YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Development of Dissolution Test Method for Acebrophylline Capsules and Bromhexine Hydrochloride Tablets in Korean Pharmaceutical Codex

고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발

  • Lee, Tae-Woong (Hazardous Substances Analysis Division, Daejeon Regional Korea Food & Drug Administration) ;
  • Jeong, Rae-Seok (Hazardous Substances Analysis Division, Daejeon Regional Korea Food & Drug Administration) ;
  • Jeong, Seung-A (Hazardous Substances Analysis Division, Daejeon Regional Korea Food & Drug Administration) ;
  • Kim, Jeong-Hyun (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) ;
  • Shim, Young-Hun (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) ;
  • Kim, In-Kyu (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) ;
  • Park, Chang-Won (Hazardous Substances Analysis Division, Daejeon Regional Korea Food & Drug Administration)
  • 이태웅 (대전지방식품의약품안전청 유해물질분석과) ;
  • 정래석 (대전지방식품의약품안전청 유해물질분석과) ;
  • 정승아 (대전지방식품의약품안전청 유해물질분석과) ;
  • 김정현 (식품의약품안전평가원 의약품규격연구과) ;
  • 심영훈 (식품의약품안전평가원 의약품규격연구과) ;
  • 김인규 (식품의약품안전평가원 의약품규격연구과) ;
  • 박창원 (대전지방식품의약품안전청 유해물질분석과)
  • Received : 2013.05.16
  • Accepted : 2013.06.24
  • Published : 2013.06.30
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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 specification in Korean Pharmaceutical Codex (KPC). So, with each reference and test drugs, the dissolution test method and an analytical procedure by HPLC were developed and validated to establish dissolution specification for acebrophylline capsules and bromhexine hydrochloride tablets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Ministry of Food and Drug Safety (MFDS). The analytical method of HPLC was validated in specificity, linearity, precision and accuracy. Final dissolution test was performed with commercially available samples of 3 lots to establish specification. In addition, no difference was observed by the inter-laboratory evaluation. Dissolution specifications and conditions will be used for revising the monograph of acebrophylline capsules and bromhexine hydrochloride tablets in next supplement of KPC.

Keywords

References

  1. 식품의약품안전처 고시 : 대한민국약전외 의약품 기준 (2013).
  2. 대한민국약전 10개정 : 경구용의약품의 용출규격 설정 가이드라인 (2013).
  3. FDA, Center for Drug Evaluations and Research, Guidance for Industry-Extended release oral dosage forms : Development, evaluations and application of in vitro/in vivo correlation (1997).
  4. 식품의약품안전처 고시 : 의약품동등성시험기준 (2013).
  5. 대한민국약전 10개정 : 의약품등 시험방법 밸리데이션 가이드라인 (2013).
  6. 대한민국약전 10개정 : 일반시험법 (2013).
  7. United States Pharmacopoeial Convention, Inc. : The United States Pharmacopeia 35th (2009).
  8. Society of Japanese Pharmacopoeia : The Japanese Pharmacopoeia 16th (2011).
  9. ICH : Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter Q4B Annex 7(R2) (2010).
  10. 사홍기 : 비교용출시험과 용출규격의 상관성 연구, 식품의약품안전청 용역연구개발사업 (2004).
  11. 사홍기 : 의약품 제제동등성평가(III)-경구용 제제의 제제동등성평가, 식품의약품안전청 용역연구개발사업 (2004).
  12. Foppoli, A., Zema, L., Gazzaniga, A., Caira, M. R., Nassimbeni, L. R., Borkum, E., Bettini, R. and Giordano, F. : Solid-state chemistry of ambroxol theophylline-7-acetate. J. Pharm. Sci. 96, 1139 (2007). https://doi.org/10.1002/jps.20951
  13. Abdel-Ghani, N. T., Rizk, M. S. and Mostafa, M. : Extractive determination of ephedrine hydrochloride and bromhexine hydrochloride in pure solutions, pharmaceutical dosage form and urine samples. Spectrochim. Acta A Mol. Biomol. Spectrosc. 111C, 131 (2013).
  14. Mehran Javanbakht, Mohammad Hadi Namjumanesh and Behrouz Akbari-adergani : Molecularly imprinted solid-phase extraction for the selective determination of bromhexine in human serum and urine with high performance liquid chromatography. Talanta 80, 133 (2009). https://doi.org/10.1016/j.talanta.2009.06.033
  15. Abdelwahab, N. S. : Determination of ambroxol hydrochloride, guaifenesin, and theophylline in ternary mixtures and in the presence of excipients in different pharmaceutical dosage forms. J. AOAC Int. 95, 1629 (2012). https://doi.org/10.5740/jaoacint.10-444
  16. Jia Liu, Xiaoyan Chen, Youhong Hu, Gang Cheng and Dafang Zhong : Quantification of the major metabolites of bromhexine in human plasma using RRLC-MS/MS and its application to pharmacokinetics. Journal of Pharmaceutical and Biomedical Analysis 51, 1134 (2010). https://doi.org/10.1016/j.jpba.2009.11.024