Thursday 5 June 2014

With effect from 2010-2011 SYLLABUS FOR PRE-PH.D EXAMINATIONS IN PHARMACEUTICAL SCIENCES Paper – I:

1
With effect from 2010-2011
SYLLABUS FOR PRE-PH.D EXAMINATIONS IN PHARMACEUTICAL SCIENCES
Paper – I:
___________________________________________________________


S.NO Subject Name Subject Code
1 MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES 10PH101
Paper-II (Choose any one subject)
S.NO Subject Name Subject Code
1 ADVANCED PHARMACEUTICAL ANALYSIS 10PH201
2 ADVANCED MEDICINAL CHEMISTRY 10PH202
3 ADVANCES IN PHARMACEUTICS 10PH203
4 PHARMACEUTICAL BIOTECHNLOLOGY 10PH204
5 ADVANCED PHARMACOLOGY 10PH205
6 ADVANCED PHARMACOGNOSY & PHYTOCHEMISTRY 10PH206
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Paper 1
(Paper common for all candidates)
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
Unit I
a. Column Chromatography: Adsorption and partition, theory, preparation, procedure and methods of
detection
b. Thin Layer Chromatography: Theory, preparation, procedures, detection of compounds
c. Paper Chromatography: Theory, different techniques employed, filter papers used, qualitative and
quantitative detection
d. Counter – current extraction, solid phase extraction techniques, gel filtration
Unit II
a. Gas chromatography: Introduction, fundamentals, instrumentation, columns: preparation and operation,
detection, dramatization.
b. HPLC: Principles and instrumentation, solvents and columns used, detection and applications
Unit III
a. UV-Visible spectroscopy: Introduction, electromagnetic spectrum, absorbance laws and limitations,
instrumentation-design and working principle, chromophore concept, auxochromes, Wood-Fisher rules
for calculating absorption maximum, applications of UV-Visible spectroscopy
b. IR spectroscopy: Basic principles-Molecular vibrations, vibrational frequency, factors influencing
vibrational frequencies, sampling techniques, instrumentation, interpretation of spectra, FT-IR, theory
and applications
Unit IV
Mass spectroscopy: Theory, ionization techniques: electron impact ionization, chemical ionization,
field ionization, fast atom bombardment, plasma desorption, fragmentation process: types of fission,
resolution, GC/MS, interpretation of spectra and applications for identification and structure
determination
Unit V
NMR: Theory, instrumentation, chemical shift, shielding and deshielding effects, splitting of signals,
spin-spin coupling, proton exchange reactions, coupling constant(J), nuclear overhauser effect(NOE), 13C NMR
spectra and its applications, 2D-NMR, COSY and applications in pharmacy
TEXT BOOKS
1) Instrumental Methods of Chemical Analysis by B.K Sharma
2) A Text book of Pharmaceutical Analysis by Kerrenth A. Connors
3) Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
REFERENCES :
1) Organic spectroscopy by Y.R Sharma
2) Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
3) Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
4) Organic Chemistry by I. L. Finar
5) Organic spectroscopy by William Kemp
6) Quantitative Analysis of Drugs by D. C. Garrett
7) Spectrophotometric identification of Organic Compounds by Silverstein
8) HPTLC by P.D. Seth
9) Indian Pharmacopoeia 2007
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Paper II
ADVANCED PHARMACEUTICAL ANALYSIS
Unit I
An advanced study of the principles and procedures involved in Non-aqueous, Complexometric,
Oxidation-reduction and Diazotization methods
An advanced study of the principles and procedures involved in the electrometric methods:
Coductometry, Potentiometry, and Polarography and Amperometry
Unit II
Detailed study of the principle and procedures involved in the quantitative determination of the organic
functional groups: Amines, Aldehydes, Ketones, Ester and Hydroxy
Principles and procedures involved in using the following reagents in pharmaceutical analysis with
suitable examples
i. MBTH (3-methyl-2- benzothizolone hydrazone)
ii. F.C. Reagent (Folin-Ciocalteau)
iii. PDAB (Para Dimethyl Amino Benzaldehyde)
iv. 2, 3, 5 – Triphenyl tetrazolium salt
v. 2,6 Dichloroquinone Chlorimide
Unit III
Principles and procedures involved in quantitative determination of various pharmaceutical
preparations and dosage forms of the following:
1. Quinine
2. Penicillin G
3. Vitamin- C
4. Liquorice
5. Progesterone
6. Thiazides
7. BHA
Unit IV
Concepts of Analytical Method Development validation and calibration of various Analytical
Instruments such as UV and visible spectrophotometer, Spectrofluorimenter, HPLC and GC-MS and analytical methods
Unit V
Study of general principles and methods for the determination of Proteins, Carbohydrates, Fats, Crude
fibre, Moisture and Nitrogen
Identification and quantitative determination of preservatives, Antioxidants, Colouring materials,
Emulsifiers and Stabilizers in Pharmaceutical formulation
TEXT BOOKS
1) Pharmaceutical Chemistry by Becket and Stanlake
2) Quantitative Analysis of Drugs in Pharmaceutical Formulations by P.D. Sethi
3) Pharmaceutical Analysis by Higuchi, Bechmman and Hassan
REFERENCES
1) Remington’s Pharmaceutical Sciences by Alfonso and Gennaro
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2) Theory and Practice of Industrial Pharmacy by Lieberman and Lachman
3) Indian Pharmacopoeia 1996, 2007
4) Instrumental Methods of Chemical Analysis By B.K. Sharma
5) A Text Book of Pharmaceutical Analysis by Kerrenth A. Conners
6) Journals (Indian Drugs, IJPS etc.)
7) Quality Assurance of Pharmaceuticals (A compendium of guidelines and selected materials) Vol. I& II (Pharma Book Syndicate, Book Street, Hyderabad)
*****
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ADVANCED MEDICINAL CHEMISTRY
Unit-I Theoretical Aspects of Drug Action
Types of drug action, Physiochemical parameters and pharmacological activity, Non empirical Electronic
parameters, steric parameters and Stereo Chemical aspects of Drugs. Drug Receptors, Receptor types and
isolation, Drug Receptor Interaction, theories of drug action, mechanism of drug action.
Unit-II Targets for the development of following chemotherapeutic agents:
Anti-tubercular, Anti malarial , Anti – fungal, Immuno- modulators, Anti- amoebic drugs.
Targets for the development of following pharmacodynamic agents – Antiulcer, Analgesic – Anti Inflammatory,
Anti atherosclerotic, Anti- Angiogenesis, anti – hypertensives.
Biotransformation of drugs- Prodrug approach, Soft Drug approach, enzymes responsible for biotransformation,
microsomal and non microsomal mechanisms. Factors influencing enzyme induction and inhibition.
Design of Local anesthetics, diuretics, Anti- HIV, anticancer, Introduction, general considerations on the
development of new drugs, classical and rational procedures for the development of local anesthetics
Genesis of New Drugs: Serendipity, Random Screening, Extraction of active principles from Natural Sources,
Molecular Modification of Known Drugs, Selection or Synthesis of Soft Drugs, Drug Latentiation and rational
drug design
Unit-III : Rational Drug Design: QSAR: Parameters involved in QSAR, lipophilicity (Polarisabiltiy, electronic
and steric parameters). Quantitative models. Hansch Analysis, Free Wilson Analysis and their relationships,
linear relationships and applications of Hansch and Free Wilson Analysis.
Molecular Modeling: Introduction, molecular methods, Known receptors, unknown receptors.
Unit-IV : Natural Products as Leads for New Drugs
Introduction/History, approaches to discovery and development of natural
products as potential new drugs, selection and optimization of lead compounds for further developments from
CNS, anticancer antibiotics and cardiovascular drugs.
Unit-V: Structure based drug design : Inhibitors of HIV-I Prokinase, Structural studies of HIV-I
Reverse transcriptase and implications for drug design, Bradykinin receptor Antagonists, Design of purine
nucleoside and Phosphorylase inhibitors, Aldose Reductase Inhibitors, Thrombin inhibitors. Rhinoviral-Capsidbiding
Inhibitors.
TEXT BOOKS
1. William O Foye Medicinal Chemistry
2. Berger’s Medicinal Chemistry and Drug Design. 6th Edition.
3. Richard B. Silvermann, Org. Chemistry of Drug Design and drug Action.
REFERENCE BOOKS
1. Korolkovas Essentials of Medicinal Chemistry
2. Purcell Strategies of Drug Design
3. Alfred Berger Biochemical Basis of Drug Design
4. Corwin , Hansen Comprehensive Medicinal Chemistry
5. Testa B and Jenner P. Drug Metabolism Chemical & Biochemical Aspects, Marcel Dekker
6. Gyorgy Keri & Istdan Toth Molecular Pathomechanism and New Trends in Drug Research, Taylor &
Francis Pub.
7. Ariens. Drug design medicinal chemistry a series of monograph-volume 11- III, academic press, an imprint
of Elsevier pub.
8. Structure based Drug Design by Pandi Veerapandion
*****
6
ADVANCES IN PHARMACEUTICS
Unit-I
Kinetics and drug stability: Stability calculations, rate equation, complex order kinetics, kinetics of
some decompositions, strategy of stability testing, method of stabilization, method of accelerated stability
testing in dosage forms, Freeze Thaw methods, centrifugal methods, temperature and humidity control,
physical stability testing of pharmaceutical products.
Unit-II
1. Bioavailability and bioequivalence studies: Designing of bioavailability and bioequivalence
studies and interpretation of results.
2. Physicochemical properties affecting bioavailability, pH-partition theory, dissolution, surface
area adsorption, complexation, polymorphism and techniques of enhancing dissolution rate.
3. Formulation factors affecting bioavailability of drugs in dosage forms of tablets, capsules,
parenterals, liquid orals and topical dosage forms.
Unit-III
Basic concepts of pharmacokinetics: compartment models: One, two and non-compartmental
approaches to pharmacokinetics. Recent trends, merits and limitations of these approaches.
Application of these models to determine the various pharmacokinetic parameters pertaining to
a. Absorption: (wherever applicable) absorption rate constant, absorption half-life, lag
time and extent of absorption, AUC.
b. Distribution: Apparent volume of distribution and its determination.
c. Metabolism: Metabolic rate constant
d. Elimination: Over all apparent elimination rate constant, and half life.
All the above under the following conditions:
1. Intravenous bolus injection
2. Intravenous infusion
3. Single dose oral administration
4. Multiple dose injections
5. Multiple dosage oral administration
e. Noninvasive methods of estimating pharmacokinetics parameters with emphasis on
salivary and urinary compartments
f. Concept of clearance: organ, total clearance, hepatic clearance, lung clearance and renal
clearance.
Unit-IV
1. Fundamentals of controlled drug delivery systems, use of polymers in controlled drug
delivery, pharmacokinetic and pharmacodynamic basis of controlled drug delivery. Design,
fabrication, evaluation and applications of the following controlled releasing systems
(a) Controlled release oral drug delivery systems
(b) Parenteral controlled release drug delivery systems
(c) Implantable therapeutic systems
(d) Transdermal delivery systems including iontophoresis
(e) Ocular and intrauterine delivery systems
(f) Bioadhesive drug delivery systems
(g) Proteins and peptide drug delivery
Unit-V
Biochemical and molecular biology approaches to controlled drug delivery of
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1. Micro particulate drug carriers: Liposomes, Niosomes, Microspheres,
Nanoparticle and Resealed erythrocytes.
2. Monoclonal antibodies
3. Drug targeting to particular organs:
(a) Problems of drug delivery to the brain and targeting to brain
(b) Drug targeting in neoplastic diseases
TEXT BOOKS
1. Physical Pharmacy by Alfred Martin.
2. Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi.
3. Controlled and Novel drug delivery systems by N. K. Jain.
REFERENCE BOOKS
1. Novel Drug Delivery System by Yie W. Chien.
2. Controlled Drug Deliver by Joseph R. Robinson and Vincent H. L. Lee.
3. Targeted and Controlled Drug Delivery (Novel carrier systems) by S. P. Vyas and Khar.
4. Modern Pharmaceutics by Gilbert S. Banker and Christopher T. Rhodes.
5. Controlled Drug Deliver by N.K Jain.
6. Biopharmaceutics and Clinical pharmacy by Robert E. Notari.
7. Biopharmaceutics and Clinical Pharmacokinetics - An Introduction by Robert E. Notari.
8. Bio-Pharmaceutics and Pharmacokinetics by D.M. Brah.
9. Pharmaceutical Dosage forms by Howard. C. Ansel.
10. Practical Physical Pharmacy (Vol-I and Vol-II) by Gaud and Gupta.
11. Cooper and Gunn`s Tutorial Pharmacy by S.J Carter.
12. Cooper and Gunn`s Dispensing for Pharmaceutical Students by S.J. Carter.
*****
8
PHARMACEUTICAL BIOTECHNLOLOGY
Unit I
An Introduction process: the range of fermentation process, microbial biomass, microbial enzymes,
microbial metabolites, recombinant products, transformation process.
Microbial growth kinetics: Batch cultures, continuous cultures, fed batch cultures, continuous with
recycle culture, cascade cultures. The Isolation of industrially important micro organisms, preservation
of industrially important micro organisms & improvement of industrially important micro organisms.
Unit II
Media for industrial fermentation: Introduction, types of media. Media formulation: water, carbon
source, Energy source, Nitrogen source, minerals, buffers, Precursors, Inhibitors, Inducers, Antifoams,
oxygen requirements. Media optimization techniques with special emphasize on statistical techniques,
placket-Burman design, response surface methodology.
Sterilization: Introduction, Medium sterilization, the design of batch sterilization process, the design of
continuous sterilization process, sterilization of fermented, sterilization of the feed, sterilization of
liquid wastes and filter sterilization.
Unit III
The development of inocula of Industrial fermentations: Introduction, criteria for the transfer of
inoculum, the development of inocula for yeast process, the development of inocula for bacterial
process, the development of inocula for mycelia process, the development of inocula for vegetative
fungi. The Aseptic inoculation of plant fermented.
Unit IV
Design of a Fermented: Introduction, basic function of fermenter for microbial & Animal cell culture,
Aseptic operation & contaminant, overall contaminant categorization, Body construction, Aeration &
Agitation, the agitators, baffles, the achievement & maintenance of aseptic condition, valves & steam
traps. And other fermentation vessels.
Unit V
Applications of fermentation technology-I: Alcohol (Methanol, Butanol, Ethanol etc), Acids (citric
acid, Acetic acid, Gluconic acid etc), Solvents (glycerol, Acetone, Butanol etc).
Applications of fermentation technology-II: Antibiotics (penicillin, Streptomycin, tetracycline)
Amino acids (lysine, Glutamic acid), Single Cell Protein, Mineral beneficiation & Oil recovery.
TEXT BOOKS
1. Principles of fermentation technology by Peter F Stanbury, Allan Whitaker and Stephen J Hall,
pergamon Publications.
2. Introduction to Biochemical Engineering by Dr. D.G. Rao, the Mc Graw Hill companies.
9
ADVANCED PHARMACOLOGY
Unit-I
Drugs acting at Synaptic and neuro effector junctional sites.
A. Autonomic & Somatic nervous systems.
B. Muscarinic receptor agonists & antagonists.
C. Anticholinesterases.
D. Agents acting at Neuro Muscular Junction and autonomic ganglia.
E. Sympathomimetic drugs, Catecholamines and Adrenergic antagonists.
Unit-II
Drugs acting on the Central Nervous System.
a. Neurotransmission and CNS.
b. Drugs used in the treatment of
1. Anxiety & Psychosis
2. Depression & Mania
3. Epilepsy
4. Migraine
5. CNS degenerative disorders
6. Parkinson’s Disease
Unit-III
Drugs affecting renal and cardiovascular function.
Diuretics
Renin & Angiotensin
Drugs used in the treatment of
1. Myocardial Ischemia
2. Hypertension
3. CHF
4. Hyperlipidemia
Anticoagulants, Thrombolytics & antiplatelet drugs.
Unit IV
Autacoids : Drugs therapy of Inflammation.
A. Histamine, Bradykinin & their antagonists
B. Eicosanoids & PAF (Platelet Activating Factors)
C. Anti-inflammatory, analgesic & antipyretic agents.
D. Antiasthamatic agents.
Unit V
A. Bioassays: Basic principles of Biological standardization: Methods used in the bio-assay of Rabbis Vaccine , Oxytocin , Test for pyrogens, Test for undue toxicity
B. Toxicity tests:OECD guidelines. Determination of LD50, Acute, subacute and chronic toxicity studies.
C. Organization of screening for the Pharmacological activity of new substances with emphasis on the evaluation of psychopharmacological,anti-inflammatory, analgesic, anti diabetic, hepatoprotective, nootropic and anti cancer activities.
TEXT BOOKS:
1. Pharmacology by H.P Rang M.M, Dale, J.M.Ritter & P.K.Moore
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2. The Pharmacological basis of therapeutics by Joel G.Hardman. Lee E Limbird and Alfred Goodman Gilman
3. Screening methods in Pharmacology, Vol.-1&2 by Robert .A. Turner and Peter Hebborn.
REFERENCE BOOKS.
1. Pharmacology and Pharmacotherapeutics by R.S Satoskar, S.D Bhandarkar and S.S Ainapure.
2. Essentials of Medical Pharmacology by K.D.Tripathi
3. Drug discovery and evaluation by H.G.Vogel and W.H.Vogel, Springerverlag, Berlin Heideleberg.
4. Handbook of experimental pharmacology by S.K. Kulkarni, Vallabh Prakashan, Delhi.
5. Textbook of clinical trials edited by David Machin, Simon Day and Sylvan green.
6. Principles of clinical research edited by Giovanna di ignazio, Di Giovanna and Haynes
11
ADVANCED PHARMACOGNOSY & PHYTOCHEMISTRY
Unit I
Plant drug cultivation:
a) General aspects involved in the cultivation of medicinal plants: Conservation of medicinal
plants, ex-situ and in-situ cultivation, biodiversity law, WTO & TRIPS agreement.
b) Factor involved in production of crude drug.
i) Exogenous
ii) Edaphic factors
iii) Mineral supplements
iv) Nutrients
v) Growth regulators and inhibitors
Unit II
c) Pest & weed control: study of pesticides and weedicides with special importance to natural
pesticides & weedicides
d) Disease management of medicinal and aromatic plants
e) Profiles for commercial cultivation technology & post harvest care of following medicinal plant-
Ashwagandha, Periwinkle, medicinal yams, Guggul, Senns, Isapgol, Sterodi bearing Solanum,
Digitalis.
f) Technology for Commercial scale cultivation & processing of following aromatic plants-Lemon
grass, Geranium, Basil, Vetier, Patchouli, Celery and Davana.
Unit III
Detailed phytochemical study of following class of phytoconstituents, including important drugs. 7
Hours
a) Phospholipids
b) Terpenes and terpenoids
c) Resins and related compounds
d) Plant phenols
e) Alkaloids
f) Glycosides
g) Steroids
• Study of information retrieval methods of natural plants and herbal databases. Screening and
review of literature for the following:
1. Anti-hepatotoxics
2. Anti-fertility agents
3 Anti-microbials & Anti-Virals
4. Anti-cancer agents
5. Hypolipidaemics
6. Anti-obesity agents
7. Anti-diabetics
8. Antiallergics
9. Adaptogenics
10. Immunomodulators
11. Cardio-vascular agents.
Unit IV
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Chemotaxonomy:
a) Definition, significance, types
b) Chemotaxonomic significance of flavanoids and alkaloids.
• Biosynthetic studies on the following:
a) Shikimic acid patway – Atropine and Morphine
b) Acetate pathway – Cardiac glycosides and Anthraquinone glycosides
Unit V
Structural elucidation of important phytoconstituents belonging to deffernt groups.
a) Alkaloids – Nicotine, Atropine, Morphine, Caffeine.
b) Glycosides – Amygdalin, strophanthidin.
c) Steroids – Cholesterol
d) Terpenes - Citral
• Marine Pharmacognosy
a) Definition, present status, classification of important bioactive agents.
b) General methods of isolation and purification.
c) Study of important bioactive agents including chemistry& uses.
• Complementary Alternative medicines including ethnomedicine
Definition, principles and applications.
Recent advances in phytochemical research
TEXT BOOKS
1.Text Book of Pharmacognosy by Trease & Evans
2. Text Book of Pharmacognosy by Titler, Brady & Robber
3. Pytochemical methods by J.B.Haroborne

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