Pharmaceutical Quality of Glibenclamide Products A Multinational Postmarket Comparative Study

Abstract

A multinational postmarket comparative study of pharmaceutical quality of glibenclamide products was performed in cooperation with large number of laboratories and under anspices of the Section of Official Laboratories and Medicines Control Services of FIP and World Health Organization. 28 countries from Europe, Africa, North and South America, Asia and Australia participated in this study. Altogether 142 glibenclamide tablet formulations of the respective countries were investigated. The products were tested for identity, purity, content, uniformity of content and in-vitro dissolution properties. Most products tested fulfilled the pharmacoepial requirements concerning identity, purity and content (95–115%). Marked differences were recorded in respect of in-vitro dissolution behaviour. This applies not only to the products of different countries but also among products of the same country. It is anticipated that products, which are markedly differentiated in their in-vitro dissolution properties, exhibit therapeutically relevant differences in bioavailability.