Développement de fabrication d’un comprimé Pergus ® 10 mg

Abstract

The aim of this work is to develop the galenic form of a generic drug, PERGUS®, in the form of coated immediate-release tablets, based on Prasugrel (active ingredient) at a dose of 10mg. The manufacturing development was carried out successively on powder mixing, dry granulation, grain compaction, grinding, compression and finally tablet coating. Quality control of production intermediates and semi-finished products was carried out in accordance with European pharmacopoeia standards. Pharmaco-technical and physico-chemical tests have shown satisfactory results and compliance with the specifications required by the European Pharmacopoeia. The generic PERGUS® 10mg was successfully developed using a galenic process and reliable, reproducible analytical and biopharmaceutical techniques.