Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
권호 표지
DOI QR코드

DOI QR Code

Survey and Classification of Pharmaceutical Excipients

국내 의약품 첨가제 정보체계 연구

  • Park, In-Sook (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Park, Sang-Aeh (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Kim, Eun-Jung (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Park, Hyo-Min (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Hong, Chong-Hui (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Jnng, Joo-Yeon (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Kim, Ho-Jung (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Lee, Ji-Hyun (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Han, Eui-Sik (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Kang, Shin-Jung (Drug Evaluation Department, Korea Food and Drug Administration) ;
  • Lee, Sun-Hee (Drug Evaluation Department, Korea Food and Drug Administration)
  • 박인숙 (식품의약품안전청 의약품평가부) ;
  • 박상애 (식품의약품안전청 의약품평가부) ;
  • 김은정 (식품의약품안전청 의약품평가부) ;
  • 박효민 (식품의약품안전청 의약품평가부) ;
  • 홍정희 (식품의약품안전청 의약품평가부) ;
  • 정주연 (식품의약품안전청 의약품평가부) ;
  • 김호정 (식품의약품안전청 의약품평가부) ;
  • 이지현 (식품의약품안전청 의약품평가부) ;
  • 한의식 (식품의약품안전청 의약품평가부) ;
  • 강신정 (식품의약품안전청 의약품평가부) ;
  • 이선희 (식품의약품안전청 의약품평가부)
  • Published : 2006.08.21
Download PDF
⟨ Previous Next ⟩

Abstract

Due to the development of new dosage forms and the improvement or pharmaceutics, the pharmaceutical excipients have become more specified and diverse, and the reclassification on them became necessary. Also with the increasing interests on the kinds and usage amount, related provisions, and evaluation of the pharmaceutical excipients, the systemic and effective control of them was in its demand. Therefore, in this research, we provided the following information on excipients: the type, amount and specification. In order to provide the information, we investigated, analysed and summarized the excipients that are approved by KFDA and published $\ulcorner$Handbook of Pharmaceutical Excipients$\lrcorner$). This handbook is expected to be used as a reference in the development of the pharmaceutics and evaluation in them. As the importance of excipients in pharmaceutics are increasing, IPEC which consist of IPEC-America, IPEC-Europe and JPEC, PDG and ICH have tried to make an international harmonization on excipient. This current status was not an exception to Korea, therefore, the result of this research is expected to make a progress in the evaluation on the excipients to an advanced level.

Keywords

References

  1. 대한약전 제8개정, 2002, p4
  2. 식품의약품안전청고시 제2003-28호(2003.5.9) 의약품.의약외품의 제조.수입.품목허가 신청(신고)서 검토에 관한 규정 제9조
  3. 식품의약품안전청고시 제2003-28호(2003.5.9) 의약품등의 안전성.유효성 심사에 관한 규정 제3조, 제5조, 제9조 및 제12조
  4. 식품의약품안전청고시 제2005-31호(2005.6.7) 생물학적동등성시험기준 별표3
  5. 식품의약품안전청고시 제2005-64호(2005.11.8.) 의약품동등성시험관리규정
  6. M.S. Choi, C.H. Hong, S.J. Jang and C.S. Kang, The Quality Regulation of Drug Excipients, J. Kor. Pharm. Sci., 33(1), 67-71 (2003)