Regression Analysis of the Drug Dissolution Profile and Estimation of the Drug Release Mechanism

Abstract

A drug dissolution profile is one of the most important characteristics of the dosage form with controlled drug release. Obtained dissolution data can be used for evaluation of a drug release rate and mechanism of its release from the dosage form. Nowadays various mathematical models can be used for this purpose. An accordance with a particular mathematical model is determined by regression characteristics and by the relevance of the regression model parameter estimation. Since the dissolution curves are not linear with the exception of the zero-order kinetics, the transformation of dependencies into a linear form is often performed. However, linearization is connected with a change in the deviation magnitudes and the resulting function does not minimize squared deviations. The main aim of this manuscript was to show an overview of basic mathematical models in a form suitable for nonlinear regression which work with original experimental data and to summarize basic steps for determining the drug release mechanism and rate constants.