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Einfluß der Teilchengröße von Mefenaminsäure auf Dissolution und Bioverfügbarkeit von Tabletten

Daniel Hummel und Stephan Buchmann

Spirig Pharma AG, Abteilung Galenik, Egerkingen (Schweiz)

Influence of Mefenamic Acid Particle Size on Dissolution and Bioavailability of Tablets In the course of development and bioequivalence testing of mefenamic acid tablets the general relationship between particle size distribution of poorly water soluble drugs and their bioavailability was observed: comminution of mefenamic acid resulted in a significant increase of absorption and bioavailability, respectively. Moreover, the data of in vitro dissolution are not correlated to the results of the performed bioavailability studies. Therefore, in the case of mefenamic acid one can not evade the bioavailability study and performance of in vitro dissolution tests alone is not jusitified with regard to efficacy and safety of the generic product.

Key words Bioäquivalenz · Bioverfügbarkeit · Dissolution · Generika · Mefenaminsäure · Teilchengröße