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.
WEI He, LI Xue-mei.
Discussion on Alcohol-induced Dose Dumping in the Development of Generic Oral Modified-Release Preparations[J]. Chinese Pharmaceutical Journal, 2022, 57(3): 209-213 https://doi.org/10.11669/cpj.2022.03.007
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