약학회지 (YAKHAK HOEJI)

  • 제54권5호
  • /
  • Pages.362-369
  • /
  • 2010
  • /
  • 0377-9556(pISSN)
  • /
  • 2383-9457(eISSN)
대한약학회 (The Pharmaceutical Society of Korea)
권호 표지

고시 수재 의약품의 용출규격 설정 - 구연산니카메테이트 정, 노르플록사신 캡슐

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

  • 김희연 (서울지방식품의약품안전청 유해물질분석과) ;
  • 최선희 (서울지방식품의약품안전청 유해물질분석과) ;
  • 방수진 (서울지방식품의약품안전청 유해물질분석과) ;
  • 한경진 (서울지방식품의약품안전청 유해물질분석과) ;
  • 최승희 (서울지방식품의약품안전청 유해물질분석과) ;
  • 백지윤 (서울지방식품의약품안전청 유해물질분석과) ;
  • 김동섭 (식품의약품안전평가원 의료제품연구부) ;
  • 김영옥 (식품의약품안전평가원 심사과학과) ;
  • 손경희 (식품의약품안전평가원 심사과학과) ;
  • 송영미 (식품의약품안전청 약효동등성과) ;
  • 사홍기 (이화여자대학교 약학대학) ;
  • 최후균 (조선대학교 약학대학)
  • 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)
  • 투고 : 2010.07.02
  • 심사 : 2010.09.02
  • 발행 : 2010.10.31
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

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

참고문헌

  1. 이종기 : 노르플록사신의 체내동태에 대한 신장해의 영향. 약제학회지 25(3), 265 (1995).
  2. 식품의약품안전청 : 경구용의약품의 용출규격 설정 가이드라인(2005).
  3. 식품의약품안전청 : 의약품 등 시험방법 밸리데이션에 대한 가이드라인 적용을 위한 해설서.
  4. 식품의약품안전청 : 대한약전 제9개정 (2007).
  5. 식품의약품안전청 : 대한약전외의약품등기준 제3개정 (2007).
  6. The United States Pharmacopoeia 32, United States Pharmacopoeial Convention, Inc. (2009).
  7. British Pharmacopoeia 2008, Medicines Commission London (2008).
  8. The Japanese Pharmacopoeia 15th, Society of Japanese Pharmacopoeia (2006).
  9. European Pharmacopoeia 6. (2008).
  10. FDA, Guidance for Industry Drug Substance Chemistry, Manufacturing, and Controls Information (2004).
  11. ICH, ICHQ6A "Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances" (1999).
  12. EMEA, Chemistry of New Active Substance (2009).
  13. EMEA, Investigation of Chiral Active Substance (1992).
  14. EMEA, Summary of Requirements for Active Substance in Quality Part of the Dossier (2003).
  15. EMEA, Active Substance Master File Procedure (2006).
  16. 식품의약품안전청 : 의약품동등성시험관리규정 (2009).
  17. 식품의약품안전청 : 의약품등의 품목허가.신고.심사 규정 (2009).
  18. EMEA, Specifications and Control Tests on the Finished Product (1991).
  19. ICH, ICH Q8 "Pharmaceutical development" (2004).