M.PHARM REVISED SYLLABUS
(2003-2004)
WITH MINOR MODIFICATIONS EFFECTIVE FROM 2004-2005 ACADEMIC YEAR ONWARDS
UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES
KAKATIYA UNIVERSITY, WARANGAL – 506 009.
SPECIALIZATIONS:
1Pharmaceutics
2.Pharmaceutical Chemistry
3.Pharmacognosy
4.Pharmacology
5.Industrial Pharmacy (Self – financing)
M. PHARM. (PHARMACEUTICS)
I Semester
Theory
M.I. CEU. T1: Advanced Physical Pharmaceutics:
1.
Theory of solubilization and solubilization techniques: solubility and solubilization of non electrolytes, solubilization by the use of surfactants, cosolvents, complexation, drug derivatisation and solid state manipulation.
2.
Theories of Dispersion: Solid liquid dispersion: adsorption, wetting, crystal growth mechanisms and prevention of crystal growth.
Emulsion: Formation and stability of emulsion with special emphasis on electrical theory, H.L.B, theory and di-electric properties. Preparation, evaluation, and applications of multiple and micro emulsions.
3.
Solid state properties: Crystal properties and polymorphism techniques for study of Crystal properties; solid state stability, flow properties of powders, segregation and its importance.
4.
Theories of compaction and compression: Compression, consolidation strength of granules, compression and consolidation under high loads, effects 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.
5.
Polymer Science: properties of polymers, thermodynamics of polymer solution, phase separation, polymers in solid state. Applications of polymers in pharmaceutical formulations.
6.
Diffusion and Dissolution: Diffusion, steady state diffusion procedures and apparatus. Diffusion principles in biological systems, Thermodynamics of diffusion. Dissolution : Basic theories of dissolution, models. Sink conditions in dissolution and its importance. In-vitro-in-vivo correlations.
7.
Kinetics and Drugs stability: Stability calculations, rate equation, kinetics of some decomposition, strategy of stability testing, methods of stabilization, methods of accelerated stability testing in dosage forms. Freeze thaw methods, centrifugal methods, temperature and humidity control.
M.I.CEU.T.2: BIO-PHARMACEUTICS & PHARMACOKINETICS
I.
Bio-availability, Bioequivalence and Therapeutics equivalence: Designing of bioavailability studies, and interpretation of results.
II. Physico-Chemical properties affecting bioavailability, pH – Partition theory, dissolution, surface area, adsorption, complexation, polymorphism etc., and techniques of enhancing dissolution rate.
III. Formulation factors affecting bioavailability of drugs in dosage forms of Tablets, capsules, parenterals, liquid orals and topical dosage forms.
IV. Basic concepts of pharmacokinetics: Compartmental 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 -
i) Absorption: (wherever applicable) Absorption rate constant, Absorption half life, lag time and extent of absorption, AUC
ii) Distribution: Apparent volume of distribution and its determination
iii) Metabolism: Metabolic rate constant.
iv) Elimination: Over all apparent elimination rate constant, and half life.
Under the following conditions:
a.
Intravenous bolus injection
b.
Intravenous infusion
c.
Single dose oral administration
d.
Multiple dose injections
e.
Multiple dosage oral administration.
v). Non invasive methods of estimating pharmacokinetic parameters with emphasis on salivary and urinary compartments.
vi). Concept of Clearance: Organ clearance, total clearance, hepatic clearance, gut wall, lung clearance and renal clearance.
V). Non-liner Pharmacokinetics: Concepts of linear and non linear pharmacokinetics, Michaelis - Menton kinetics characteristics. Basic kinetic parameters, possible causes of non induction, non linear binding, non linearity of pharmacological responses
VI) Time dependent pharmacokinetics: Introduction, classification, physiologically induced time dependency: Chronopharmacokinetics, chemically induced time dependency.
VII) Drug Metabolism – sites of metabolism, factors affecting drug metabolism (genetics, species and environmental).
VIII) Clinical pharmacokinetics: Altered kinetics in pregnancy, child birth, infants and geriatrics, kinetics in G.I. disease, malabsorption syndrome, liver, cardiac, renal and pulmonary disease states.
IX) Drug interactions: Kinetics of drug interaction, study of drug-drug interactions mediated through absorption, distribution, metabolism and elimination, Mechanisms of interaction and consequence. Influence of alcohol, smoking, food and beverages on drug action.
PRACTICALS
M.I.CEU.P.1 Practicals based on M.I.CEU.T.1
M.I.CEU.P.2 Practicals based on M.I.CEU.T.2
M.PHARM.
SEMESTER - II
M.II.CEU.T. 1: ADVANCES IN DRUG DELIVERY SYSTEMS
A.
Fundamentals of controlled drug delivery system, Theory of mass transfer, use of polymers in controlled drug delivery, pharmacokinetic and Pharmacodynamic basis of controlled drug delivery. Design, fabrication, evaluation and applications of the following controlled release systems.
1.Controlled release oral drug delivery systems.
2.Parenteral controlled release drug delivery systems
3.Implantable therapeutic systems.
4.Transdermal therapeutic systems and iontophoresis.
5.Ocular and intrauterine delivery systems.
6.Bioadhesive drug delivery systems.
7.Proteins and peptide drug delivery.
B.Biochemical and molecular biology approaches to controlled drug delivery.
1.Micro particulate drug carriers: Liposomes, Neosomes, Micropspheres, Nanoparticles and Resealed erythrocytes.
2.Monoclonal antibodies for drug delivery.
C. Drug targeting to particular organs:
1.Drug delivery to respiratory system.
2.Problems of drugs delivery to the brain and targeting to brain.
3.Drug delivery to eye.
4.Drug targeting in neoplastic diseases.
D. Drug carrier systems targeted to widely dispersed cells.
1.Delivery to Macrophages.
2.Delivery to lymphoid cells of Immune network.
3.
Delivery to lysosomal storage diseases.
M.II.CEU.T.2. ADVANCED PHARMACEUTICAL TECHNOLOGY
1. Preformulation studies:
Goals of preformulation, preformulation parameters, methodology, solid state properties, Solubility and partition coefficient, Solubility and dissolution, Modern concepts in rheology, Drug excipient compatibility.
2. Formulation Development:
(a) Solid dosage forms:
Improved production techniques for tablets: New materials, process, equipments improvements, high shear mixers, compression machines, coating machines, coating techniques in tablet technology for product development, physics of tablet compression and computerization for in process quality control of tablets.
(b) Powder dosage forms:
Formulation development and manufacture of powder dosage form for internal and external use including inhalation dosage forms.
(c) Liquid and Semi-solid dosage forms:
Recent advances in formulation aspects and manufacturing of monophasic dosage forms, recent advances in formulation aspect and manufacturing of suspensions and semi-solid dosage forms.
(d) Parenteral dosage forms:
Advances in materials and production techniques, filling machines, sterilizers and aseptic processing.
(e) Aerosols:
Advances in propellants, metered dose inhaler designs, dry powder inhalers, selection of containers and formulation aspects in aerosol formulation, manufacture and quality control.
3. Aseptic Processing Operation:
Introduction, contamination control, microbial environmental monitoring, microbiological testing of water, microbiological air testing, characterization of aseptic process, media and incubation condition, theoretical evaluation of aseptic operations.
4. Quality control: Process and Dosage form:
Process control: Control of manufacturing process, statistical quality control, control charts, of automated process control, Dosage form control, Testing programme and method, product identification system, Adulteration and misbranding, Drug information profile.
5. Optimization techniques in pharmaceutical and processing
Optimization parameters, statistical design and other applications, design, development and optimization of in-vitro test systems to evaluate and monitor the performance of different types of dosage forms, relevance and importance of in-vitro/in-vivo associations at every stage of product development and manufacture, regulatory evolution and current thinking on this aspect, application of statistical techniques in product development and evaluation including quality control.
6. Documentation:
Importance of documentation, statutory requirement and procedure for documentation, critical examination of documents.
7. Scale-up Techniques:
Effect of scale up on formulation, process parameters like mixing, granulation, drying, compression, coating, packaging, stability, selection and evaluation of suitable equipments.
8. Process Validation
Regulatory basis, validation of solid dosage forms, Sterile products, Liquid dosage forms. Process validation of raw materials, Validation of analytical methods, Equipment, and process.
9. Packaging Technology:
Packaging materials, Closures and containers units of dose packaging, blister packing, strip packing. FDA regulations, packs for tablets, capsules, ointments and aerosols.
PRACTICALS
M.II.CEU.P. 1 Practicals based on M.II.CEU.T. 1
M.II.CEU.P. 2 Practicals based on M.II.CEU.T. 2
M. PHARM. SEM - I (PHRAMACEUTICAL CHEMISTRY)
M.I.CHEM.T.1 ADVANCED ORGANIC CHEMISTRY
I. Stereochemistry of Carbon and Nitrogen Compounds:
(i) Optical Isomerism (due to asymmetric or chiral carbon atoms)
Compounds with one asymmetric carbon atom, compounds with two or more unequal asymmetric carbon atoms, compounds containing like asymmetric carbon atoms, compounds with asymmetric carbon atoms in branched chains.
(ii) Stereo-chemistry of Biphenyls
(iii) Racemic modification:
Nature of racemic modifications, formation of racemic modifications, (a) by mixing, (b) by synthesis, (c) by racemization and (d) by chemical transformation.
(iv) Configuration:
Definition, notation, absolute configuration and Relative configuration.
(v) Synthesis of optically active compounds:
Stereoselective synthesis and stereospecific synthesis
(vi) Stereo-chemistry of Nitrogen Compounds:
II. Mechanisms of Organic Reactions: Mechanism of free radical addition, substitution and plymerisation reactions, Mechanism of electrophilic addition and substitution reactions, mechanism of nucleophilic addition and substitution (SN1 & SN2 ) reactions, Elimination Reactions, mechanistic features of E1 & E2 reactions, Saeytzef’s rule, Hofmann’s rule; Hofmann’s Vs. Saeytzef’s; substitution Vs, Elimination. Factors influencing Nucleophilic substitution and Elimination reactions with suitable examples. Electrocyclic Reactions, Pericyclic reactions and Sigmatropic Reactions.
Molecular Rearrangements: Claisen allylation, Wagner Meerwein Rearrangement of Bicylic C10 - Terpenes, Wolf Rearrangement, pinacol-pinacolone Rearrangement.
III. Reagents and their synthertic applications:
Methods of preparation, physical and chemical properties and important synthetic applications of the following reagents:
1.
Lithium aluminium hydride(LAH) & Sodium borohydride.
2.
N-Bromosuccinimide (NBS)
3.
Lead tetra acetate (LTA)
4.
Diazomethane (DM)
M.I.CHEM.T.2 ADVANCED MEDICINAL CHEMISTRY – I
I. Genesis of New Drugs: Source, random screening, leads from natural products, moleculer modifications, prodrug and soft drug concepts.
II. Theoretical aspects of drug design: Structural features and pharmacological activity, significances of various types of isomerism with respect to pharmacological activity, concept of isosterism.
III. Pscychopharmacological agents: a) Biochemical basis of mental disorders:- Abnormal protein factors, endogenous amines and related substances, faulty energy metabolism, genetic factors and nutritional disorders; Phenothiazines: chemistry, synthesis and evaluation methods. The important pharmacological activities of phenothiazines; SAR of phenothiazines, toxicity and clinical significance of phenothiazines.
b) Antidepressants: MAO inhibitors, tricyclic antidepressants and Miscellaneous compounds. Mechanism of action, clinical and biological uses, side effects and their SAR studies. Synthesis of clinically useful drugs of each of the above classes.
IV. Chemothorapy of Cancer: A detailed classification of antineoplatic agents, mechanisms of action of different classes; Alkylating agents and radiomimetic agents, antimetabolites, their SAR studies, sex hormones & analogs, and antibiotics. A mention of natural products used in cancer treatment; Vinca alkaloids (Vincristine and Vinblastine) podophyllum and paclitaxel.
V. Drugs Related to Hormones and other autocoids: A study of the following hormones and other autocoids with a special reference to their agonists and antagonists:
a)
Peptide Hormones: Insulin, Vasopressin and Oxytocin.
b)
Histamine (H1 and H2) and 5-HT.
c)
Thyroid Hormones (T3 and T4).
PRACTICALS
M.I.CHEM.P: 1 Practicals based on theory M.I. CHEMI. T.1.
M.I.CHEM.P.2: Practicals based on theory M.I.CHEM.T2
M.PHARM. II SEMESTER
M.II.CHEM.T.1 ADVANCED MEDICINAL CHEMISTRY-II
I. Theoretical Aspects of Drug Action: Receptors, their types, location and isolation, types of interactions with the drug molecules, dosage-response relationships, mechanisms of drug action (Receptor theories).
II. Rational Drug Design: QSAR: parameters involved in QSAR, lipophilicity, polarisability, electronic and steric parameters. Quantitative models. Hansch analysis, Free Wilson analysis and their relationships, linear relationships and applications of Hansch and Free-Wilson analysis.
III. Enzyme Inhibitors-I: A detailed study of the following types of enzyme inhibitors, related drugs and their pharmaceutical significance:
a)
P.G. Synthetase (cycloxygenese and lipoxygenase inhibitors)
b)
Phosphodiesterase (PDE) inhibitors.
c)
Carbonic anhydrase inhibitors.
d)
Angiotensin converting of Enzyme (ACE) Inhibitors,
e)
Acetylcholine esterase (AChE) Inhibitors.
IV. Drug Metabolism:
a)Introduction. b) Drug bio-transformation pathway (Phase I metabolism): Human hepatic cytochrome P450 enzyme system, oxidation catalyzed by cytochrome P450 isoforms, N-and S-oxidations catalyzed by flavin monooxygenase, and Non- microsomal oxidations.
c) Drug conjugation pathways (Phase II metobolism).
V. Miscellaneous Classes of Drugs: Recent advances in the following classes of drugs:
a)
Proton-pump inhibitors as antiulcer agents.
b)
Immunosuppressive and immunostimulant agents.
c)
Antiviral agents.
d)
β – Adrenergic blockers.
II SEMESTER
M. PHARMACY (PHRMACEUTICAL CHEMISTRY)
M.II.CHEM.T.2 ADVANCED CHEMISTRY OF NATURAL PRODUCTS
(Theory)
I. Alkaloids: Study of the following classes of alkaloids.
a)
Alkaloids of Opium: Structure elucidation of Morphine, Opioid receptors; Endorphines and Enkephations; structure activity relationships in morphine molecule; Development of morphine analogues based on SAR; relative potencies; antitussive agents; antidiarrhoeals; morphine antagonists.
b) Alkaloids of Atropa belladonna ; Atropine, Hyoscyamine and Hyoscine; Structure elucidation of Atropine; Structural considerations of Atropine; Homatropine; Therapeutic uses.
c) Alkaloids of Vinca rosea ; Vincristine and vinblastine; Structure elucidations; Structural modifications and semisynthetic derivatives.
d) Alkaloids of Ergot: Classification; Structures; Structure elucidation of Erogometrine; therapeutic uses of ergot alkaloids and derivatives (vinyl and methylsergide).
II Steroids:
a)
Steroid nomenclature, stereochemistry and numbering; New insights on steroid receptors; chemical and physical properties of steroids; changes to modify pharmacokinetic properties of steroids.
b)
Sources and structure elucidation of cholesterol; sources and structures of related steroids – Ergosterol. Stigmasterol, β- sitosterol and Diosgenin.
c)
Steroidal Anti-inflammatory Agents; structures; structure-activity relationships; therapeutic uses.
d)
Steroidal Anti-fertility agents: Structures; mechanism of action; regimen.
e)
Anabolic Steroids: Structures; uses.
f)
Steroids in the treatment of cancers.
III Antibiotics:
a) Cephalosporins: Historical background; Nomenclature; Natural and semi- synthetic cephalosporins; cephamycins; classifications; structures; chemical degradations;spectrum of activity; β – Lactamase resistance; Antipseudomonal cephalosporins.
b) Anticancer Antibiotics: Source, structure, description of the structural features, mechanism of action, SAR, uses of the following antibiotics.
i) Actinomycines – Dactinomycin.
Anthracyclines – Daunorubicin and Doxorubicin – Their metabolic products: Daunomycinol and Adriamycinol- Their semisynthetic derivatives: the 4’-Deoxy and 4’-epidoxorubicines. Nogalamycin and menogaril.
ii) Aureolic acid group – Mithramycin
iii) The Bleomycines, Mitomycins and streptozocin.
IV A Brief Account of the Following:
a) Anticancer Agents of Plant Origin: Sources and structures of podophyllotoxin, Taxol and camptothecin; their semi synthetic derivatives; their uses and mechanism of action.
b)Ginseng: Historical background; structures of Ginsenosides, protopanaxadiols and triols; uses.
c) Phototherapy: sources and structures of psoralens; Photodegradation of 8 – methoxypsoralen; PUVA therapy in psoriasis and ritiligo; khellin and KUVA therapy xanthotoxin in the treatment of psoriasis.
PRACTICALS
M.II.CHEM.P.1: Practical based on M.II.CHEM.T.1.
M.II.CHEM.P.2 : Practical based on M.II.CHEM.T.2. (Detailed list of Experiments included)
M. PHARM (PHARMACEUTICAL CHEMISTRY) II SEMESTER
ADVANCED CHEMISTRY OF NATURAL PRODUCTS (PRACTICALS)
I. Isolation, purification and characterization of some of the following phytoconstituents.
a. Piperine from Black pepper
b. Strychnine and Brucine from Strychnos nuxvomica
c. Caffeine from Tea powder
d. Curcumin from Turmeric
e. Bixin from Bixa orellena
f. Diosgenin from Dioscorea tubers
g. Sennosides from Senna
h. Hesperidin from orange peel
i. Embelin from Embelia ribes
j. Glycyrrhizin from Glycyrrhiza glabra
k. Plumbagin from plumbago rosea
l. Pectin from orange peel
m. Tannins from myrobalans
II. The use of Column chromatography, Flash Chromatography and Vacuum liquid chromatography in the isolation of some of the above mentioned phytoconstituents.
M.PAHRM. (PHARMACOGNOSY) I SEMESTER
MAJOR COURSES
M.I.COG.T.1I - MEDICINAL PLANT BIOTECHNOLOGY
A. Historical perspectives, prospects for development of plant biotechnology
as source of medicinal agents. Applications in pharmacy and allied fields.
B. Types, techniques, nutritional requirements and growth of plant tissue cultures. Organogenesis and embryogenisis. Protoplast fusion and cultures, artificial seeds, micropropogation of medicinal and aromatic plants. Genetic stability of tissue cultures.
C. Secondary metabolism in tissue cultures with emphasis on production of medicinal agents and its impact in pharmacy. Screening and selection of high yielding cell lines. Effect of cultural practices, precursors and elicitors on production of biomedicinals.
D. Biotransformation, bioreactors, industrially potential tissue culture systems for pilot and large scale cultures of plant cells, cellular totipotency, cryopreservation and retention of biosynthetic potential in cell cultures.
E. Immobilized plant cell culture systems, immobilization techniques, effect of immobilization on secondary metabolism and realization of chemosynthetic potential in immobilized cells.
F. Genetic transformation methods, Hairy root cultures and their applications.
G. Techniques employed in elucidation of biosynthetic pathway. Biogenesis of tropane, quionoline, Imidazole, Isoquinoline and Indole alkaloids; Sterols, Anthraquinone and Saponin glycosides; Flavanoids; and Isoprenoid compounds of pharmaceutical significance.
M.I.COG.T.2 INDUSTRIAL PHARMACOGNOSY-I
A.
Exogenous and endogenous factors influencing production of crude drugs. Plant growth regulators and their applications in pharmacy. Disease management of medicinal and aromatic plants. Variability in crude drug activity.
B.
Technology for commercial scale cultivation and processing of following aromatic plants: Lemongrass, Geranium, Basil, Palmarosa, Vetiver, Patchouli, Japanese Mint, Rose, Hops, Clove, Cardamom, Cinnamom Jasmine, Sandal, Dill, Celery, Anise, Davana.
C.
Phytochemical screening of crude drugs : Extraction and qualitative evaluation for drug constituents.
D.
Pharmaceutical aids: Profile for manufacture and commerce of Papain, Pectin, Pharmaceutical gums, Starch, Absorbent cotton and Gelatin.
PRACTICALS
M.I.COG.P.1. Medicinal Plant Biotechnology
1. Representative exercises based on establishment of callus and suspension cultures. Study of their growth profiles. Aseptic transfer of bio-mass.
2. Experiment for exogenous, nutritional and precursor factors of influencing production of metabolites in tissue cultures.
3. Establishment of some hairy root cultures and study of their growth and bioproductive profile.
M.I.COG.P.2. Industrial Pharmacognosy – I
1. Phytochemical screening of plant extracts : Preparation of extracts and detection of phytoconstitutents by different techniques.
2. Representative exercised based on extraction of pharmaceutical aids and volatile oils listed in theory.
II semester
M.II.COG.T.1 Industrial Pharmacognosy-II
A. Profiles for commercial cultivation technology/and post-harvest care of following medicinal plants : Ashwagandha, Periwinkle, Medicinal Yams, Ergot, Guggul, Belladonna, Senna, Neem, Papaya, Opium poppy, Psyllium, Steroid bearing Solanums, Ammi majus, Ipecac, Cinchona, Liquorice, Safed Musli, Aloe, Henbane, Digitalis, Saffron.
B. Bioactive Compounds: Occurrence, Methodology for extraction and chemical nature of sennosides, digoxin, ginsenosides, solasodine, berberine, quinine, scopolamine, atropine, emetine, ergot alkaloids, caffeine, taxol, withanolides, podophyllotoxin, cod-liver oil, shark-liver oil.
C. Preparation of standardized extracts suitable for incorporation in solid dosage forms like tablets, capsules etc.
D. Herbal formulations : Types of herbal formulations. 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.
E. World Health Organisation guide lines for herbal drugs including standards for pesticide residue / aflatoxins. Current status of regulatory affairs for herbal formulations.
M.II.COG.T.2. ADVANCED PHARMACOGNOSY
(a) Problems encountered in and prospects of discovering new drugs from plants. Natural substances as raw materials in drug synthesis. Biomedicinals of recent discovery.
(b) Emerging plant drugs: A review of hepatoprotective, antimalarial and anti-hypertensive.
(c) Current status of anti-cancer, anti-HIV and anti-diabetic plant drugs. Immunomodulatory herbal drugs.
(d) Bioevaluation of herbal drugs.
(e) Application of various chromatotgraphics techniques and spectrometry to natural products: TLC, GLC and HPLC; Flourimetry and colorimetry. Uses of UV, IR, NMR and mass spectrometry in the structural elucidation of natural products.
(f) Recent trends in utilization of vegetable laxatives and vegetable bitters.
(g) Natural sweetening agents and coloring agents.
(h) Hallucinogenic, allergic, teratogenic and other toxic plants. Drugs and Pharmaceuticals from marine source (Marine Pharmacognosy) with special reference to cardiovascular, cytotoxic, antimicrobial and anti-inflammatory compounds.
(j) Endangered species of medicinal plants. Current status of plants used in alternative system of medicines.
II SEMESTER
M. II.COG. P.1. INDUSTRIAL PHARMACOGNOSY – II (PRACTICALS)
1)
Representative exercises based on extraction of bioactive compounds listed in theory.
2)
Preparation of selected poly-herbal formulations.
M.II.COG. P.2. ADVANCED PHARMACOGNOSY (Practical)
1)
Representative exercises based on physical, chemical and biological techniques of evaluation of plant constituents/extracts.
I SEMESTER
M.PHARM. (PHARMACOLOGY)
M.I.COL.T.1. ADVANCED PHARMACOLOGY – I
I.
Drugs acting at synoptic and neuro effecto junctional sites.
A.
Autonomic & somatic nervous systems.
B.
Muscarinic receptor agonists & antagonists.
C.
Anticholinesterases
D.
Agents acting at NMJ and autonomic ganglia
E.
Sympathomimetic drugs. Catecholamines and adrenergic antagonists.
II.
Drugs acting on the Central Nervours 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 & abuse
III.
Drugs affecting renal and cardiovascular function
A.
Diuretics
B.
Renin & Angiotensin
C.
Drugs used in the treatment of
1.
Myocardial Ischemia
2.
Hypertension
3.
CHF
4.
Hyperlipidemia
IV.
Drugs acting on the blood & blood forming organs
A.
Growth factors
B.
Anticoagulants, thrombolytics & antiplatelet drugs.
M.I.COL.T.2. ADVANCED PHARMACOLOGY – II
I. Autacoids; Drug therapy of Inflammation
A.
Histamine, Bradykinin & their antagonists
B.
Eicasonoids & PAF
C.
Antiinflammatory, analgesic & antipyretic agents
D.
Antiasthmatic agents.
II. Drugs affecting gastro intestinal function.
A.
Agents for control of acidity and antiulcer drugs
B.
Emetics & anti emetics.
III. Chemotherapy of
A.
Malaria
B.
Microbial infections.
(i)
Fluroquinolones
(ii)
Cephalosporins and other newer agents
(iii)
Antifungal & antiviral drugs including Anti HIV drugs.
C.
Neoplastic diseases
IV. Oral hypoglycemic agents.
V. Estrogens, Progestins and Androgens.
PRACTICALS
M.I.COL.P.1 Practicals based on theory M.1.COL.T.1.
M.I.COL.P.2 Practicals based on theory M.1.COL.T.2.
II SEMESTER
M.PHARM (PHARMACOLOGY)
M.II.COL.T.1. I. Clinical Pharmacology & Pharmacotherapeutics
I. Principles of Pharmacokinetics
A.
Revision of basic concepts
B.
Clinical Pharmacokinetics
i.
Dose – response in man
ii.
Influence of renal and hepatic disease on pharmacokinetics
iii.
Therapeutic drug monitoring
iv.
Population pharmacokinetics
II. Adverse Drug Reactions, Drug Interactions and ADR monitoring.
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.
IV. Drug therapy in
A.
Geriatrics
B.
Pediatrics
C.
Pregnancy & Lactation
V. Pharmacogenetics: Interracial and individual variability in drug metabolism.
M.II.COL.T2. & M.II.ELE.T.2.
SCREENING METHODS IN PHARMACOLOGY AND CLINICAL RESEARCH
1. a. Drug discovery process: Principles, techniques and strategies used in new drug discovery. High throughput screening, human genomics, robotics and economics of drug discovery. Regulations for laboratory animal care and ethical requirements.
b. Bioassays: Basic principles of bioassays, official bioassays, experimental models and statistical designs employed in biological standardization. Biological standardization of vaccines and sera, vasopressin, oxytocin, Acetylcholine, Adrenaline, insulin, d-tubocurarine, HCG, hyaluronidase, corticotrophine, pertussis, rabies and plague.
c. Introduction to biostatistics, parametric and non parametric tests.
2. Preclinical and clinical models employed in the screening of new drugs belonging to following categories
Antifertility agents, sympathomimetics, parasympathomimetics, muscle relaxants (both central and peripheral), sedatives, hypnotics, antiarrhythmic agents, cardiac stimulants, cardiotonic agents, bronchodilators, antihistaminics, eicosanoids.
Antipsychotic agents, antianxiety agents; nootropic drugs; antidepressant drugs; antiParkinsoinan agents; antiepileptics; analgesics and anti-inflammatory agents; antiulcer agents; infarction; antiatherosclerotic drugs; antimalarials; anthelmintics; antidiabetics; models for status epilepticus, intracerebroventricular and other newer techniques of drug administration and development; transgenic animals and other genetically prone animal models.
3. Alternatives to animal screening procedures, cell-line, patch-clamp technique, in-vitro models, molecular biology techniques.
4. Principles of toxicity evaluations, ED50, LD50 and TD values. International guidelines (ICH recommendations).
PRACTICALS
M.II.COL.P.1. Clinical pharmacology and pharmocotherapeutics practicals based on M.II.COL.T.1.
M.II.COL.P.2. Screening Methods in pharmacology and clinical Research practicals based on M.II.COL.T.2.
M.Pharm. (Industrial Pharmacy)
I – SEMESTER
M.I.IND.T.1: Quality Assurance & Regulatory affairs:
1.
Design and instrumentation of the buildings and their maintenance as per current good manufacturing practices for the bulk production of different pharmaceutical dosage forms.
2.
Installation, validation and maintenance of typical equipment used in the bulk manufacture and packaging different dosage forms with a special reference to GMP models.
3.
Good manufacturing practices, production optimization and process validation of raw materials and analytical methods, with a special reference to sterile products and solid dosage form. CGMP, GLP, ISO 9002 and documentation.
4.
Quality Control: Process and Dosage form: Process control: Control of manufacturing process, statistical quality control, control charts of automated process control, Dosage form control. Testing programme and methods, product identification system, Adulteration and misbranding, Drug information profile.
5.
Optimization techniques in Pharmaceutical and Processing: Optimization parameters, statistical design and other applications, design development and optimization of in-vitro test systems to evaluate and monitor the performance of different types of dosage forms, the relevance and importance of in- vitro/in-vivo associations at every stage of product development and manufacture, the regulatory evaluation and current thinking on this aspect, application of statistical techniques in product development and evaluation including quality control.
6.
Documentation: Importance of documentation, statutory requirement and procedure for documentation, critical examination of documents.
7.
Process Validation: Regulatory basis, validation of solid dosage forms, sterile products, liquid dosage forms. Process validation of raw materials, validation of analytical methods, equipment and process.
8.
New Drug Application: Steps involved in the development of a new drug. New drug application as per WHO guidelines and abbreviated NDA. Requirement and guidelines on clinical trials for import and manufacture.
9.
Industrial Safety: Industry hazards due to fire accidents, mechanical and electrical equipment, chemicals and pharmaceuticals. Monitoring and prevention systems. Industrial efficiency testing.
10.
Stability Studies: ICH guidelines and WHO guidelines and stability protocols for dosage forms.
M.I.IND.T.2 & M.I.CEU.T.2: Bio-Pharmaceutics & Pharmacokinetics
I. Bio-availability, Bioequivalence and Therapeutic equivalence: Designing of bioavailability studies, and interpretation of results.
II. Physico-Chemical properties affecting bioavailability, pH-partition theory, dissolution, surface area, adsorption, complexation, polymorphism etc., and techniques of enhancing dissolution rate.
III. Formulation factors affecting bioavailability of drug in dosage forms of tablets, capsules, parenterals, liquid oral and topical dosage forms.
IV. Basic concepts of Pharmacokinetics: Compartmental 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.
i.
Absorption: (wherever applicable) Absorption rate constant. Absorption half life, lag time and extent of absorption, AUC.
ii.
Distribution: Apparent volume of distribution and its determination.
iii.
Metabolism: Metabolic rate constant and its determination.
iv.
Elimination: Over all apparent elimination rate constant and half life.
Under the following conditions:
a)
Intra venous bolus injection
b)
Intra venous infusion.
c)
Single dose oral administration.
d)
Multiple dose injections.
e)
Multiple dosage oral administration.
v. Non invasive methods of estimating pharmacokinetic parameters with emphasis on salivary and urinary compartments.
vi. Concept of clearance: Organ clearance, total clearance, hepatic clearance, gut wall clearance, lung clearance and renal clearance.
V) Non-liner Pharmacokinetics: Concepts of linear and non linear pharmacokinetics, Michaelis - Menten kinetics characteristics. Basic kinetic parameters, possible causes of non induction, non linear binding, non linearity of pharmacological response.
VI) Time dependent Pharmacokinetics: Introduction, classification, physiologically induced time dependency: Chronopharmacokinetics, chemically induced time dependency.
VII) Drug Metabolism – sites of metabolism, factors affecting drug metabolism (genetics, species and environmental).
VIII) Clinical Pharmacokinetics: Altered kinetics in pregnancy, child birth, infants and geriatrics, kinetics in G.I. disease, malabsorption syndrome, liver, cardiac, renal and pulmonary disease states.
IX) Drug interactions: Kinetics of drug interaction, study of drug-drug interactions mediated through absorption, distribution, metabolism and elimination, Mechanisms of interaction and consequence. Influence of alcohol, smoking, food and beverages on drug action.
PRACTICALS
M.I.IND.P.1. Practicals based on M.I.IND.T.1.
M.I.IND.P.2. Practicals based on M.I.IND.T.2.
SEMESTER - II
M.II.IND.T.1: Advances in drug delivery systems
1. Review of Fundamentals of controlled drug delivery systems
Fundamentals, rationale of sustained/controlled drug delivery, factors influencing the design and performance of sustained/controlled release products, Pharmacokinetic/Pharmacodynamic basis of controlled drug delivery. Types and structure of polymers, Use of polymers in controlled release of active agents, Biocompatibility of polymers and methods to improve it, Polymer degradation, Module for gastrointestinal tract. Transdermal module, Module for eye.
2. Drug targeting principles and approaches:
Active and passive targeting. Tumor targeting, Bone marrow targeting. Brain targeting, Antibody-drug conjugates, Limitations of antibody targeting, Drug loading, Receptor saturation, Biodistribution of antibody, Radioisotopes, Further prospects.
3. Design and fabrication of controlled release drug delivery systems:
Principle involved and Formulation of : Oral dosage forms – Diffusion system, Reservoir devices, Osmotic systems, Systems utilizing dissolution, Systems utilizing ion exchange resins, prodrugs, Multiple Emulsions, Parenteral dosage forms, Intramuscular injections, implantable therapeutic systems, Colon specific systems, Transmucosal systems and mucoadhesive systems, Nasal delivery, Ocular systems, intravaginal and intrauterine systems, Lung delivery systems.
4. Carrier Based delivery system:
Principle involved and Formulation of : Microparticulate drug carriers, Liposomes, Niosomes, Microspheres, Magnetic microspheres, Cellular-particulate systems, Resealed erythrocytes.
5. Delivery of peptides/proteins/Biotechnology Drugs: formulation
aspects:
Preformulation studies and problems: Protectants, delivery kinetics. Overview of delivery systems, Site specific proteins, Stability problems, Evaluation of recombinant proteins.
6. Vaccine delivery:
Evidence and mechanism of uptake and transport, Monoclonal antibodies, Delivery systems used to promote uptake, Absorption enhancers, Lipid carrier systems, Oral immunization, Peyer’s patches, Common mucosal immune system, Controlled release microparticles for vaccine development, Single dose vaccine delivery systems using biodegradable polymers.
M.II.IND.T.2: ADVANCED PHARMACEUTICAL TECHNOLOGY
1. Preformulation studies:
(A) Goals of preformulation, Preformulation parameters, Methodology, Solid state properties, Solubility and Partition coeffcient, Solubility, Modern concepts in rheology, Drug excipient compatibility.
(B) Dissolution: Theory, Mathematical models, types of dissolution equipments, sink condition and its importance. Automation in dissolution, “In-vitro / In-vivo” correlations, Recent advances in dissolution testing.
2. Excipients used in pharmaceutical dosage forms:
(a) Polymers
(b) Properties and selection criteria for various excipients like surfactant, viscosity promoters, diluents, coating materials, plasticizers, preservatives, flavors and colours.
3. Formulation Development:
(a) Solid dosage forms:
Improved Production techniques for tablets: New materials, process, equipments improvements, high shear mixers, compression machines, coating machines, Coating techniques in tablet technology for product development, Physics of tablet compression computerization for in process quality control of tablets, types of tablets and their manufacture Formulations, production and evaluation of hard and soft gelatin capsules.
Powder dosage forms:
Formulation development and manufacture of power dosage form for internal and external use including inhalations dosage forms.
(b) Compaction and compression:
compaction of powders with special reference to distribution and measurement of forces in the powder mass undergoing compression. Effect of particle size, moisture content and lubrication on the strength of tablets.
(c) Liquid and Semi-solid dosage forms:
Recent advances in formulation aspects and manufacturing of monophasic dosage forms. Recent advances in formulation aspects and manufacturing of suspensions, dry syrups and Semi-solid dosage forms.
(d) Parenteral dosage forms:
Advances in materials and production techniques, filling machines, sterilizers and aseptic processing. Manufacturing of small and large volume parenterals and quality control.
(e) Aerosols:
Advances in propellants, metered dose inhaler designs, dry powder inhalers, selection of containers and formulation aspects in aerosol formulation, Manufacture and quality control.
4. Aseptic processing operation:
Introduction, contamination control, microbial environmental monitoring, microbiological testing of water, Microbiological air testing, characterization of aseptic process, media and incubation condition, theoretical evaluation of aseptic operations.
5. Pilot plant and scale-up techniques for the production of different pharmaceutical dosage forms.
6. Packaging Technology: Packaging materials, closures and containers, unit dose packaging, blister packing, strip packing. FDA regulations, packaging of tablets, capsules, ointments and aerosols.
PRACTICALS
M.II.IND.P.1: Practicals based on theory M.II.IND.T.1.
M.II.IND.P.2: Practicals based on theory M.II.IND.T.2.
ELECTIVES OF I SEMESTER M.I.ELE.T.1. DRUG REGULATORY AFFAIRS AND INTELLECTUAL PROPERTY
RIGHTS
1.Pharmaceutical development:
Preformulation studies, introduction to solid, liquid and semi-solid dosage forms, controlled release prearation, injection, ocular preparation, regulatory requirements as per European community, united states, and Indian regulatory authorities.
2. Manufacturing:
Introduction, regulatory requirements as per European community, united slates, Indian and other regulatory authorities for manufacturing information, manutacturing formula, process, validation of manufacturing process, equipment, documentation, inspection requirements, regulatory guidelines for active ingredients, data requirement for new drug as per regulatory requirements as per European community, united states, Indian and other regulatory authorities, international aspects of excipients approval as per guidelines of all the territories. Regulatory guidelines for packaging materials, test and evaluation of packaging materials, biological test elastomer test, microbiological test and evaluation of closures.
3. Stability testing:
Introduction, scientific and technical background to the design of stability testing, regulatory requirements as per European community, united states, Indian and other regulatory authorities for testing of new active substances, bulk active drug substances, dosage form in their final packaging. Extension of shelf life after authorization of drug, international harmonization and current guidelines.
Analytical method validation as per, regulatory requirements of European community, united states, Indian and other regulatory authorities, pharmacokinetic and toxicokinetic validation.
4. Biopharmaceutics:
Introduction, definition, factors related to formulation, dosage form, manufacturing process, stability, storage, different testing parameters and
standards as per regulatory requirements of European community, united states, Indian and other regulatory authorities.
5. Preclinical aspects of biopharmaceutics, clinical bioavailability, study design, presentation, documentation, statistical analysis, current guidelines and developments as per regulatory requirements of European community, united states, Japanese, Indian and other regulatory authorities.
6. Clinical pharmacology and Pharmacodynamics:
Introduction, regulatory requirements, pharmacokinetics in men, ethnic, genetic and environmental factors.
Clinical study design, documentation, presentation and interpretation.
Clinical trials: definition, phase I, Phase II, Phase III, and phase IV studies, design documentation, presentation and interpretation, statistical analysis of clinical data, factorial design, guidelines as per European community, united states, Japanese, Indian and other regulatory authorities.
6. Intellectual property rights:
Introduction, purpose, international scenario and Indian scenario, guidelines as per European community, united states, Indian and other regulatory authorities documentation, presentation, application.
M.I.ELE.T.2. CELL AND MOLECULAR BIOLOGY
I. Structural Organization of life.
A.
The cell doctrine
B.
Cell types
C.
Organization of Pro and Eukaryotes
II. Surface artchitecture
A.
Extracellular environment
B.
Cell wall, surface, projections
C.
Cell recognition, aggregation.
III. Cell membrane: Structure and Functions
A.
Molecular models, transport
B.
Transmembrane signals
C.
Antigen mediated responses.
IV. Nucleus and Cytoplasmic matrix
A.
Nucleus
B.
Chromatin and Chromosomes
C.
Cytoplasm & cytoskeleton
D.
Endo membrane systems.
V. Cell growth and Division.
VI. Molecular Organization and Genome
A.
Concept of Gene
B.
Behaviour of the Genome
VII. DNA Replication and Transcription
A.
Replication: Mechanism, Enzymes.
B.
Transcription: Mechanism, Enzymes.
VIII. Mechanism of Protein Synthesis.
IX. Genetic recombination
A.
Plasmids
B.
Transduction and Transformation.
X. Molecular basis of mutation.
A.
Souce of variations, types of mutations
B.
Chromosomal aberrations
XI. Cell differentiation
A.
Factors affecting differentiation
B.
Levels and mechanism of diffentiation.
XII. Molecular biology of aging and cancer.
A.
Theories of aging.
B.
Types of tumors, Etiology of cancer
C.
Carcinogenesis.
M.I.ELE.T.3. ADVANCED INSTRUMENTAL METHODS OF ANALYSIS
I.A. Theory, knowledge of instrumentation and application with regard to drug analysis, decomposition product identification and estimation, metabolite analyses, and special methods based on the following.
Ultraviolet – visible spectrophotometry
Infrared spectrophotometry
Fluorimetry
I.B. Theory, knowledge of instrument and basic principles of :
i) 1H Nuclear Magnetic Resonance Spectroscopy (1H NMR): Concepts of chemical shift, spin spin coupling, coupling constant, shielding and deshielding effects.
ii) Mass Spectroscopy; Introduction, different techniques of ionization (CI, EI & FAB MS) isotopic abundance, molecular on fragmentation, base peaks etc., Nitrogen rule.
II. Chromatographic methods (Gas – chromatography including GC-MS; High
performance liquid chromatography; electrophoresis (gel and capillary) with an emphasis on specific examples in biological assay methods.
III. Special Techniques:
a)
Immunological methods (RIA – ELISA)
b)
H.P.C.P.C.
c)
H.P.T.L.C.
d)
Super critical liquid chromatography
IV. Good laboratory practices (GLP), Laboratory maintenance standard operating procedure (SOPs), Methods of validation.
BOOKS RECOMMENDED
M.I.ELE.T.3
1. Spectroscopic identification of organic compounds.
R.M. Silverstein, G.C. Bassler, T.C. Morrill
Pub: John Wiley and Sons
2. Spectroscopic identification of organic compounds.
John Dyer
3. Organic Spectroscopy
W. Kemp
4. NMR spectroscopy (Basic Principles, concepts and application in Chemistry)
Herald Gunther, (John Wiley and Sons)
M.I.ELE.T.4 COSMETIC TECHNOLOGY
1. Preformulation studies:
Preformulation studies and stability testing of Cosmetic products- Shelf-life determination of Cosmetic products, Effects of environmental factors like light, temperatures etc. on product stability.
2. Raw materials used for Cosmetic preparation:
Detailed knowledge of various raw materials used in cosmetic industry, like surfactants, humectants, cream bases, Aerosol propellants, perfumes, colours.
Knowledge of generic and proprietary products.
3. Good Manufacturing Practices and Regulatory Requirements.
Knowledge of the Legal/Regulatory Standards/Systems governing Cosmetic products Indian as well as International.
Development of Cosmetic Products.
Documentation requirements.
4. Hair Care Products
Introduction, Hair structure, Shampoos, Conditioners, Setting lotion, Hair creams, Hair dyes.
5. Skin Care products
Introduction, anatomy and physiology of skin, formulation of skin cleaners, moisturizers, sunscreen products, acne products, anti ageing creams.
6. Colour Cosmetics
Introduction, lip colour, nail polish, face make-up eye make-up.
7. Dental product:
Dentifrices, Oral rinses, Tooth powder, Tooth paste.
8. Personal Hygiene Products:
Shaving creams and after shave products, Antiperspirants and deodorants.
9. Safety testing of Cosmetic Products:
Microbiology in Cosmetics.
Knowledge of the various microbial contaminants in cosmetic products.
Knowledge of various preservative systems for cosmetic products.
Selection criteria for preservatives.
Efficacy and safety testing of preservatives in cosmetic products.
10. Packaging in Cosmetics:
Knowledge of various Packaging materials used in cosmetic products.
Knowledge of various machines used for packing of cosmetic products.
Contemporary trends in cosmetics packaging.
Compatibility and stability testing of packaging materials in cosmetic products.
ELECTIVES OF II SEMESTER
M.II.ELE.T.1. COMPUTER AIDED DRUG DESIGN
1. Database and software systems.
Databases: Biological databases, chemical databases, 2D and 3D data bases, Reaction data bases.
Soft ware systems: Cambridge structural database. Chem. DBS-3D MACCS 3D, sybyl/3DB. Unity (Tripos) Thorn/Merlin, synthetic reaction information management software.
2. QSAR with computers.
Rational drug Design; c-logp, QSAR and computer applications. CoMFA & CoMSIA: Introduction, parameters, Quantitative models, statistical methods. Design of Test series on QSAR, 3D-QSAR approaches, summary and conclusions.
3. Molecular modeling
Introduction; known receptors: Definition of site, characterization of site, design of ligands, calculation of affinity; homolog y modeling.
Unknown receptors: Pharmacophore v/s binding site models, searching for similarity, molecular comparison, finding the common pattern, conclusions.
4. Sequence Analysis:
Sequence comparison algorithms, sequence comparison scoring systems. PAM, BLOSUM, GONNET database, similarity searches: BLAST, FASTA, Dsi-BLAST Pairwise sequence alignment;- Needleman and Wunsch algorithms, Smith Waterman algorithm, multiple sequence alignment; CLUSTAL Sequence database.
(a) Genomics and proteomic Expressed sequence Tags : Clusting and Assembly Target selection/design, data validation, statistical analysis, data resources.
Genomics: Data production and data flow: mapping. DNA sequencing, generations of scaffolds and contigs.
GENE PREDICTION: AB INITIO AND SIMILARITY BASED GENOME ANNOTATION; PIPELINES, DATABASES.
Proteomics: 2D gel data: image analysis, Transcriptional profiling, pharmacogenomics principles, analysis, information, integration data validations, peptide sequence determination.
M.II.ELE.T.2.
SCREENING METHODS IN PHARMACOLOGY AND CLINICAL RESEARCH
1. a. Drug discovery process: Principles, techniques and strategies used in new drug discovery. High throughput screening, human genomics, robotics and economics of drug discovery. Regulations for laboratory animal care and ethical requirements.
b. Bioassays: Basic principles of bioassays, official bioassays, experimental models and statistical designs employed in biological standardization. Biological standardization of vaccines and sera, vasopressin, oxytocin, Acetylcholine, Adrenaline, insulin, d-tubocurarine, HCG, hyaluronidase, corticotrophine, pertussis, Rabies and plague.
c. Introduction to biostatistics, parametric and non parametric tests.
2. Preclinical and clinical models employed in the screening of new drugs belonging to following categories
Antifertility agents, sympathomimetics, parasympathomimetics, muscle relaxants (both central and peripheral), sedatives, hypnotics, antiarrhytamic agents, cardiac stimulants, cardiotonic agents, bronchodilators, antihistaminics, eicoganoids.
Antipsychotic agents, antianxiety agents; nootropic drugs; antidepressant drugs; antiParkinsoinan agents; antiepileptics; analgesics and anti-inflammatory agents; antiulcer agents; infarction; antiatherosclerotic drugs; antimalarials; anthelmintics; antidiabetics; models for status epilepticus, intracerebroventricular and other newer techniques of drug administration and development; transgenic animals and other genetically prone animal models.
3. Alternatives to animal screening procedures, cell-line, patch-clamp technique, in-vitro models, molecular biology techniques.
4. Principles of toxicity evaluations, ED50, LD50 and TD values. International guidelines (ICH recommendations).
M.II.ELE.T.3. DRUG AND DRUG PRODUCTS STABILITY
1. Overview of kinetic concepts – First, 2nd , and pseudo orders.
2. Complex order kinetics – concepts, equations and their application.
Serires, consecutive and reversible reaction, steady state approximation.
3. Stability prediction by pharmacist and calculation protocols.
4. Temperature as a stress : Arrhenius theory, activation energy calculations, Q10 value calculations.
5. Interpretation of kinetic data: Transition state theory, media effects ,
catalysis, pH effects. Some practical applications.
6. Drug decomposition mechanisms:
a) Hydrolysis and acyltransfers,
Nature of reaction, structure and utility, stabilization of pharmaceuticals, pharmaceutical examples.
b)
Oxidation
Nature of oxidation
Kinetics of oxidation
Oxidation pathways of Pharmaceutical interest, inhibition of oxidation
c)
Photolysis
Energetics of photolysis
Kinetics of photolysis
Photolytic reactions of Pharmaceutical interest
Prevention of photolytic reactions
7. Solid state chemical decomposition
Kinetics of solid state decomposition
Pharmaceutical examples of solid state decomposition pure drugs, drug-excipient and drug-drug interaction in solid state methods of stabilization.
8. Physical stability testing of dosage forms
(1)
Solids – tablets, capsules, powder and granules
(2)
Disperse systems
(3)
Microbial decomposition
(4)
Over view, physical stability of novel drug carriers, liposomes, niosomes and nano particles.
9. Strategy and tactics of stability testing.
(A)
Regulatory requirements
(B)
Stability protocols
(C)
Experimental design
(D)
Interpretation of data
M.II.ELE.T.4. PHARMACEUTICAL BIOTECHNOLOGY
1. Microbial biotechnology
A. Aerobic and Anaerobic fermentation: The design of a fermenter
for the fermentations. Fed batch and continuous systems.
B. Antibiotic fermentations of penicillin and Rifamipicin in detail and a brief knowledge of peptide antibiotics.
C. Bio transformation of steroids and for the synthesis of chiral drugs and production of optically pure L and D aminoacids.
D. Bio degradation of xenobiotics, Microbial production of bio degradable plastics.
E. Single cell protein for food and feed.
2. Enzyme technology:
B.
Classification, general properties of enzymes, dynamics of enzymatic activity, sources of enzymes, extraction and purification. Applications – Pharmaceutical, therapeutic and clinical.
C.
Production of amylo glucosidase, glucose isomerase, amylase and trypsin and papain.
D.
Techniques of immobilization of enzymes and cells and their applications in the industry. Reactors for immobilized enzyme systems.
3. Immunobiotechnology:
B.
Hybridoma techniques – fusion methods for myeloma cells and B-Lymphocytes, selection and screening techniques. Production and purification of monoclonal antibodies and their applications in clinical diagnosis, immunotherapy and pharmaceutical research.
C.
Immuno diagnosis of infectious diseases and diagnostic agents.
D.
Vaccinology – knowledge of Extended programme of Immunisation. Classification of immunologicals. Manufacture techniques for bacterial and viral vaccines. Immunopotenciation, adjuvants. Living and non-living antigens, newer delivery systems. Naked DNA vaccines, sub
4. DNA technology:
B.
Genetic engineering: Techniques of gene manipulation, cloning strategies, procedures, cloning vectors, expression vectors, recombinant selection and screening – expression in E-coli and yeasts.
C.
Knowledge of site directed mutagenesis, polymerase are chain reaction and analysis of DNA sequences.
D.
Gene library and DNA.
E.
Applications of the above techniques in the production of
i)
regulatory proteins, interferon, interleukins, etc.
ii)
Blood products – erythropoietin, tPA
iii)
Vaccines – Hepatitis B
iv)
Hormones – Insulin
F.
Study on controlled and site specific delivery of therapeutic peptides and proteins through various routes of administration.
G.
Production of useful proteins in transgenic animals and gene therapy and restriction fragment length polymorphisms (RFLP) in diagnosis.
H.
Signal transduction, oncogenes and their proteins.
I.
The human genome project - a brief study.
5. Cell culture technology:
A.
Animal cell culture – General Requirements for establishing the animal cell culture, media, conditions and methods for cell cultures. Applications in Pharmacy.
B.
Plant tissue culture: General requirements for establishing the plant tissue culture system and their application for pharmaceuticals.
6. Bio informatics:
A brief knowledge of bio-informatics and its use in pharmacy and medicine.
SYLLABUS FOR M.PHARMACY COURSE
(2 YEARS DURATION) REVISED
2003 – 2004
WITH MINOR MODIFICATIONS EFFECTIVE FROM 2004-2005 ACADEMIC YEAR ONWARDS
KAKATIYA UNIVERSITY
WARANGAL – 506 009
(2003-2004)
WITH MINOR MODIFICATIONS EFFECTIVE FROM 2004-2005 ACADEMIC YEAR ONWARDS
UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES
KAKATIYA UNIVERSITY, WARANGAL – 506 009.
SPECIALIZATIONS:
1Pharmaceutics
2.Pharmaceutical Chemistry
3.Pharmacognosy
4.Pharmacology
5.Industrial Pharmacy (Self – financing)
M. PHARM. (PHARMACEUTICS)
I Semester
Theory
M.I. CEU. T1: Advanced Physical Pharmaceutics:
1.
Theory of solubilization and solubilization techniques: solubility and solubilization of non electrolytes, solubilization by the use of surfactants, cosolvents, complexation, drug derivatisation and solid state manipulation.
2.
Theories of Dispersion: Solid liquid dispersion: adsorption, wetting, crystal growth mechanisms and prevention of crystal growth.
Emulsion: Formation and stability of emulsion with special emphasis on electrical theory, H.L.B, theory and di-electric properties. Preparation, evaluation, and applications of multiple and micro emulsions.
3.
Solid state properties: Crystal properties and polymorphism techniques for study of Crystal properties; solid state stability, flow properties of powders, segregation and its importance.
4.
Theories of compaction and compression: Compression, consolidation strength of granules, compression and consolidation under high loads, effects 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.
5.
Polymer Science: properties of polymers, thermodynamics of polymer solution, phase separation, polymers in solid state. Applications of polymers in pharmaceutical formulations.
6.
Diffusion and Dissolution: Diffusion, steady state diffusion procedures and apparatus. Diffusion principles in biological systems, Thermodynamics of diffusion. Dissolution : Basic theories of dissolution, models. Sink conditions in dissolution and its importance. In-vitro-in-vivo correlations.
7.
Kinetics and Drugs stability: Stability calculations, rate equation, kinetics of some decomposition, strategy of stability testing, methods of stabilization, methods of accelerated stability testing in dosage forms. Freeze thaw methods, centrifugal methods, temperature and humidity control.
M.I.CEU.T.2: BIO-PHARMACEUTICS & PHARMACOKINETICS
I.
Bio-availability, Bioequivalence and Therapeutics equivalence: Designing of bioavailability studies, and interpretation of results.
II. Physico-Chemical properties affecting bioavailability, pH – Partition theory, dissolution, surface area, adsorption, complexation, polymorphism etc., and techniques of enhancing dissolution rate.
III. Formulation factors affecting bioavailability of drugs in dosage forms of Tablets, capsules, parenterals, liquid orals and topical dosage forms.
IV. Basic concepts of pharmacokinetics: Compartmental 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 -
i) Absorption: (wherever applicable) Absorption rate constant, Absorption half life, lag time and extent of absorption, AUC
ii) Distribution: Apparent volume of distribution and its determination
iii) Metabolism: Metabolic rate constant.
iv) Elimination: Over all apparent elimination rate constant, and half life.
Under the following conditions:
a.
Intravenous bolus injection
b.
Intravenous infusion
c.
Single dose oral administration
d.
Multiple dose injections
e.
Multiple dosage oral administration.
v). Non invasive methods of estimating pharmacokinetic parameters with emphasis on salivary and urinary compartments.
vi). Concept of Clearance: Organ clearance, total clearance, hepatic clearance, gut wall, lung clearance and renal clearance.
V). Non-liner Pharmacokinetics: Concepts of linear and non linear pharmacokinetics, Michaelis - Menton kinetics characteristics. Basic kinetic parameters, possible causes of non induction, non linear binding, non linearity of pharmacological responses
VI) Time dependent pharmacokinetics: Introduction, classification, physiologically induced time dependency: Chronopharmacokinetics, chemically induced time dependency.
VII) Drug Metabolism – sites of metabolism, factors affecting drug metabolism (genetics, species and environmental).
VIII) Clinical pharmacokinetics: Altered kinetics in pregnancy, child birth, infants and geriatrics, kinetics in G.I. disease, malabsorption syndrome, liver, cardiac, renal and pulmonary disease states.
IX) Drug interactions: Kinetics of drug interaction, study of drug-drug interactions mediated through absorption, distribution, metabolism and elimination, Mechanisms of interaction and consequence. Influence of alcohol, smoking, food and beverages on drug action.
PRACTICALS
M.I.CEU.P.1 Practicals based on M.I.CEU.T.1
M.I.CEU.P.2 Practicals based on M.I.CEU.T.2
M.PHARM.
SEMESTER - II
M.II.CEU.T. 1: ADVANCES IN DRUG DELIVERY SYSTEMS
A.
Fundamentals of controlled drug delivery system, Theory of mass transfer, use of polymers in controlled drug delivery, pharmacokinetic and Pharmacodynamic basis of controlled drug delivery. Design, fabrication, evaluation and applications of the following controlled release systems.
1.Controlled release oral drug delivery systems.
2.Parenteral controlled release drug delivery systems
3.Implantable therapeutic systems.
4.Transdermal therapeutic systems and iontophoresis.
5.Ocular and intrauterine delivery systems.
6.Bioadhesive drug delivery systems.
7.Proteins and peptide drug delivery.
B.Biochemical and molecular biology approaches to controlled drug delivery.
1.Micro particulate drug carriers: Liposomes, Neosomes, Micropspheres, Nanoparticles and Resealed erythrocytes.
2.Monoclonal antibodies for drug delivery.
C. Drug targeting to particular organs:
1.Drug delivery to respiratory system.
2.Problems of drugs delivery to the brain and targeting to brain.
3.Drug delivery to eye.
4.Drug targeting in neoplastic diseases.
D. Drug carrier systems targeted to widely dispersed cells.
1.Delivery to Macrophages.
2.Delivery to lymphoid cells of Immune network.
3.
Delivery to lysosomal storage diseases.
M.II.CEU.T.2. ADVANCED PHARMACEUTICAL TECHNOLOGY
1. Preformulation studies:
Goals of preformulation, preformulation parameters, methodology, solid state properties, Solubility and partition coefficient, Solubility and dissolution, Modern concepts in rheology, Drug excipient compatibility.
2. Formulation Development:
(a) Solid dosage forms:
Improved production techniques for tablets: New materials, process, equipments improvements, high shear mixers, compression machines, coating machines, coating techniques in tablet technology for product development, physics of tablet compression and computerization for in process quality control of tablets.
(b) Powder dosage forms:
Formulation development and manufacture of powder dosage form for internal and external use including inhalation dosage forms.
(c) Liquid and Semi-solid dosage forms:
Recent advances in formulation aspects and manufacturing of monophasic dosage forms, recent advances in formulation aspect and manufacturing of suspensions and semi-solid dosage forms.
(d) Parenteral dosage forms:
Advances in materials and production techniques, filling machines, sterilizers and aseptic processing.
(e) Aerosols:
Advances in propellants, metered dose inhaler designs, dry powder inhalers, selection of containers and formulation aspects in aerosol formulation, manufacture and quality control.
3. Aseptic Processing Operation:
Introduction, contamination control, microbial environmental monitoring, microbiological testing of water, microbiological air testing, characterization of aseptic process, media and incubation condition, theoretical evaluation of aseptic operations.
4. Quality control: Process and Dosage form:
Process control: Control of manufacturing process, statistical quality control, control charts, of automated process control, Dosage form control, Testing programme and method, product identification system, Adulteration and misbranding, Drug information profile.
5. Optimization techniques in pharmaceutical and processing
Optimization parameters, statistical design and other applications, design, development and optimization of in-vitro test systems to evaluate and monitor the performance of different types of dosage forms, relevance and importance of in-vitro/in-vivo associations at every stage of product development and manufacture, regulatory evolution and current thinking on this aspect, application of statistical techniques in product development and evaluation including quality control.
6. Documentation:
Importance of documentation, statutory requirement and procedure for documentation, critical examination of documents.
7. Scale-up Techniques:
Effect of scale up on formulation, process parameters like mixing, granulation, drying, compression, coating, packaging, stability, selection and evaluation of suitable equipments.
8. Process Validation
Regulatory basis, validation of solid dosage forms, Sterile products, Liquid dosage forms. Process validation of raw materials, Validation of analytical methods, Equipment, and process.
9. Packaging Technology:
Packaging materials, Closures and containers units of dose packaging, blister packing, strip packing. FDA regulations, packs for tablets, capsules, ointments and aerosols.
PRACTICALS
M.II.CEU.P. 1 Practicals based on M.II.CEU.T. 1
M.II.CEU.P. 2 Practicals based on M.II.CEU.T. 2
M. PHARM. SEM - I (PHRAMACEUTICAL CHEMISTRY)
M.I.CHEM.T.1 ADVANCED ORGANIC CHEMISTRY
I. Stereochemistry of Carbon and Nitrogen Compounds:
(i) Optical Isomerism (due to asymmetric or chiral carbon atoms)
Compounds with one asymmetric carbon atom, compounds with two or more unequal asymmetric carbon atoms, compounds containing like asymmetric carbon atoms, compounds with asymmetric carbon atoms in branched chains.
(ii) Stereo-chemistry of Biphenyls
(iii) Racemic modification:
Nature of racemic modifications, formation of racemic modifications, (a) by mixing, (b) by synthesis, (c) by racemization and (d) by chemical transformation.
(iv) Configuration:
Definition, notation, absolute configuration and Relative configuration.
(v) Synthesis of optically active compounds:
Stereoselective synthesis and stereospecific synthesis
(vi) Stereo-chemistry of Nitrogen Compounds:
II. Mechanisms of Organic Reactions: Mechanism of free radical addition, substitution and plymerisation reactions, Mechanism of electrophilic addition and substitution reactions, mechanism of nucleophilic addition and substitution (SN1 & SN2 ) reactions, Elimination Reactions, mechanistic features of E1 & E2 reactions, Saeytzef’s rule, Hofmann’s rule; Hofmann’s Vs. Saeytzef’s; substitution Vs, Elimination. Factors influencing Nucleophilic substitution and Elimination reactions with suitable examples. Electrocyclic Reactions, Pericyclic reactions and Sigmatropic Reactions.
Molecular Rearrangements: Claisen allylation, Wagner Meerwein Rearrangement of Bicylic C10 - Terpenes, Wolf Rearrangement, pinacol-pinacolone Rearrangement.
III. Reagents and their synthertic applications:
Methods of preparation, physical and chemical properties and important synthetic applications of the following reagents:
1.
Lithium aluminium hydride(LAH) & Sodium borohydride.
2.
N-Bromosuccinimide (NBS)
3.
Lead tetra acetate (LTA)
4.
Diazomethane (DM)
M.I.CHEM.T.2 ADVANCED MEDICINAL CHEMISTRY – I
I. Genesis of New Drugs: Source, random screening, leads from natural products, moleculer modifications, prodrug and soft drug concepts.
II. Theoretical aspects of drug design: Structural features and pharmacological activity, significances of various types of isomerism with respect to pharmacological activity, concept of isosterism.
III. Pscychopharmacological agents: a) Biochemical basis of mental disorders:- Abnormal protein factors, endogenous amines and related substances, faulty energy metabolism, genetic factors and nutritional disorders; Phenothiazines: chemistry, synthesis and evaluation methods. The important pharmacological activities of phenothiazines; SAR of phenothiazines, toxicity and clinical significance of phenothiazines.
b) Antidepressants: MAO inhibitors, tricyclic antidepressants and Miscellaneous compounds. Mechanism of action, clinical and biological uses, side effects and their SAR studies. Synthesis of clinically useful drugs of each of the above classes.
IV. Chemothorapy of Cancer: A detailed classification of antineoplatic agents, mechanisms of action of different classes; Alkylating agents and radiomimetic agents, antimetabolites, their SAR studies, sex hormones & analogs, and antibiotics. A mention of natural products used in cancer treatment; Vinca alkaloids (Vincristine and Vinblastine) podophyllum and paclitaxel.
V. Drugs Related to Hormones and other autocoids: A study of the following hormones and other autocoids with a special reference to their agonists and antagonists:
a)
Peptide Hormones: Insulin, Vasopressin and Oxytocin.
b)
Histamine (H1 and H2) and 5-HT.
c)
Thyroid Hormones (T3 and T4).
PRACTICALS
M.I.CHEM.P: 1 Practicals based on theory M.I. CHEMI. T.1.
M.I.CHEM.P.2: Practicals based on theory M.I.CHEM.T2
M.PHARM. II SEMESTER
M.II.CHEM.T.1 ADVANCED MEDICINAL CHEMISTRY-II
I. Theoretical Aspects of Drug Action: Receptors, their types, location and isolation, types of interactions with the drug molecules, dosage-response relationships, mechanisms of drug action (Receptor theories).
II. Rational Drug Design: QSAR: parameters involved in QSAR, lipophilicity, polarisability, electronic and steric parameters. Quantitative models. Hansch analysis, Free Wilson analysis and their relationships, linear relationships and applications of Hansch and Free-Wilson analysis.
III. Enzyme Inhibitors-I: A detailed study of the following types of enzyme inhibitors, related drugs and their pharmaceutical significance:
a)
P.G. Synthetase (cycloxygenese and lipoxygenase inhibitors)
b)
Phosphodiesterase (PDE) inhibitors.
c)
Carbonic anhydrase inhibitors.
d)
Angiotensin converting of Enzyme (ACE) Inhibitors,
e)
Acetylcholine esterase (AChE) Inhibitors.
IV. Drug Metabolism:
a)Introduction. b) Drug bio-transformation pathway (Phase I metabolism): Human hepatic cytochrome P450 enzyme system, oxidation catalyzed by cytochrome P450 isoforms, N-and S-oxidations catalyzed by flavin monooxygenase, and Non- microsomal oxidations.
c) Drug conjugation pathways (Phase II metobolism).
V. Miscellaneous Classes of Drugs: Recent advances in the following classes of drugs:
a)
Proton-pump inhibitors as antiulcer agents.
b)
Immunosuppressive and immunostimulant agents.
c)
Antiviral agents.
d)
β – Adrenergic blockers.
II SEMESTER
M. PHARMACY (PHRMACEUTICAL CHEMISTRY)
M.II.CHEM.T.2 ADVANCED CHEMISTRY OF NATURAL PRODUCTS
(Theory)
I. Alkaloids: Study of the following classes of alkaloids.
a)
Alkaloids of Opium: Structure elucidation of Morphine, Opioid receptors; Endorphines and Enkephations; structure activity relationships in morphine molecule; Development of morphine analogues based on SAR; relative potencies; antitussive agents; antidiarrhoeals; morphine antagonists.
b) Alkaloids of Atropa belladonna ; Atropine, Hyoscyamine and Hyoscine; Structure elucidation of Atropine; Structural considerations of Atropine; Homatropine; Therapeutic uses.
c) Alkaloids of Vinca rosea ; Vincristine and vinblastine; Structure elucidations; Structural modifications and semisynthetic derivatives.
d) Alkaloids of Ergot: Classification; Structures; Structure elucidation of Erogometrine; therapeutic uses of ergot alkaloids and derivatives (vinyl and methylsergide).
II Steroids:
a)
Steroid nomenclature, stereochemistry and numbering; New insights on steroid receptors; chemical and physical properties of steroids; changes to modify pharmacokinetic properties of steroids.
b)
Sources and structure elucidation of cholesterol; sources and structures of related steroids – Ergosterol. Stigmasterol, β- sitosterol and Diosgenin.
c)
Steroidal Anti-inflammatory Agents; structures; structure-activity relationships; therapeutic uses.
d)
Steroidal Anti-fertility agents: Structures; mechanism of action; regimen.
e)
Anabolic Steroids: Structures; uses.
f)
Steroids in the treatment of cancers.
III Antibiotics:
a) Cephalosporins: Historical background; Nomenclature; Natural and semi- synthetic cephalosporins; cephamycins; classifications; structures; chemical degradations;spectrum of activity; β – Lactamase resistance; Antipseudomonal cephalosporins.
b) Anticancer Antibiotics: Source, structure, description of the structural features, mechanism of action, SAR, uses of the following antibiotics.
i) Actinomycines – Dactinomycin.
Anthracyclines – Daunorubicin and Doxorubicin – Their metabolic products: Daunomycinol and Adriamycinol- Their semisynthetic derivatives: the 4’-Deoxy and 4’-epidoxorubicines. Nogalamycin and menogaril.
ii) Aureolic acid group – Mithramycin
iii) The Bleomycines, Mitomycins and streptozocin.
IV A Brief Account of the Following:
a) Anticancer Agents of Plant Origin: Sources and structures of podophyllotoxin, Taxol and camptothecin; their semi synthetic derivatives; their uses and mechanism of action.
b)Ginseng: Historical background; structures of Ginsenosides, protopanaxadiols and triols; uses.
c) Phototherapy: sources and structures of psoralens; Photodegradation of 8 – methoxypsoralen; PUVA therapy in psoriasis and ritiligo; khellin and KUVA therapy xanthotoxin in the treatment of psoriasis.
PRACTICALS
M.II.CHEM.P.1: Practical based on M.II.CHEM.T.1.
M.II.CHEM.P.2 : Practical based on M.II.CHEM.T.2. (Detailed list of Experiments included)
M. PHARM (PHARMACEUTICAL CHEMISTRY) II SEMESTER
ADVANCED CHEMISTRY OF NATURAL PRODUCTS (PRACTICALS)
I. Isolation, purification and characterization of some of the following phytoconstituents.
a. Piperine from Black pepper
b. Strychnine and Brucine from Strychnos nuxvomica
c. Caffeine from Tea powder
d. Curcumin from Turmeric
e. Bixin from Bixa orellena
f. Diosgenin from Dioscorea tubers
g. Sennosides from Senna
h. Hesperidin from orange peel
i. Embelin from Embelia ribes
j. Glycyrrhizin from Glycyrrhiza glabra
k. Plumbagin from plumbago rosea
l. Pectin from orange peel
m. Tannins from myrobalans
II. The use of Column chromatography, Flash Chromatography and Vacuum liquid chromatography in the isolation of some of the above mentioned phytoconstituents.
M.PAHRM. (PHARMACOGNOSY) I SEMESTER
MAJOR COURSES
M.I.COG.T.1I - MEDICINAL PLANT BIOTECHNOLOGY
A. Historical perspectives, prospects for development of plant biotechnology
as source of medicinal agents. Applications in pharmacy and allied fields.
B. Types, techniques, nutritional requirements and growth of plant tissue cultures. Organogenesis and embryogenisis. Protoplast fusion and cultures, artificial seeds, micropropogation of medicinal and aromatic plants. Genetic stability of tissue cultures.
C. Secondary metabolism in tissue cultures with emphasis on production of medicinal agents and its impact in pharmacy. Screening and selection of high yielding cell lines. Effect of cultural practices, precursors and elicitors on production of biomedicinals.
D. Biotransformation, bioreactors, industrially potential tissue culture systems for pilot and large scale cultures of plant cells, cellular totipotency, cryopreservation and retention of biosynthetic potential in cell cultures.
E. Immobilized plant cell culture systems, immobilization techniques, effect of immobilization on secondary metabolism and realization of chemosynthetic potential in immobilized cells.
F. Genetic transformation methods, Hairy root cultures and their applications.
G. Techniques employed in elucidation of biosynthetic pathway. Biogenesis of tropane, quionoline, Imidazole, Isoquinoline and Indole alkaloids; Sterols, Anthraquinone and Saponin glycosides; Flavanoids; and Isoprenoid compounds of pharmaceutical significance.
M.I.COG.T.2 INDUSTRIAL PHARMACOGNOSY-I
A.
Exogenous and endogenous factors influencing production of crude drugs. Plant growth regulators and their applications in pharmacy. Disease management of medicinal and aromatic plants. Variability in crude drug activity.
B.
Technology for commercial scale cultivation and processing of following aromatic plants: Lemongrass, Geranium, Basil, Palmarosa, Vetiver, Patchouli, Japanese Mint, Rose, Hops, Clove, Cardamom, Cinnamom Jasmine, Sandal, Dill, Celery, Anise, Davana.
C.
Phytochemical screening of crude drugs : Extraction and qualitative evaluation for drug constituents.
D.
Pharmaceutical aids: Profile for manufacture and commerce of Papain, Pectin, Pharmaceutical gums, Starch, Absorbent cotton and Gelatin.
PRACTICALS
M.I.COG.P.1. Medicinal Plant Biotechnology
1. Representative exercises based on establishment of callus and suspension cultures. Study of their growth profiles. Aseptic transfer of bio-mass.
2. Experiment for exogenous, nutritional and precursor factors of influencing production of metabolites in tissue cultures.
3. Establishment of some hairy root cultures and study of their growth and bioproductive profile.
M.I.COG.P.2. Industrial Pharmacognosy – I
1. Phytochemical screening of plant extracts : Preparation of extracts and detection of phytoconstitutents by different techniques.
2. Representative exercised based on extraction of pharmaceutical aids and volatile oils listed in theory.
II semester
M.II.COG.T.1 Industrial Pharmacognosy-II
A. Profiles for commercial cultivation technology/and post-harvest care of following medicinal plants : Ashwagandha, Periwinkle, Medicinal Yams, Ergot, Guggul, Belladonna, Senna, Neem, Papaya, Opium poppy, Psyllium, Steroid bearing Solanums, Ammi majus, Ipecac, Cinchona, Liquorice, Safed Musli, Aloe, Henbane, Digitalis, Saffron.
B. Bioactive Compounds: Occurrence, Methodology for extraction and chemical nature of sennosides, digoxin, ginsenosides, solasodine, berberine, quinine, scopolamine, atropine, emetine, ergot alkaloids, caffeine, taxol, withanolides, podophyllotoxin, cod-liver oil, shark-liver oil.
C. Preparation of standardized extracts suitable for incorporation in solid dosage forms like tablets, capsules etc.
D. Herbal formulations : Types of herbal formulations. 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.
E. World Health Organisation guide lines for herbal drugs including standards for pesticide residue / aflatoxins. Current status of regulatory affairs for herbal formulations.
M.II.COG.T.2. ADVANCED PHARMACOGNOSY
(a) Problems encountered in and prospects of discovering new drugs from plants. Natural substances as raw materials in drug synthesis. Biomedicinals of recent discovery.
(b) Emerging plant drugs: A review of hepatoprotective, antimalarial and anti-hypertensive.
(c) Current status of anti-cancer, anti-HIV and anti-diabetic plant drugs. Immunomodulatory herbal drugs.
(d) Bioevaluation of herbal drugs.
(e) Application of various chromatotgraphics techniques and spectrometry to natural products: TLC, GLC and HPLC; Flourimetry and colorimetry. Uses of UV, IR, NMR and mass spectrometry in the structural elucidation of natural products.
(f) Recent trends in utilization of vegetable laxatives and vegetable bitters.
(g) Natural sweetening agents and coloring agents.
(h) Hallucinogenic, allergic, teratogenic and other toxic plants. Drugs and Pharmaceuticals from marine source (Marine Pharmacognosy) with special reference to cardiovascular, cytotoxic, antimicrobial and anti-inflammatory compounds.
(j) Endangered species of medicinal plants. Current status of plants used in alternative system of medicines.
II SEMESTER
M. II.COG. P.1. INDUSTRIAL PHARMACOGNOSY – II (PRACTICALS)
1)
Representative exercises based on extraction of bioactive compounds listed in theory.
2)
Preparation of selected poly-herbal formulations.
M.II.COG. P.2. ADVANCED PHARMACOGNOSY (Practical)
1)
Representative exercises based on physical, chemical and biological techniques of evaluation of plant constituents/extracts.
I SEMESTER
M.PHARM. (PHARMACOLOGY)
M.I.COL.T.1. ADVANCED PHARMACOLOGY – I
I.
Drugs acting at synoptic and neuro effecto junctional sites.
A.
Autonomic & somatic nervous systems.
B.
Muscarinic receptor agonists & antagonists.
C.
Anticholinesterases
D.
Agents acting at NMJ and autonomic ganglia
E.
Sympathomimetic drugs. Catecholamines and adrenergic antagonists.
II.
Drugs acting on the Central Nervours 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 & abuse
III.
Drugs affecting renal and cardiovascular function
A.
Diuretics
B.
Renin & Angiotensin
C.
Drugs used in the treatment of
1.
Myocardial Ischemia
2.
Hypertension
3.
CHF
4.
Hyperlipidemia
IV.
Drugs acting on the blood & blood forming organs
A.
Growth factors
B.
Anticoagulants, thrombolytics & antiplatelet drugs.
M.I.COL.T.2. ADVANCED PHARMACOLOGY – II
I. Autacoids; Drug therapy of Inflammation
A.
Histamine, Bradykinin & their antagonists
B.
Eicasonoids & PAF
C.
Antiinflammatory, analgesic & antipyretic agents
D.
Antiasthmatic agents.
II. Drugs affecting gastro intestinal function.
A.
Agents for control of acidity and antiulcer drugs
B.
Emetics & anti emetics.
III. Chemotherapy of
A.
Malaria
B.
Microbial infections.
(i)
Fluroquinolones
(ii)
Cephalosporins and other newer agents
(iii)
Antifungal & antiviral drugs including Anti HIV drugs.
C.
Neoplastic diseases
IV. Oral hypoglycemic agents.
V. Estrogens, Progestins and Androgens.
PRACTICALS
M.I.COL.P.1 Practicals based on theory M.1.COL.T.1.
M.I.COL.P.2 Practicals based on theory M.1.COL.T.2.
II SEMESTER
M.PHARM (PHARMACOLOGY)
M.II.COL.T.1. I. Clinical Pharmacology & Pharmacotherapeutics
I. Principles of Pharmacokinetics
A.
Revision of basic concepts
B.
Clinical Pharmacokinetics
i.
Dose – response in man
ii.
Influence of renal and hepatic disease on pharmacokinetics
iii.
Therapeutic drug monitoring
iv.
Population pharmacokinetics
II. Adverse Drug Reactions, Drug Interactions and ADR monitoring.
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.
IV. Drug therapy in
A.
Geriatrics
B.
Pediatrics
C.
Pregnancy & Lactation
V. Pharmacogenetics: Interracial and individual variability in drug metabolism.
M.II.COL.T2. & M.II.ELE.T.2.
SCREENING METHODS IN PHARMACOLOGY AND CLINICAL RESEARCH
1. a. Drug discovery process: Principles, techniques and strategies used in new drug discovery. High throughput screening, human genomics, robotics and economics of drug discovery. Regulations for laboratory animal care and ethical requirements.
b. Bioassays: Basic principles of bioassays, official bioassays, experimental models and statistical designs employed in biological standardization. Biological standardization of vaccines and sera, vasopressin, oxytocin, Acetylcholine, Adrenaline, insulin, d-tubocurarine, HCG, hyaluronidase, corticotrophine, pertussis, rabies and plague.
c. Introduction to biostatistics, parametric and non parametric tests.
2. Preclinical and clinical models employed in the screening of new drugs belonging to following categories
Antifertility agents, sympathomimetics, parasympathomimetics, muscle relaxants (both central and peripheral), sedatives, hypnotics, antiarrhythmic agents, cardiac stimulants, cardiotonic agents, bronchodilators, antihistaminics, eicosanoids.
Antipsychotic agents, antianxiety agents; nootropic drugs; antidepressant drugs; antiParkinsoinan agents; antiepileptics; analgesics and anti-inflammatory agents; antiulcer agents; infarction; antiatherosclerotic drugs; antimalarials; anthelmintics; antidiabetics; models for status epilepticus, intracerebroventricular and other newer techniques of drug administration and development; transgenic animals and other genetically prone animal models.
3. Alternatives to animal screening procedures, cell-line, patch-clamp technique, in-vitro models, molecular biology techniques.
4. Principles of toxicity evaluations, ED50, LD50 and TD values. International guidelines (ICH recommendations).
PRACTICALS
M.II.COL.P.1. Clinical pharmacology and pharmocotherapeutics practicals based on M.II.COL.T.1.
M.II.COL.P.2. Screening Methods in pharmacology and clinical Research practicals based on M.II.COL.T.2.
M.Pharm. (Industrial Pharmacy)
I – SEMESTER
M.I.IND.T.1: Quality Assurance & Regulatory affairs:
1.
Design and instrumentation of the buildings and their maintenance as per current good manufacturing practices for the bulk production of different pharmaceutical dosage forms.
2.
Installation, validation and maintenance of typical equipment used in the bulk manufacture and packaging different dosage forms with a special reference to GMP models.
3.
Good manufacturing practices, production optimization and process validation of raw materials and analytical methods, with a special reference to sterile products and solid dosage form. CGMP, GLP, ISO 9002 and documentation.
4.
Quality Control: Process and Dosage form: Process control: Control of manufacturing process, statistical quality control, control charts of automated process control, Dosage form control. Testing programme and methods, product identification system, Adulteration and misbranding, Drug information profile.
5.
Optimization techniques in Pharmaceutical and Processing: Optimization parameters, statistical design and other applications, design development and optimization of in-vitro test systems to evaluate and monitor the performance of different types of dosage forms, the relevance and importance of in- vitro/in-vivo associations at every stage of product development and manufacture, the regulatory evaluation and current thinking on this aspect, application of statistical techniques in product development and evaluation including quality control.
6.
Documentation: Importance of documentation, statutory requirement and procedure for documentation, critical examination of documents.
7.
Process Validation: Regulatory basis, validation of solid dosage forms, sterile products, liquid dosage forms. Process validation of raw materials, validation of analytical methods, equipment and process.
8.
New Drug Application: Steps involved in the development of a new drug. New drug application as per WHO guidelines and abbreviated NDA. Requirement and guidelines on clinical trials for import and manufacture.
9.
Industrial Safety: Industry hazards due to fire accidents, mechanical and electrical equipment, chemicals and pharmaceuticals. Monitoring and prevention systems. Industrial efficiency testing.
10.
Stability Studies: ICH guidelines and WHO guidelines and stability protocols for dosage forms.
M.I.IND.T.2 & M.I.CEU.T.2: Bio-Pharmaceutics & Pharmacokinetics
I. Bio-availability, Bioequivalence and Therapeutic equivalence: Designing of bioavailability studies, and interpretation of results.
II. Physico-Chemical properties affecting bioavailability, pH-partition theory, dissolution, surface area, adsorption, complexation, polymorphism etc., and techniques of enhancing dissolution rate.
III. Formulation factors affecting bioavailability of drug in dosage forms of tablets, capsules, parenterals, liquid oral and topical dosage forms.
IV. Basic concepts of Pharmacokinetics: Compartmental 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.
i.
Absorption: (wherever applicable) Absorption rate constant. Absorption half life, lag time and extent of absorption, AUC.
ii.
Distribution: Apparent volume of distribution and its determination.
iii.
Metabolism: Metabolic rate constant and its determination.
iv.
Elimination: Over all apparent elimination rate constant and half life.
Under the following conditions:
a)
Intra venous bolus injection
b)
Intra venous infusion.
c)
Single dose oral administration.
d)
Multiple dose injections.
e)
Multiple dosage oral administration.
v. Non invasive methods of estimating pharmacokinetic parameters with emphasis on salivary and urinary compartments.
vi. Concept of clearance: Organ clearance, total clearance, hepatic clearance, gut wall clearance, lung clearance and renal clearance.
V) Non-liner Pharmacokinetics: Concepts of linear and non linear pharmacokinetics, Michaelis - Menten kinetics characteristics. Basic kinetic parameters, possible causes of non induction, non linear binding, non linearity of pharmacological response.
VI) Time dependent Pharmacokinetics: Introduction, classification, physiologically induced time dependency: Chronopharmacokinetics, chemically induced time dependency.
VII) Drug Metabolism – sites of metabolism, factors affecting drug metabolism (genetics, species and environmental).
VIII) Clinical Pharmacokinetics: Altered kinetics in pregnancy, child birth, infants and geriatrics, kinetics in G.I. disease, malabsorption syndrome, liver, cardiac, renal and pulmonary disease states.
IX) Drug interactions: Kinetics of drug interaction, study of drug-drug interactions mediated through absorption, distribution, metabolism and elimination, Mechanisms of interaction and consequence. Influence of alcohol, smoking, food and beverages on drug action.
PRACTICALS
M.I.IND.P.1. Practicals based on M.I.IND.T.1.
M.I.IND.P.2. Practicals based on M.I.IND.T.2.
SEMESTER - II
M.II.IND.T.1: Advances in drug delivery systems
1. Review of Fundamentals of controlled drug delivery systems
Fundamentals, rationale of sustained/controlled drug delivery, factors influencing the design and performance of sustained/controlled release products, Pharmacokinetic/Pharmacodynamic basis of controlled drug delivery. Types and structure of polymers, Use of polymers in controlled release of active agents, Biocompatibility of polymers and methods to improve it, Polymer degradation, Module for gastrointestinal tract. Transdermal module, Module for eye.
2. Drug targeting principles and approaches:
Active and passive targeting. Tumor targeting, Bone marrow targeting. Brain targeting, Antibody-drug conjugates, Limitations of antibody targeting, Drug loading, Receptor saturation, Biodistribution of antibody, Radioisotopes, Further prospects.
3. Design and fabrication of controlled release drug delivery systems:
Principle involved and Formulation of : Oral dosage forms – Diffusion system, Reservoir devices, Osmotic systems, Systems utilizing dissolution, Systems utilizing ion exchange resins, prodrugs, Multiple Emulsions, Parenteral dosage forms, Intramuscular injections, implantable therapeutic systems, Colon specific systems, Transmucosal systems and mucoadhesive systems, Nasal delivery, Ocular systems, intravaginal and intrauterine systems, Lung delivery systems.
4. Carrier Based delivery system:
Principle involved and Formulation of : Microparticulate drug carriers, Liposomes, Niosomes, Microspheres, Magnetic microspheres, Cellular-particulate systems, Resealed erythrocytes.
5. Delivery of peptides/proteins/Biotechnology Drugs: formulation
aspects:
Preformulation studies and problems: Protectants, delivery kinetics. Overview of delivery systems, Site specific proteins, Stability problems, Evaluation of recombinant proteins.
6. Vaccine delivery:
Evidence and mechanism of uptake and transport, Monoclonal antibodies, Delivery systems used to promote uptake, Absorption enhancers, Lipid carrier systems, Oral immunization, Peyer’s patches, Common mucosal immune system, Controlled release microparticles for vaccine development, Single dose vaccine delivery systems using biodegradable polymers.
M.II.IND.T.2: ADVANCED PHARMACEUTICAL TECHNOLOGY
1. Preformulation studies:
(A) Goals of preformulation, Preformulation parameters, Methodology, Solid state properties, Solubility and Partition coeffcient, Solubility, Modern concepts in rheology, Drug excipient compatibility.
(B) Dissolution: Theory, Mathematical models, types of dissolution equipments, sink condition and its importance. Automation in dissolution, “In-vitro / In-vivo” correlations, Recent advances in dissolution testing.
2. Excipients used in pharmaceutical dosage forms:
(a) Polymers
(b) Properties and selection criteria for various excipients like surfactant, viscosity promoters, diluents, coating materials, plasticizers, preservatives, flavors and colours.
3. Formulation Development:
(a) Solid dosage forms:
Improved Production techniques for tablets: New materials, process, equipments improvements, high shear mixers, compression machines, coating machines, Coating techniques in tablet technology for product development, Physics of tablet compression computerization for in process quality control of tablets, types of tablets and their manufacture Formulations, production and evaluation of hard and soft gelatin capsules.
Powder dosage forms:
Formulation development and manufacture of power dosage form for internal and external use including inhalations dosage forms.
(b) Compaction and compression:
compaction of powders with special reference to distribution and measurement of forces in the powder mass undergoing compression. Effect of particle size, moisture content and lubrication on the strength of tablets.
(c) Liquid and Semi-solid dosage forms:
Recent advances in formulation aspects and manufacturing of monophasic dosage forms. Recent advances in formulation aspects and manufacturing of suspensions, dry syrups and Semi-solid dosage forms.
(d) Parenteral dosage forms:
Advances in materials and production techniques, filling machines, sterilizers and aseptic processing. Manufacturing of small and large volume parenterals and quality control.
(e) Aerosols:
Advances in propellants, metered dose inhaler designs, dry powder inhalers, selection of containers and formulation aspects in aerosol formulation, Manufacture and quality control.
4. Aseptic processing operation:
Introduction, contamination control, microbial environmental monitoring, microbiological testing of water, Microbiological air testing, characterization of aseptic process, media and incubation condition, theoretical evaluation of aseptic operations.
5. Pilot plant and scale-up techniques for the production of different pharmaceutical dosage forms.
6. Packaging Technology: Packaging materials, closures and containers, unit dose packaging, blister packing, strip packing. FDA regulations, packaging of tablets, capsules, ointments and aerosols.
PRACTICALS
M.II.IND.P.1: Practicals based on theory M.II.IND.T.1.
M.II.IND.P.2: Practicals based on theory M.II.IND.T.2.
ELECTIVES OF I SEMESTER M.I.ELE.T.1. DRUG REGULATORY AFFAIRS AND INTELLECTUAL PROPERTY
RIGHTS
1.Pharmaceutical development:
Preformulation studies, introduction to solid, liquid and semi-solid dosage forms, controlled release prearation, injection, ocular preparation, regulatory requirements as per European community, united states, and Indian regulatory authorities.
2. Manufacturing:
Introduction, regulatory requirements as per European community, united slates, Indian and other regulatory authorities for manufacturing information, manutacturing formula, process, validation of manufacturing process, equipment, documentation, inspection requirements, regulatory guidelines for active ingredients, data requirement for new drug as per regulatory requirements as per European community, united states, Indian and other regulatory authorities, international aspects of excipients approval as per guidelines of all the territories. Regulatory guidelines for packaging materials, test and evaluation of packaging materials, biological test elastomer test, microbiological test and evaluation of closures.
3. Stability testing:
Introduction, scientific and technical background to the design of stability testing, regulatory requirements as per European community, united states, Indian and other regulatory authorities for testing of new active substances, bulk active drug substances, dosage form in their final packaging. Extension of shelf life after authorization of drug, international harmonization and current guidelines.
Analytical method validation as per, regulatory requirements of European community, united states, Indian and other regulatory authorities, pharmacokinetic and toxicokinetic validation.
4. Biopharmaceutics:
Introduction, definition, factors related to formulation, dosage form, manufacturing process, stability, storage, different testing parameters and
standards as per regulatory requirements of European community, united states, Indian and other regulatory authorities.
5. Preclinical aspects of biopharmaceutics, clinical bioavailability, study design, presentation, documentation, statistical analysis, current guidelines and developments as per regulatory requirements of European community, united states, Japanese, Indian and other regulatory authorities.
6. Clinical pharmacology and Pharmacodynamics:
Introduction, regulatory requirements, pharmacokinetics in men, ethnic, genetic and environmental factors.
Clinical study design, documentation, presentation and interpretation.
Clinical trials: definition, phase I, Phase II, Phase III, and phase IV studies, design documentation, presentation and interpretation, statistical analysis of clinical data, factorial design, guidelines as per European community, united states, Japanese, Indian and other regulatory authorities.
6. Intellectual property rights:
Introduction, purpose, international scenario and Indian scenario, guidelines as per European community, united states, Indian and other regulatory authorities documentation, presentation, application.
M.I.ELE.T.2. CELL AND MOLECULAR BIOLOGY
I. Structural Organization of life.
A.
The cell doctrine
B.
Cell types
C.
Organization of Pro and Eukaryotes
II. Surface artchitecture
A.
Extracellular environment
B.
Cell wall, surface, projections
C.
Cell recognition, aggregation.
III. Cell membrane: Structure and Functions
A.
Molecular models, transport
B.
Transmembrane signals
C.
Antigen mediated responses.
IV. Nucleus and Cytoplasmic matrix
A.
Nucleus
B.
Chromatin and Chromosomes
C.
Cytoplasm & cytoskeleton
D.
Endo membrane systems.
V. Cell growth and Division.
VI. Molecular Organization and Genome
A.
Concept of Gene
B.
Behaviour of the Genome
VII. DNA Replication and Transcription
A.
Replication: Mechanism, Enzymes.
B.
Transcription: Mechanism, Enzymes.
VIII. Mechanism of Protein Synthesis.
IX. Genetic recombination
A.
Plasmids
B.
Transduction and Transformation.
X. Molecular basis of mutation.
A.
Souce of variations, types of mutations
B.
Chromosomal aberrations
XI. Cell differentiation
A.
Factors affecting differentiation
B.
Levels and mechanism of diffentiation.
XII. Molecular biology of aging and cancer.
A.
Theories of aging.
B.
Types of tumors, Etiology of cancer
C.
Carcinogenesis.
M.I.ELE.T.3. ADVANCED INSTRUMENTAL METHODS OF ANALYSIS
I.A. Theory, knowledge of instrumentation and application with regard to drug analysis, decomposition product identification and estimation, metabolite analyses, and special methods based on the following.
Ultraviolet – visible spectrophotometry
Infrared spectrophotometry
Fluorimetry
I.B. Theory, knowledge of instrument and basic principles of :
i) 1H Nuclear Magnetic Resonance Spectroscopy (1H NMR): Concepts of chemical shift, spin spin coupling, coupling constant, shielding and deshielding effects.
ii) Mass Spectroscopy; Introduction, different techniques of ionization (CI, EI & FAB MS) isotopic abundance, molecular on fragmentation, base peaks etc., Nitrogen rule.
II. Chromatographic methods (Gas – chromatography including GC-MS; High
performance liquid chromatography; electrophoresis (gel and capillary) with an emphasis on specific examples in biological assay methods.
III. Special Techniques:
a)
Immunological methods (RIA – ELISA)
b)
H.P.C.P.C.
c)
H.P.T.L.C.
d)
Super critical liquid chromatography
IV. Good laboratory practices (GLP), Laboratory maintenance standard operating procedure (SOPs), Methods of validation.
BOOKS RECOMMENDED
M.I.ELE.T.3
1. Spectroscopic identification of organic compounds.
R.M. Silverstein, G.C. Bassler, T.C. Morrill
Pub: John Wiley and Sons
2. Spectroscopic identification of organic compounds.
John Dyer
3. Organic Spectroscopy
W. Kemp
4. NMR spectroscopy (Basic Principles, concepts and application in Chemistry)
Herald Gunther, (John Wiley and Sons)
M.I.ELE.T.4 COSMETIC TECHNOLOGY
1. Preformulation studies:
Preformulation studies and stability testing of Cosmetic products- Shelf-life determination of Cosmetic products, Effects of environmental factors like light, temperatures etc. on product stability.
2. Raw materials used for Cosmetic preparation:
Detailed knowledge of various raw materials used in cosmetic industry, like surfactants, humectants, cream bases, Aerosol propellants, perfumes, colours.
Knowledge of generic and proprietary products.
3. Good Manufacturing Practices and Regulatory Requirements.
Knowledge of the Legal/Regulatory Standards/Systems governing Cosmetic products Indian as well as International.
Development of Cosmetic Products.
Documentation requirements.
4. Hair Care Products
Introduction, Hair structure, Shampoos, Conditioners, Setting lotion, Hair creams, Hair dyes.
5. Skin Care products
Introduction, anatomy and physiology of skin, formulation of skin cleaners, moisturizers, sunscreen products, acne products, anti ageing creams.
6. Colour Cosmetics
Introduction, lip colour, nail polish, face make-up eye make-up.
7. Dental product:
Dentifrices, Oral rinses, Tooth powder, Tooth paste.
8. Personal Hygiene Products:
Shaving creams and after shave products, Antiperspirants and deodorants.
9. Safety testing of Cosmetic Products:
Microbiology in Cosmetics.
Knowledge of the various microbial contaminants in cosmetic products.
Knowledge of various preservative systems for cosmetic products.
Selection criteria for preservatives.
Efficacy and safety testing of preservatives in cosmetic products.
10. Packaging in Cosmetics:
Knowledge of various Packaging materials used in cosmetic products.
Knowledge of various machines used for packing of cosmetic products.
Contemporary trends in cosmetics packaging.
Compatibility and stability testing of packaging materials in cosmetic products.
ELECTIVES OF II SEMESTER
M.II.ELE.T.1. COMPUTER AIDED DRUG DESIGN
1. Database and software systems.
Databases: Biological databases, chemical databases, 2D and 3D data bases, Reaction data bases.
Soft ware systems: Cambridge structural database. Chem. DBS-3D MACCS 3D, sybyl/3DB. Unity (Tripos) Thorn/Merlin, synthetic reaction information management software.
2. QSAR with computers.
Rational drug Design; c-logp, QSAR and computer applications. CoMFA & CoMSIA: Introduction, parameters, Quantitative models, statistical methods. Design of Test series on QSAR, 3D-QSAR approaches, summary and conclusions.
3. Molecular modeling
Introduction; known receptors: Definition of site, characterization of site, design of ligands, calculation of affinity; homolog y modeling.
Unknown receptors: Pharmacophore v/s binding site models, searching for similarity, molecular comparison, finding the common pattern, conclusions.
4. Sequence Analysis:
Sequence comparison algorithms, sequence comparison scoring systems. PAM, BLOSUM, GONNET database, similarity searches: BLAST, FASTA, Dsi-BLAST Pairwise sequence alignment;- Needleman and Wunsch algorithms, Smith Waterman algorithm, multiple sequence alignment; CLUSTAL Sequence database.
(a) Genomics and proteomic Expressed sequence Tags : Clusting and Assembly Target selection/design, data validation, statistical analysis, data resources.
Genomics: Data production and data flow: mapping. DNA sequencing, generations of scaffolds and contigs.
GENE PREDICTION: AB INITIO AND SIMILARITY BASED GENOME ANNOTATION; PIPELINES, DATABASES.
Proteomics: 2D gel data: image analysis, Transcriptional profiling, pharmacogenomics principles, analysis, information, integration data validations, peptide sequence determination.
M.II.ELE.T.2.
SCREENING METHODS IN PHARMACOLOGY AND CLINICAL RESEARCH
1. a. Drug discovery process: Principles, techniques and strategies used in new drug discovery. High throughput screening, human genomics, robotics and economics of drug discovery. Regulations for laboratory animal care and ethical requirements.
b. Bioassays: Basic principles of bioassays, official bioassays, experimental models and statistical designs employed in biological standardization. Biological standardization of vaccines and sera, vasopressin, oxytocin, Acetylcholine, Adrenaline, insulin, d-tubocurarine, HCG, hyaluronidase, corticotrophine, pertussis, Rabies and plague.
c. Introduction to biostatistics, parametric and non parametric tests.
2. Preclinical and clinical models employed in the screening of new drugs belonging to following categories
Antifertility agents, sympathomimetics, parasympathomimetics, muscle relaxants (both central and peripheral), sedatives, hypnotics, antiarrhytamic agents, cardiac stimulants, cardiotonic agents, bronchodilators, antihistaminics, eicoganoids.
Antipsychotic agents, antianxiety agents; nootropic drugs; antidepressant drugs; antiParkinsoinan agents; antiepileptics; analgesics and anti-inflammatory agents; antiulcer agents; infarction; antiatherosclerotic drugs; antimalarials; anthelmintics; antidiabetics; models for status epilepticus, intracerebroventricular and other newer techniques of drug administration and development; transgenic animals and other genetically prone animal models.
3. Alternatives to animal screening procedures, cell-line, patch-clamp technique, in-vitro models, molecular biology techniques.
4. Principles of toxicity evaluations, ED50, LD50 and TD values. International guidelines (ICH recommendations).
M.II.ELE.T.3. DRUG AND DRUG PRODUCTS STABILITY
1. Overview of kinetic concepts – First, 2nd , and pseudo orders.
2. Complex order kinetics – concepts, equations and their application.
Serires, consecutive and reversible reaction, steady state approximation.
3. Stability prediction by pharmacist and calculation protocols.
4. Temperature as a stress : Arrhenius theory, activation energy calculations, Q10 value calculations.
5. Interpretation of kinetic data: Transition state theory, media effects ,
catalysis, pH effects. Some practical applications.
6. Drug decomposition mechanisms:
a) Hydrolysis and acyltransfers,
Nature of reaction, structure and utility, stabilization of pharmaceuticals, pharmaceutical examples.
b)
Oxidation
Nature of oxidation
Kinetics of oxidation
Oxidation pathways of Pharmaceutical interest, inhibition of oxidation
c)
Photolysis
Energetics of photolysis
Kinetics of photolysis
Photolytic reactions of Pharmaceutical interest
Prevention of photolytic reactions
7. Solid state chemical decomposition
Kinetics of solid state decomposition
Pharmaceutical examples of solid state decomposition pure drugs, drug-excipient and drug-drug interaction in solid state methods of stabilization.
8. Physical stability testing of dosage forms
(1)
Solids – tablets, capsules, powder and granules
(2)
Disperse systems
(3)
Microbial decomposition
(4)
Over view, physical stability of novel drug carriers, liposomes, niosomes and nano particles.
9. Strategy and tactics of stability testing.
(A)
Regulatory requirements
(B)
Stability protocols
(C)
Experimental design
(D)
Interpretation of data
M.II.ELE.T.4. PHARMACEUTICAL BIOTECHNOLOGY
1. Microbial biotechnology
A. Aerobic and Anaerobic fermentation: The design of a fermenter
for the fermentations. Fed batch and continuous systems.
B. Antibiotic fermentations of penicillin and Rifamipicin in detail and a brief knowledge of peptide antibiotics.
C. Bio transformation of steroids and for the synthesis of chiral drugs and production of optically pure L and D aminoacids.
D. Bio degradation of xenobiotics, Microbial production of bio degradable plastics.
E. Single cell protein for food and feed.
2. Enzyme technology:
B.
Classification, general properties of enzymes, dynamics of enzymatic activity, sources of enzymes, extraction and purification. Applications – Pharmaceutical, therapeutic and clinical.
C.
Production of amylo glucosidase, glucose isomerase, amylase and trypsin and papain.
D.
Techniques of immobilization of enzymes and cells and their applications in the industry. Reactors for immobilized enzyme systems.
3. Immunobiotechnology:
B.
Hybridoma techniques – fusion methods for myeloma cells and B-Lymphocytes, selection and screening techniques. Production and purification of monoclonal antibodies and their applications in clinical diagnosis, immunotherapy and pharmaceutical research.
C.
Immuno diagnosis of infectious diseases and diagnostic agents.
D.
Vaccinology – knowledge of Extended programme of Immunisation. Classification of immunologicals. Manufacture techniques for bacterial and viral vaccines. Immunopotenciation, adjuvants. Living and non-living antigens, newer delivery systems. Naked DNA vaccines, sub
4. DNA technology:
B.
Genetic engineering: Techniques of gene manipulation, cloning strategies, procedures, cloning vectors, expression vectors, recombinant selection and screening – expression in E-coli and yeasts.
C.
Knowledge of site directed mutagenesis, polymerase are chain reaction and analysis of DNA sequences.
D.
Gene library and DNA.
E.
Applications of the above techniques in the production of
i)
regulatory proteins, interferon, interleukins, etc.
ii)
Blood products – erythropoietin, tPA
iii)
Vaccines – Hepatitis B
iv)
Hormones – Insulin
F.
Study on controlled and site specific delivery of therapeutic peptides and proteins through various routes of administration.
G.
Production of useful proteins in transgenic animals and gene therapy and restriction fragment length polymorphisms (RFLP) in diagnosis.
H.
Signal transduction, oncogenes and their proteins.
I.
The human genome project - a brief study.
5. Cell culture technology:
A.
Animal cell culture – General Requirements for establishing the animal cell culture, media, conditions and methods for cell cultures. Applications in Pharmacy.
B.
Plant tissue culture: General requirements for establishing the plant tissue culture system and their application for pharmaceuticals.
6. Bio informatics:
A brief knowledge of bio-informatics and its use in pharmacy and medicine.
SYLLABUS FOR M.PHARMACY COURSE
(2 YEARS DURATION) REVISED
2003 – 2004
WITH MINOR MODIFICATIONS EFFECTIVE FROM 2004-2005 ACADEMIC YEAR ONWARDS
KAKATIYA UNIVERSITY
WARANGAL – 506 009
