作者
Brendan T Griffin, Martin Kuentz, Maria Vertzoni, Edmund S Kostewicz, Yang Fei, Waleed Faisal, Cordula Stillhart, Caitriona M O’Driscoll, Christos Reppas, Jennifer B Dressman
发表日期
2014/4/1
期刊
European Journal of Pharmaceutics and Biopharmaceutics
卷号
86
期号
3
页码范围
427-437
出版商
Elsevier
简介
The objectives of this study were to characterise three prototype fenofibrate lipid-based formulations using a range of in vitro tests with differing levels of complexity and to assess the extent to which these methods provide additional insight into in vivo findings. Three self-emulsifying drug delivery systems (SEDDS) were prepared: a long chain (LC) Type IIIA SEDDS, a medium chain (MC) Type IIIA SEDDS, and a Type IIIB/IV SEDDS containing surfactants only (SO). Dilution, dispersion and digestion tests were performed to assess solubilisation and precipitation behaviour in vitro. Focussed beam reflectance measurements and solid state characterisation of the precipitate was conducted. Oral bioavailability was evaluated in landrace pigs. Dilution and dispersion testing revealed that all three formulations were similar in terms of maintaining fenofibrate in a solubilised state on dispersion in biorelevant media. During in …
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