作者
Daniel Juenemann, Ekarat Jantratid, Christian Wagner, Christos Reppas, Maria Vertzoni, Jennifer B Dressman
发表日期
2011/2/1
期刊
European journal of pharmaceutics and biopharmaceutics
卷号
77
期号
2
页码范围
257-264
出版商
Elsevier
简介
The ability of in vitro biorelevant dissolution tests to predict the in vivo performance of nanosized fenofibrate (Lipidil 145 ONE®) and microsized fenofibrate (Lipidil – Ter®) was evaluated in this study. In vitro dissolution was carried out using USP apparatus 2 (paddle method) with updated biorelevant media to simulate the pre- and postprandial states. Membrane filters with different pore sizes were evaluated for their ability to hold back undissolved, nanosized drug particles. It was shown that filters with pore sizes of 0.1μm and 0.02μm were able to separate molecularly dissolved drug from colloidal and undissolved particles. In vitro results obtained with a suitable filter were used to generate simulated plasma profiles in combination with two different models using STELLA® software: (a) under the assumption of no permeability restrictions to absorption and (b) under the assumption of a permeability restriction. The …
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