IVIVC in Oral Absorption for Fenofibrate Immediate Release Tablets Using a Dissolution/Permeation System

被引:67
作者
Buch, Philipp [1 ]
Languth, Peter [1 ]
Kataoka, Makoto [2 ]
Yamashita, Shinji [2 ]
机构
[1] Johannes Gutenberg Univ Mainz, Dept Pharmaceut Technol & Biopharmaceut, D-55099 Mainz, Germany
[2] Setsunan Univ, Fac Pharmaceut Sci, Osaka 5730101, Japan
关键词
biopharmaceutics classification system (BCS); Caco-2; cells; dissolution; permeation; in vitro/in vivo correlations (IVIVC); food-effect-studies; WATER-SOLUBLE DRUGS; FOOD; PERMEATION; PREDICTION; MICRONIZATION; FORMULATIONS; ENHANCEMENT; SOLUBILITY; DELIVERY; HUMANS;
D O I
10.1002/jps.21576
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
The usefulness of a dissolution/permeation (D/P) system to predict the in vivo performance of solid dosage forms containing the poorly Soluble drug, fenofibrate, was studied. Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in order to simulate the effect of food on the absorption of fenofibrate. Moreover, the results obtained from the D/P system were correlated with pharmacokinetic parameters obtained following in. vivo studies in rats. The in vitro parameter (amount permeated in the D/P system) reflected well the in vivo performance in rats in terms of AUC and C-max of fenofibric acid. This study thus demonstrates the potential of the D/P system as valuable tool for absorption screening of dosage forms for poorly soluble drugs. (C) 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2001-2009, 2009
引用
收藏
页码:2001 / 2009
页数:9
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