PHARMACEUTICAL QUALITY OF GLIBENCLAMIDE PRODUCTS A MULTINATIONAL POSTMARKET COMPARATIVE-STUDY

A multinational postmarket comparative study of pharmaceutical quality of glibenclamide products was performed in cooperation with large num ber of laboratories and under anspices of the Section of Official Labo ratories and Medicines Control Services of FIP and World Health Organi zation. 28 countries from Europe, Africa, North and South America, Asi a and Australia participated in this study. Altogether 142 glibenclami de 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 fulf illed the pharmacoepial requirements concerning identity, purity and c ontent (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 i s anticipated that products, which are markedly differenticated in the ir in-vitro dissolution properties, exhibit therapeutically relevant d ifferences in bioavailability.