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KMID : 0370220100540050362
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Yakhak Hoeji
2010 Volume.54 No. 5 p.362 ~ p.369
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Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph - Nicametate Citrate Tablet, Norfloxacin Capsule
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Kim Hee-Yun
Choi Seon-Hee
Bang Su-Jin
Han Kyung-Jin
Choi Sung-Hee
Baek Ji-Yun
Kim Dong-Sup
Kim Young-Ok
Sohn Kyung-Hee
Song Young-Mi
Sah Hong-Kee
Choi Hoo-Kyun
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Abstract
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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.
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KEYWORD
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dissolution specifications, nicametate citrate tablet, norfloxacin capsule
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Listed journal information
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