Development of a bionic system for the simultaneous prediction of the release/absorption characteristics of enteric-coated formulations.

Abstract:

PURPOSE:To develop a new bionic system from an existing drug dissolution/absorption simulating system (DDASS) to simultaneously predict the release and absorption of enteric-coated formulations. METHODS:In accordance with the pH-dependent characteristics of enteric-coated formulations, the modified DDASS was designed to effectively imitate the pH change process of the formulations' transfer from stomach to intestine in vivo. Omeprazole enteric-coated tablets were chosen as the model drug to verify the rationality and feasibility of the modified DDASS. The correlations between USP I system release and beagle dog absorption, as well as between modified DDASS elution/permeation and beagle dog absorption, were investigated by linear and nonlinear regression analyses, respectively. RESULTS:In vitro-in vivo correlation between the modified DDASS elution/permeation method and beagle dog absorption was higher than between the USP I system release and beagle dog absorption in both analytical methods. The ratio of first-order permeation rate constant to first-order release rate constant was consistent with that from modified DDASS. CONCLUSIONS:The modified DDASS provided more information than the USP I system did in the evaluation of enteric-coated formulations. The proposed bionic system model could serve as a new method for improving drug effectiveness.

journal_name

Pharm Res

journal_title

Pharmaceutical research

authors

Liu W,He X,Li Z,Gao X,Ma Y,Xun M,Liu C

doi

10.1007/s11095-012-0905-3

subject

Has Abstract

pub_date

2013-02-01 00:00:00

pages

596-605

issue

2

eissn

0724-8741

issn

1573-904X

journal_volume

30

pub_type

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