Master of Pharmacy - Nagpur University
Master of Pharmacy - Nagpur University
Master of Pharmacy - Nagpur University
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9. Study <strong>of</strong> compendia – Evolution, Study <strong>of</strong> parts <strong>of</strong> compendia like: Policies, General<br />
notices, Monographs, Comparative picture <strong>of</strong> IP, USP, BP, EP & GP.<br />
10. New Drug Application (NDA), Investigational New Drug Application (INDA),<br />
Abbreviated New Drug Application (ANDA).<br />
11. Material Safety Data Sheet (MSDS) preparation and Industrial Safety & Health<br />
RECOMMENDED BOOKS: -<br />
1. Forensic <strong>Pharmacy</strong> by B.S. Kuchekar, A. M. Khadatare and S. C. Jitkar, 6 th<br />
Ed., Nirali<br />
Prakashan<br />
2. Drugs and Cosmetics Laws by Krishnan Arora, Pr<strong>of</strong>essional Book Publishers, New<br />
Delhi<br />
3. Mittal B.M., A Textbook <strong>of</strong> Forensic <strong>Pharmacy</strong>, 9 th<br />
Ed., Vallabh Prakashan<br />
4. James Swarbrick, James C Boylon, Encyclopedia <strong>of</strong> Pharmaceutical Technology, 2 nd<br />
Ed. Marcel Dekker Inc.<br />
5. Deshpande S.W., Drugs and Cosmetic Act.1940<br />
6. Bubuarm N.R, Whatever one should know about patent, 2 nd<br />
Ed., Pharma Book<br />
Syndicate<br />
7. Gnarino Richard A, New Drug Approval Process, 3 rd<br />
Edition, Marcel Dekker Inc<br />
8. Deshpande S.W, Drug and Magic Remedies Act 1954.<br />
9. P. Warayan, Intellectual Property Laws, Eastern Law House.<br />
10. Drug and Cosmetic Act 1940, Eastern Book company by Vijay Malic, 11th Ed. Patents<br />
for Medicine, by N. B. Zareri, Indian Drug Manufacturers Association (IDMA)<br />
11. <strong>Pharmacy</strong> Law and Ethics by Dale and Appelbes, The Pharmaceutical Press, Joy<br />
Winfield.<br />
12. Guidelines <strong>of</strong> various countries like MCA, TGA, ICH.<br />
13. GLP regulation by Alen Hirsch Vol 38 Marcel Decker series.<br />
14. GMP for pharmaceuticals forth edition by S. Willing, J. Stocker Marcel Decker series<br />
1997.<br />
15. I.P., B.P., U.S.P. International Pharmacopoeia<br />
Subject code: MPH-S4<br />
Subject : ADVANCED PHARMACEUTICS<br />
THEORY: 60 Hours (4 hrs. /week)<br />
1. Preformulation Studies: Timings and goals <strong>of</strong> Preformulation, Pre-formulation<br />
methodology, solid state properties, partition coefficient, solubility, dissolution, crystal<br />
form and stability, Thermal Analysis, X-ray diffraction:- Techniques to generate &<br />
characterize amorphous & crystalline forms, compatibility tests, dissolution <strong>of</strong> drug<br />
substances and dosage.<br />
2. Kinetic Principles and Stability Testing: Order <strong>of</strong> reaction, influence <strong>of</strong> pH,<br />
temperature, Acid - base catalysis. Effect <strong>of</strong> Ionic strength on degradation, Complex<br />
reactions, amide hydrolysis, Ring alteration, Oxidation - reduction, Chemical &Physical<br />
stability <strong>of</strong> dosage forms, Influence <strong>of</strong> packaging components on dosage form stability.<br />
Overages and ICH guidelines.<br />
3. Excipients: Overview <strong>of</strong> excipients used in formulations. Factors affecting the<br />
selection. Introductory aspects <strong>of</strong> drug-excipient and excipient, package interactions.<br />
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