摘要
目的探讨口服调释类仿制药研发中乙醇诱导的剂量倾泻研究要求。方法结合审评实际情况,对口服调释类仿制药乙醇诱导的剂量倾泻研究中常见问题进行了分析,总结了国内外药品监管机构相关的技术要求,提出了研究建议。结果与结论乙醇可能会改变调释制剂药物释放特性,带来用药安全性和有效性问题。建议口服调释类仿制药研发时予以关注,并进行相应的体外研究,以评价制剂在体内乙醇环境中出现药物突释(剂量倾泻)的可能性。
OBJECTIVE To discuss the the requirements of alcohol-induced dose dumping in the development of generic oral modified-release preparations. METHODS Based on the review, the common problems on alcohol-induced dose dumping in the development of generic oral modified-release preparations were analyzed, the recommendations on dose dumping of domestic and foreign drug regulatory authorities were summarized, and general considerations were put forward. RESULTS AND CONCLUSION Alcohol may alter the release characteristics of modified-release preparations and cause safety and effectiveness problems. In vitro studies are recommended to evaluate the possibility of sudden drug release(dose dumping) in the presence of alcohol in vivo.
作者
魏赫
李雪梅
WEI He;LI Xue-mei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2022年第3期209-213,共5页
Chinese Pharmaceutical Journal
关键词
调释制剂
乙醇诱导
剂量倾泻
药物研发
关键质量属性
体外评价
modified-release preparations
alcohol-induced
dose dumping
drug development
critical quality attribute
in vitro evaluation
