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BP 603 T. HERBAL DRUG TECHNOLOGY (Theory)45 hoursScope: This subject gives the student the knowledge of basic understanding of herbal drugindustry, the quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics,natural sweeteners, nutraceutical etc. The subject also emphasizes on Good ManufacturingPractices (GMP), patenting and regulatory issues of herbal drugsObjectives: Upon completion of this course the student should be able to:1. understand raw material as source of herbal drugs from cultivation to herbal drugproduct2. know the WHO and ICH guidelines for evaluation of herbal drugs3. know the herbal cosmetics, natural sweeteners, nutraceuticals4. appreciate patenting of herbal drugs, GMP .Course content:UNIT-I11 HoursHerbs as raw materialsDefinition of herb, herbal medicine, herbal medicinal product, herbal drug preparationSource of HerbsSelection, identification and authentication of herbal materialsProcessing of herbal raw materialBiodynamic AgricultureGood agricultural practices in cultivation of medicinal plants including Organic farming.Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.Indian Systems of Medicinea) Basic principles involved in Ayurveda, Siddha, Unani and Homeopathyb) Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas,Ghutika,Churna, Lehya and Bhasma.UNIT-II7 HoursNutraceuticalsGeneral aspects, Market, growth, scope and types of products available in the market. Healthbenefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritablebowel syndrome and various Gastro intestinal diseases.Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic,Honey, Amla, Ginseng, Ashwagandha, SpirulinaHerbal-Drug and Herb-Food Interactions: General introduction to interaction andclassification. Study of following drugs and their possible side effects and interactions:Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra.UNIT-IIIHerbal Cosmetics10 Hours134

Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gumscolours, perfumes, protective agents, bleaching agents, antioxidants in products such as skincare, hair care and oral hygiene products.Herbal excipients:Herbal Excipients – Significance of substances of natural origin as excipients – colorants,sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.Herbal formulations :Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage formslike phytosomesUNIT- IV10 HoursEvaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugsStability testing of herbal drugs.Patenting and Regulatory requirements of natural products:a) Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting andBiopiracyb) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma& Neem.Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation ofmanufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.UNIT-V07 HoursGeneral Introduction to Herbal IndustryHerbal drugs industry: Present scope and future prospects.A brief account of plant based industries and institutions involved in work on medicinal andaromatic plants in India.Schedule T – Good Manufacturing Practice of Indian systems of medicineComponents of GMP (Schedule – T) and its objectivesInfrastructural requirements, working space, storage area, machinery and equipments,standard operating procedures, health and hygiene, documentation and records.135

BP 609 P. HERBAL DRUG TECHNOLOGY (Practical)4 hours/ week1.2.3.4.5.6.7.8.9.To perform preliminary phytochemical screening of crude drugs.Determination of the alcohol content of Asava and AristaEvaluation of excipients of natural originIncorporation of prepared and standardized extract in cosmetic formulations like creams,lotions and shampoos and their evaluation.Incorporation of prepared and standardized extract in formulations like syrups, mixturesand tablets and their evaluation as per Pharmacopoeial requirements.Monograph analysis of herbal drugs from recent PharmacopoeiasDetermination of Aldehyde contentDetermination of Phenol contentDetermination of total alkaloidsRecommended Books: (Latest Editions)1.Textbook of Pharmacognosy by Trease & Evans.2.Textbook of Pharmacognosy by Tyler, Brady & Robber.3.Pharmacognosy by Kokate, Purohit and Gokhale4.Essential of Pharmacognosy by Dr.S.H.Ansari5.Pharmacognosy & Phytochemistry by V.D.Rangari6.Pharmacopoeal standards for Ayurvedic Formulation (Council of Research inIndian Medicine & Homeopathy)7.Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation ofBotanicals. Business Horizons Publishers, New Delhi, India, 2002.136

BP 604 T. BIOPHARMACEUTICS AND PHARMACOKINETICS(Theory)45 HoursScope:This subject is designed to impart knowledge and skills of Biopharmaceuticsand pharmacokinetics and their applications in pharmaceutical development, design ofdose and dosage regimen and in solving the problems arised therein.Objectives: Upon completion of the course student shall be ableto:1. Understand the basic concepts in biopharmaceutics and pharmacokinetics andtheir significance.2. Use of plasma drug concentration-time data to calculate the pharmacokineticparameters to describe the kinetics of drug absorption, distribution,metabolism, excretion, elimination.3. To understand the concepts of bioavailability and bioequivalence of drugproducts and their significance.4. Understand various pharmacokinetic parameters, their significance iontoBiopharmaceuticsAbsorption; Mechanisms of drug absorption through GIT, factors influencing drugabsorption though GIT, absorption of drug from Non per oral extra-vascularroutes, Distribution Tissue permeability of drugs, binding of drugs, apparent, volumeof drug distribution, plasma and tissue protein binding of drugs, factors affectingprotein-drug binding. Kinetics of protein binding, Clinical significance of proteinbinding of drugsUNIT- II10HoursElimination: Drug metabolism and basic understanding metabolic pathways renalexcretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non renalroutes of drug excretion of drugsBioavailability and Bioequivalence: Definition and Objectives of bioavailability,absolute and relative bioavailability, measurement of bioavailability, in-vitro drugdissolution models, in-vitro-in-vivo correlations, bioequivalence studies, methods toenhance the dissolution rates and bioavailability of poorly soluble drugs.UNIT- III10 HoursPharmacokinetics: Definition and introduction to Pharmacokinetics, Compartmentmodels, Non compartment models, physiological models, One compartment openmodel. (a). Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extravascular administrations. Pharmacokinetics parameters - KE ,t1/2,Vd,AUC,Ka, Clt andCLR- definitions methods of eliminations, understanding of their significance andapplication

137UNIT- IV08 HoursMulticompartment models: Two compartment open model. IV bolusKinetics of multiple dosing, steady state drug levels, calculation of loading andmainetnance doses and their significance in clinical settins.UNIT- V07 HoursNonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity.c. Michaelis-menton method of estimating parameters, Explanation with example ofdrugs.Recommended Books: (Latest Editions)1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and AndrewB.C.YU 4th edition,Prentice-Hall Inernational edition.USA4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar andSunil B.Jaiswal,Vallabh Prakashan Pitampura, Delhi5. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.6. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott byADIS Health Science Press.7. Biopharmaceutics; By Swarbrick8. Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack,Publishing Company,Pennsylvania 1989.11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th editionRevised and expanded by Rebort F Notari Marcel Dekker Inn, New York andBasel, 1987.12. Remington’s Pharmaceutical Sciences, By Mack Publishing Company,Pennsylvnia

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BP 605 T. PHARMACEUTICAL BIOTECHNOLOGY (Theory)45 HoursScope: Biotechnology has a long promise to revolutionize the biological sciences andtechnology. Scientific application of biotechnology in the field of genetic engineering,medicine and fermentation technology makes the subject interesting. Biotechnology is leading to new biological revolutions in diagnosis, preventionand cure of diseases, new and cheaper pharmaceutical drugs. Biotechnology has already produced transgenic crops and animals and the futurepromises lot more. It is basically a research-based subject.Objectives: Upon completion of the subject student shall be able to;1. Understanding the importance of Immobilized enzymes in PharmaceuticalIndustries2. Genetic engineering applications in relation to production of pharmaceuticals3. Importance of Monoclonal antibodies in Industries4. Appreciate the use of microorganisms in fermentation technologyUnit I10 Hoursa) Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.b) Enzyme Biotechnology- Methods of enzyme immobilization and applications.c) Biosensors- Working and applications of biosensors in Pharmaceutical Industries.d) Brief introduction to Protein Engineering.e) Use of microbes in industry. Production of Enzymes- General consideration Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.f)Basic principles of genetic engineering.Unit II10 Hoursa) Study of cloning vectors, restriction endonucleases and DNA ligase.b) Recombinant DNA technology. Application of genetic engineering in medicine.c) Application of r DNA technology and genetic engineering in the production of:i) Interferon ii) Vaccines- hepatitis- B iii) Hormones-Insulin.d) Brief introduction to PCR139

Unit III10 HoursTypes of immunity- humoral immunity, cellular immunitya) Structure of Immunoglobulinsb) Structure and Function of MHCc) Hypersensitivity reactions, Immune stimulation and Immune suppressions.d) General method of the preparation of bacterial vaccines, toxoids, viral vaccine,antitoxins, serum-immune blood derivatives and other products relative to immunity.e) Storage conditions and stability of official vaccinesf) Hybridoma technology- Production, Purification and Applicationsg) Blood products and Plasma Substituties.Unit IV08Hoursa)Immuno blotting techniques- ELISA, Western blotting, Southern blotting.b)Genetic organization of Eukaryotes and Prokaryotesc)Microbial genetics including transformation, transduction, conjugation, plasmids andtransposons.d)Introduction to Microbial biotransformation and applications.e)Mutation: Types of mutation/mutants.Unit V07 Hoursa)Fermentation methods and general requirements, study of media, equipments,sterilization methods, aeration process, stirring.b)Large scale production fermenter design and its various controls.c)Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid,Griseofulvin,d)Blood Products: Collection, Processing and Storage of whole human blood, driedhuman plasma, plasma Substituties.Recommended Books (Latest edition):1. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applicationsof RecombinantDNA: ASM Press Washington D.C.2. RA Goldshy et. al., : Kuby Immunology.3. J.W. Goding: Monoclonal Antibodies.4. J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal

2. Text book of Forensic Pharmacy by B.M. Mithal 3. Hand book of drug law-by M.L. Mehra 4. A text book of Forensic Pharmacy by N.K. Jain 5. Drugs and Cosmetics Act/Rules by Govt. of India publications. 6. Medicinal and Toilet preparations act 1955 by Govt. of India publications. 7. Narcotic drugs and psychotropic substances act by Govt. of .