YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Development of Dissolution Testing Method for Piracetam Tablets and Fenoterol Hydrobromide Tablets in Korean Pharmaceutical Codex

고시 수재 의약품 중 피라세탐 정 및 브롬화수소산페노테롤 정의 용출시험법 개발

  • 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)
  • 김은정 (광주지방식품의약품안전청 유해물질분석과) ;
  • 이진하 (광주지방식품의약품안전청 유해물질분석과) ;
  • 박찬호 (광주지방식품의약품안전청 유해물질분석과) ;
  • 손경희 (식품의약품안전평가원 의약품규격연구과) ;
  • 김인규 (식품의약품안전평가원 의약품규격연구과) ;
  • 김동섭 (식품의약품안전평가원 의료제품연구부) ;
  • 사홍기 (이화여자대학교 약학대학) ;
  • 최후균 (조선대학교 약학대학)
  • Received : 2011.05.30
  • Accepted : 2011.06.20
  • Published : 2011.08.31
Download PDF
⟨ Previous Next ⟩

Abstract

Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specifications in Korean Pharmaceutical Codex (KPC). Among those commercially available, Piracetam Tablets and Fenoterol hydrobromide Tablets were selected to develop the dissolution testing method. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korea Food & Drug Administration (KFDA). The dissolution test for Piracetam Tablets was carried out under sink condition with distilled water as dissolution medium, paddle rotation speed at 50 rpm and medium volume of 900 ml. More than 80% of its label claim was released within 30 min. In case of Fenoterol hydrobromide Tablets, distilled water was also found to be suitable to ensure sink condition. The rotation speed of 50 rpm and 900 ml of dissolution medium were used to evaluate the dissolution profile. The dissolution rate of fenoterol hydrobromide was over 90% in 15 min. The HPLC analysis methods were validated in terms of accuracy, precision, specificity, linearity, quantitation limit and range. The results suggested that the analytical methods used are simple and suitable to measure the dissolution rate of piracetam and fenoterol hydrobromide. Therefore, the analysis methods could be utilized in setting dissolution specifications of Piracetam Tablets and Fenoterol hydrobromide Tablets in the revised version of KPC.

Keywords

References

  1. 식품의약품안전청 : 대한약전외의약품등 기준 제 3개정 (2007).
  2. 식품의약품안전청 : 경구용의약품의 용출 규격 설정 지침. 대한약전 제 9개정 (2009).
  3. 식품의약품안전청 : 의약품등 분석법의 밸리데이션에 대한 지침. 대한약전 제 9개정 (2009).
  4. 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.
  5. USP, Disintegration and Dissolution of dietary supplements <2040> In USP 32-NF 27, USP (2009).
  6. 사홍기 : 비교용출시험과 용출규격의 상관성 연구, 식품의약품안 전청 용역연구개발사업 (2004).
  7. 사홍기 : 의약품의 제제동등성평가(II)-경구용 제제의 제제성 평가, 동등식품의약품안전청 용역연구개발사업 (2003).
  8. 사홍기 : 의약품의 제제동등성평가(III)-경구용 제제의 제제동등성 평가, 식품의약품안전청 용역연구개발사업 (2004).
  9. 박상애 등 : 의약품 규격의 국제화사업(I), 식품의약품안전청 연구개발사업 (2003).
  10. 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). https://doi.org/10.1016/j.jpba.2007.04.032
  11. 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). https://doi.org/10.1016/j.jpba.2006.01.050
  12. Ansel, H., Allen Jr., L. and Popovich, N. : Pharmaceutical Dosage Forms and Drug Delivery systems (7th ed.), Lippincott Williams & Wilkins, Baltimore (1999).
  13. Gudrun, F. : Guideline on dissolution profile comparision. Drug Inform. J. 35, 865 (2001). https://doi.org/10.1177/009286150103500325
  14. 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).