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Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph - Nicametate Citrate Tablet, Norfloxacin Capsule  

Kim, Hee-Yun (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Choi, Seon-Hee (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Bang, Su-Jin (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Han, Kyung-Jin (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Choi, Sung-Hee (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Baek, Ji-Yun (Hazardous Substances Analysis Division, Seoul Regional Korea Food and Drug Administration)
Kim, Dong-Sup (National Institute of Food and Drug Safety Evaluation, Pharmaceuticals and Medical Devices Research Department)
Kim, Young-Ok (National Institute of Food and Drug Safety Evaluation, Scientific Drug Evaluation and Research Division)
Sohn, Kyung-Hee (National Institute of Food and Drug Safety Evaluation, Scientific Drug Evaluation and Research Division)
Song, Young-Me (Korea Food & Drug Administration, Bioequivalence Evaluation Division)
Sah, Hong-Kee (College of Pharmacy, Ewha Womans University)
Choi, Hoo-Kyun (College of Pharmacy, Chosun University)
Publication Information
YAKHAK HOEJI / v.54, no.5, 2010 , pp. 362-369 More about this Journal
Abstract
Despite the fact that the dissolution test can serve as an effective tool for drug quality control and prediction of in vivo drug performance, there are a number of drugs with no established dissolution specifications because they were developed quite a long time ago. Under this circumstances, KFDA started the new project that establishes dissolution method and specifications for drugs with no dissolution specifications listed in the Korea Pharmaceutical Codex (KPC). This project aims for promoting the appropriate management of oral solid dosage forms. Seoul regional KFDA selected 2 items, Nicametate citrate tablet and Norfloxacin capsule, for establishing dissolution specifications. We went through the following procedures to develop the dissolution method and specifications: (1) Validation of dissolution test equipment, (2) Purchase of test drugs, (3) Preliminary test with one of the test products (1 lot), (4) Validation of analysis methods (3 lots), (5) Final tests and cross tests among other laboratory to establish dissolution specifications, (6) Additional test with the other test drugs. The outcome of this study will be reflected in revision of the KPC. It is believed that the quality control and evaluation of oral solid dosage forms listed in KPC will be advanced with the revision which adds additional dissolution test and specifications for the drugs with no established dissolution specifications.
Keywords
dissolution specifications; nicametate citrate tablet; norfloxacin capsule;
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