Nonlinear mixed-effects model for the dissolution assays of drugs

Sustained or controlled release delivery systems can achieve predictable and reproducible drug release rates. With the aim of optimizing the bioavailability of conventional drugs with minimum side effects, new drug delivery systems continue to attract much attention. This research has been addressed to investigate in vitro metoclopramide release behavior from inert polymeric matrix tablets. Model-dependent and model-independent approaches are commonly used to investigate the release process and a fitted model results for each experimental condition. The aim of this work was to study the release characterization of the whole batch, therefore, we have developed a population model, taking into account the differences between tablets, experimental conditions, heterogeneity, and autocorrelation of residuals. The study of dissolution profiles was carried out using a mixed-effect model, which has provided a satisfactory tool for this kind of data.