Journal of the Korea Academia-Industrial cooperation Society (한국산학기술학회논문지)

The Korea Academia-Industrial cooperation Society (한국산학기술학회)
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Comparative Study on the Regulations about In-Use Stability, and Analysis the In-Use Stability Application on Approved Syrups - Focused on the Guidelines in US, Europe and Korea -

국내외 의약품 개봉 후 안정성 규정 비교와 국내 시럽제의 안정성 적용 현황 분석 - 미국, 유럽, 한국의 가이드라인을 중심으로 -

  • Park, Onnuri (School of Pharmacy, Sungkyunkwan University) ;
  • Jang, Kyoung won (Department of Pharmaceutical Quality, Daewon University College) ;
  • Ha, Dong mun (School of Pharmacy, Sungkyunkwan University)
  • Received : 2019.11.06
  • Accepted : 2020.03.06
  • Published : 2020.03.31
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Abstract

Syrup agents are often used after opening, and therefore, there is a high possibility of decreased quality. The Ministry of Food and Drug Safety (MFDS) published guideline on stability testing for pharmaceuticals after opening in December, 2016. We compared guidelines related to the period of use after opening between the United States of America (USA), Europe (EU), and Korea, and we analyzed whether the period of use or storage conditions is stated based on the data of drug approval for 4 dry syrups and 3 large packing syrups before and after the introduction of the guideline. First, in USA and EU, the period of use and storage conditions after opening should be listed on the label on the packaging container (as well as the expiration date), while in Korea, those are included in the area of precautions for use. Second, all of the analyzed drugs were not changed by the guidelines for establishing the new post-opening period of use, and they were only presented for the existing expiration date prior to the establishment of the guideline. Medicines that are used for multiple uses after opening may need improved instructions to ensure that the period of use and storage conditions are listed on the packaging according to stability evaluation after opening.

의약품에 기재되어 있는 보관조건 및 사용기간은 안정성 시험 결과에 따라 결정된다. 특히, 시럽제 의약품의 경우 개봉 후 자주 사용됨에 따라 의약품 품질 저하의 발생 가능성이 높다. 식품의약품안전처에서도 의약품의 안전한 사용을 위해 2016년 12월 '완제의약품 개봉 후 사용기간 설정을 위한 가이드라인'을 발표하였다. 이에 본 연구에서는 미국, 유럽과 한국의 관련 가이드라인을 비교해보고 가이드라인 제정 전후 품목허가(신고)된 시럽제중 건조시럽 4성분 및 덕용시럽 3개 성분의 허가사항을 검토하여 개봉 후 사용기간 또는 보관조건 기재여부 현황을 분석하였다. 그 결과 첫째 미국과 유럽은 포장용기의 라벨에 유효기간과 더불어 개봉 후 사용기간 및 보관조건을 기재하도록 하였으나, 한국의 경우 '사용상의 주의사항'에 기재토록 하는 차이가 있었다. 둘째, 분석한 모든 의약품이 새로 도입한 개봉 후 사용기간 설정을 위한 가이드라인에 의해 변경되지 않았고 가이드라인 제정 이전의 유효기간에 대해서만 제시되었다. 개봉 후 다회용으로 사용되는 의약품들은 개봉 후 안정성 평가를 통해 사용기간과 보관조건이 의약품의 포장 용기에 기재하도록 하는 제도 개선이 필요할 것으로 사료된다.

Keywords

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