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

Abstract:

: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.

journal_name

J Pharm Sci

authors

Lánský P,Weiss M

doi

10.1002/jps.10419

subject

Has Abstract

pub_date

2003-08-01 00:00:00

pages

1632-47

issue

8

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(16)31302-8

journal_volume

92

pub_type

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