고시 수재 의약품의 용출규격 설정 - 구연산니카메테이트 정, 노르플록사신 캡슐

• 영문명: Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph - Nicametate Citrate Tablet, Norfloxacin Capsule
• 발행기관: 대한약학회
• 저자명: 김희연(Hee Yun Kim) 최선희(Seon Hee Choi) 방수진(Su Jin Bang) 한경진(Kyung Jin Han) 최승희(Sung Hee Choi) 백지윤(Ji Yun Baek) 김동섭(Dong Sup Kim) 김영옥(Young Ok Kim) 손경희(Kyung Hee Sohn) 송영미(Young Me Song) 사홍기(Hong Kee Sah) 최후균(Hoo-Kyun Choi)
• 간행물 정보: 『약학회지』제54권 제5호 (2010년), 362~369쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2010.10.31

영문 초록

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.

키워드

dissolution specifications nicametate citrate tablet norfloxacin capsule