Classification of dissolution profiles in terms of fractional dissolution rate and a novel measure of heterogeneity.

Dissolution profiles are classified in accordance with the shape of fractional dissolution rate function. This function is constant in time for the classical first-order model and, in this case, the dissolution is described by a monoexponential function. Therefore, any deviation of the fractional dissolution rate from the constant level suggests the presence of different (nonlinear/nonhomogenous) mechanisms in the dissolution process. The shapes of the fractional dissolution rate depend on the type of the model of dissolution; thus, classification with respect to this function is proposed as a tool for model selection. The Kullback-Leibler information distance is proposed for measuring similarity between two different drug dissolution profiles. The method is applied mainly to compare the first-order model, which characterizes a homogenous dosage form, with other common descriptors of dissolution and with experimental data. Copyright 2003 Wiley-Liss, Inc.