Dissolution Rate Testing with the Column method: Methodology and Results

Abstract

A detailed description of a column (flow-through) type dissolution apparatus is given, including features of automated sampling, assay, and computerized data processing. Standardized testing parameters are presented which permit reproducible performance in different laboratories, under conditions close to those of physiological dissolution and absorption. Without major modifications the same apparatus can be used for various dosage forms such as powders, granules, tablets, coated tablets, and capsules. Examples are given which demonstrate reproducibility as well as correlation with in-vivo data. It is suggested that this methodological approach be regarded as a promising alternative to the present official methods.