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5. Pharmaceutical Dosage Forms: Parenteral medications. Vols. I, II, II], Ed Kenneth A. Avis, Leon Lachman and H. A. Liberman,, Marcel Dekker INC., , 6. Pharmacetuical Technology, Vols. I, I], RS R Murthy, Ashutosh Kar, New Age Int. Ltd., , 7. Pharmaceutical dosage forms: Parental medications, Vol. I, Il, III, ed. by Kenneth A. Avis, Leon Lachman and H. A. Liberman,, Marcel Dekker Inc., 1986., , 8. Pharmaceutics. The Science of dosage form design ed. by M. E. Aulton, 2 nd ed., Churchill Livingstone, 2002., , 9. Modern Pharmaceutics, 4 th ed. Revised and Expanded ed. by Gilbert S. Banker and Christopher T. Rhodes, Marcel Dekker INC.,, 2002., , 10. The theory and practice of industrial pharmacy, ed. by Leon Lachman, H. A. Liberman, J. I. Kanig, 3 rd ed., Verghese Publishing, house, 1987., , 11. Ophthalmic drug delivery, ed. by Ashim K. Mitra, 1993, Marcel Dekker INC., , 12. Turco and Kings, Sterile Dosage forms, 3 rd Edn., Lea & Febiger, Philadelphia, 1985., , 13. Michael J. Akers, Quality Control of Parenterals, Marcel Dekker, , 14. Controlled drug delivery — Fundamentals and Applications”, Robinson Joseph R., Lee Vincent H., Vol. 29, Marcel Dekker Inc, , 15. Leon Shargel, Susanna Wu — Pong, Andrew B.C, Applied Biopharmaceutics and Pharmacokinetics, Singapor, , 16. Brahmankar D.M and Jaiswal Sunil B, Biopharmaceutics and Pharmacokinetics — A Treatise, Vallabh Prakashan., , Note: References to latest amendments of Schedule M and Schedule U of Drugs and Cosmetics Act 1940 to be made wherever, itis appropriate, , BPH_C_803_L-— Pharmaceutical Chemistry Lab II- 4 Hr/Wk), , Course Objectives, 1) To introduce the learner to various hands-on experimental organic synthetic techniques including column chromatography, , and thin layer chromatography., 2) To learn characterization of intermediates and final products by TLC and IR, 3) To review important topics such as cyclization, reduction, rearrangement, condensation reactions., 4) To introduce the leamer to the concepts of green chemistry., 5) To study the source, disposal and prevention of chemical waste., Course Outcomes, The learner should be able to, 1) Design and perform various unit operations of organic synthetic reactions, 2) Characterize reaction intermediates and final products., 3) Know the theoretical concepts behind organic synthesis., 4) Understand the concept and techniques of waste management., , Synthesis of the following Drugs and Drug Intermediates, 1. Synthesis of Benzilic Acid: Conventional Method and Green Modification as in Green Chemistry DST Monograph, , Three Component Synthesis of Pyrimidone using Ethylacetoacetate, Benzaldehyde and Urea as per Green Chemistry DST, Monograph, , 3. Hofimann rearrangement: Anthranilic acid from Phthalimide., , 4. Reduction reaction: PABA from p-nitrobenzoic acid., , 5. Pechmann condensation for coumarin synthesis using clay catalyst (Clay catalyzed solid state synthesis of 7-hydroxy-4methylcoumarin)., , 6. Synthesis of resacetophenone (Ref. Vogel page 983), , 7. Synthesis of 4-methylcarbostyryl (old syllabus experiment), , 8. Synthesis of Phenytoin, , 9. Synthesis of Hippuric Acid, , (https://www. linfield.edu/assets/files/chem/Courses/CHEM%20322/3bAmide_synthesis_2015.pdf), Or Synthesis of adipic acid (Ref, DST Monograph pg. 38), , Monitoring the progress of any two reactions by using TLC: Aim is to only monitor the completion of the reaction under, consideration. Student can comment on status of the reaction (completion/ incompletion) using TLC; they must develop the solvent, system, , Books:, , 1. Vogel’s A Text book of Practical Organic Chemistry by Vogel, Longman group limited, London., 2. Practical Organic Chemistry by Mann FC & Saunders BC, Longman Group Limited, London., , 3. Laboratory Techniques in Organic Chemistry, Ahluwalia V.K. LK. Publishers., , 4, Green Chemistry, V. K. Ahluwalia.
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5. New Trends in Green Chemistry, V K Ahluwalia and M Kidwai, KluwerAcademic Publishers, 6. Monograph on Green laboratory Experiments, Grenn Chemistry Task Force Committee, DST., 7. Practical Organic Synthesis: A Student's Guide - Reinhart Keese, Martin Brindle, Trevor Toube., 8. Advanced practical Medicinal Chemistry by Ashutosh Kar, New Age International Publications., , , , BPH_C_804_L - Pharmaceutics Lab IV- (4 Hr/Wk), , Course Objectives, To train the learner with the practical aspects of formulation, manufacturing and quality control tests of parenteral and ophthalmic, products., Course Outcomes, Upon completion of the course, the learner shall be able to:, 1. Demonstrate the intricacies of formulation and development of parenterals and ophthalmic products., 2. Understand and know about quality control and documentation of a manufacturing process., 3. Know about the pharmacopoeial tests for these products and their packaging materials., 4. Explain the concept of dissolution testing as an important quality control tool and relate to its importance from regulatory point of, view., 5. Apply pharmacokinetic principles of oral routes of administration., 6. Demonstrate oral and written communication skills and ability to plan the experimentation with proper time management, , , , , , , , , , , , EXPERIMENTS, No. Details, 1 Preparation & Testing of WFT as per IP, 2 Processing and monographic testing of Glass containers and rubber closures as per IP., 3 Preparation and documentation of the following injections:, , a. Calcium Gluconate injection IP, b. Ascorbic acid injection IP., ¢. Sodium chloride & Dextrose Injection IP, , , , 4 Preparation and documentation of following ophthalmic products:, a. Sulphacetamide eye drops, IP, b. Official antibiotic eye ointment (any one), , , , 5 Preparation and in vitro release evaluation of sustained release oral tablets (matrix type), , , , 6 Dissolution testing of marketed formulations of conventional tablets containing poorlywater soluble, drug (selection of medium), , , , , , , , , , , , , , , , , , , , , , 7 Calculations of pharmacokinetic parameters -i.v. administration (plasma samples provided)., 8 Microencapsulation of solid/liquid core using phase separation coacervation technique, 9 Preparation and evaluation of mucoadhesive buccal formulation (tablet/film), 10 Validation of process- mixing/milling, ul Assignment on SOP’s of dissolution apparatus/tablet press/coating equipment, 12 Assignment on excipient/API specifications. (One example of each), Books:, , All books listed in the theory syllabus as well as Current editions of IP, BP and USP., , BPH_E_805_D-— Project- (12 Hr/Wk), , ANY TWO SUBJECTS FROM THE FOLLOWING 4 CREDIT SUBJECTS TO BE CHOSEN AS, ELECTIVES FOR A TOTAL OF 8 CREDITS, , BPH_E_806_T — Phytopharmaceutical Technology- (4 Hr/Wk), , Course Objectives