Résumé:
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.
