Development of Dissolution Testing Method for Piracetam Tablets and Fenoterol Hydrobromide Tablets in Korean Pharmaceutical Codex
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Kim, Eun-Jung
(Gwangju Regional Food and Drug Administration, Hazardous Substances Analysis Division)
Lee, Jin-Ha (Gwangju Regional Food and Drug Administration, Hazardous Substances Analysis Division) Park, Chan-Ho (Gwangju Regional Food and Drug Administration, Hazardous Substances Analysis Division) Sohn, Kyung-Hee (Pharmaceutical Standardization Research and Testing Division, National Institute of Food and Drug Safety Evaluation) Kim, In-Kyu (Pharmaceutical Standardization Research and Testing Division, National Institute of Food and Drug Safety Evaluation) Kim, Dong-Sup (Pharmaceuticals and Medical Divices Research Department, National Institute of Food and Drug Safety Evaluation) Sah, Hong-Kee (Ehwa Womnas University, College of Pharmacy) Choi, Hoo-Kyun (Chosun University, College of Pharmacy) |
1 | J. Sean, S., Alex M., O., Beverly, N., Hong, J., Monica, D. and Mark, B. : Validation of dissolutoin method with HPLC analysis for lasofoxifen tartrate low dose tablets. J. Pharm. Biomed. Anal. 44, 1064 (2007). DOI ScienceOn |
2 | Garcia, C. V., Paim, C. S., Steppe, M. and Schapoval, E. E. S. : Development and validation of a dissolution test for reveprazole sodium in coated tablets. J. Pharm. Biomed. Anal. 41, 833 (2006). DOI ScienceOn |
3 | Ansel, H., Allen Jr., L. and Popovich, N. : Pharmaceutical Dosage Forms and Drug Delivery systems (7th ed.), Lippincott Williams & Wilkins, Baltimore (1999). |
4 | Gudrun, F. : Guideline on dissolution profile comparision. Drug Inform. J. 35, 865 (2001). DOI |
5 | Food and Drug Administration : Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms. US department of health and human services/Food and drug administration/Center for drug evaluation and research, Rockville MD (1997). |
6 | 사홍기 : 비교용출시험과 용출규격의 상관성 연구, 식품의약품안 전청 용역연구개발사업 (2004). |
7 | 사홍기 : 의약품의 제제동등성평가(II)-경구용 제제의 제제성 평가, 동등식품의약품안전청 용역연구개발사업 (2003). |
8 | FDA, Center for Drug Evaluation and Research, Guidance for Industry-Extended release oral dosage forms : development, evaluation and application of in vitro/in vivo correlation, September 1997. |
9 | 사홍기 : 의약품의 제제동등성평가(III)-경구용 제제의 제제동등성 평가, 식품의약품안전청 용역연구개발사업 (2004). |
10 | 박상애 등 : 의약품 규격의 국제화사업(I), 식품의약품안전청 연구개발사업 (2003). |
11 | USP, Disintegration and Dissolution of dietary supplements <2040> In USP 32-NF 27, USP (2009). |
12 | 식품의약품안전청 : 의약품등 분석법의 밸리데이션에 대한 지침. 대한약전 제 9개정 (2009). |
13 | 식품의약품안전청 : 대한약전외의약품등 기준 제 3개정 (2007). |
14 | 식품의약품안전청 : 경구용의약품의 용출 규격 설정 지침. 대한약전 제 9개정 (2009). |
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