Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch PHARMACEUTICAL SCIENCES [SPECILISATION CODE: 22] PAPER- I (Common paper) S.NO SUBJECT NAME SUBJECT CODE 1 INSTRUMENTAL METHODS OF R52201 PHARMACEUTICAL ANALYSIS Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch PHARMACEUTICAL SCIENCES [SPECILISATION CODE: 22] PAPER II (Choose Any ONE Subject) S.NO SUBJECT NAME SUBJECT CODE 1. PHARMACEUTICAL BIOTECHNOLOGY R52251 2. ADVANCED PHARMACEUTICS (PHARMACY) R52252 3. ADVANCED PHARMACOGNOSY R52253 4. ADVANCED PHARMACEUTICAL CHEMISTRY R52254 5. ADVANCED PHARMACOLOGY R52255 6. ADVANCED PHARMACEUTICAL ANALYSIS R52256 Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch Subject Code: R52201 INSTRUMENTAL METHODS OF PHARMACEUTICAL ANALYSIS Unit – I UV – Visible spectroscopy: Introduction, Beers law and its limitations, molar extinction coefficient, wood wards Fiesher rules for calculating absorption maximum, instrumentation design and applications. Unit – II IR Spectroscopy : Basic Principles – Molecular vibrations, vibrational frequency and its influencing factors, sampling techniques, instrumentation and applications of FT – IR. Unit – III NMR Spectroscopy : Principle, Chemical shifts, shielding and deshielding effects, splitting of signals, computing constants, instrumentations and applications (H&CNMR). Unit – IV Mass spectroscopy : Principle, Ionization Techniques, Fragmentation pattern, Instrumentation and applications. Unit – V GLC and HPLC : Principles, instrumentation with special emphasis on different column and detectors and applications. Unit – VI HPTLC, Ion-exchange Chromatography and Gel filtration: Principle, instrumentation and applications. Unit – VI Potentiometry and Conductometry : Principle, instrumentation and applications. Unit – VIII:- Polarimetry Fluorimetry and Refractometry : Principle, Instrumentation and applications with suitable examples. Books: 1. Instrumental Methods of Analysis - Scog and West 2. Instrumental Methods of Analysis - Willand, Dean and Merrit 3. Instrumental Methods of Analysis by B.K.Sarma 4. Introduction to Instrumental Analysis - Robert D.Braun. Reference Books : 1. Vogel’s text book of Quantitative Chemical Analysis 2. A Text Book of Pharmaceutical Analysis - Kenneth A.Connors. Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch Subject Code: R52251 PHARMACEUTICAL BIOTECHNOLOGY 1. Introduction to Proteins and Nucleic acids and their structure and features 2. Introduction to Genetic Engineering, enzymes and vectors in genetic engineering, concepts of cloning, cDNA and genomic libraries, Cloning for production of Biopharmaceuticals, Screening and detection methods for clones. 3. Recombinant DNA products and their applications 4. Immune System – Innate and acquired immunity, Monoclonal antibodies and immunological techniques. 5. Basic techniques of mammalian cell culture in vitro; disaggregation of tissue and primary culture, maintenance of cell culture; cell separation, and applications of mammalian cell culture. 6. Different areas and applications of plant tissue culture. Nutritional components of tissue culture media. Totipotency 7. Transgenic Plants and animals and their applications. 8. Introduction to Bioinformatics overview and applications. Text Books: 1. Bio-Chemistry - Stryer 2. Bio-Technology - Dr.U.Satyanarayana 3. Molecular cell Biology - Baltimore 4. Med.Plant Biotechnology - Ciddi Veereshan. Reference Books: 1. Gene cloning - T.A.Brown 2. Cell and Molecular Biology - Geral Corp 3. Essential immunology (1998) VII Edition - I.Roitt 4. Plant Tissue Culture - J.Stewart 5. Animal Cell Biotechnology methods & Protocols - Negel Jenkins 6. Bio Informatics Basics - Buelher. Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch Subject: Code: R52252 ADVANCED PHARMACEUTICS (PHARMACY) Unit -1 Introduction to pharmacokinetics – Pharmacokinetics models, physiological models, one compartment open model drug disposition, plasma elimination half life, two compartment open model drug disposition, Drug Distribution:- Apparent volume of distribution (one and two compartment models), protein binding of drugs – Implications of drug protein binding in pharmacokinetics and therepy kinetics of drug – protein binding. Unit -2 Biotransformation of drugs:- Phase I and II biotransformation reactions, factors affecting, Excretion of drugs – renal and nonrenal drug excretion – mechanism of renal excretion, clearance- renal clearance, hepatic clearance, kinetics of drug absorption- one compartment oper model, evaluation of pharmacokinetic parameters. Unit -3 Dosage form Evaluation-Bioavailability –rate and extent of bioavailability, assessing bioavailability, multiple dosing – bioavailability, in vitro bioavailability studies (dissolution), Bio equivalence – General principles, criteria for establishing bioequivalence requirement, criteria for waiver of evidence for bioequivalence requirement, methodology, pharmacokinetics parameters – logarithmic transformations. Unit -4 Multiple dosage regimens – drugs accumulation, i.v and oral regiment, loading dosing, scheduling, Diseases-Dose adjustment – hepatic disease – dose adjustment, renal disease – dose adjustment, therapeutics drug monitoring, Non-compartment model-pharmacokinetics – statistical movement theory, pharmacokinetics parameters. Unit -5 Concept & Models for NDDS: Classification of rate controlled drug delivery system (DDS), rate programmed release, activation modulated & feedback regulated DDS, Fundamentals of rate controlled drug delivery – Introduction, mechanistic analysis of controlled release drug delivery, effect of system parameters in controlled drug delivery, evaluation of controlled release drug delivery systems. Unit -6 Oral drug delivery and delivery systems: Development of novel drug delivery systems for oral controlled release drug administration, modulation of gastrointestinal transit time, overcome hepatic first pass elimination, Mucosal drug delivery: human mucosa, transmucosal systemic delivery of drugs. Unit -7 Transdermal Drug Delivery systems: Skin site for transdermal drug administration, recent developments in transdermal drug delivery, fundamentals of skin permeabtion, technologies for developing transdermal systems, Evaluation of transdermal systems, Particulate drug carriers – liposomes and nanoparticles – Concepts, applications, preparation, and evaluation, in vivo barriers to particulate distribution, selected examples of drug delivery. Unit -8 Target Oriented Drug Delivery Systems: Rationale for targeted drug delivery, biological processes and events involved in drug targeting, pharmacokinetics and pharmacodynamic considerations, targeted drug delivery systems, targeting in the gastrointestinal tracts and other mucosal surfaces. Text Books : 1. Y.W.Chein – Novel Drug Deliuery Systems – Vol – 50 2nd Edition Marcel Deckker – 2005 2. Robinson & Lee, control Drug Delivery Systems, Vol-29, 2nd Edition, Marcel Deckker – 2005 3. Milo Gibaldi Biopharmaceutics & Clinical Pharmacokinetics, 4th Edition, PHarma syndicate, Hyderabad (2005). Reference Books: 1. NK Jain Controlled Novel Drug Delivery, C.B.S.Publishers, New Delhi-2002 2. Brahmankar & Jaiswal Bio pharmaceutics and Pharmacokinetics, Atreatise Vallabha Prakashan, Delhi – 2005. Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch Subject Code: R52253 ADVANCED PHARMACOGNOSY Unit – I General methods and Principles of extraction methods, types of extraction and their merits and demerits for Crude Drugs; Selection and purification of solvents for extraction; screening of the plant extracts for chemicals. General methods of isolation of different classes of phytochemical. Unit – II: Screening of plant extracts / phytochemicals for analgesic, anti-inflammatory, anti- diabetic, diuretic, anti-fertility, anti-epileptic, hepatoprotective, immunomodulatory, anticancer cardiovascular and antimicrobial activity. Unit – III Techniques employed in elucidation of bio synthetic pathway. Study of basic metabolic pathways (Shikkinic, Acetatemerolonate pathway 2 calvins cycle) Biogenesis of tropane, quinoline, Imidazole, Isoquinoline and Indole alkaloids; sterols, anthraquinone, saponin glycosides and flavonoids compounds of pharmaceutical significance. Unit – IV Current status of anti-cancer, anti-HIV, anti-diabetic and Immunomodulatory herbal drugs. A review of Bio medicinals of recent discovery. Current status of plants used in alternative systems of medicines. Unit – V Application of various chromatographic techniques and spectrometry to natural products : TLC, GC, HPLC and HPTLC; Flourimetry and colorimetry. Uses of UV, IR, NMR and mass spectrometry in the structural elucidation of natural products. Unit – VI Herbal formulations : Types of herbal formulations preparation of standardized extracts suitable for incorporation into solid dosage form like tablets capsules etc. Recent trends in poly- herbal medicines. Herbal cosmetics and herbal teas. Manufacture, packaging and approach to quality control of herbal formulations. GMP for herbal drug formulations. Unit – VII World Health Organisation guide lines for herbal drugs including standards for pesticide residue / aflatoxins. Current status of regulatory affairs for herbal formulations. Patents, Intellectual property rights. Unit – VIII Current trends in tissue culture and its applications in Pharmaceutical and allied fields. Immobilized cell systems and techniques of immobilization, Biotransformation resulting into pharmaceutically important secondary metabolites, using tissue cultures. Micro propagation, Hairy-root cultures and their applications in Pharmacy. Text Books: 1. Text Book of Pharmacognosy by Trease & Evans 2. Phytochemical methods by J.B.Heraborne 3. Instrumental methods of Analysis – B.K.Sharma 4. Pharmacognosy and Phytochemistry- Vinod Rangari 5. Plant Tissue culture by Razdawn. Reference Books: 1. Text Book of Pharmacogonsy by Brady & Tyler 2. Instrumental Analysis by Chatwal & Anand 3. Pharmacognosy and Pharmacobiotechnology – Aushthoskar 4. Pharmacognosy – Gene Bruneton 5. Quality control of Herbal Drugs and approach to evaluation of Botanicals by Dr.Paulok K.Mukarjee 6. Aromatic Planats cultivation of process and uses – H.Panda 7. Meidcinal plant Biotechnology By ciddi Veeresham. Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch Subject Code: R52254 ADVANCED PHARMACEUTICAL CHEMISTRY UNIT-I: Structural Elucidation: Structural Elucidation of some important Natural, Synthetic and Semi synthetic drugs by using spectroscopic data. [UV, IR, H1NMR, C13 NMR, Mass]. UNIT-II : Reaction Mechanisms: Generation, Stability, structure and reactivity of free radicals, Carbocations and Carbenes. Mechanism of free radical, electrophitic, Nucleophitic (Addition and substitution) reactions, eliminaton reactions with examinable UNIT-III Basic Principles and strategies to plan synthetic reactions schemes by using different reagents. UNIT-IV: Molecular Boric of Being Action: Concept of receptors and receptor theories. The role of functional groups in drying receptors, interactions with specific reference to Opiod, thiotaminergic , Dorpaminergic, Adrenergic, Cholinergic, GABA nergic receptors. UNIT-V : Recent advances in the treatment of Diabetes Mellitub, Cardiovasenlan disease, CNS diseases, Viral, Cancer, Malaria and Tuberculosis. UNIT-VI: New drug development and lead approach: Identification of lead molecule for natural products. Lead optimization for the New drying development with suitable example from CNS, CNS, Chemotherapeutic. Agents. UNIT-VII: Drying Resign:- History and development of QSAR, physicochemical parameters. Hansch analysis., free klison analysis. Molecular modeling: Molecular mechanics quantum mechanism. UNIT-VIII: Design and application of prodrugs. Structure based drug design. Combinational chemistry: Combinational approached chemical peptide and small molecule librarian. Assays and Screening combinational libraries introduction to high through puts. Screening (HTS) Text Books: 1. Organic Chemistry - Vol I & II – I.L.Finar 2. Advanced Organic Chemistry - Jerry March 3. Medicinal Chemistry Vol I to V - Barger 4. Organic Medicinal & Pharmaceutical Chemistry - Willon and Gisword Reference Books: 1. Identification of Organic Compounds - Silverstain 2. Principles of Medicinal Chemistry - Foye 3. Organic Synthesis - Lednicer. Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch Subject Code: R52255 ADVANCED PHARMACOLOGY UNIT – I Receptor Pharmacology & Mechanisms : Types of Receptors, theories of receptors, G-protein coupled receptors, NMDA receptors, Kinase linked receptors, ion channels, second messengers, DNA linked receptors, signal transduction mechanism, proliferation and apoptosis. UNIT – II Pharmacogenetics, Drug Interactions – invitho (biopharmaceutical) Pharmacokinetic and Pharmacodynamic interaction, Adverse drug reactions. UNIT – III Neurohumoral transmission in CNS, ANS and somatic various system a. Molecular basis, underlying mechanism of action of adrenergic, Cholinergic, Dopaminergie, Serotoninergie and GBA ergie system. b. Pharmacological actions and possible physiological role of serotononin, Noradrenalene, Adrenaline. Acetylcholine and Dopamine. UNIT – IV Chemotherapy : a. Molecular and bio chemical mechanisms Pharmacology involved in the activity of various antiviral and anticancer drugs. b. Concepts on free radicle mediated injury, TAT inhibitors and its role in HIV. UNIT – IV Cardiovascular Pharmacology : Cardiotonics, Antiarrhythonics, Antihypertensive, antianginal & anti hyperlipidemic agents. UNIT – V Organisation of screening for the pharmacological activity of new substances with emphasis on the evaluation of antihypertensives, Cardiac, Psychopharmacological, analgesic, anti inflammatory anti diabetic, hepatoprotective, antistress and nootropic agents. UNIT – VI a Biotransformation of drugs : Phase I & II biotransformation reactions b. Excretion of drugs : Renal & nonrenal –Mechanisms and factors affecting. c. Clearance : Renals & hepatic clearance. d. Kinetics of drug absorption – compartment models evaluation of Pharmacokinetic parameters. UNIT – VII a. Design & testing of drugs in humans – clinical trials bio equivalence studies. b. Acute and Chronic toxicity studies in animals models. TEXT BOOKS: 1. Bio Pharmaceutics and Pharmacokinetics an introduction by Robert E.Notari 2. The Pharmacological basics of Therapeutics by Goodman and Gillman’s 3. Pharmacology by M.M.Ranga and H.D.Dale 4. Screening Methods in Pharmacology by Robert A.Turner Reference Books: 1. Drug Metabolism by Bernard Testa and Peter Jenner 2. Remington’s Pharmaceutical Sciences Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch 3. Drug Evaluation by voges 4. Methods in Pharmacology by Swarbrick 5. Basic and Clinical Pharmacology by Bertram G.Katzung 6. Clinical Pharmacology by Molmon and Morelli 7. Essentials of Medical Pharmacology by Tripathi. Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch Subject Code: R52256 ADVANCED PHARMACEUTICAL ANALYSIS UNIT – I Interpretation of FTIR spectra, Raman Spectroscopy 1Hz13CMR and its significance uses of 2D NMR techniques in the characterization of organic compounds. UNIT – II Analysis of drugs and excipients in solid state – particle size analysis, DTA, DSC, DGA – Principles, instrumentation, applications, X-ray diffraction – applications in Pharmacy, Powered XRD, single crystal x ray crystallography. UNIT – III Multi component analysis using uv spectro photometric method, radio immunoassay principle, theory application and methods. UNIT – IV Principles and procedures involved in the use of the following reagents in Pharmaceutical analysis. i. N, 1-naphthyl ethylene diamine ii P-dimethylamine benzaldehyde (DDNB) iii 2,6 Dichloro quinine chlorimide iv 2,3,5, Triphenyl tetrazolium salt v FC ragent vi P – dimethylamine cinnamaldehyde vii 3-Methyl, 2-benzothiazoline hydrazone viii 2,4 dinitrophenyl hydrazine ix DPPH UNIT – V Quality control and in process quality control of tablets, capsules, liquid dosage forms, pasenteral and sterile preparations. UNIT – VI Validation and calibration of various instruments used for drug analysis such as uv-visible spectrophotometer, IR spectro photometer, HPLC, GC, and HPTLC. UNIT – VII Study of principles and procedures involved in the following biological tests and assays tests for effectiveness of antimicrobial preservatives, absorbed diphtheria vaccine, adsorbed diphtheria, Microbiological assays of cyanocobalamine neomycin sulphate, oxytocin and tetanus toxoid. UNIT – VIII Quality Control Laboratory – Responsibilities, good laboratory practices, routine controls, instruments, protocol non clinical testing, stability testing of pharmaceuticals and shelf life predictions, ICH guidelines. Text Books: 1. Instrumental Analysis - Eving 2. Instrumental method of Analysis - Skog & West 3. B.K.Sharma - 4. Quantitative Analysis of Drugs - Jenkin 5. Introduction of Instrumental Analysis - Robert D.Braun Syllabi for Pre.PhD/Pre M.Phil/ Pre MS. W.e.f. 2005-2006 Batch Reference Books: 1. A Text Book of Pharmaceutical Analysis - Kenneth A.Connors 2. Instrumental Methods of Analysis - Willad, Dean & Merrit 3. Quantitative Analysis of Drugs - P.D.Sethi 4. Quantitative Analysis of Drugs - D.C.Garret 5. Pharmaceutical Analysis Modern Methods Part-A&B - J.W.Munson(Marcel Dekker) 6. IP, BP, USP 7. Vogel – Quantitative Analysis.