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G.Pulla Reddy College of Pharmacy

Hyderabad

Osmania University

1Chairperson, BoS Head of the Department Dean of the Faculty

SEMESTER - II

SEMESTER – III

SCHEME OF INSTRUCTION, EXAMINATION AND EVALUATION Program Code: 884 M. Pharm. (Pharmaceutical Chemistry)

2015 – 16

SEMESTER - I

Course Code Course Title Hours /Week Credits Marks Durationof Exam L T P Internal End Exam

PY.09.884.11.T Pharmaceutical Analytical Techniques 3 0 - 3 25 75 3 PY.09.888.12.T Adv. Chemistry of Natural Products 4 0 - 4 25 75 3 PY.09.884.13.T Adv. Pharm. Organic Chemistry – I 4 0 0 4 25 75 3 PY.09.884.14.T Advanced Medicinal Chemistry – I 4 0 0 4 25 75 3 PY.09.884.15.T Drug Design and Development 3 0 0 3 25 75 3 PY.09.884.11.P Pharmaceutical Analytical Techniques - 0 4 2 25 75 6 PY.09.888.12.P Adv. Chemistry of Natural Products - 0 4 2 25 75 6 22 175 525 PY.09.884.10.S SAIL 1 2 0 2 Grade PY.09.884.11.S Seminar 1 0 2 2 Grade

Course Code Course Title Hours /Week Credit s Marks Durationof Exam L T P Internal End Exam

PY.09.885.21.T Int. Property Rights & Reg. Affairs 3 0 - 3 25 75 3 PY.09.884.22.T Adv. Pharm. Organic Chemistry – II 4 0 - 4 25 75 3 PY.09.884.23.T Advanced Medicinal Chemistry – II 4 0 0 4 25 75 3 PY.09.884.24.T Drug Screening Methods 4 0 0 4 25 75 3 PY.09.88X.25.T Elective * 3 0 0 3 25 75 3 PY.09.884.22.P Adv. Pharm. Organic Chemistry – II - 0 4 2 25 75 6 PY.09.884.23.P Advanced Medicinal Chemistry – II - 0 4 2 25 75 6 22 175 525 PY.09.884.20.S SAIL 1 2 0 2 Grade PY.09.884.21.S Seminar 1 0 2 2 Grade * Discipline Centric – Herbal Drug Standardization / Bulk Drug Technology; Open – Research Methodology & Biostatistics

Course Code Course Title Hours /Week Credits Marks Duration in Weeks Internal External

PY.10.884.31.P Design Seminar 30 6 50 - 6 PY.10.884.32.P Progressive Seminar 30 10 50 - 10

480 16 100

SEMESTER – IV

Course Code Course Title Hours /Week Credits Marks Duration in Weeks Internal External

PY.10.884.41.P Pre-Submission Seminar 30 10 50 10 PY.10.884.42.P Submission and Adjudication 30 12 200 6 PY.10.884.43.P Final Viva-voce 30 2 50 1

510 24 300 17

CONTROLLED DOCUMENTGPRCP-EXT/MPS/9-10/PCH/01

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Hyderabad

Osmania University

2 Chairperson, BoS Head of the Department Dean of the Faculty

PHARMACEUTICAL ANALYTICAL TECHNIQUES

Scheme of Instruction Scheme of Examination

Total Duration : 60 Hrs. Max. Marks : 100 Hours/Week : 3 Hrs. Mid Semester : 20 Credits : 3 Quiz : 05 Instruction Mode : Lecture End Semester : 75 Course Code : PY.09.884.11.T Exam Duration : 3 Hrs.

Course Objectives: To familiarize students in conventional and modern techniques ofanalysis used in different areas of pharmacy. To understand the experimental concepts, the procedures and safety considerations in a quality control lab. To give training in use of the technique and its applications in day to day practice. To build on the basics learned at UG level and give latest advances in the area.

Course Outcomes: By pursuing this course students are prepared for:

- Research and Development - Food, Bio and Pharma Industries - Clinical Research and Quality Control Administration

Unit - I : UV-Visible Spectroscopy: Basic principles, interaction ofelectromagnetic radiation with matter and its effects (electronic transitions). Concept of chromophore and Auxo-chrome, effect of conjugation, solvent and pH. Instrumentation (components and their significance). Absorption spectra oforganic compounds and complexes illustrating the phenomenon and its utilization in qualitative and quantitative studies of drugs inclu ding multicomponent analysis. Woodward-Fieser rules for calculating absorption maximum for unsaturated hydrocarbons. Difference and derivative spectra. Infra-Red Spectroscopy: Interaction of infrared radiation with organic molecules and it’s effects on bonds. Instrumentation- Dispersive IR spectrophotometers and Fourier transform spectrophotometers. Sample handling for IR spectroscopy. Interpretation of IR spectra. Brief note on ATR. (Attenuated Total Reflectance).

Unit - II : Nuclear Magnetic Resonance Spectroscopy: Fundamental Principles of NMR, Chemical shifts concept, spin- spin coupling, spin-spin decoupling, shielding, de-shielding, shift reagents and solvents. Signal multiplicity phenomena in high resolution PMR. Interpretation of PMR spectra. Brief introduction about Carbon-13 NMR Spectroscopy. Mass Spectrometry: Basic principles Mass Spectrometry. Ionization techniques (EI and CI), Mass spectrum and its characteristics, molecular ion, metastable ions, fragment ions; fragmentationprocesses, Nitrogen Rules, Relative abundances of isotopes and their contribution to characteristic peaks and molecular formula determination.

Unit - III : Chromatographic Techniques: General Principles, Classification of Chromatographic Methods Thin Layer Chromatography, Paper Chromatographyand Column Chromatography and Methods based on Mechanism. Gas Chromatography: Instrumentation, Column efficiencyparameters, derivatization methods, applications in pharmaceutical analysis. Liquid Chromatography: Principles of HPLC, Instrumentation, Normaland Reversed Phase Packing Materials, Column Selection, Mobile Phase Selection, Efficiency Parameters, Applications in Pharmaceutical Analysis. Chiral Chromatography, Flash Chromatography, and Supercritical Fluid Chromatography (SFC).


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ADVANCED CHEMISTRY OF NATURAL PRODUCTS



Course Objectives: To inculcate knowledge of natural products and their medicinal applications.

Course Outcomes: To develop the ability to effectively apply knowledge of natural products chemistry in development of newer drugs, excipients, their safety and efficacy, in the management of diseases.

Unit - I : Natural Products as leads for New Drugs: Approaches to discovery and development of natural products; New drugs selection and optimization of lead compounds; Developmentofantibiotics, CNS, and cardiovascular agents;, Extraction of Plant constituents

Unit - II : Alkaloids: Isolation, classification and General methods of structure elucidation; Opium alkaloids: Morphine- structural elucidation, development of morphine analogues and morphine antagonists; Rauwolfia alkaloids: Reserpine-structural elucidation, structural modifications and therapeutic uses;

Unit - III : Steroids: Nomenclature and stereochemistryof steroids; Structural elucidation ofcholesterol and chemistryof diosgenin; Structural modifications and therapeutic uses of steroidal anti-inflammatoryand anti-fertility agents; Chemistry of Cardiac Steroids;

Unit - IV : Polypeptides and Proteins: General methods of separation of degradation and end group analysis; General methods of synthesis of peptides; Primary, secondary, tertiary and quaternary structure of proteins; Chemistry of insulin; Structural elucidation of thyroxine;

Unit - V : ß-Lactam Antibiotics: Historical accountofdiscovery of Penicillin Formulations and SAR of Cephalosporins.

Anticancer agents of Plant Origin: Instead: Sources, structures, mechanism of action, synthetic analogues and therapeutic uses of Taxol, Camptothecin and Vinca alkaloids

Books and References: 1. Finar IL. Organic Chemistry-stereochemistryand the chemistryofnatural products. 5th ed. vol 2. Dorling

Kindersley (India) Pvt. Ltd., New Delhi; 2006. 2. Abraham DJ, editor. Burger's medicinal chemistryand drug discovery. 6th ed. vol 1-6, John Wiley& Sons,

2007. 3. Morrison RT, Boyd RN. Organic Chemistry. 6th ed. Delhi: Pearson educationPvt. Ltd., New Delhi; 2003. 4. Pelletier SW. Alkaloids-chemical & biological perspectives. vol 1-15. Pergamon; London: 2001.

5. Alagarsamy V, Pharmaceutical Chemistry of Natural Products, Elsevier: New Delhi: 2012. 6. Steroids by Fischer & Fischer.


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ADVANCED PHARMCEUTICAL ORGANIC CHEMISTRY - I



Course Objectives: To inculcate knowledge ofbasics oforganic chemistry, reaction mechanisms, techniques oforganic synthesis, and their application in drug development.

Course Outcomes: To develop the ability to effectively apply knowledge of organic chemistry and reaction mechanisms in the synthesis of medicinal products.

Unit - I : Stereochemistry: Stereoisomerism; Elements of symmetry (Plane of symmetry, Centre of Symmetry, Axis of Symmetry and Alternating Axis of Symmetry); D, L and R, S – Nomenclature and sequence rules; Kinds of molecules displaying optical activity; Cis/T rans, E-Z isomerism in alkenes, monocyclic and fused ring systems; Stereochemistry of biphenyls, allenes and spiranes; Racemic modifications and methods of resol ution of racemic mixtures;

Unit - II : Reactive Intermediates: Structure, generation, stability and reactivity of Free radicals, Carbo-cations, Carbanions, Carbenes, Nitrenes and Nitrenium ions;

Unit - III : Mechanisms of Organic Reactions: Addition and Substitution Reactions for Electrophilic; Nucleophilic and Free Radical Reagents; Elimination Reactions (E1, E2 and E1cb Mechanisms);

Unit - IV : Synthetic Reagents and their Applications: Lead Tetra Acetate (LTA) and Osmonium Tetraoxide; N-Bromo Succinamide (NBS); Lithium Aluminum Hydride and Sodium Boro-Hydride; Di-Cyclohexyl Carbodimide (DCC), and 2,3-Dichlro-5,6-Dicyano-1,4-Benzo-Quinone (DDQ)

Unit - V : Rearrangement Reactions: Carbon to Carbon Migration: Wagner-Meerwin, Pinacol-Pinacolone and Benzil- Benzilic Acid Rearrangements; Carbon to Nitrogen Migration: Hoffmann, Curtius, and Beckmann and Lossen Rearrangement; Carbon to Oxygen Migration: Bayer- Villager Rearrangement and Rearrangement of Hydroperoxides; Aromatic Rearrangements - Fries Rearrangement;

Books and References:

1. Carey FA, Sundberg RJ. Advanced organic chemistry. Part- B: Reactions and synthesis. 5th ed. New York: Springer; 2007.

2. Eliel EL, Wilen SH. Stereochemistry of organic compounds. Delhi: John Wiley & Sons;2008 3. March J. Advanced organic chemistry: reactions, mechanisms and structures. 4th ed. Singapore: John

Wiley & Sons; 2003. 4. Finar IL. Organic Chemistry. 5th ed. vol 1. Delhi: Dorling Kindersley (India) Pvt. Ltd; 2006.


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ADVANCED MEDICINAL CHEMISTRY - I



Course Objectives: To inculcate knowledge of synthetic medicinal compounds, their mechanisms of action and safety.

Course Outcomes: To develop the ability to effectively apply knowledge of synthetic medicinal products in development of newer drugs, their safety and efficacy.

Unit - I : Chiral Drugs:Chirality and the importance ofchiral drugs; Techniques for preparing chiral drugs (Chiralitypool, enzymatic transformation and asymmetric synthesis); Role of Chirality in selective and specific therapeutic agents; Enantio selectivity in drug absorption, metabolism, distribution and elimination;

Unit - II : Principles of Drug Metabolism: Enzymes responsible for biotransformation; Microsomal and non-microsomal mechanisms; Phase-I and phase-II bio-transformations; Factors influencing bio-transformations;

Unit - III : Anti - Viral Agents: Structure and life cycle ofvirus and viral diseases; Antiviral agents used against DNAvirus- herpes, chicken pox; Antiviral agents used against RNA virus - HIV, influenza;

Unit - IV : Chemotherapy of Cancer: Molecular biologyof cancer and types of cancer; SAR and mechanismofaction of alkylating agents and antimetabolites; Antitumor antibiotics; Drug resistance in cancer chemotherapy; Novel targets and recent developments in cancer therapy;

Unit - V : TherapeuticAgents: Targets, Therapeutic approaches, Mechanismof Action of Synthetic Analogues and their SAR of the following Therapeutics - Anti-ulcer drugs; Lipid lowering Agents; Anti-angiogenesis Agents; Antihypertensive drugs;

Books and References: 1. Abraham DJ, editor. Burger's Medicinal Chemistryand Drug Discovery, 6th Ed. Vol 1-6. John Wiley& Sons;

New Jersey: 2007. 2. Hansch C, editor. Hansch's Comprehensive Medicinal Chemistry, Raj kamal Electronic Press; Delhi: 2005. 3. Silvermann RB. The Organic Chemistry of Drug Design and Drug Action. 2nd ed. Academic press

(Elsevier); London: 2004. 4. Ariens EJ, editor. Drug Design vol. I-X.: Academic Press; Noida 2009. 5. Lednicer D, Mitscher LA, The Organic Chemistry of Drug Synthesis, Volume-1-6.: A Wiley-Interscience

Publication; New York; 2005. 6. Alagarsamy V, Text Book of Medicinal Chemistry, Elsevier; New Delhi; 2010. 7. Roth HJ, Kleemann A. PharmaceuticalChemistry. Vol-I. Drug synthesis. Ellis HarwoodLtd; New York; 1988.


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DRUG DESIGN AND DEVELOPMENT



Course Objectives: To inculcate knowledge of various software used for synthetic medicinal products


Unit - I : Introduction to Drug Design: Concept, Lead Discovery Physicochemical Properties in Relation to Biological Action; Receptors and Genesis of New Drugs: Types of receptors; Forces involved in drug-receptor interactions; Theories of drug-receptor interactions; Topographical and stereo chemical considerations; Discovery of drugs from natural origin; Serendipity, random and non-random screening of drugs; Bio-isosterism concept and molecular modification approaches in genesis of drugs;

Unit - II : Rational Drug Design: Types of Rational drug design, Rational drug design techniques; QSAR descriptors: hydrophobicity, electronic effects, steric factors, molar refractivity, verloop steric parameter; Hansch analysis, Free- Wilson approach and Topliss scheme; 2D and 3D QSAR and molecular graphics in drug design; Drug development–cimetidine;

Unit - III : Molecular Modeling and Docking: Molecular mechanics: Energy minimization, force field calculations and molecular dynamic simulations; Quantam mechanics: Quantum chemical calculations and applications; Modeling ligands for known and unknown receptors; Molecular docking approaches and scoring techniques; Molecular docking applications;

Unit - IV : Combinatorial Chemistry- Introduction, Solid Phase Synthesis, Liquid Phase Synthesis, Methods of Parallel and Mixed Combinatorial Synthesis, Deconvolution and High Throughput Screening; De-convolution techniques, tagging and photolithography; Planning, designing and limitations of combinatorial synthesis; Dynamic combinatorial chemistry; Applications of combinatorial chemistry

Unit - V : Homology Modeling: Biological databases; Sequence alignmentmethods (pair wise and multiple sequence); Phylogenetic analysis; Homologymodeling algorithms, scoring systems; 3D structure predictionand evaluation;

Text Books and References:

1. Abraham DJ, editor. Burger's Medicinal Chemistry and Drug Discovery, 6th ed. Vol 1-6. New Jersey: John Wiley & Sons; 2007.

2. Lemke TL, Williams DA, editor. Foye's principles of medicinal chemistry. 6th ed. New Delhi: Wolters


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PHARMACEUTICAL ANALYTICAL TECHNIQUES


Total Duration : 60 Hrs. Max. Marks : 100 Hours/Week : 4 Hrs. Mid Semester : 20 Credits : 2 Quiz : 05 Instruction Mode : Practical End Semester : 75 Course Code : PY.09.884.11.P Exam Duration : 6 Hrs.

Course Objectives: To make students familiar with the principles of modern analytical techniques and application of analytical instruments in pharmacy.

Course Outcomes: At the end of the course, the student will be able to understand the fundamental concept of modern analytical techniques, which is important for qualitative as well as quantitative analysis of drug substances and drug product.

List of Experiments :

1. UV/Visible spectrum scanning of a few organic compounds for UV- absorption and correlations of

structures (5 compounds) and isosbestic point in case of mixtures. 2. Effect of solvents and pH on UV spectrum ofdrugs (2 experiments). 3. Estimation of multicomponent formulation byUV- Spectrophotometer in formulations. (2

experiments).

4. Experiments based on the application ofderivative spectroscopy. (2 experiments). 5. Experiments based on HPLC (Isocratic and Gradientelution) techniques. (2 experiments). 6. Interpretation of drugs by IR spectra. 7. Workshop of spectroscopy: (UV, IR, NMR, MASS) structural elucidation of at least 5 compounds (4

experiments). 8. Separation of protein drug substances by electrophoresis.

9. Any other relevant experiments based on theory.



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Osmania University


INTELLECTUAL PROPERTY RIGHTS & REGULATORY AFFAIRS


Total Duration : 60 Hrs. Max. Marks : 100 Hours/Week : 3 Hrs. Mid Semester : 20 Credits : 3 Quiz : 05 Instruction Mode : Lecture End Semester : 75 Course Code : PY.09.885.21.P Exam Duration : 3 Hrs.

Course Objectives: To make students familiar with the fundamental principles of IPR and Drug Regulatory Affairs

Course Outcomes: On completion of the course the student would understand the principle and importance of IPR and Drug Regulatory Affairs in the Competitive World. Further to familiarize with Safety and Pollution Control Regulations in addition to Other Product Regulations and Sustainable Development Principles.

Unit - I : Intellectual Property Rights (IPR): Objectives, types of IPR, Patents-advantages, types, criteria, inventions – patentable, Impact on Pharmaceutical Industry, copyrights-types rights, trademarks-functions, types, geographical indications-significance, types, industrial designs, and trade secrets. India Patents Act, 1970, Amendments, 1999, 2002, 2005, stages of patenting, patent opposition (Post Grant), maintaining the patent rights – Conditions, patent information – search and sources

Unit - II : International Patent Filing Procedures – Requirements for patenting, utility, novelty non-obviousness, patent specification & claims, patent infringement and doctrine of equivalents, federal circuit and patent system. International Organizations and Agreements – IPR: General Agreement on Tariffs and Trade (GATT)- Historical perspectives, objectives and impact, World Trade Organization (WTO)- scope, functions, structure, withdrawal ofmembership, dispute settlement, World Intellectual PropertyOrganization (WIPO) - objectives and programs, Paris Convention – background, scope, impact, Berne Convention, TRIPS Agreement-scope general features, specific features, The Doha Declaration, Patent Cooperation Treaty (PCT), Madrid Protocol.

Unit - III : ICH – Guidelines: Harmonization Efforts, Basic Principles (Quality, Safety and Efficacy), ICH Q11 (Quality Management Systems); Common Technical Document (CTD) and Generic Drug Products. WHO – Guidelines: Sampling Operations PICS Guidelines: Basic Requirements of Medicinal Products and API’s OECD Guidelines: Clinical Studies US-FDA: Orange Book, FDA Guidelines on Investigational New Drugs (IND), New Drug Applications (NDA).

Unit - IV : Regulatory Affairs: Indian Context - Drugs and Cosmetics Act 1940 and Rules 1945 with reference to Schedule M, U and Y. Drug Regulatory Controls and Authorities; Important Regulations: Importand Export of Drugs; Preparation and Submission of Marketing Application of India, US and Europe; Approval and Appeals Present and Issues of Confidentiality.


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Osmania University


ADVANCED PHARMACEUTICAL ORGANIC CHEMISTRY - II



Course Objectives: To inculcate knowledge of advances in applications of synthetic reagents and synthetic strategies, approaches for synthesis of heterocyclics, specific applications named reactions in drug development. Course Outcomes:

To apply the knowledge and skills of synthetic organic chemistry and reaction mechanisms in the in drug development. Unit - I : Reaction Mechanism and Applications: Claisen Ester Condensation; Mannich Reaction; Micheal Addition; Reformatsky Reaction; Perkin Reaction; Birch Reduction; Sharpless Epoxidation;

Unit - II : Heterocyclic Chemistry: Synthetic Approaches for Building Heteroaromatc Fused Ring Systems (Benzofuran, Benzothiaphene, Benzisoxazole, Benzthiazole, Benzimidazole, Indole, Quinoline, Benzazepine, Quinazoline, Phthalazine,,Benzodiazepine, Chromone), Diazines and Triazines (6 - Membered Heterocycles), Azoles (5 - Membered Heterocycles.);

Unit - III : Pericyclic Reactions: Electrocyclic, Cycloaddition and Sigmatropic Reactions; Molecular Orbitals of Ethene, 1,3-Butadiene and 1, 3, 5-Hexatriene and their Symmetry Properties, Mechanism of Pericyclic Reactions - Frontier Molecular Orbital T heory, Huckel-Mobius Theory, Woodward Hoffmann Rules; Applications of Pericyclic Reactions - Claisen Rearrangement and Cope Rearrangement;

Unit - IV : Synthetic Strategies: Disconnection Approach; Consecutive vs Convergent Synthesis; Strategic Approaches in Retro Synthesis; Strategic Bond Approach-Preliminary Scan; Criteria in Disconnection of Strategic Bonds; Identifying Strategic Bonds in Rings;

Unit - V : Scale up Process for the Pharmaceuticals: Selection, Developmentand Scale up, Optimization of Synthetic Routes; Yield Improvement, Investigative Approach and Streamlining the Process; Principles and Applications of Green Chemistry; Phase Transfer Catalysis: Principles and Applications;


1. Carrruthers W, Coldham I. Modern Methods of Organic Synthesis. 4th Ed. Cambridge UniversityPress; New Delhi: 2007.

2. Clayden J, Greeves N, Warren S, Wothers P. Organic Chemistry. Oxford UniversityPress; NewDelhi: 2001. 3. Carey FA, Sundberg RJ. Advanced Organic Chemistry. Part- B: Reactions and Synthesis. 5th Ed. Springer;

New York; 2007.


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ADVANCED MEDICINAL CHEMISTRY - II


Total Duration : 60 Hrs. Max. Marks : 100 Hours/Week : 4 Hrs. Mid Semester : 20 Credits : 4 Quiz : 05 Instruction Mode : Lecture End Semester : 75 Course Code : PY.09.884.14.T Exam Duration : 3 Hrs.Course Objectives: To inculcate knowledge of synthetic medicinal compounds, their mechanisms of action and safety.


Unit - I : Design and Application of Prodrugs: Prodrug Concept, Choice and Function of Pro-moiety, Bio-reversible Derivatives for various Functional groups, Applications of the Prodrug Approach; Targeted Prodrugs

Unit - II : Design and Application of Soft Drugs: Soft Drug concept, Soft Analogues, Active metabolite based Soft Drugs, Inactive metabolite based Soft Drugs, Activated Soft Compounds, Natural Soft Drugs, Applications of the Soft Drug Approach.

Unit - III : Rational Design of Enzyme Inhibitors: Cyclooxygenase and Lipoxygenase Inhibitors; Phosphodiesterase (PDE) Inhibitors; HMG Co A Reductase Inhibitors; Angiotensin Converting Enzyme (ACE) Inhibitors; Carbonic Anhydrase Inhibitors;

Unit - IV : Anti-tubercularAgents: Targets, Therapeutic Approaches, Mechanism of Action; Synthesis, Structural Activity Relationship and Metabolic Consideration of Drugs; Anti-malarial Agents: Life cycle, Targets, Therapeutic Approaches; Mechanismof Action; Synthesis, Structural Activity Relationship and Metabolic consideration of Different Classes of Drugs;

Unit - V : Therapeutic Approaches: Targets, Mechanism of Action, Synthesis, Structural Activity Relationship and Metabolic consideration of Drugs used in Alzheimer and Parkinsonism T herapy.

Books and References: 1. Abraham DJ, editor. Burger's Medicinal Chemistryand Drug Discovery, 6th Ed. Vol 1-6, John Wiley& Sons;

New Jersey: 2007. 2. Lemke TL, Williams DA, editor. Foye's Principles of Medicinal Chemistry. 6th Ed. Wolters Kluwer and

Lippincott Williams & Wilkins; New Delhi; 2008. 3. Ariens EJ, editor. Drug Design vol. I-X. Academic Press; Noida: 2009. 4. Purcell, Strategy of Drug Design. 5. Hansch C, editor. Hansch's Comprehensive Medicinal Chemistry, Rajkamal Elec. Press; New Delhi: 2005. 6. Alagarsamy V, Text Book of Medicinal Chemistry, Elsevier: New Delhi: 2010. 7. Silvermann RB. The Organic Chemistryof Drug Design and Drug Action. 2nd Ed. Academic Press (Elsevier);

London: 2004.


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1988.


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Hyderabad

Osmania University


DRUG SCREENING METHODS


Total Duration : 60 Hrs. Max. Marks : 100 Hours/Week : 4 Hrs. Mid Semester : 20 Credits : 4 Quiz : 05 Instruction Mode : Lecture End Semester : 75 Course Code : PY.09.884.24.P Exam Duration : 3 Hrs.

Course Objectives: This course offer practical advantages in fine-tuning the understanding ofvarious drug screening techniques by using various Bioassay Methods.

Course Outcomes: Upon completion of the course the student shall be able to,

- Describe the various newer screening methods involved in the drug discovery process. - Learn the applicability and importance of bioassays in preclinical research. - Appreciate and correlate the preclinical data to humans.

Unit - I : Design of Experiment: Principles of Randomization, Replication and Local Control, Completely Randomized Block of the Above Designs in Pharmaceutical Research, Statistical Quality Control, Process Control, Control Charts, Acceptance Sampling - Sampling Plans.

Unit - II : High throughput Screening: Introduction, Bioassay Design, and Screen Construction-Assay Design, Assay Construction, Homogenous and Non-homogeneous Biochemical Assays and Cellular Assays.

Unit - III : Bioassay: Different Types: Dose Effect Relationships, Calculation of LD50, ED50 - Probit Analysis.

Unit - IV : In vivo Screening Methods: Antihypertensive, Antiarrythmic, Cardiotonic, and Anticancer and Diuretic Drugs.

Unit - V : In vivo Screening Methods: Analgesic, Anti-inflammatory, Antiepileptic, CNS Depressants, Antidiabetic, Antifertility and Antiulcer Drugs.

Books and References: 1. Abraham DJ, Burger's Medicinal Chemistryand Drug Discovery, 6th Ed. vol 1- 6. John Wiley& Sons; NJ: 2007. 2. Vogel. WH. Drug Discovery and Evaluations-Pharmacological Assays. 2nd Ed. Springer; Germany: 2002. 3. Seethala R, Fernandes PB. Hand Book of Drug Screening. CBS Publishers & Distributors; New York: 2008. 4. Lewis AE. Biostatistics, 2nd ed. Reinhold Publishers Corporation; New York: 1984. 5. Alder HL, Roesseler EB. Introduction to Probability and Statistics. 12th Ed.: WH. Freemann; SF 2006. 6. Gupta SC, Kapoor VK. Fundamentals ofapplied statistics. 4th ed. Sultan Chandandsons; New Delhi: 2007. 7. Saunders and Fleming. Mathematics and Statistics for use in Pharmacy, Biology and Chemistry. 8. Gupta SK. Drug Screening Methods. Jaypee Brothers Medical Publishers (P) Ltd; New Delhi: 2004. 9. Arora PN, Malhan PK. Biostatistics. Himalaya Publishing House; Mumbai: 2008. 10. Bolton S, Bon C, Pharmaceutical statistics, 4th Ed. Marcel Dekker Inc; New York: 2004.


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Osmania University


Books and References: 1. Vogel HG and Vogel WH, Drug discovery and Evaluation, Pharmacological Assays, Springer – Verlag. 2. Ayurvedic Pharmacopoeia 3. Thin Layer Chromatography by E. Stahl 4. Herbal Phamacopoeia 5. Herbal Drugs Industry by R.D. Chaudari. 6. Standardization of Botanicals by D. Rajpal, Eastern publishers. 7. General Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems WHO 2004. 8. General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine WHO/EDM/

TRM/ 2000.1 9. Herbal Drug Technology by SS Agarwal and M paridhavi, 2nd Edition, Universities Press, 2007. 10. Quality Control of Herbal Drugs by Pulok K Mukherjee, 1st Edition Business Horizones, Pharmaceutical

Publisher, New Delhi, 2005.


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Osmania University


Unit - V : Scientific Writing and Reporting: Different types of Research Papers; Title and Author Names; Abstract and Key Words; Methodology; Scientific Presentation: Importance, Types and Different Skills; Content, Format of Model, Introduction and Ending; Skills for Oral Presentation and Types of Visual Aids; Questionnaire Patents: Product Patents and Process Patent; Patent Search; Patent Analysis; Patent Drafting; Patent Filing;

Books and References: 1. Pharmaceutical Statistics – Practical and Clinical Applications, Bolton S., Marcel Dekker, Inc. N., USA 2. Biostatistics: A Foundation for Analysis in Health Sciences, Wayne W Daniel, John Wiley & Sons, Inc. 3. Introduction to Statistical Analysis, Dixon W. J. and MasseyF. J., McGraw Hill, N.Y., USA. 4. Statistical Methods, Snedecor G. W. and Cochran W. G., Iowa State University Press, Ames, Iowa. 5. Research in Education, John W Best and James V Khan, Prentice Hall of India Pvt. Ltd. 6. Effective Business Report Writing, Brown Leland, Prentice Hall Inc. India. 7. Presentation Skills, Michael Hatton, Indian Societyfor Technical Education, New Delhi. 8. Thesis and Assignmentwriting, Anderson Jonathan and Durston Berry H, Wiley Eastern Ltd., Bangalore. 9. Writing a Technical Paper, Donald H Menzel, McGraw Hill Book Company, Inc., New York.


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ADVACED PHARMACEUTICAL ORGANIC CHEMISTRY - II


Total Duration : 60 Hrs. Max. Marks : 100 Hours/Week : 4 Hrs. Mid Semester : 20 Credits : 2 Quiz : 05 Instruction Mode : Practical End Semester : 75 Course Code : PY.09.884.22.P Exam Duration : 6 Hrs.

Course Objectives: To introduce different experiments to develop the skills and strategic approaches for organic synthesis .

Course Outcomes: Develop hands on expertise to design and conduct the experiments independently

List of Experiments (Minimum of 8 Experiments shall be conducted) 1. Synthesis of Following Compounds

a. Benzanilide by bechmann rearrangement b. 4-benzylidine-2-methyloxazol-5-one (or) azalactone c. N-(m-nitrobenzyl) aniline from m- nitrobenzaldehyde d. 2,3-diphenylquinoxaline e. 1H-indole-3-carbaldehyde f. 3,4-dihydropyrimidin-2(1H)-one from benzaldehyde, ethyl acetoacetate and urea in

presence of CaCl2 catalyst g. Schiffbase by microwave irradiation h. Cinnamic acid byperkin reaction i. β-dimethylamino propiophenone hydrochloride ( mannich base) j. 2-phenyl indole k. Dimedone (5,5-dimethyl cyclohexane-1,3-dione) l. 3-bromo cyclohexene from cyclohexene using NBS. m. p-amino benzyl alcohol from p-amino bezaldehyde using sodium borohydride. n. Cyclohexane-2,5-dicarboxylic acid from benzoic acid (hydrogenation).

2. Any other relevant experiments based on theory. Books and References: 1. Roth HJ, Kleemann A. Pharmaceutical Chemistry. Vol-I. Drug Synthesis. NY: Ellis Harwood Ltd; 1988. 2. Mann FG, Saunders BC. Practical Organic Chemistry. 4th ed. New Delhi: Orient Longman; 2005. 3. Furniss BS, Hanaford AJ, Smith PWG, Tatchell AR. Vogel’s T extbook of Practical Organic Chemistry. 5th

Ed. Singapore; Longman Singapore: Publishers P Ltd; 1989 4. Vogel A, ElementaryPractical Organic Chemistry. Part 1 : Small Scale Preparations. 2nd Ed. New Delhi: CBS

Publishers and Distributors; 2004. 5. Bansal RK. Laboratory Manual of Organic Chemistry. 4th Ed. New Delhi: New Age Int. (P) Ltd; 2005. 6. Kar A. Advanced Practical Medicinal Chemistry. New Delhi: New Age International (P) Limited; 2006.


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SAIL


RESEARCH METHODOLOGY

Scheme of Instruction Scheme of Examination Total Duration : 30 Hrs. Max. Marks : 50 Hours/Week : 2 Hrs. Assignment : 20 Credits : 2 Attendance : 05 Instruction Mode : Tutorial Seminar : 25 Course Code : PY.09.880.X2.I Exam Duration : 1 Hr.

Course Objectives: To give exposure on how to do literature survey for the project work. To develop technical writing skills in the form of a research report. Course Outcomes: To able to organize the research in an effective fashion

Unit – I : Basics of Research: Definition, objectives, motivation, types of research and approaches; Descriptive research, conceptual, theoretical, applied and experimental. Formation of Research Problem: Research Process: To determine what type of research to be done, plan of research work; Selection of research area, prioritization of research; Literature review: importance and methods, sources; Objectives and scope ofwork, developing research plan and schedule; Scheduling constraints, steps, problems in scheduling, limitations. Experimental Modeling: Definition ofexperimental design, examples, single factor experiments, blockingand Nuisance factors, guidelines for designing experiments; General model of process: Input factors/ variables, Output parameters / variables controllable / uncontrollable variables, dependent / independent variables, experimental validity; Introduction to Risk assessment, reliability, sustainability, and uncertainty.

Unit – II : Analysis of Data: Types of data: parametric and nonparametric, descriptive and inferential data; Collection of data: normal distribution, calculation of co-relation coefficient; Data processing: analysis, error analysis, meaning, and differentmethods; analysis of variance, significance ofvariance, analysis of covariance, multiple regressions, testing linearity/nonlinearity of model, testing adequacy of model; Test to be used in data exploration and their choice; Introduction of software used in data analysis. Research Deliverables: Various Forms of Publication: T hesis, paper, research proposal; Thesis Writing: Introduction, literature review/state-of-the-art, research approach (methodology), results / findings, discussions, conclusions, scope for future work, references, appendices; Presentation: Poster, thesis, proposal, and paper. Ethical and Plagiarism issues in research: Historical perspectives, General principles on ethical consideration involving human participation, General ethical evaluation ofdrugs/ device/ diagnostics/ vaccines/ herbal remedies. Statement of specific principles for human genetics and genomic research. International Conference on Harmonization. Good clinical practices norms, Ethical principles related to animal experiments; Issues related to plagiarism, copyright laws, acknowledging the sources, format for manuscript writing, documentation, organization of reference material, bibliography, end note.

References: 1. C.R. Kothari, 2004. “Research Methodology”. 2nd Ed. New Age International (p) Limited, Publishers. 2. D. Montgomary, 2000. “Design of Experiments”. 5th Ed. Wiley Interscience. 3. K.P. Willkinsion, L. Bhandarkar, “Formulation of Hypothesis”. 3rd ed. Himalaya publishing, Mumbai. 4. Schank Fr, 2008.“Theories of Engineering Experiments”. 2nd Ed. Tata McGraw Hill. 5. J.W. Best and J.V. Kahn, 2006. “Research in Education”. 10th Ed. PHI publication.


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SAIL


ENREPRENEURSHIP DEVELOPMENT


Total Duration : 30 Hrs. Max. Marks : 50 Hours/Week : 2 Hrs. Assignment : 20 Credits : 2 Attendance : 05 Instruction Mode : Tutorial Seminar : 25 Course Code : PY.09.880.X4.I Exam Duration : 1 Hr.

Course Objectives: To provide conceptual inputs regarding entrepreneurship management. To sensitize and motivate the students towards entrepreneurship management. To orient and impart knowledge towards identifying and implementing entrepreneurship opportunities.

Course Outcomes: To develop managementskills for entrepreneurship management

Unit - I : CONCEPTUAL FRAME WORK: Concept need and process in entrepreneurship development; Role of enterprise in national and global economy; Types ofenterprise – Merits and Demerits; Governmentpolicies and schemes for enterprise development; Institutional support in enterprise development and management; THE ENTREPRENEUR: Dynamics of Entrepreneurial Motivation; Concepts; Developing Entrepreneurial Competencies; Requirements and understanding the process of entrepreneurship development; self- awareness, interpersonal skills, creativity, assertiveness, achievement, factors affecting entrepreneur'’ role.

Unit - II : LAUNCHING AND ORGANISING AN ENTERPRISE: Environmentscanning – Information, sources, schemes of assistance, problems; Enterprise selection, marketassessment, enterprise feasibility study, SWOT Analysis; Resource mobilization - finance, technology, raw material, site and manpower; Costing and marketing management and quality control; Feedback, monitoring and evaluation; Project work – Feasibility report; Planning, resource mobilization and implementation. GROWTH STRATEGIES AND NETWORKING; Performance appraisal and assessment; Profitability and control measures, demands and challenges; Need for diversification; Future Growth – Techniques ofexpansion and diversification, vision strategies; Concept and dynamics; Methods, Joint venture, co-ordination and feasibility study;

References: 1. Akhauri, M.M.P.(1990): Entrepreneurship for Women in India, NIESBUD, New Delhi. 2. Hisrich, R.D & Brush, C.G.(1996) The Women Entrepreneurs, D.C. Health & Co., Toranto. 3. Hisrich, R.D. and Peters, M.P. (1995): Entrepreneurship – Starting, Developing and Managing a New

Enterprise, Richard D., Inwin, INC, USA. 4. Meredith, G.G. etal (1982): Practice of Entrepreneurship, ILO, Geneva. 5. Patel, V.C.(1987): Women Entrepreneurship – Developing New Entrepreneurs, Ahmedabad EDII.


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SAIL


Laboratory Design, Safety and Management



Course Objectives: To expose them to existing national safety standards To acquaintwith Laboratory Design and Management

Course Outcomes: On Completion of the course the studentwill be able to perform the Experiments as per cGLPnorms.

Unit - I : Lab Design Criteria; Codes, Standards and References; Architectural Considerations, Walls, Doors, Windows, Security, Ceiling, Flooring, Cleanability, Sinks, Storage, Exit Paths, Engineering Considerations – Electrical, Plumbing, Utilities – Air, Water, Steam and Gases, Heating, Ventilation, Air Conditioning and Fume Hoods; Laboratory Furniture Design and Location; General Laboratory Safety Practices; Standard Operating Procedures (SOP’s);

Unit - II : Management of Analytical Laboratory: Organization of Laboratories based on their types, staffing, skill development and training, budgeting and financing, purchase of costly equipment, qualities of laboratory manager and management styles. Laboratory Inspections: Internal inspection, external audit, concepts, preparing for inspections and audits. Reference standards: Types, preparation, containers, labeling, storage and use. Documentation-STPs: Certificate of Analysis (COA.), LaboratoryNote Books: Typical Documents used in a GLP Laboratory including Standard Test Protocols (STP’s),

References: 1. Laboratory Design Guidelines – University of North Carolina, USA 2. Laboratory Design Hand Book 3. Designing and Planning of Laboratories (2009) 4. Laboratory Design and Construction Guidelines (2010) – Departmentof Environment, Health and Safety,

University of South Carolina, USA 5. Laboratory Safety Design Guide,(2007) – Departmentof Environment, Health and Safety, University of

California, USA 6. Laboratory Safety Guidance,(2011) – OSHA, USA

7. Safe Lab (2007) Web site at www.cpsc.gov


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SAIL


Employability Skills



Course Objectives: To enhance the employability skills of learners with a special focus on presentation skills, group discussion and interview skills. To enable them to improve their soft skills necessary for workplace contexts. To equip them with effective communicative competence for a global reach.

Course Outcomes: Participate in conversations both formal and informal, attend phone calls and interviews successfully. Read different types of texts and Listen to, and understand foreign accents.

Unit - I : SPEAKING SKILLS: Conversationalskills (formaland informal contexts) - telephonic communication, attending job interviews (responding to FAQs) - taking part in GDs - making presentations. WRITING SKILLS: Job applications – cover letter – resume – applying online – writing proposals – e-Mails – letters – reports – memos – minutes – blogging – tweeting – writing recommendations and instructions – writing for publications. READING SKILLS: Vocabularybuilding – speed reading (skimming – scanning) – reading different genres of texts from newspapers to philosophical treatises – criticalreading – effective reading strategies such as reading ‘beyond the lines’, summarizing, graphic organizers and distinguishing facts from opinions. Unit - II : LISTENING/VIEWING SKILLS: Speeches of different nationalities with focus on American and British accent (TED talks, podcasts) – listening to lyrics – lectures – instructions – dialogues – news casting – talk shows – interviews (Hard talk, Devil’s Advocate) SOFT SKILLS: Motivation - persuasive skills – negotiations – time management – emotional intelligence – stress management – creative and critical thinking.

References: 1. Barker, A. Improve Your Communication Skills. New Delhi: Kogan Page India Pvt. Ltd., 2006. 2. Craven, Miles. Listening Extra – A resource book of multi-level skills activities.Cambridge University

Press, 2004. 3. Gammidge, Mick. Speaking Extra - A resource book of multi-level skills activities. Cambridge

University Press, 2004. 4. Hartley, Peter. Group Communication. London: Routledge, 2004. 5. John Seely. The Oxford Guide to Writing and Speaking. New Delhi: Oxford University Press, 2004. 6. Naterop Jean & Rod Revell. Telephoning in English. Cambridge University Press,1987. 7. Ramesh, Gopalswamy and Mahadevan Ramesh. The ACE of Soft Skills. New Delhi: Pearson, 2010.

Web Sources: 1. www.humanresources.about.com 2. www.careerride.com


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