Methods to Compare Dissolution Profiles

Abstract

The objective of this work was to apply several profile comparison approaches to dissolution data of four different Metoprolol tartrate tablet formulations in order to quantify each method's metric for comparing dissolution profiles. Dissolution was performed using the United States Pharmacopeia (USP) monograph method on four formulations of metoprolol tartrate tablets. Two general approaches to compare dissolution profiles were examined: model-independent approaches and model-dependent approaches. The model-independent methods included ANOVA-based procedures, ratio test procedures, and pair-wise procedures. The model-dependent approaches included zero-order, first-order, Hixson-Crowell, Higuchi, quadratic, Weibull, Gompertz, and logistic models. It is concluded that the ratio test procedures, the pair-wise procedures, and several model-dependent approaches yielded numerical results which can possibly serve as objective and quantitative metrics for comparing entire dissolution profiles of the four metopro...