The goal of this study was to investigate the in vitro-in vivo correlation (IVIVC) for fenofibrate immediate release (IR) tablet formulations based on MeltDose-technique. The in vitro determined drug solubility and permeability data were related to the C(max) values observed from two in vivo human s
IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system
โ Scribed by Philipp Buch; Peter Langguth; Makoto Kataoka; Shinji Yamashita
- Book ID
- 102395586
- Publisher
- John Wiley and Sons
- Year
- 2009
- Tongue
- English
- Weight
- 144 KB
- Volume
- 98
- Category
- Article
- ISSN
- 0022-3549
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โฆ Synopsis
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.
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