOKS RECOMMENDED
1. H.M.Willard, L.L,Meritt, J. A. Dean and F. A. Settle, 'Instrumental methods of
Analysis", CBS Publishers, Delhi.
2. D.A.Skoog & P.M.West, "Principles of Instrumental Analysis".
3. W. Kamp, "Organic Spectroscopy”.
4. G.H.W.Ewing, "Instrumental Methods of Chemical Analysis.
22B: EVALUATION OF HERBAL DRUGS AND FORMULATIONS (CG)
THEORY
1. Development of Ayurvedic and Herbal formulations and their evaluation by
physical methods, chemical methods and microscopical techniques.
2. Application of various chromatographic methods in separation and identification
of marker compounds in the formulations. Fingerprinting techniques and its
importance.
3. Development of analytical techniques for the estimation of markers present in the
Herbal and classical formulations.
4. Evaluation of Herbal drugs and formulations by Biological methods. General
animal models for screening of Herbal drugs and formulations.
5. Toxicological evaluations of herbal drugs and formulations. Methods and
materials for Acute, sub acute and chronic toxicity studies. Teratogenicity,
mutagenicity and carcinogenicity studies. WHO and other regulatory
requirements for toxicological evaluations.
6. WHO and Indian regulatory requirements of Clinical trials for herbal
formulations.
7. Techniques in estimation of enzymes and endogenous substances in body fluids in
physiological and pathological conditions.
8. Schedule T requirements and other regulatory requirements for the manufacturing
of Herbal and Ayurvedic products.
PRACTICAL
Laboratory examination including oral and Practical examination in general course
illustrative of Theory section in the syllabus.
BOOKS RECOMMENDED
1. Biological standardization by J.N.Barn, D.J.Finley and L.G. Good win
2. Indiand pharmacopoea, Indian Herbal Pharmacopoea and other pharmacopoea.
3. Ayurvedic Formulary of India.
4. Screening methods of Pharmacology By Robert turner
5. Evaluation of drug activities by Laurance and Bachrach.
6. Methods in Pharmacology by Arnold Schwartz.
7. Fundamentals of experimental pharmacology by. M. N. Ghosh
8. Text book of invitro Practical pharmacology by Ian Kitchen.
9. Peach - Tracey - Modern Methods of Plant Analysis
10. WHO guide lines for the quality control of Herbal plant materials
11. Wagner, Plant drug analysis.
12. The Practical evaluation of Phytopharmaceuticals by Brain and Turner.
13. Thin layer chromatography by Egon stahl.
14. Drug Discovery & Evaluation by H.Gerhard Vogel
15. Quality Standards of Indian Medicinal Plants Vol-I, ICMR, New Delhi
22C: PATHOPHYSIOLOGY AND PHARMACOTHERAPEUTICS – II (CP)
THEORY
Pharmacotherapeutic management of selected acute and chronic diseases and disorders.
Emphasis is on designing and monitoring of drug therapy to ensure optimum therapeutic
outcomes for following diseases.
1. Cardiovascular
Hypertension, angina pectoris, congestive heart failure, myocardial
infarction,cardiac arrhythmias, atherosclerosis.
2. CNS
Epilepsy, Parkinsonism, schizophrenia, depression, migraine, Alzheimerdisease.
3. Renal
Acute renal failure, chronic renal failure.
4. Respiratory
Chronic Pulmonary obstructive diseases including bronchial asthma.
5. Gastrointestinal
Peptic ulcer disease, ulcerative colitis, hepatitis, cirrhosis.
6. Haemopoetic
Anemias.
7. Joint and Connective Tissue
Rheumatoid arthritis, osteo arthritis, gout and hyperuricemia
8. Endocrine
Endocrinal disorders including Diabetes mellitus, thyroid and parathyroid diseases.
9. Neoplastic
Acute leukemias, Hodgkins disease and carcinoma of breast etc.
10. Infections
Various infectious diseases including Tuberculosis, urinary tract infections, enteric
infections, upper respiratory tract infections, sexually transmitted
diseases and AIDS.
11. Concept of acute care medicine
Managing ICUs, T.P.N. and Emergencies
12. Diseases of skin and eye.
PRACTICAL
1. Hospital based ward rounds and clinical case study.
2. Interaction with patients in community and patient counselling.
BOOKS RECOMMENDED
1 British National Formulary (Current Edition) – BMA/RPSGB
2 Medicines, Ethics & Practice. The Pharmaceutical Press
3 Oxford Text Book of Clinical Pharmacology and Drug Therapy, 3rd edition, GrahamSmith D. and Aronson J., Oxford University Press
4 Hand Book of Pharmacy Health Care. The Pharmaceutical Press
5 Drug Interactions. Stockley I.H. (1996). The Pharmaceutical Press
6 Katzung. B.B., Basic and Clinical Pharmacology. Prentice Hall, International.
7 Harrisons Principles of Internal Medicine. Medical Toxicology (Ellen Horns)
8 Davidson’s Principle and Practice of Medicine, Eds. Christopher R. W., Edwards &
Ian A.D. Boucher ELBS with Cdnorchill Living stone. Edinburgh. Latest
Edition.
9 Oxford Text Book of Medicine, 4th edition, David A. Warrell, Timothy M. Cox, John
D. Firth.
10 CRC desk reference of Clinical Pharmacology, Manuchair Ebadi.
11 Oxford Text Book of Pharmaceutical Medicine, 4th edition, John P. Griffin, John
O’Grady.
12 Principles of Pharmacology, the Pathophysiologic Basis of Drug Therapy,Lippincott,
Williams & Wilkins.
13 Drug Interaction Facts, 2003. David S. Tatro.
14 Emergency Toxicology, 2nd edition. Peter Viccellio.
15 Toxicology - The basic science of poisons, international edition, Curtis D.Klaassen,
6th edition.
16 Toxicology – Principles and Applications, Raymond J.M.Niesink, John de.Vries,
Mannfred A. Hollinger.
17. Clinical Pharmacy and Therapeutics. Roger Walker and Clive Edwards, Churchill
Livingstone Edinburg/ London.
18. Pathology & Therapeutics for Pharmacists. Russel. J. Greene and Normal F.Harris.
Chapman & Hall, London/ Glasgow/ Madras.
19. Text Book of Therapeutics: Drug and Disease Management. 7th Edition. Editors: Eric
T. Herfindal and Dick R. Gourley, Williams and Wilkins, 2000
20. Davidson’s Principles and Practice of Medicine, Eds. Christopher R.W.Edwards and
Lan A.D.Bouchier ELBS with Churchill Livingstone, Edinburgh. Latest
Edition.
21. Applied Therapeutics: The Clinical Use or Drugs Eds. Brian S.Katcher, Lioyd Yee
Young, Marry Anne Koda-Kimble, Applied Therapeutics Inc. Spokane.
Latest Edition.
22. Pathology & Therapeutics for Pharmacists. Greene, R.J & Harris, N.D. (1993). The
Pharmaceutical Press.
23. De Gruchi’s Clinical Haemotology in Medical Practice. Frank Firkin, Bryan Rush,
David Penington, Colin Chesterman. Blactwell Scientific Publication. 5th
edition.
24. Robbins Pathologic Basis of Disease. Cartran, Kumar, Collins, W.B.Saunders. 6th
edition.
25. Textbook of Medical laboratory Technology. Praful B. Godkar, Darshan P.Godkar,
Bhalani Publication House, Mumbai. 2nd edition.
26. Manual of basis techniques for a health laboratory, 2nd edition, World Health
Organization, Geneva
22D : PHARMACEUTICAL CHEMISTRY-I (PC)
THEORY
1. Molecular basis of drug action:
a) Receptor: Drug Receptor Interaction: Basic ligand concept, agonist, antagonist,
partial agonist, inverse agonist, receptor Theories - Occupancy, Rate &
Activation Theories, receptor Binding Assays, determination of B-max and Kd
by transforming data with Hill plot and Scatchered plot., above concepts
with special reference to Opioid, Histaminergic, Adrenergic and GABA nergic
receptors.
b) Enzyme Inhibition – Enzyme structure: primary, secondary, tertiary and
quaternary, enzyme Kinetics, enzyme Inhibitors - reversible, irreversible, Kcat
inhibitors. Transition state analogs, enzyme Inhibitors as drugs - ACE,
leukotrienes, Lipoxygenase, Cycloxygenase, Aromatase, Xanthine oxidase, DNA
PolymeraseInhibitors, HIV - Protease / Reverse Transcriptase, Integrase and
Cytochrome P-450 Inhibitors.
c) Drug binding to nucleic acid -- Antimalarial, anti-cancer, antiviral.
2. Synthon approach:
Definition of terms - disconnection, synthon, functional group interconversion (FGI),
Basic rules in Disconnection, Use of synthon approach in synthesis of following
compounds: Trimethoprim, Terfenadine, lbuprofen, Propanolol, Fentanyl,
Ciprofloxacin, Cimetidine Piroxicam, Rosiglitazone, Diclofenac, Captopryl,
Nifedipine, Losartan.
3. Combinatorial Chemistry
Introduction, combinatorial approaches, chemical Peptide and small molecule
libraries, applications, methodology, combinatorial organic synthesis, assays and
screening of combinatorial libraries, i6ntroduction to High Throughputs Screening
(HTS)
1. Nanochemistry
2. Synthesis of vitamins
3. Microwave synthesis
4. Drugs acting on the Central Nervous System:
Anesthetics agents, Sedative and Hypnotics, Opioid analgesics, NSAID,
Antiparkisonian and Psychopharmacological agents.
5. Drugs acting on the Cardiovascular System:
Antihypertensive agents, Antianginal and Vasodilators, Lipid lowering agents.
6. Chemotherapeutic agents:
Antibacterials, Antivirals, Antifungals, Antineoplastic, Antiprotozoles
7. Insulin and oral hypoglycemic agents
8. Drug Metabolism and concepts in prodrug
PRACTICAL
The practical syllabus comprises of the exercises based on the topics mentioned in the
Theory syllabus.
BOOKS RECOMMENDED
1. Burger: Medicinal Chemistry (John Wiley & Sons N.Y.)
2. Foye: Principles of Medicinal Chemistry (Varghese & Co.)
3. Ledinicer: Organic Drug synthesis Vol. 1,2,3,4 (John Wiley &. Sons N.Y.)
4.
5.
6.
7.
8.
Ariens : Medicinal Chemistry Series.
Ellis and West : Progress in Medicinal Chemistry Series.
Butterworther: Progress in Medicinal Chemistry Series.
Wilson and Gisvold: Text book of Medicinal Chemistry (J.B. Lippincoff cam).
Stuart Warren : Organic Synthesis – The Disconnection Approach (John Wiley &
Sons).
9. Comprehensive Medicinal Chemistry - Series -I-VI (Academic Press).
10. Nanochemistry: A chemical approach to nanomaterials, G Ozin, A. Arsenault,
(RSCPublishing).
11. Microwaves in organic and medicinal Chemistry, C.O. Kappe, A. Stadler, (WileyVch) June 2005
22E/22F : DESIGN & DEVELOPMENT OF NOVEL DELIVERY SYSTEMS (DB,
PT)
THEORY
1.
Theory of controlled release drug delivery systems : Zero order kinetics,
theory of diffusion : Release and diffusion of drug from polymers – mechanism
and kinetics – General methods of design and evaluations of controlled release
products.
2.
Microencapsulation – Methods of encapsulation, kinetics of drug release
from microcapsules, technology and applications.
3.
Transdermal drug delivery systems – Theory, formulation, production and
evaluation.
4.
Implants and Inserts – Types of implants, Osmotic pumps, design and
evaluation methods. Types if Inserts, design and evaluation methods.
5.
Targetted drug delivery systems – concept of drug targeting, importance in
therapeutics; Principals of molecular biology – Cell recognition and signaling –
signal transduction – cell surface receptors – Methods in Drug Targetting.
6.
Liposomes – Structure and stability, composition of liposomes, methods
of preparation, application in drug delivery and drug targeting. Commercial
concepts in liposomes. Neosomes and pharmacosomes – Long circulating
liposomes.
7.
Advanced concepts in the design, development and production of
sustained release products.
8.
Recent innovations in conventional dosage form like tablets, capsules,
sterile dosage forms, pellets, Mucoadhesive system, GRDDS etc.
9.
Introduction of formulation of protein and peptides, supercritical fluid
technique, PEGylation, Biotechnology based pharmaceuticals, taste masking,
particle coating.
PRACTICAL
The practical syllabus comprises of the exercises formulated based on the topics
mentioned in the Theory syllabus.
BOOKS RECOMMENDED
1. Joseph R. Robinson, “Sustained and Controlled Release Drug Delivery Systems”,
Drugs & Pharm. Sci. Series, Vol. 6 Marcel Inc.,N.Y.
2. Yie W. Chien, Novel Drug Delivery Systems, Drugs and Pharm. Sci. Series,
Vol.14, Marcel Dekker Inc.N.Y.
3. J.N.Nixon, Microencapsulation, Drugs and Pharm. Sci. Series, Vol.3, Marcel
Dekker Inc., N.Y.,
4. G. Jolles and R.H. Wooldridge, Drug Design – Fact of Fantasy? Academic Press,
1984
5. J.R.Robinson and Vincent H.L. Lee, Controlled Drug Delivery, Drugs and Pharm.
Sci. Series, Vol. 29, Marcel Dekker Inc. N.y.
6. J.R.Juliano, Drug Delivery Systems Oxford University Press, Oxford, 1980.
7. M.I.Gutcho, Microcapsules and Microencapsulation Techniques, Noyes Data
Corporation, 1976.
8. E.B.Roche, Design of Biopharmaceutical properties through prodrug and analogs,
Am. Pharm. Assoc. Academy of Pharm. Sci. 1977.
9. Lisbeth, llum & Stanley S. Davis. Polymers in controlled drug delivery wright
Bristol (1987)
22G : PHARMACOMETRICS AND EVALUATION OF DRUGS (CL)
THEORY
Screening and evaluation (including modern methods like molecular pharmacology)
Techniques of the following:
1.
Parasympathomimetics
2.
Parasympathetic blocking agents
3.
Sympathomimetics
4.
Sympathetic blocking agents
5.
Ganglion stimulants and blockers
6.
Neuromuscular stimulants and blockers
7.
General and local anaesthetics
8.
Sedatives and Hypnotics
9.
Antiepileptics
10.
Psychopharmacological agents
11.
Analgesics
12.
Anti-inflammatory agents
13.
Drugs used in Alzeimer’s disease
14.
Drugs used in Migraine
15.
Anti-Parkinson’s drugs
16.
CNS Stimulants
17.
Cardiotonics
18.
Anti-Hypertensive drugs
19.
Anti-Arrhythmic drugs
20.
Drugs used in Ischaemic Heart Disease
21.
Drugs used in Atherosclerosis
22.
Diuretics
23.
Drugs used in Gastro-intestinal disorders
24.
Drugs used in Respiratory disorders
25.
Drugs used in Urino-genical disorders
26.
Drugs used in Diabetes
27.
Hormone and Endocrine disorders Concepts of high throughput screening,
cell lines and stem cell research
PRACTICAL
Practical related to above-mentioned syllabus for Paper IV
BOOKS RECOMMENDED
Latest editions of
1) Drug Discovery & Evaluation by H.Gerhard Vogel
2) Pharmacology & Pharmacotherapeutics by Satoskar & Bhandarkar
3) Goodmann & Gilman’s The Pharmacological Basis of Therapeutics –
J.G.Hardman & L.E.Limbird
4) Fundamentals of Experimental Pharmacology by M.N.Ghosh
5) Handbook of Experimental Pharmacology – by S.K.Kulkarni.
23A/23E/23F : VALIDATION AND CGMP (QA, DB, PT)
THEORY
1. Detailed study of the equipments required in the manufacture of different dosage
forms as per schedule M
2. Pharmaceutical factory location: selection, layout, planning, selection of utilities
and process equipments.
3. Pilot plant and scale up technique.
4. Production planning and control.
5. Preparation of manufacturing documents like, MFR, BMR, BPR.
6. Preparation of standard operating procedures (SOPs) regarding production,
engineering and quality systems.
7. GMP- Validation:
Approaches to validation and scope of validation, relationship between validation
& qualification, calibration & verification, validation master plan,
qualifications of utilities and process equipments (protocols & reports for DQ, IQ,
OQ, PQ), validation of manufacturing process for sterile and
non-sterile products (protocols and reports), validation of HVAC systems,
validation of water systems, cleaning validation and validation of
computerized systems.
8. History and various phases of drug development and drug approval, Investigational
New drug (IND), New Drug Application (NDA) (Phase I-IV):
content and format, Abbreviated new drug application (ANDA), Content,
development flow sheet and format.
9. Present status & scope of Pharmaceutical industry in India.
10. Regulatory scenario in India:
Regulatory aspects of pharmaceutical and bulk drug manufacture and drug
analysis, loan license (contract manufacture) auditing, recent amendments to
drugs and cosmetics act, provisions of consumer protection act, environment
protection act.
BOOKS RECOMMENDED
1. Lachman ‘The thory and practice of Industrial pharmacy edition.
2. Remington ‘ Pharmaceutical Science’
3. Bently’s Pharmaceutics
4. Pilot plants model and scale-up methos, by Johnstone and Thring.
5. GMP practices for pharmaceutical- James swarbrick.
6. How to practice GMPs by P.P. Sharma.
7. Chemical Engineering Plant Design by Vibrant.
8. Pharmaceutical Process Validation by Loftus and Nash.
9. Drug and Cosmetic Act 1940.
10. WHO: Technical report series 937: 40th report on specifications for pharmaceutical
preparations.
23B : BIOTECHNOLOGY & CULTIVATION OF MEDICINAL PLANTS (CG)
THEORY
1. Factors affecting plants and their constituents such as hybridization, polyploidy,
mutation, gene selection, allelopathy, chemical races, plant growth
regulators, geographical sources, altitude, rainfall, Ontogenic variations, soil and
soil fertility.
2. Plant insecticides and Pesticides, Biofertilizers and Biopesticides.
3. Recent developments in cultivation of some important medicinal and aromatic
plants such as Senna, Digitalis, Ergot, Isabgol, Glycyrrhiza, Dioscorea,
Mentha, Cardamom, Pinus, Ginger, Musli, Taxas baccata, Ginseng, Guggal,
Artimisia, Cinchona, Hyocyamus, Dubosia, Opium poppy, Jatropa curcus.
4. Plant tissue culture techniques: including types, media, methodology,
micropropagation, hairy root culture, protoplast culture, biotransformation,
immobilization, Role of elicitors, artificial seeds, transgenic plants and
commercial applications.
BOOKS RECOMMENDED:
1. Ramstad - Modem Pharmacognosy.
2. Herskowitz - Principles of Genetics
3. Stricknerger - Genetics
4. Hess - Plant Physiology.
5. William - Genetical Principles and Plant Breeding
6. Kruse - Patterson - Tissue Culture - Methods and Applications.
7. Bartz - Reinhard - Zenk - Plant Tissue Culture and its
8. Biotechnical Applications.
9. John - Dodds - Lorin - Experiments in Plant Tissue Culture.
10. Handa S.S. & Kaul. K.L. Supplement to cultivation & utilization of medicinal
plants.
11. Gamborg, O.L. an Wetter, L.R., Plant Tissue Culture Methods, National Research
Council of Canada, Saskatchewan.
12. HE Street Plant Tissue and Cell Culture, Blackwell Scientific Publication.
13. P.Prave, U.Fause, W. Sittig, and D.A. Sukatsch; Fundamentals of Biotechnology,
VCH Publisher.
14. Alan T Bull, Howard Dalton and Murray Mao-Young, Comprehensive
Biotechnology. The principles, Application & Regulation of Biotechnology in
Industry, Agriculture & Medicine; Vol. 1 to 4
15. Medicinal plants: Alkaloids and Glycosides By Toronto
16. CSIR- Cultivation and Utilization of Medicinal Plants
17. CSIR - Wealth of India, Raw Materials
23C : CLINICAL RESEARCH AND APPROVAL OF NEW DRUGS (CP)
THEORY
1. Clinical Research
(A) Basic concepts and introduction to Clinical Drug Development.
(B) Clinical Trials
Introduction to the fundamentals of the design and analysis of clinical trials.
Ethical considerations intention-to-treat versus efficacy trials, principles of
sampling and exclusion, methods of allocation and techniques of randomization,
parallel versus cross over designs, monitoring treatment outcomes,
adverse effects, stopping rules, data interpretation and logistical issues in the
management of clinical trials. Schedule – Y, DCGI and FDA guidelines for
clinical trials, reviews and approval of a clinical study. GCP, ICMR, ICH , and
WHO guidelines.
2. Approval of New Drugs
Principal of IND submission, format and content of IND, content of investigator
brochure. General consideration of the NDA, specific requirements, content
and format of NDA, manufacturing and control requirements of NDA.
BOOKS RECOMMENDED
1. New Drug Approval Process, Third Edition by Richard A. Guarino, Volume 100,
Marcel Decker Inc.
2. IND and NDA Guidelines of Various Regulatory Authorities
23D : PHARMACEUTICAL CHEMISTRY-II (PC)
THEORY
1. Drug Discovery
Historical perspective, Drug Discovery Strategies in Direct Drug Design (Structure
based) and Indirect drug design, Target selection and lead identification, Natural
product sources, Fermentation / Microbial sources, Synthetic, Introduction to
Pharmacogenomics.
2. QSAR
Parameters - Lipophilicity, electronic, Stearic factors, Quantitative Models –
Hansch analysis, Free Wilson Analysis, Mixed approach, Other QSAR
Approaches, Applications of Hansch Analysis, Free Wilson Analysis.
3. Enzymes, Peptides in Drug Design
4. Molecular Modeling in Drug Design
Introduction to Computer aided drug design and Molecular Modeling: Concepts
and Methods, Molecular Mechanics - force fields (Potential energy
function), Energy Minimization Methods - Steepest, descent. Conjugate gradients,
Newton methods (Non mathematical), Conformational AnalysisSystematic search, Monte Carlo simulations, Molecular dynamics simulations,
Ligand design based on 3D structure of receptor /enzyme
BOOKS RECOMMENDED
1. Hugo Kubingi - QSAR, Hansch Analysis and Related approaches Vol I.
2. Poul Krogsgaand Larsen: A textbook of Drug Design and Development first
Edition.
3. Thomas J. Penim, C.L-Propst - Computer Aided Drug Design.
4. Pandi Veerapandian - Structure Based Drug design.
5. Paul S. Charifson - Practical Applications of Computer Aided Drug Design
(Marcel & Dekkar Inc. New York).
6. Paul Leff-Receptor Based Drug Design.
7. Bernard Testa, Walter Fuhrer – Perspectives in-Medicinal Chemistry.
8. C. Hansch Comprehensive Medicinal Chemistry Vol.-IV
23G : CLINICAL PHARMACOTHERAPEUTICS AND TOXICOLOGY (CL)
THEORY
1.
General principles of toxicology and various preclinical toxicity tests as
per schedule Y
and ICH guidelines.
2.
3.
4.
5.
Clinical trials, GCP, ICH and WHO guidelines.
General principles of chemotherapy.
Sulphonamides – trimethoprim – nitrofurans.
Antibiotics.
6.
Chemotherapy of tuberculosis – leprosy – malaria- amoebiasis –
helminthiasis – viral diseases – fungal diseases – neoplastic diseases.
7.
Introduction to diseases – Patho- physiology, Symptoms and General
principles of
treatments of the following:
Cardiovascular system
Central nervous system
Respiratory system- excretory system
Gastrointestinal system
Endocrine system
Infectious diseases
Immunological disorders
8.
Clinical pharmacy practice. Clinical pharmacology and therapeutics of
above mentioned diseases
9.
Clinical
Pharmacokinetics.
10.
Drug allergies – drug dependence – drug tolerance and drug
interactions.
11.
Management in acute care medicine – role in intense care unit.
Emergencies, total prenatal nutrition.
12.
Heavy metals poisoining and chelating agents.
13.
Adverse drug reactions, Iatrogenic diseases and their importance in
clinical pharmacy.
14.
Radioactive isotopes – Handling of cytotoxic drugs and
radiopharmaceuticals.
15.
Drug and poison information Pharmacy administration
16.
Social pharmacy, development of interpersonal skills, pharmacy practice
and prescription analysis.
BOOKS RECOMMENDED
Latest editions of
1) Clinical Pharmacology by D.R.Lawrence, P.N.Bennatte and M. J. Brown
2) Clinical Pharmacology By James M Ritter et al.Clinical Pharmacology and Drug
Therapy By D G Grahame Smith and J K Aronson
3) Modern Pharmacology with Clinical Application By Charles R. Craies and
Robert E. Stitzal
4) Goodmann & Gilmanns The Pharmacological Basis of Therapeutics
5) Clinical Pharmacy & therapeutics by Roger Walker & Clive Edwards
6) Davidson’s Principle & Practice of Medicine by Christopher Haslett,
E.R.Chilvers, J.A.A.Hunter, N.A.Boon.
7) Professional Guide to Pathophysiology – Lippincott Williams & Wilkins
8) Clinical Pharmacokinetics by Malcolm Rowland, T.N.Tozer
9) Principle of Internal medicine Vol I & II by Harrison.
10) Drug interactions.
11) Pharmacotherapy & Pathophysiology – Dipiro & Josep.
12) Toxicology – Principle & applications – RJM Niesink, J.Devries, M.A.Hollinger
13) Text book of Therapeutics – E.T.Herfindal, D.R.Gourley.
14) Clinical PsycoPharmacology By Jerrodd G. Bermstein
15) Clinical Methods By Michael and Swash
16) Handbook of Antibiotics By Rochard E. Reese, Robert F. Betts and Bera
Gumustop
17) Toxicology Priciples and Applications By Raymond J H et al.
18) Basis of Toxicology Testing Edited by Douald J Ecobichon
19) CRC Handbook of Toxicology edited by Michael J Derelanko et al