Candesartan Cilexetil In Vitro-In Vivo Correlation: Predictive Dissolution as a Development Tool.

ABSTRACT: The main objective of this investigation was to develop an in vitro-in vivo correlation (IVIVC) for immediate release candesartan cilexetil formulations by designing an in vitro dissolution test to be used as development tool. The IVIVC could be used to reduce failures in future bioequivalence studies. Data from two bioequivalence studies were scaled and combined to obtain the dataset for the IVIVC. Two-step and one-step approaches were used to develop the IVIVC. Experimental solubility and permeability data confirmed candesartan cilexetil. Biopharmaceutic Classification System (BCS) class II candesartan average plasma profiles were deconvoluted by the Loo-Riegelman method to obtain the oral fractions absorbed. Fractions dissolved were obtained in several conditions in USP II and IV

SUBMITTER: Figueroa-Campos A 

PROVIDER: S-EPMC7408357 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature