Pharmacopeia Lecture Notes PDF

History of pharmacopeia  Introduction Pharmacopeia : A book of direction and requirement of preparation of medicine Pharmakon: a drug Poiein: to make Legislation of country: sets standard and obligatory quality indices Periodic Publication by Phar...

History of pharmacopeia  Introduction Pharmacopeia : A book of direction and requirement of preparation of medicine Pharmakon: a drug Poiein: to make Legislation of country: sets standard and obligatory quality indices Periodic Publication by Pharmaceutical Society of nation Monograph: A complete description of a specific pharmaceutical which includes nomenclature, classification, physical characteristics, dosage, purity, limits for impurities, identification, assay and conditions of storage  PHARMACOPOEIAS ◆ Standard reference book ◆ Official book; Information about useful drugs; mol. formula, str.formula, method of preparation, actions, uses and adverse effects ◆ Publish and revised after every 5 years by legal authority of Govt. ◆ New manufactured & sold drug must take confirmation from pharmacopeias  TYPES OF PHARMACOPOEIAS 1) BRITISH PHARMACOPOEIA (B.P) UK, PAK, other countries Published by GMC Dose range i.e. dose of morphine 10-20 mg 2) UNITED STATES PHARMACOPOEIA (U.S.P.) 3) EUROPIAN PHARMACOPOEIA (E.P.) 4) INTERNATIONAL PHARMACOPOEIA (P.I.) 5) BRITISH PHARMACEUTICAL CODEX (BPC) Council of pharmaceutical society of UK publishes official and non-official drugs 6) EXTRA-PHARMACOPOEIA (EP) Council of Pharmaceutical Society Details (trade names, actions, uses and adverse effects) of official and non official drugs  Indian Pharmacopoeia Indian Pharmacopoeia is the official book of standards for drugs included therein, in terms of the Second Schedule to the Drugs and Cosmetics Act, 1940so as to specify the: Standards of identity, purity and strength for the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India.  Indian Pharmacopoeia Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. The set of standards are published under the title Indian Pharmacopoeia (IP) which has been modelled over and historically follows from the British Pharmacopoeia  Indian Pharmacopoeia It is a reference document for various stockholders like enforcement agency, industry, lab, academic institutions etc. Compliance with IP Standards by drug manufacturing industry assures consumers, patients and healthcare professionals of their quality.  Indian Pharmacopoeia As India is the best developer of generic pharmaceuticals and taking the lead in adopting new technologies Therefore there is a need for the sustainable compliance of quality specifications of drugs and pharmaceuticals. IP ensures the control of the quality of not only the formulations (dosage forms) but also of the active pharmaceutical ingredients (APIs).  Indian Pharmacopoeia Timelines 1944: Bengal Pharmacopeia 1948: First Pharmacopeia committee constituted by Government of India Chairman: Dr. B.N. Ghosh 1955: First edition of Indian Pharmacopeia (I.P.) 1960: Supplement 1966: Second edition of I.P. 1975: Supplement 1985: Third edition I.P. (2 volumes) 1989 and 1991: Supplement 1996: Fourth edition I.P. 2000, 2002 and 2005: Supplement 2007: Fifth edition I.P. (3 volumes) 2010: Sixth edition I.P. 2012: Supplement 2014: Seventh edition I.P. (4 volumes) 2018: Eighth edition I.P. 2019: Addendum 2022: Ninth edition I.P.  Better representations of Timelines Edition Year Addendum/Supplement 1st Edition 1955 Supplement 1960 2nd Edition 1966 Supplement 1975 Addendum 1989 3rd Edition 1985 Addendum 1991 Addendum 2000 Vet Supplement 2000 4th Edition 1996 Addendum 2002 Addendum 2005 5th Edition 2007 Addendum 2008 6th Edition 2010 Addendum 2012 Addendum 2015 7th Edition 2014 Addendum 2016 8th Edition 2018 Addendum 2019 9th Edition 2022  Salient features of First I.P. Covers 986 monographs Titles of monographs in Latin Weights and measures in metric system Doses in both metric and English List of preparations given at the end of monograph Abbreviated titles used Descriptive terms used for solubility instead of exact solubility  Salient features of Seventh I.P. Published in 2014 Contains 2567 monographs and 577 new monographs Introduced 19 radiopharmaceuticals for the first time 10 Antibiotic, 31 herbal, 5 vaccines and sera, 6 insulin products, 7 biotech and 19 new general chapters included  Salient features of Eighth I.P. Published in 2018 with 4 volumes Contains 2829 monographs and 220 new monographs, Revisions for 366 and Omissions:07 170 New Chemical Monographs: 49 API 64 Formulations 53 Fixed Dose Formulations 02 Excipients 02 Antibiotics 15 New Herbs and Herbal Products Monographs 03 New Radiopharmaceutical Monographs 14 New Veterinary Non-Biological Monographs 18 New Biological Monographs: 02 Vaccines & Immunosera for Human Use 06 Biotechnology Derived Therapeutic Products 10 Blood and Blood Related Products Salient features of I.P. 2022  SUMMARY ◆ PHAMACOPOEIA ➔ OFFICIAL DRUGS ◆ PHARM.CODEX ➔ OFFICIAL+UNOFFICIAL DRUGS ◆ EXTRAPHARACOPOEIA➔DETAILED INFORMATION OF OFFICIAL+UNOFFICIAL DRUGS ◆ FORMULARY➔REGISTERED DRUGS FOR MARKETING