Code (Common subject) R102201 Code R102253 R102254 R102255

PHARMACY [SPECILISATION CODE: 22]

Sl. No. Paper – I

(Common subject) Code

1 Modern Pharmaceutical Analytical Techniques R102201

Sl. No. Paper – II

(Choose any one subject) Code

1 Biopharmaceutics and Pharmacokinetics R102251 2 Advances in Pharmaceutical Technology R102252 3 Advanced Physical Pharmaceutics R102253 4 Screening Methods and Clinical Research R102254 5 Advanced Pharmacology R102255 6 Clinical Pharmacology and Pharmacotherapeutics R102256 7 Advanced Pharmacognosy & Phytochemistry. R102257 8 Industrial Pharmacognosy R102258 9 Advanced Pharmaceutical Organic Chemistry R102259 10 Advanced Medicinal Chemistry R102260 11 Advanced Pharmaceutical Analysis R102261 12 Analytical Method Development and Validation R102262 13 Fermentation Technology R102263 14 Enzyme Engineering & Technology R102264

To select from the above list paper-I is Compulsory and Paper-II is elective related to your Research Area

Subject Code R102201

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 REFERENCES :

1) Instrumental Methods of Chemical Analysis by B.K Sharma 2) Organic spectroscopy by Y.R Sharma 3) A Text book of Pharmaceutical Analysis by Kerrenth A. Connors 4) Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel 5) Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake

6) Organic Chemistry by I. L. Finar 7) Organic spectroscopy by William Kemp 8) Quantitative Analysis of Drugs by D. C. Garrett 9) Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi 10) Spectrophotometric identification of Organic Compounds by Silverstein 11) HPTLC by P.D. Seth 12) Indian Pharmacopoeia 2007


BIOPHARMACEUTICS AND PHARMACOKINETICS Unit-I

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-II

4. 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-III 5. Non-linear pharmacokinetics: Concepts of linear and non-liner

pharmacokinetics, Michaelis-Menton Kinetics characteristics. Basic Kinetic parameters, possible causes of non-induction, non-linear binding, and non-linearity of pharmacological responses.

6. Clinical Pharmacokinetics: Altered kinetics in pregnancy, child birth, infants and geriatrics. Kinetics in GI disease, malabsorption syndrome, liver, cardiac, renal and pulmonary disease states.

Unit-IV

7. Time dependent pharmacokinetics: Introduction, classification, physiologically induced time dependency: Chronopharmacokinetics, chemically induced dependency.

8. Drug metabolism: Site of metabolism, factors affecting drug metabolism (genetic, species and environmental).

Unit-V

9. Drug Interactions: Kinetics of drug interaction, study of drug-drug interaction mediated through absorption, distribution, metabolism and elimination, mechanisms of interaction and consequence. Influence of alcohol, smoking, food and beverages on drug action.

Text Books 1. Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi. 2. Biopharmaceutics and Clinical pharmacy by Robert E. Notari. 3. Biopharmaceutics and Clinical Pharmacokinetics - An Introduction by Robert E. Notari. Recommended Books 1. Bio-Pharmaceutics and Pharmacokinetics by D.M. Brahmankar and Sunil B. Jaiswal. 2. Bio-Pharmaceutics and Pharmacokinetics by V.Venkateshwarlu. 3. Text Book of Biopharmaceutics by R. H. Shobharani.


ADVANCES IN PHARMACEUTICAL TECHNOLOGY

Unit-1 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

Unit-2 (a) Transdermal delivery systems including iontophoresis (b) Ocular and intrauterine delivery systems (c) Bioadhesive drug delivery systems

(d) Proteins and peptide drug delivery Unit-3

Biochemical and molecular biology approaches to controlled drug delivery of 1. Micro particulate drug carriers: Liposomes, Niosomes,

Microspheres, Nanoparticle and Resealed erythrocytes. 2. Monoclonal antibodies

Unit-4

Drug targeting to particular organs: (a) Drug delivery to respiratory systems (b) Problems of drug delivery to the brain and targeting to brain (c) Drug delivery to eye (d) Drug targeting in neoplastic diseases

Unit-5 Drug carrier systems targeted to widely dispersed cells

a) Delivery to Macrophages b) Delivery to lymphoid cells of immune network c) Delivery to lysosomal storage diseases

Text Books 1. Novel Drug Delivery System by Yie W. Chien. 2. Controlled Drug Deliver by Joseph R. Robinson and Vincent H. L. Lee. 3. Controlled and Novel drug delivery systems by N. K. Jain. 4. Targeted and Controlled Drug Delivery (Novel carrier systems) by S. P. Vyas and Khar. 5. Modern Pharmaceutics by Gilbert S. Banker and Christopher T. Rhodes.

6. Controlled Drug Deliver by N.K Jain.


ADVANCED PHYSICAL PHARMACEUTICS Unit-I

1. Particle science and powder technology: Crystal structure, amorphous state polymorphism, particle size distribution, particle size analysis methods, solid dispersions/ solid solutions.

2. Physics of tablet compression: Compression and consolidation, strength of granules, compression and consolidation under high loads, effect of friction, distribution of forces in compaction, force volume relationships, Heckel plots, compaction profiles, energy involved in compaction, strength of tablet, crushing strength, friability, lamination, instrumentation of tablet machines.

Unit-II

3. 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-III

4. Theories on stability of disperse systems: Adsorption, wetting, crystal growth mechanisms, physical stability of suspensions and emulsions, stability testing of emulsions and suspensions and release of drugs from suspension and emulsion formulations. Biopharmaceutical aspects of disperse systems.

5. Rheology: Theoretical consideration, instrumentation, rheological properties of disperse systems and semisolids.

Unit-IV

6. Dissolution and solubility: Solubility and solubilization of nonelectrolytes, solubilization by the use of surfactants, cosolvents, complexation, drug derivatisation and solid state manipulation, dissolution rates of solids in liquids, measurement of dissolution rates.

Unit-V

7. Polymer science: Properties of polymers, phase separation, polymers in solid state and application of polymers in pharmaceutical formulations.

Text Books 1. Physical Pharmacy by Alfred Martin. 2. Pharmaceutical Dosage forms by Howard. C. Ansel. Recommended Books: 1. Practical Physical Pharmacy (Vol-I and Vol-II) by Gaud and Gupta. 2. Cooper and Gunn`s Tutorial Pharmacy by S.J Carter. 3. Cooper and Gunn`s Dispensing for Pharmaceutical Students by S.J. Carter.


SCREENING METHODS AND CLINICAL RESEARCH

Unit I Care Handling and breeding techniques of laboratory animals, Regulations for laboratory animals, CPCSEA guidelines, alternatives to animal studies. Good laboratory Practices.

Unit II Bioassays: Basic principles of Biological standardization: Methods used in the bio-assay of Rabbis Vaccine , Oxytocin , Tetanus Antitoxin and Diphtheria Vaccine . Test for pyrogens. Unit III Toxicity tests:OECD guidelines. Determination of LD50, Acute, subacute and chronic toxicity studies. Unit IV Organization of screening for the Pharmacological activity of new substances with emphasis on the evaluation cardiac, psychopharmacological,anti-inflammatory, analgesic and anti diabetic. Unit V Clinical evaluation of new drugs, Phases of clinical trial, protocol design, Ethics in human research. Text Books: 1. Screening methods in Pharmacology, Vol.-1&2 by Robert .A. Turner and Peter Hebborn. 2. Drug discovery and evaluation by H.G.Vogel and W.H.Vogel, Springerverlag, Berlin Heideleberg. 3. Handbook of experimental pharmacology by S.K. Kulkarni, Vallabh Prakashan, Delhi. 4. Textbook of clinical trials edited by David Machin, Simon Day and Sylvan green. 5. Principles of clinical research edited by Giovanna di ignazio, Di Giovanna and Haynes Reference Books. 1. ICH of technical requirements for registration of pharmaceuticals for human use, ICH harmonized Tripartite guidelines - Guidelines for good clinical practice, E6, May 1996. 2. Good clinical practice - Guidelines for Clinical trails on pharmaceutical products in India, Central drug standard control organization, New Delhi, Minister of Health- 2001.


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 7. Pain

c. Drug addiction,dependence and abuse. Unit-III Drugs affecting renal and cardiovascular function.

d. Diuretics e. Renin & Angiotensin f. Drugs used in the treatment of

1. Myocardial Ischemia 2. Hypertension 3. CHF 4. Hyperlipidemia

Drugs acting on the blood & blood forming organs. g. Growth factors h. Anticoagulants, Thrombolytics & antiplatelet drugs.

Dermatological pharmacology,Vitamins & Chelating agents 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 Drugs affecting gastro intestinal function. A.Agents for control of acidity and antiulcer drugs. B.Emetics & anti emetics.

Chemotherapy of A.Malaria B.Microbial infections

(i) Fluoroquinolones (ii) Cephalosporins and others newer agents. (iii) Antifungal & antiviral drugs including anti HIV drugs.

C.Neoplastic diseases D.Immunomodulators

Insulin,Oral hypoglycemic agents, Thyroid and Anti-Thyroid agents Estrogens, Progestins and Androgens


CLINICAL PHARMACOLOGY & PHARMACOTHERAPEUTICS

Unit-I Principles of Pharacokinetics

A. Revision of basic concepts. B. Clinical Pharmacokinetics.

i) Dose – response in man ii) Influence of renal and hepatic disease on Pharmacokinetics iii) Therapeutics drug monitoring iv) Population Pharmacokinetics.

Unit-II Adverse Drug Reactions, Drug Interactions and ADR monitoring.

Unit-III

Pathophysiology and drug therapy of the following disorders.

Schizophrenia, anxiety, depression, epilepsy, Parkinson’s, alzheimer’s diseases, migraine, hypertension, angina pectoris, arrhythmias, atherosclerosis, myocardial infaraction, TB, leprosy, leukemia, solid tumors, lymphomas, psoriasis, respiratory, urinary, g.i. tract infections, endocarditis, fungal and HIV infection, rheumatoid arthritis, glaucoma, menstrual disorders, menopause.

Unit-IV Drug therapy in

A. Geriatrics B. Pediatrics C. Pregnancy & Lactation.

Unit-V

Pharmacogenetics : Inter-racial and individual variability in drugs metabolism.


ADVANCED PHARMACOGNOSY & PHYTOCHEMISTRY

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

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.

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.

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

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


INDUSTRIAL PHRAMACOGNOSY

General methods of isolation, purification, identification and estimation of phytoconstituents.

Isolation and estimation of phytopharmaceuticals: a) Acorus calamus-Asarone b) Aloe barbadensis –Aloin & Aloesin c) Adhatoda vasica-vasicine d) Andrographis paniculata- Andrographolides e) Bacopa monnieri-Bacosides f) Berberis aristata-Berberine g) Curcuma longa-Curcumin h) Garcinia cambogia-L-Hydroxy citric acid i) Glycyrrhiza glabra-Glycyrrhizinic acid & its other derivatives j) Gymnema sylvestre-Gymnemic acid k) Mucuna pruriuens –L-Dopa l) Phyllanthus amarus-Phyllanthin m) Piper ringrum/longum – Piperine n) Picrorhiza kurroa- Kutkin o) Polygal senga/ tennuifolia/ chinensis- Totall Triterpenoid Saponins p) Psoralea corylifolia- Psoralin q) Tinospora cordifolia- Cordifolioside r) Tribulus terestris – Total saponins s) Valeriana wallichii- Valepotriates t) Withania somnifera- Withanolides u) Zingiber officinale- Gingerol v) Coleus forskoli- Forskolin. w) Commiphora mukul- guggulsterone x) Trigonella foenum- Saponins Commerce and quality control of drugs: a) Indian and International trade in medicinal and aromatic plants b) Quality control methods for medicinal plant materials.

i) Factors affecting herb quality ii) Development of standardization parameters according to

WHO guidelines for assessment of crude drugs: - Evaluation of identity. purity and quality of crude drugs. - Determination of pesticide residue. - Determination of arsenic and heavy metals. - Determination of micro-organisms.

iii) Pharmacopoeial studies: Study of Herbal Pharmacopoeia and Compendiae; Indian Pharmacopoeia, Ayurvedic Pharmacopoeia, Chinese Pharmacopoeia & United States Pharmacopoeia for Herbal monographs.

Herbal based industries: Types, forms, scope and applications

a) Study of infrastructure for different types of industries involved in making standardized extracts and various dosage forms including traditional ayurvedic dosage forms and modem dosage forms.

b) Research: Needs, areas and current on going research. Application of pharmacy concepts, analytical methods and clinical evaluation techniques.

c) Quality assurance in Herbal Drug Industry Concept ofTQM., GMP, GLP, ISO-9000 and HACCP in Traditional System of Medicine.

Patents :

a. Indian and International' patent laws, proposed amendments as applicable to herbal/natural products and processes; important points to be kept in mind while drafting and filing a patent.

b. Plant breeders rights Study of Herbal Extracts

Processing, Equipment and analytical profiles of extracts of drugs listed in Sec(2) of the courses content.

Study of Herbal formulation and their standardization: a. Study of traditional formulations as per Ayurvedic Formulary of India and few

dosage forms (modem) in market b. Shelflife study, protocols to study stabilization of herbal based products.

Approaches for both physical. physico-chemical and chemical parameters of assessment at different stages, interpretation of data and its limitations

Herbal Cosmetics: a. Raw materials of herbal origin used in cosmetics: Oil, Waxes, Gums, Hydrop

perfumes, proective agents, bleaching Agents, preservatives, Anti Oxidation Agents.

b. Formulation aspects incorporating herbal extracts in various preparations, deodorants, Anti-perspirants, Hair care preparations.

c. Detailed methods of preparation of new representative preparations & star categories

TEXT BOOKS; 1. Herbal Drug Industry by R.D. Choudhary, 1st edition, Eastern Publisher, New Delhi 2. Trease and Evans Pharmacognosy by W C Evans, 15th Edition W.B Saunders E REFERENCE BOOKS: 1. Quality Control of Herbal Drugs by Pulok K. Mukkhargee, 1st Edition, Business

Horizons Pharmaceutical Publisher, New Delhi, 2002 2. Indian Hearbal Pharmacopoeia, vol. 1 & 2, RRL, IDMA, 1998, 2000 3. Standardization of Botanicals by V.Rajpal, Vol.1, Eastern Publisher, New Delhi 4. PDR for Herbal Medicines, 2nd edition, medicinal economic company, New Jersey,

2000


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-Capsid-biding Inhibitors. Recommended Books 1. Richard B. Silvermann, Org. Chemistry of Drug Design and drug Action. 2. Berger’s Medicinal Chemistry and Drug Design. 6th Edition.

3. Korolkovas Essentials of Medicinal Chemistry 4. Purcell Strategies of Drug Design 5. Alfred Berger Biochemical Basis of Drug Design 6. Corwin , Hansen Comprehensive Medicinal Chemistry 7. William O Foye Medicinal Chemistry 8. Testa B and Jenner P. Drug Metabolism Chemical & Biochemical Aspects, Marcel

Dekker 9. Gyorgy Keri & Istdan Toth Molecular Pathomechanism and New Trends in Drug

Research, Taylor & Francis Pub. 10. Ariens. Drug design medicinal chemistry a series of monograph-volume 11- III,

academic press, an imprint of Elsevier pub. 11. Structure based Drug Design by Pandi Veerapandion


ADVANCED PHARMACEUTICAL ORGANIC CHEMISTRY Unit I. Stereochemistry: Elements of symmetry, simple axis of symmetry . Notation, relative configuration and absolute configuration .Compounds with a chiral carbon atom, compounds with other quadrivalent chiral atoms. Optical isomerism in compounds containing no chiral atom, biphenyl, allenes, compounds with exocylic double bonds and spirans. Chirality due to helical shape.. Cis / Trans, E – Z isomerism resulting from double bonds, monocyclic compounds, fused ring system. Racemic modifications and methods for resolution of racemic mixtures. Asymmetric synthesis and stereo – selective synthesis. Unit-II: a. Reactive Intermediates: Definitions, generation, stability, structure and reactivity of

free radicals carbocations, carbanions, carbenes, Nitrenes/Nitrenium ions. b. . Concepts of aromaticity and anti aromaticity, non benzenoid aromatic compounds.

Mechanisms of organic reactions: Free radical, Electrophilic, Nucleophilic reactions of aliphatic and aromatic compounds

Elimination Reactions: E1, E2, E1CB and E2CB mechanisms, Mechanisms and orientation in Pyrolytic eliminations, effect of substrate structure, Attacking base, leaving group and reaction bond, medium and reactivity addition to carbon – carbon multiple bond reactions. Mechanisms, Orientation and reactivity.

Unit-III: Electrocyclic, pericyclic and sigmotropic reactions: introduction, terminology and mechanism with suitable examples. Unit-IV Synthetic Reagents & Applications: Lead Tetra Acetate (LTA), N- Bromosuccinimide (NBS), Osmium Tetroxide, Lithium Aluminum Hydride (LAH) and Sodium Borohydride. Unit Process in Organic Synthesis: Catalytic hydrogenation, Nitration, Sulphonation, Halogenation, Amination, Acetylation, Esterification and Hydrolysis. a. Scale Up Techniques for process optimization, Maximization of productivity, in –

process control techniques with examples. b. Molecular Rearrangements & their applications: Carbon to Carbon Migration: Wagner – Meerwin rearrangement, Claisen

rearrangement and benzil – benzilic acid rearrangement. Carbon to Nitrogen Migration: Hoffmann rearrangement, Curtius rearrangement

and Lossen rearrangement, Beckman rearrangement. Carbon to Oxygen Migration: Bayor – Villiger rearrangement, Rearrangement of

hydro peroxides and Wittig rearrangement. Unit-V

Synthetic Strategies : Introduction, target selection , retro synthesis , various strategic approaches, criteria or a disconnection of strategic bonds, strategic bonds in rings, degradation techniques for retro synthesis. Combinatorial Chemistry – Parallel Synthesis, real combinatorial chemistry and deconvolution methods. Recommended Books

1. Francis A. Carey & Richard J. Sunberg, Advanced Org. Chemistry , III rd Edition , Par B; Reactions and synthesis , Plenum Press, new York , London , Latest Edition.

2. Eliel I. Ernest and Samuel h, Stereochemistry of Org. Compounds, John Wiley and sons, New York, 2003 Edition.

3. Roland E. Lehr & Alan P Marchard, Orbital Symmetry: A Problem solving approach, Academic Press, New York Latest Edition.

4. J. March , Advanced Org. Chemistry , Reactions Mechanisms and Structure , 4th Edition, John Wiley & Sons , New York Latest Edition

5. I. L. Finar , Organic Chemistry , ELBS 6. Herbert O. Modern Synthesis Reactions IInd Edition W.A. Beenamis Inc. Menco

Park California 7. W. Carruthers, Some Modern Methods of Org. Synthesis, III rd Edition,

Cambridge University Press, Cambridge. 8. Groggins, Unit process in Org. Synthesis, McGraw Hill Book Crop. 9. S. Warren, Org. Synthesis. The Disconnection Approach, J. Wiley & Sons. NY 10. Gorgy Keri and Istarian Toth , Molecular Patho-mechanisms and New Trends in

Drug Research – Taylor and Francis Group ,London 2003 11. R.K. Mackie , A Guidebook to Organic Thesis – Prentice Hall 12. T.W. Greene and PGM Warts ,Protecting Groups – John Willey 13. Michael B. Smith , Organic Synthesis


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 An advanced study of the principles and procedures involved in the instrumental methods of Flamephotometry, Fluorimetryc , Nephelo-Turbidimetry, and Refractometry 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 REFERENCES 1) Remington’s Pharmaceutical Sciences by Alfonso and Gennaro 2) Pharmaceutical Chemistry by Becket and Stanlake 3) Quantitative Analysis of Drugs in Pharmaceutical Formulations by P.D. Sethi 4) Pharmaceutical Analysis by Higuchi, Bechmman and Hassan

5) Theory and Practice of Industrial Pharmacy by Lieberman and Lachman 6) Indian Pharmacopoeia 1996, 2007 7) Instrumental Methods of Chemical Analysis By B.K. Sharma 8) A Text Book of Pharmaceutical Analysis by Kerrenth A. Conners 9) Journals (Indian Drugs, IJPS etc.) 10) Quality Assurance of Pharmaceuticals (A compendium of guidelines and selected

materials) Vol. I & II (Pharma Book Syndicate, Book Street, Hyderabad)


ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Unit I Concepts of Analytical Method Development validation and calibration of various Analytical Instruments such as UV and visible spectrophotometer, Spectrofluorimenter, HPLC and GC-MS Unit II Validation of

a. Air-handling equipment and facilities in zone b. Water supply systems: de-ionized, distilled water and water for injection

Unit III

Validation of Analytical Procedures, Analyst, Water Supplies and Animal House Unit IV

New Drug Development and Approval Process: Investigational New Drugs (IND), New Drug Applications (NDA), Supplemental New Drug Application (SNDA). ICH requirements for registration of Pharmaceuticals Unit V Accuracy, Methods of Precision, linearity, sources of errors in analysis, use of significant figures, and their correct usage, intraday and interday analysis. System suitability and ruggedness of the method

REFERENCES 1) Pharmaceutical Process Validation by Ira R. Berry and Robert A. Nash 2) Quality assurance and TQM for analytical laboratories by M. Parkany, The Royal Society of Chemistry 3) SOP Guidelines by D. H. Shah 4) Quality Assurance of Pharmaceuticals (A compendium of guidelines and selected materials) Vol. I & II (Pharma Book Syndicate, Book Street, Hyderabad) 5) Basic Tests for Pharmaceutical substances WHO (1988, 1991) 6) A guide to total quality management K. Maitra and S.K. Ghosh 7) Good Manufacturing Practice (GMP) by Mehra 8) Packaging Drugs and Pharmaceuticals W.A. Jenkins & K. R. Osborn. 9) Indian Pharmacopoeia 2007

Subject Code R102263 FERMIENTATION TECHNLOLOGY

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.

Subject Code R102264 ENZYME ENGINEERING AND TECHNOLOGY

UNIT: I The enzyme, introduction, nomenclature and classification, applications in Industrial, Medical,Analytical,Chemical,Pharmaceutical and Food Sectors. specific activity, turnover number. Basis of enzymatic reaction, collision theory and transition state theory and role of entropy in catalysis Enzyme kinetics, Michaelis-Menten equation, Brigg’s-Haldane equation & estimation of constants using graphical technique, UNIT II: Hydrolytic, covalent, acid-base, electrostatic and metal ion involved catalysis. Energetics of substrate binding. The mechanism of action of chymotrpsin losoenzyme, glyceraldehyde 3 phosphate etc., Determination of the number of active sites of enzyme. Enzyme inhibition kinetics, substrate and product and toxic substance inhibition. UNIT III: Temperature dependence of rate constants of enzymatic reaction, thermal deactivation, pH effect on rate constants and protein structure. Stoichiometry of bioreaction and energetics of enzymatic reaction, ATP and redox potential balance. Yield coefficients and their correlation with the stoichiometry UNIT IV: Pre-steady–state kinetics, determination of rate constants, rapid mixing, stopped flow and relaxation technique. Enzyme kinetics at limiting condition, enzyme kinetics at interface and kinetics of multi substrate reactions. UNIT V: Immobilization of biocatalysts an introduction, Electrostatic Effect, effect of charged and uncharged support, Effect of external and internal mass transfer, Damkohler number, effectiveness factor, Intraparticle diffusion kinetics, Biot number TEXT BOOKS : 1. Blanch HW and Clark DS: Biochemical Engineering Marcel Decker Year of Publication 1987. 2. Enzymes by palmer, 3. Prace and stevens, 4. Blanch HW and Clark DS: Biochemical Enginering, Marcel Decker REFERENCES: 1. Bailey JE, Ollis, DF: Biochemical Engineering Fundamentals 2. Schugerl K., Bellgart KH (Eds): Biorection Engineering, modeling and control: Springer-Verlag, Berlin 3. Wiseman, A: Handbook of Enzyme Biotechnlogy, 3rd Edition, Ellis Horwood Publication 4. Moser, A: Bioprocess technology, kinetics and reactors: Springer Verlag

5. Biochemical Engineering Principles and functions by Syed Trnveer Ahmed Inamdar, PHI Learning Private limited.

Code (Common subject) R102201 Code R102253 R102254 R102255

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