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M.Pharm (Industrial Pharmacognosy) Subjects First Semester MPGC 101: Instrumental methods of Analysis Theory (Common to all Branches) MPGC 102: Modern Analytical Techniques Theory (Common to all Branches) MPGC 103: Dosage Form Design (Theory) (Common with M. Pharm. Industrial Pharmacy) MPGC 104: Advanced Pharmacognosy (Theory) MPGC 105: Pharmacology and Screening Methods Theory (common with M.Pharm Pharmacology, Pharmaceutical Chemistry) MPGP 106: Pharmaceutical Analysis Practical (Common to all Branches) MPGP 107: Advanced Pharmacology Practical (Common with M.Pharm Pharmacology) Second Semester MPGC 201: Herbal Drug Technology Theory MPGC 202: Quality Assurance of Herbal Drugs Theory (Common with M.Pharm. Quality Assurance) MPGC 203: Industrial Pharmacognosy Theory MPGC 204: Natural Products Chemistry Theory (Common with M.Pharm Pharm. Chemistry) MPGC 205: Pharmaceutical Production Management Theory (Common with M.Pharm Industrial Pharmacy) MPGP 206: Herbal Drug Technology Practical MPGP 207: Quality Control of Herbal Drugs & Herbal Products Practical (Common with M.Pharm. Quality Assurance) Third Semester: www.Pharmainfo.Net www.Pharmainfo.Net

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M.Pharm (Industrial Pharmacognosy)Subjects

First Semester

MPGC 101: Instrumental methods of Analysis Theory (Common to all Branches)

MPGC 102: Modern Analytical Techniques Theory (Common to all Branches)

MPGC 103: Dosage Form Design (Theory) (Common with M. Pharm. Industrial

Pharmacy)

MPGC 104: Advanced Pharmacognosy (Theory)

MPGC 105: Pharmacology and Screening Methods Theory (common with M.Pharm

Pharmacology, Pharmaceutical Chemistry)

MPGP 106: Pharmaceutical Analysis Practical (Common to all Branches)

MPGP 107: Advanced Pharmacology Practical (Common with M.Pharm Pharmacology)

Second Semester

MPGC 201: Herbal Drug Technology Theory

MPGC 202: Quality Assurance of Herbal Drugs Theory (Common with M.Pharm. Quality

Assurance)

MPGC 203: Industrial Pharmacognosy Theory

MPGC 204: Natural Products Chemistry Theory (Common with M.Pharm Pharm.

Chemistry)

MPGC 205: Pharmaceutical Production Management Theory (Common with M.Pharm

Industrial Pharmacy)

MPGP 206: Herbal Drug Technology Practical

MPGP 207: Quality Control of Herbal Drugs & Herbal Products Practical (Common with M.Pharm. Quality Assurance)

Third Semester:

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MPGC 301: Research methodology and Pharmaceutical Statistics Theory (Common to all

branches)

MPGE 302:

1. MPGE 302(1) Advances in Industrial pharmacy Theory 2. MPGE 302(2) Pharmaceutical Healthcare Theory 3. MPGE 302(3) Analytical Method Development- Theory 4. MPGE 302(4) Clinical Pharmacology- Theory 5. MPGE 302(5) Strategy in Drug Synthesis-Theory 6. MPGE 302(6) Pharmacobiotechnology- Theory

MPGT 303: Thesis Phase I

Fourth Semester MPGT 401: Thesis Phase II

Scheme of Examinations

Subject Hrs/Week Credits Evaluation (Marks) L T P sessional Univ.

Exam Total

I-Semester MPGC 101 Instrumental methods of

Analysis Theory 2 1 -- 3 25 75 100

MPGC 102 Modern Analytical Techniques Theory 2 1 -- 3 25 75 100

MPGC 103 Dosage Form Design Theory 2 1 -- 3 25 75 100

MPGC 104 Advanced Pharmacognosy- Theory 2 1 -- 3 25 75 100

MPGC 105 Pharmacological Screening Methods Theory 2 1 -- 3 25 75 100

MPGP 106 Pharmaceutical Analysis Practical -- -- 4 2 25 75 100

MPGP 107 Advanced Pharmacology Practical -- -- 6 3 25 75 100

II-Semester MPGC 201 Herbal Drug Technology -

Theory 2 1 -- 3

25 75 100

MPGC 202 Quality Assurance of Herbal Drugs Theory 2 1 -- 3 25 75 100

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MPGC 203 Industrial Pharmacognosy Theory 2 1 -- 3 25 75 100

MPGC 204 Natural Products Chemistry Theory 2 1 -- 3 25 75 100

MPGC 205 Pharmaceutical Production Management Theory 2 1 -- 3 25 75 100

MPGP 206 Herbal Drug Technology Practical -- -- 4 2 25 75 100

MPGP 207 Quality Control of Herbal Drugs & Herbal Products Practical -- -- 6 3 25 75 100

III -Semester MPGC 301 Research Methodology &

Pharmaceutical Statistics 2 1 -- 3

25 75 100

MPGC 302 Elective 2 1 -- 3 25 75 100

MPGT 303 Thesis Phase I 15 6 25 75 100

IV- Semester MPGT 401 Thesis Phase II

13 25 75 100

Syllabus

FIRST SEMESTER

MPGC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory) 35 Hrs.

1. UV-Visible Spectrophotometry: Theory Beer and Lambert - Limitations of the law, Design and working of single beam and double beam spectrophotometers. Applications of UV absorptions spectrophotometry in qualitative analysis and quantitative analysis.

2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence. Chemical structure and fluorescence - factors affecting fluorescence intensity. Instrumentation and Pharmaceutical applications of fluorimetry.

3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation Types of interference and elimination of interference - Pharmaceutical applications

4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion exchange chromatography and super critical fluid chromatography.

5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle, Instruments and application. Chromatographic attributes: Capacity factor, resolution, theoretical plates and symmetry factor

6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass spectrometry

7. Introduction to Radio Immuno Assay

Books for Reference:

1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of quantitative inorganic analysis, ELBS, London.

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2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone Press London.

3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry, Saunders College publishing, New York.

4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college publishing, New York.

5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis, Wadsworth, New York.

6. V.K. Srivastava and K.K. Srivastav, Introduction to Chromatography, S. Chand & Company, New Delhi.

7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall London.

9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric Identification of organic Compounds, John Wiley & Sons, New York.

10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.

11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.

12.

13. Pharmacopoeia of India, Govt. of India, Ministry of Health.

14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.

15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.

16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.

17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea & Febiger, Philadelphia.

MPGC 102: MODERN ANALYTICAL TECHNIQUES (Theory) 35 Hrs.

1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample preparation - application of IR spectrophotometry in pharmacy. Introduction to FTIR

2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift, magnetic equivalence spin-spin decoupling shift reagents, applications of NMR spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple organic compound as example)

3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron bombardment, chemical ionization, field desorption, fast atom bombardment. Different analysers. Interpretation of mass spectra, determination of molecular weight and molecular formula and applications of mass spectrometry

4. Theory, instrumentation and applications of Differential Thermal Analysis and Differential Scanning Calorimetry.

5. A preliminary study of principle, Instrument and applications of 13C NMR

6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins & antibiotics

Books for reference:

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1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone Press London.

2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college publishing, New York.

3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis, Wadsworth, New York.

4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall London.

6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric Identification of organic Compounds, John Wiley & Sons, New York.

7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.

8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.

9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.

10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.

MPGC 103: DOSAGE FORM DESIGN (Theory) 35 Hrs.

1. Manufacturing and Quality control of solid dosage forms: Tablets and Capsules. 2. Manufacturing and Quality control of liquid dosage forms: orals and topicals. 3. a) Parenterals formulation development and evaluation

b) Aerosol Formulation Development and its Quality Control 4. Radio pharmaceuticals: Background information, dosage formulation, diagnostic and therapeutic

uses, production, quality assurance, storage and safety hazards. 5. Selection and evaluation of packaging materials, containers and closures, special problems of

container product interactions. Pharmacopoeial specifications, tests and standards for packaging materials.

Books for Reference:

1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.

2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3rd Edn, Vergese Publishing House, Mumbai, 1991.

3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Marcel Dekker, Inc., New York, 1995

4. Lachman L, et al, Pharmaceutical Dosage Forms: Parenteral Medications, 2nd Edn., Vol I & II, Marcel Dekker, New York, 1992.

5. Lachman L, et al, Pharmaceutical Dosage Forms: Tablets, 2nd Edn., Vol I, II & III, Marcel Dekker, New York, 1992.

6. Turco S and King R E, Sterile Dosage Forms, 3rd Edn., Lea & Febiger, Philadelphia, 1987. 7. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International Student)

Edn., Churchill Livingstone, New York, 1996.

MPGC-104: ADVANCED PHARMACOGNOSY (Theory) 35 Hrs

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1. Plants as source of medicines. Survey of Plant derived modern drugs and their sources. Drug development from Plants a Flowchart. Principles and procedures involved in collection; identification, phytochemical screening of medicinal plants of research interest. Good Practices for Medicinal plant and herbal raw material identification and authentication. Sources of information on medicinal plants.

2. General aspects in the cultivation of medicinal and aromatic plants. Classification of herbal drugs. Introduction to Chemotaxonomy. Status and Significance of chemotaxonomy. Compounds useful in taxonomy of medicinal plants, Illustrations of Chemotaxonomical significance of some important metabolite compounds.

3. Current status and scope of Marine Pharmacognosy. Bioactive agents from Marine organisms, general methods of isolation and purification. Study of Cardiovascular, Antimicrobial, Antibiotic, Anti-inflammatory, antispasmodic, Heparin-like substances and Cytotoxic compounds from marine sources.

4. Review of Traditional System of Medicine (TSM). Role of Natural products in Alternative System of Medicines like Ayurveda, Siddha, Unani, Chinse, Homeopathy and Tribal Medicine. Study of different dosage forms and methods of preparation in TSM. Standardization of Ayurvedic, Siddha Dosage forms and associated problems.

5. Study of major Phytoconstituents, Medicinal uses, Pharmacology, Adverse effects and Herbal medicinal products of the following plant drugs: Andrographis paniculata herb, Calendula officinalis flowers, Eucalyptus oil, Hypericum perforatum herb, Peppermint oil, Ocimum sanctum herb, Silybum marianum fruits, Curcumae Longae rhizomes, Centella asiatica herb, Bacopa monnieri, Echinaceae Purpureae, Panax ginseng root, Aloe Vera Gel, Withania somnifera, Valeriana officinalis roots, Ginkgo biloba leaves, Phyllanthus amarus, Terminalia arjuna.

6. Secondary metabolism: Origin and building blocks of secondary metabolites. Shikimic acid pathway and Mevalonate pathway. Biosysnthesis of following metabolites: Geraniol, Citronellol, Limonene, Cineole, Fenchone, Menthol. Ephedrine, Hyoscyamine, Cocaine, Papaverine, Morphine, Ergotamine. Digitoxigenin, Capsaicin and Sennosides.

Books for Reference:

1. Paul M Dewick , Medicinal Natural Products Biosyntheric Approach, 2002, John Wiley & Sons, Ltd. New York, Singapore.

2. William Charles Evans, Trease & Evans' Pharmacognosy, 15th Edition, 2001, Elsevier Ltd., New York, Chennai.

3. Michael Heinrich, Joanne Barnes, Simon Gibbons and Elizabeth M. Williamson, Fundamentals of Pharmacognosy and Phytotherapy, 2004, Elsevier Ltd., New York, Chennai.

4. Ansari S.H., Essentials of Pharmacognosy, First Edition, 2006, Birla Publications Pvt. Ltd., Delhi. 5. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Edition, 2006, New Age

International Publishers Ltd., New Delhi. 6. WHO, WHO Monographs on selected medicinal plants. Vol. 1., 1999, WHO Publication,

Geneva. 7. WHO, WHO Monographs on selected medicinal plants. Vol. 2., 2004, WHO Publication,

Geneva. 8. WHO, WHO Monographs on selected medicinal plants. Vol. 3., 2007, WHO Publication,

Geneva.

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9. C. K. Kokate, A. P. Purohit, S. B. Gokhale, Pharmacognosy, 14th edition, 2008, Nirali Prakashan. 10. Gunnar Samuelsson, Drugs of Natural Origin: A Textbook of Pharmacognosy, 5th Edition, 2004,

Swedish Pharmaceutic. 11. Jean Bruneton, Pharmacognosy, Phytochemistry, Medicinal Plants, 2nd edition, 1999, Lavoisier. 12. A. P. Purohit, Modern Pharmacognosy, 2008, Alpha Science International Ltd., Oxford. 13. Partap Chauhan, Ayurvedic Pharmacognosy, 2007, Sonali Publications, by New Delhi. 14. Kaviraj Nagendra and Nath Sengupta, The Ayurvedic System of Medicine, 2 volumes, 1998. 15. Atal, C.K., and Kapur, B.M., Cultivation and utilization of Medicinal plants, RRL, CSIR, Jammu. 16. J. B. Harborne and B. L. Turner, Plant Chemosystematics, 1984, Academic Press.

MPGC 105: PHARMACOLOGICAL SCREENING METHODS - 35Hrs 1. (a)Basic principles of screening of drugs for pharmacological activities.

(b)Pre-clinical screening General screening procedure for CNS activities, General CNS profile- Study using pole climbing pattern, Rota rod, Actophotometer and Jiggle cage experiments.

2. (a)Specific screening procedure for local anesthetics Rabbit cornea, lumbar plexus of frog and Infiltration anesthesia on guinea pigs

(b) Screening for anti hypertensive agents:

How to do experimentally induced hypertension in albino rats, and using these animals for screening of anti hypertensive, anaesthetized dog method etc.

(c) Screening for anti arrhythmic activity:

A study of aconitine or digoxin or isoprenaline induced arrhythmias in animals and use of these animals to screen anti arrhythmic drugs. Studying various types of arrhythmiasis based on ECG pattern recorded - for anti arrhythmic screening and isolated frog heart.

(d) Screening for analgesic and anti-convulsent activities using, hot plate, tail flick and tail clip methods (analgesic activity) MES seizures produced in albino rats and to study the effects of anti convulsant (phenytoin), protection of electrically induced convulsion in albino rats. Protection of cardiazol induced convulsion in rat by sodium valproate.

3. (a) Screening for anti depressant, anti psychiatric, anti parkinsonism and anti ulcer effect

(b) Screening for anti fertility activity and anti pyretic & anti inflammatory.

(c) Screening for skeletal muscle relaxants effect of drugs using nerve muscle preparations, phrenic nerve diaphragm and frog rectus preparation.

4 (a) Toxicological studies:

Acute, sub acute, and chronic toxicological studies and calculation of median lethal dosage for drugs

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Books for reference:

1. th Ed.

2. Pharmacology, by H.P.Rang

3. th Ed.

4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bacharah Vol 1. and 2.

5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and V.Austel.

6. Practical approach in toxicity studies by pooley and leslie.

7. Screeining methods in Pharmacology by R.A.Tuner.

8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett.

9. Methods of clinical drug trails by Aln Sperit and Smith.

10. Alternatives to animal experiments: Developing in-vitro methods and changing legislation. TIPS., 11:1990 104-107

11. Alternatives to animals in toxicity testing. Scientific American., 261(1989), 16-22.

12. Clinical drug trial and tribulations by Allan E.cato (1980)

13. The Oxford text book of clinical Pharmacology and drug therapy by D.G.Grehame-Smith and J.K.Aronson

14. International aspects of drug evaluation and usage by Jouhar and Grayson.

MPGP 106: PHARMACEUTLICAL ANALYSIS (Practical) 45 Hrs.

1. Experiments based on theory subjects Instrumental methods of analysis and Modern Analytical techniques

2. Experiments would be selected illustrating the principles involved in estimation of raw materials and finished products representing major categories of drug formulations from pharmacopoeias.

MPGP 107: ADVANCED PHARMACOLOGY (Practical) 70 Hrs.

1. Laboratory animals : Breeding, maintanance and handling preparation of Physiological solution and drug solution

2. Screening procedure for the following drugs:

Local anesthetics, antiepileptics, antidepressants, anti-inflammatory, antidiabetics, antiulcer, analgesics and antimicrobial agents.

3.ine

4 a. Effect of drugs on blood pressure, splenic volume, intestinal movements and respiration in anesthetized dog (with software model)

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b. Acute and sub acute toxicity studies and calculation of LD50

SECOND SEMESTER

MPGC-201 HERBAL DRUG TECHNOLOGY (Theory) 35 Hrs.

1. Essential Oil Technology: Basic Chemistry of Essential Oils. Uses of Essential oils in food, cosmetics, perfumes and therapy. Industrial production of essential oils - Technology, Methods, Equipment, Fractionation and rectification of essential oils. Standardization, physical and chemical methods of analysis of essential oils. Production of Mentha oil, Eucalyptus oil, Sandalwood oil, Rose oil, Jasmine oil, Clove oil.

2. Unit operations in Herbal Raw material processing: Principles and methods of extraction including maceration, percolation, hot continuous extraction, Supercritical fluid extraction, high pressure extraction technology and Microwave assisted extraction of herbal raw materials. Their merits and demerits. Purification and Recovery of Solvents.

3. Herbal Drug Standardization: Factors affecting Variability and Quality in herbal raw material and the need for standardization. Problems and prospects of standardization of Herbal Medicinal Products. Physical, Chemical, Spectral and Chromatographic Parameters in Standardization. Role of Bio-markers in herbal drug standardization.

4. Herbal Formulations: Types of Modern herbal dosage forms and Dosage forms in traditional systems of medicine such as Ayurveda and Siddha. Methods involved in monoherbal and polyherbal formulations with their merits and demerits. Excipients used in herbal formulations. Formulation of powders, granules, capsules, tablets; liquid formulations, gels, creams, ointments and other dosage forms. Evaluation of different dosage forms. Stability studies of herbal formulations.

5. Herbal Cosmetics: Herbal raw materials used in cosmetics such as oils, extracts, waxes, gums, hydrophilic colloids, preservatives and Anti-oxidants. Preparation Skin care preparations (Creams and Lotions), Sunscreens and Sunburn applications, Hair care preparations (Hair oils and Hair shampoos, Hair dyes and Hair gels) and Beautifying preparations(Lipsticks, Face powders and Nail polish).

6. Nutraceuticals: Introduction and Classification, Health benefits of Nutraceuticals. Review on plant derived nutraceuticals and thier benefits. Flavonoids as Nutraceuticals. General extraction methods for nutraceuticals from plants with emphasis on Supercritical fluid extraction. Marine Nutraceuticals such as Omega-3 Oils, Glucosamine Sources, Applications, and Health Benefits.

BOOKS FOR REFERENCE:

1. William Charles Evans, Trease & Evans' Pharmacognosy, 15 edition, 2001, Bailliere Tindall / Elsevier.

2. John Shi, Giuseppe Mazza, Marc Le Maguer, Functional Foods: Biochemical and Processing Aspects, Volume II, 1st Edition, 2002, CRC.

3. Colin Barrow and Fereidoon Shahidi, Marine nutraceuticals and functional foods, 2008, CRC Press, Florida.

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4. -

5. Panda, H., Herbal Cosmetics Handbook, National Institute of Industrial Research, 2006, New Delhi.

6. Chaudhari R. D., Herbal drug industry, 1st edition, 1996, Eastren publisher, New Delhi. 7. Martin M. Rieger, Harry's Cosmeticology, 8th edition, 2000, CHS Press, San Francisco, USA. 8. loyd V. Allen, jr, Nicholas G Popovich and Howard C. Ansel, Ansel's Pharmaceutical Dosage

Forms and Drug Delivery Systems, 8th edition, 2005, Lippincott Williams & Wilkins, Baltimore. 9. Yoshioka, Sumie, Stella, Valentino J., Stability of Drugs and Dosage Forms, 2001, Springer-

Verlag. 10. Ram I Mahato, Pharmaceutical Dosage Forms and Drug Delivery, 2007, CRC Press, Florida. 11. Yoshioka, Sumie, Stella, Valentino J., Stability of Drugs and Dosage Forms, 2001, Springer-

Verlag. 12. NIIR Board, Modern Technology Of Perfumes, Flavours And Essential Oils, 2nd edition, 2004,

National Institute of Industrial Research, New Delhi. 13. P. K. Chattopadhyay, Herbal Cosmetics & Ayurvedic Medicines, 1998, National Institute of

Industrial Research (NIIR), New Delhi. 14. NIIR Board, Handbook on Herbal Products (Medicines, Cosmetics, Toiletries, Perfumes) 2 Vols.,

2002, NIIR, New Delhi. 15. H. Panda, The Complete Technology Book on Herbal Perfumes & Cosmetics, 2003, NIIR, New

Delhi. 16. H. Panda, The Complete Technology Book on Herbal Beauty Products with Formulations and

Processes, 2005, NIIR, New Delhi. 17. H. Panda, Essential Oils Handbook, 2003, NIIR, New Delhi. 18. NIIR Project Consultancy Services (NPCS), Selected Formulary Handbook, 2007, NPCS, New

Delhi. 19. H. Panda, Medicinal Plants Cultivation & Their Uses, 2002, NIIR, New Delhi. 20. NIIR Board, Handbook On Herbs Cultivation And Processing, 2004, NIIR, New Delhi. 21. H. Panda, Aromatic Plants Cultivation, Processing And Uses, 2004, NIIR, New Delhi. 22. H. Panda, Handbook on Ayurvedic Medicines with Formulae, Processes and Their Uses, 2002,

NIIR, New Delhi. 23.

MPGC-202: Quality Assurance of Herbal Drugs (Theory) 35 Hrs.

1. The significance of quality for efficacy and safety of herbal medicinal products. Typical problems and challenges in quality control of herbal drugs. Factors affecting Herbal drug quality. Classification of evaluation methods for plant drugs. Macro-morphological, Micro-morphological evaluation of herbal raw materials. WHO guidelines for Sampling of plant drugs.

2. Physicochemical standardization parameters for herbal drugs: Determination of Physical and chemical constants such as extractive values, moisture content, alcohol content, volatile oil

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content, ash values, bitterness values, foreign matter, and physical constants applicable to the lipid containing drugs, swelling factor, foaming index, filth, insoluble matter etc.

3. Adulteration Introduction, Adulterants, types and methods of adulteration with illustrations and their detection. Contamination of plant drugs, classification of contaminants and Need for their detection. Detection and estimation of Arsenic and Heavy Metals Cadmium and Lead. Determination of Pesticide residues. Microbial contamination, microbial load/counts etc.

4. Rationale and concepts of metabolite profiling and fingerprinting in assessing the efficacy, quality of phytomedicines and in general to plant drug analysis. Role of Molecular markers in herbal drug quality assurance and associated pitfalls. A brief review of modern extraction methods and sample-preparation techniques for the standardization and analysis of herbal medicinal products.

5. Application of various analytical tools (including Hyphenated analytical technologies [HAT]) in metabolite fingerprinting and profiling of plant drugs and its derivative products in assessing their quality and efficacy. Some typical case studies (at least 3) from scientific publications illustrating the current and modern approaches to plant drug quality assurance.

6. Guidelines proposed by regulatory bodies on quality of herbal medicinal products, Guidance on specifications, test procedures and acceptance criteria for herbal materials, herbal drug preparations and herbal medicinal products. Factors affecting stability of herbal drugs and its formulations, the relevant ICH guidelines and methods of stability testing. WHO guidelines on GMP for herbal medicines.

Books for Reference: 1. Quality Control Methods for Medicinal Plant Materials- WHO, Geneva. 2. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, 1993, WHO,

Regional Office for the Western Pacific, Manila. 3. Guidelines for the Assessment of Herbal Medicines, 1991, WHO, Geneva. 4. Good Manufacturing Practices: updated supplementary guidelines for the manufacture of

herbal medicines, WHO, July 2005. 5. Pharmacopoeia of India, Govt. of India, Ministry of Health. 6. United States Pharmacopoeia, US pharmacopoeial Convention Inc. Rocville, USA. 7. Evans, W.C., Trease and Evans Pharmacognosy, ELBS / Bailliere Tindall, London. 8. World Health Organization. Regulatory Situation of Herbal Medicine. World Wide Review.

Geneva, Switzerland: World Health Organization; 1998:1-5. 9. GMP for Botanicals : Regulatory and Quality Issues on Phytomedicines, edited by Pulok K.

Mukherjee and Robert Verpoorte. New Delhi, Business Horizons, 2003 10. Liang, Y.Z., Xie, P., and Chan, K., Quality control of herbal medicines, J Chromatogr B Analyt

Technol Biomed Life Sci. 2004, 812: 53-70. Review. 11. Quality Control on Herbal Drugs - Pulok K. Mukherjee, Eastern Publishers (Business Horizons

Ltd.) New Delhi 2002. 12. Pharmacognosy, Phytochemistry, Medicinal Plants by Jean Bruneton (1999)

MPGC-203: INDUSTRIAL PHARMACOGNOSY (Theory) 35 Hrs.

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1. Status of Herbal drug industry. International trade in medicinal and aromatic plants. Potential for MAPs based industry & herbal products. Problems and prospects of Ayurvedic and Siddha products in International markets. Intellectual property protection and management for medicinal and aromatic plants and their products. Exploratory survey of some patents in herbal products.

2. Good Agricultural and Collection practices (in sourcing raw materials) for MAPs based industry. Post-harvest technology such as garbling, drying, preservation, packing and storage in the production of herbal raw materials from medicinal plants. Rationale and Strategies for Conservation of Medicinal Plants for sustainable Herbal Drug Production.

3. Good Manufacturing Practices (GMP) in the Manufacture of Herbal Medicinal Products. Salient features of WHO, NHPD and EMEA guidelines. GMP aspects under Schedule-T for ASU medicines such as Infrastructural requirements, Standard Operating Procedure, Health, Hygiene, Documentation and Records for manufacture herbal products.

4. Evidence for safety and efficacy of finished natural health products as per WHO and NHPD Canada guidelines. Information needed to support clinical trial of herbal products (WHO Operational guidance). Fundamentals of clinical trials. Guideline for clinical trial protocols for herbal medicinal products.

5. International Regulatory Affairs on Herbal Medicinal Products. Common Terms and Abbreviations used in relavance to Herbal drug Regulatory affairs. Salient features of FDA Guidance to the industry on Botanical Drug Products, Australian regulatory guidelines for complementary medicine (TGA), EMEA, NHPD Canada guidelines.

6. Good Laboratory Practices (GLP). Common GLP terms and definitions. GLP Principles. Facilities, SOPs, Documentation. Total Quality Management (TQM) and Hazard Analysis and Critical Control Points (HACCP). Pharmaceutical Processes validation in the context of Herbal products.

Books for Reference:

1. Roy Upton, American Herbal Pharmacopoeia: Botanical Pharmacognosy-Microscopic Characterization of Botanical Medicines, 1st Edition, 2009, CRC.

2. Praveen K. Saxena, Development of Plant-Based Medicines: Conservation, Efficacy and Safety, 1st Edition, 2001, Springer.

3. John Shi, Giuseppe Mazza, Marc Le Maguer, Functional Foods: Biochemical and Processing Aspects, Volume II, 1st Edition, 2002, CRC.

4. Philip W Grubb, Patents for Chemicals, Pharmaceuticals & Biotechnology, 4th Edition, 2004, Oxford University Press, New York.

5. Jurg P. Seiler, Good Lab Practicals The Why & the How, 2002, Springer, New York. 6. WHO, Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, 1993,

WHO, Geneva. 7. WHO, WHO guidelines on developing consumer information on proper use of

traditional,complementary and alternative medicine, 2004, WHO, Geneva. 8. WHO, WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal

Plants, 2003, WHO, Geneva. 9. WHO, WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems,

2004, WHO, Geneva. 10. WHO/IUCN/WWF Guidelines on the Conservation of Medicinal Plants, 1993, IUCN,

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11.

12.13. Chaudhari R. D., Herbal drug industry, 1st edition, 1996, Eastren publisher, New Delhi. 14. Robert Verpoorte, Pulok K Mukharjee, GMP for Botanicals - Regulatory and Quality issues on

Phytomedicine, 2003, Business Horizons, New Delhi. 15. Quality control of herbal drugs by Pulok K Mukarjee, 2002, Business Horizons Pharmaceutical

publishe, New Delhi. 16. Partap Chauhan, Ayurvedic Pharmacognosy, 2007, Sonali Publications, by New Delhi. 17.

18.

19.20.

21.

22.

23.

24.25.26. -

27.28.

Eastern Publishers, New Delhi

MPGC 204: NATURAL PRODUCTS CHEMISTRY Theory 35 Hrs.

1. General methods of isolation and separation of plant constituents, Qualitative reactions employed for the detection of plant constituents. Application of GLC, HPLC and counter current distribution for separation and analysis of plant constituents. Application of IR, H1NMR, mass spectroscopy to structural determination of natural products.

2. A general study of the chemistry of anti- bacterial antibiotics, anti-fungal antibiotics, anti-viral antibiotics with detailed study of newer semi-synthetic Penicillins and Cephalosporin.

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3. WHO Guidelines for evaluation of safety and efficacy of herbal medicine, quality specifications of plant materials and toxicity studies of herbal medicines.

4. A detailed study of the following classes of natural products with special importantance to occurrence, chemistry, biosynthesis, isolation, purification and estimation by physical, chemical and biological methods.

c) Alkaloids Indole alkaloids (Reserpine, Vinblastine etc.), Morphine and related alkaloids.

d) Vitamins Vitamin A, Folic acid, Vitamin B12 and Vitamin C

5. Steroids Detailed study of the structure and stereochemistry of steroid nucleus, Transformation of Steroids by micro-organism and synthesis of the following Cholesterol, Ergosterol (irradiation product), Oestrogen, Progesterone, and Testosterone

Method of isolation and estimation of the following natural products:

a. Diosgenin,

b. Quinine

c. Emetine

d. Penicillin and streptomycin

Books for Reference :

1. I. L .Finar,Organic chemistry Vol.-II 5th edition,ELBS.

2. S. William Pelletier Alkaloid chemical and biological perspective

3. Trease and Evans Pharmacognosy, 14th edition, ELBS.

4. Tyler, V.E., Brady, L.R., Robbers, J.E., Pharmacognosy, 8th ed., Lea & Febiger, Philadelphia, USA.

5. Asolkar, Diosgenin and other steroid drug precursor, CSIR

6. Weinsten. M.I, Wegman, G.H, Antibiotics, Isolation and separation.

7. Gorog.S.,Quantitative analysis of steroids

8. E.Vardemme, Biotechnology of Industrial antibiotics

9. Vapoorte, Swendson, Chromatography of Alkaloids.

10.

11. th edition.

12. Oraganic Medicinal and Pharmaceutical Chemistry, 8th edition.

13. Phytochemical methods of chemical analysis by Horborne.

14. The use of Pharmacological techniques for the evaluation of natural products by B.N. Dhavan; R.C.Srimal, CDRI, Lucknow.

15. Weiss creger, Techniques in organic chemistry

16. Nakanishi Golo, Natural Product Chemistry

17. Bentley, The Alkaloids Part I and Part- II

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18. Fischer and Fischer, Steroid.

19. Indian Pharmacopoeia, 1996.

20. Makin and Gower, Steroid analysis.

21. Bernard Fried and Sharma, Thin Layer Chromatography techniques and applications 2nd edition.

22. N.S.Egorov, Antibiotics A Scientific Approach.

MPGC 205: PHARMACEUTICAL PRODUCTION MANAGEMENT (Theory)

35 Hrs.

1. Lay out of building, material management, Production planning and control, sales forecasting.

2. New Product development Market research, Project identification, Management and Production lunch.

3. ISO 9000 Salient features. Drug regulatory affairs Drugs and Cosmetics Act, Drugs (Price Control) Order, Essential Commodities Act.

4. Safety and environment management. 5. Human resource management Supervisory skills and communication skills. 6. US-FDA regulatory affairs: US FDA review process for Investigational New Drug (IND), New Drug

(NDA). Hatch Waxman amendment, Abbreviated New Drug Application (ANDA) for generic market - types of ANDA - Data presentation - verification and grant by FDA - Common Technical Documentation (CTD), and review process. Drug master File (DMF), Type - filing process - benefits. New product exclusivity patent term restoration - exclusivity and orange book listings federal register

7. GMP certification as per WHO: need and procedure for certification

Books for Reference: 1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott

Williams & Willkins, Philadelphia, PA, 2000.

2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3rd Edn, Vergese Publishing House, Mumbai, 1991.

3. Drugs and Cosmetics Act, 1940 and the rules there under, 1945, Government of India.

4. Drugs Price Control Order, 1995, Ministry of Health, Govt. of India.

5. Sharma PP, How to Practice GMP, 1st Edn., New Delhi, 1998.

6. ISO Standards, Bureau of Indian Standard, New Delhi.

7. Pestomji, Text Book of Personal Management

8. Rao V Subba, Text Book on Personal Management, Panther, New Delhi, 1994.

MPGP-206: HERBAL DRUG TECHNOLOGY (PRACTICALS) 50 Hrs.

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1. Isolation of Starch from Potato, Ginger Oleoresin from Ginger Rhizome, Capsicum Oleoresin from Capsicum fruits, Podophyllotoxin from Podophyllum roots.

2. Preparation of few Herbal cosmetics covered in theory.

3. Preparation and Evaluation of few Herbal formulations of different types covered in theory.

4. Isolation of some plant derived nutraceuticals.

5. Extraction / Distillation of Essential oils from Aromatic raw materials.

6. Any other experiment(s) to substantiate topics covered in theory.

MPGP-207: QUALITY CONTROL OF HERBAL DRUGS & HERBAL PRODUCTS (Practicals) 50 Hrs

a) Chromatographic analysis of plant drugs for some phytoconstiuents such as alkaloids, Anthracene glycosides, volatile oils.

b) Proximate analysis of plant-drugs to determine extractive values, ash values, insoluble matter foreign matter, welling factor etc.

c) Determination of volatile oil content of plant drug. d) Estimation of some phytoconstiuents. e) Evaluation of some parameters following as per pharmacopoeial monograph of selected drugs.

THIRD SEMESTER MPGC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS (Theory) 35 Hrs.

[Student should be familiar with pharmaceutical/chemical applications and use statistical tools, by way of calculations, but not expected to derive and find proof.]

1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of thesis and conventions adopted in writing; citing references; preparation of oral, poster presentation. Accessing required information in a systematic manner from abstracts, books journals, conference proceedings, thesis and dissertations, internet, CDROM etc. Ethics, rights, permissions

2. The Population - The sample; measures describing the center of data distributions; measurement of spread of data. Introduction to Probability - The Binomial and Normal distributions - their significance.

3. Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t tests, F tests, ANOVA [one way], Chi square test.

4. Linear regression and correlation. 5. Control charts Constructing control charts, between batch variation as a measure of variability,

quality control charts in research and development, quality control charts for proportions. 6. Non parametric methods 7. Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed rank test;

Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for randomness; Contingency tables.

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References:

1. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series. 2. How to write and publish a scientific paper, 4th Ed., Robert A Day Cambridge University

presses. 3. Fundamentals of Analytical Chemistry 7th Ed., Skoog, West, Holler Saunders College

Publishing.

MPGE 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory) 35 Hrs

1. Pre formulation studies and new formulation development.

2. New drug development and approval process: Investigational New Drugs (IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) , ICH requirements for registration of pharmaceuticals.

3. Validation techniques.

4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of dissolution characteristics, bioavailability enhancers.

5. Pharmaceutical product stability testing- ICH guidelines.

6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer solution, gel formation, coacervation, phase separation, microencapsulation, mechanical properties, biomedical uses of polymers.

Books for Reference:

1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20th Ed.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.

2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3rd Ed., Vergese Publishing House, Mumbai, 1991.

3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Ed., Marcel Dekker, Inc., New York, 1995.

4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International Student) Ed., Churchill Livingstone, New York, 1996.

5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th

Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.

6. FDA Code of Federal Regulations, Title 21, Part 300 314.

7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.

8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.

MPGE 302(2) PHARMACEUTICAL HEALTH CARE - THEORY 35 Hrs.

1. Concept and necessity of Pharmaceutical Health care. 2. A rational approach in paediatrics and geriatric care.

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3. Therapeutic consideration with rational approach during pregnancy and lactation. 4. Evaluation of Immune system and its fuctions. 5. Rational use of antimicrobials. 6. Assessment and clinical significance of malnutrition, enteral and parentral nutrition, Nutritional

consideration in major organ failure. 7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus, Peptic

Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma. 8. Self care: Constipation, Common cold, cough, pain, and sun light protection.

REFERENCES :

1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical Association, Washington.

2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569

3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.

4. Standard Treatment Guidelines

a) by WHO b) by Government of India c) by Various state governments

MPGE 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY 35 HRS.

1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision; classification of errors, estimation of errors, sources of errors, minimization of errors, normal distribution of errors. Significant figures in analytical chemistry rules and computations.

2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves external standard methods, internal standard method, standard addition method [applications in HPLC and GLC with calculations], linear regression of straight line calibration curves using the regression equation [applications and calculations].

3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques sampling techniques random, stratified, systematic, cluster, for quality control. Sample preparation reducing particle size, making solutions, separating analyte from interferants extraction, automated extraction, solid phase extraction, solid phase micro extraction, super critical fluid extraction and micro wave assisted extraction.

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4. Validating the analytical method including bio-analytical method: Need for validation; historical background; validation of analytical procedures-- methodology guidelines of ICH; FDA; USP. Understanding of the following concepts in validation accuracy, precision, specificity, limit of detection, limit of quantification, blind analysis of standard sample, ruggedness testing, robustness testing, equivalency testing. Validating the method as standard method collaborative test two sample collaborative testing, control charts.

5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column, Mobile phase, Special additives. Method Development guiding tools: Separation factor, Selectivity factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic phase, Aqueous phase, Additional Variables: pH, Stationary Phase, Temperature. Column Conditions: Flow, Column dimension, Particle diameter. Derivatisation.

6. System suitability tests as per Pharmacoepoeial specification.

7. Development of stability indicating analytical method

Books for References:

1. HPLC method development, Lunn. G(1996),John wiley & Interscience.

2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family Welfare.

3. British Pharmacopeia (1993) London, 4. ICH guide lines: validation of analytical procedures, methodology, November 1996.

5. th Ed.

6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series, 1993.

7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.

8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college publishing.

MPGE 302(4): CLINICAL PHARMACOLOGY -THEORY (35 Hrs)

1. (a) Definition and scope of clinical pharmacology, measurement of drug response in man.

(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance data analysis & presentation skills

(c) Pharmaco- epidemiology.

2 (a) Drug Drug interaction, Drug food interaction, and Drug disease interaction in clinical pharmacology.

(b) Adverse drug reactions and ADR monitoring.

3 (a) Essential drug list, national drug policy

(b) Orphans drugs

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vension in Therapeutic drug monitoring in special situations such as pediatrics, geriatric and pregnant cases.

Books for reference:

1. Goodman and Gil Pharmacological Basis of Therapeutic 9th Ed.

2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.

3. th Ed.

4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach Vol 1. and 2

5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and V.Austel

6. Practical approach in toxicity studies by pooley and leslie

7. Screeining methods in Pharmacology by R.A.Tuner

8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett

9. Methods of clinical drug trials by Aln Sperit and Smion

10. Alternatives to animal experiments: Developing in-vitro methods and changing legislation. TIPS., 11:1990 104-107

11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22

12. Clinical drug trial and tribulations by Allan E.Cato (1980).

13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.Grehame-Smith and J.K.Aronson.

14. International aspects of drug evaluation and usage by Jouhar and Grayson.

MPGE 302(5): STRATEGY IN DRUG SYNTHESIS Theory 35 Hrs. 1. Organic Name Reaction :

Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement, Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction, Reformatsky reaction, Scmidt rearrangement.

2. Introduction: Basic rules in disconnection. 3. Application of Synthon approach to drug synthesis: Case Studies.

a. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine. b. Adrenergic agents: Stimulants, Epinephrine, Ephedrine. c. Adrenergic blocking agents: Propranolol, Guanethidine. d. Psychotropic agents: Chlorpromazine, Chloprothixene.

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e. Antidepresants: Imipiramine. f. CNS Stimulants: Amphetamine. g. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.

Books for Reference:

1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.

2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.

3. Solomons Organic chemistry 5th Ed.

4. Organic Chemistry, I.L. Finar Vol. I, ELBS.

5. Modern Synthetic reaction, H.O.House.

6. Some Modern Method of Organic Synthesis, W. Carruthers.

7. Designing organic synthesis with work book a programmed introduction to the synthon approach, Stuart Warren.

MPGE-302(6): PHARMACOBIOTECHNOLOGY (Theory) 35 Hrs.

1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process. Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture, Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial growth, Down stream processing, Microbial products, Improvements in microbial strains. Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid and Penicillin.

2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes. Methods of enzyme production. Profile of some important enzymes: Hyaluronidase, Penicillinase, Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier matrices, Materials and Methods of immobilization (Adsorption method, Covalent bonding, Entrapment, Encapsulation). Advantages and disadvantages of immobilization. Application of Enzymes and Immobilized enzymes.

3.

4.

5. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell culture. Applications of plant tissue/cell culture: Micropropagation & Cloning, Genetically modified plants, Medicinal plant improvement, Production of secondary metabolites. Survey of phytochemicals produced through plant cell cultures.

6. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and Methodologies for biotransformation. Cell immobilization, Advantages of cell immobilization.

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Illustrations of biotransformations with special reference to steroids. Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine, Hydroxylation of beta methyl digitoxin, Arbutin).

7. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and enzymes involved. Steps in engineering the Genes and the enzymes involved. Cloning vectors. Introduction of rDNA into a host cell. Screening and selection of recombinants. Typical examples of Recombinant DNA technology products (human insulin, human growth hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).

Books for Reference:

1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi. 2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007, Pharma

Book Syndicate, Hyderabad. 3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age International

Publishers, New Delhi. 4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age

International Publishers Ltd., New Delhi. 5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004, NIIR, New

Delhi. 6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi. 7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.

MPGT 303: Thesis Phase I

Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to be completed at the beginning of Third Semester. The candidate has to prepare an Orientation Report.

FOURTH SEMESTER

MPGT 401: Thesis Phase II

THESIS III and IV SEMESTERS

Phase-I In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other allied organizations to provide orientation & exposure. Simultaneously the student will carry out a small project leading to a report at the end of that period. The faculty member of the department and an expert from the respective organization jointly evaluate the report for 10 marks. The students are expected to identify a project towards their thesis and start working on it and submit Phase I thesis during this stay. The students will come back to the Department to appear for third semester examination. On completion of third semester examination the students will return back to the industry/ Hospitals / other allied organizations where he was placed and would continue the thesis work under the collective guidance of a faculty member and a guide drawn from the collaborating organization.

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Phase-II The students would continue the thesis work in the fourth semester, in collaborating organizations, under the supervision of two guides one from the Department and another from collaborating organization allotted by the Head of the Department of Pharmacy.

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