作者
Edmund S Kostewicz, Bertil Abrahamsson, Marcus Brewster, Joachim Brouwers, James Butler, Sara Carlert, Paul A Dickinson, Jennifer Dressman, René Holm, Sandra Klein, James Mann, Mark McAllister, Mans Minekus, Uwe Muenster, Anette Müllertz, Miriam Verwei, Maria Vertzoni, Werner Weitschies, Patrick Augustijns
发表日期
2014/6/16
来源
European Journal of Pharmaceutical Sciences
卷号
57
页码范围
342-366
出版商
Elsevier
简介
Accurate prediction of the in vivo biopharmaceutical performance of oral drug formulations is critical to efficient drug development. Traditionally, in vitro evaluation of oral drug formulations has focused on disintegration and dissolution testing for quality control (QC) purposes. The connection with in vivo biopharmaceutical performance has often been ignored. More recently, the switch to assessing drug products in a more biorelevant and mechanistic manner has advanced the understanding of drug formulation behavior. Notwithstanding this evolution, predicting the in vivo biopharmaceutical performance of formulations that rely on complex intraluminal processes (e.g. solubilization, supersaturation, precipitation…) remains extremely challenging. Concomitantly, the increasing demand for complex formulations to overcome low drug solubility or to control drug release rates urges the development of new in vitro tools …
学术搜索中的文章
ES Kostewicz, B Abrahamsson, M Brewster… - European Journal of Pharmaceutical Sciences, 2014