Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, 15784 Athens, Greece
Research
Non-linear Mixed Effects Modeling and Simulation for Exploring Variability
Sources in Dissolution Curves: A BCS Class II Case Example
Author(s): Eleni Karatza* and Vangelis Karalis
Purpose: Irbesartan is a BCS class II compound that exhibits pH– and buffer capacity–dependent dissolution behavior. The aim of this study was to apply non-linear mixed effects modelling on dissolution data of two immediate release products containing Irbesartan in order to characterize and quantify the sources of inter-dissolution profile variability.
Methods: Nonlinear mixed effects modelling was applied to describe the dissolution curves obtained for Irbesartan in three different pH-value media (1.2, 4.5, 6.8) with two different products (reference product: Aprovel® and a generic test product). Simulations performed and the impact of inter-dissolution variability was assessed.
Results: The % Irbesartan dissolved to time was found to follow a Weibull distribution. Τhe population scale paramete.. View more»