Développement galénique des comprimés enrobés de métronidazole 500 mg.

Abstract

Tablets now account for around half of all medicines administered. Their galenic development is a delicate process that must meet numerous scientific and regulatory requirements. This study examines the various stages in the galenic development of a generic of Metronidazole in solid oral form at a dose of 500 mg. It was carried out at the SARL BIOREM pharmaceutical laboratory in Jijel. Our study first describes the techniques used to determine the physico-chemical characteristics of the active ingredient and the chosen excipients: Corn starch, PVP K 30 and Mg stearate, as well as the ten provisional formulations that were produced using the wet granulation process, varying the particle size of the active ingredient and the mixture preparation techniques. These formulas were checked in order to arrive at the optimum formula. Once this formula was established, it was optimized in order to define the factors influencing its performance, such as hardness and dissolution, before moving on to the film-coating stage. At this stage, we were able to determine the optimum hardness (between 50 N and 70 N) that wouldnot slow down the disintegration time of the tablets. Comparative dissolution kinetics enabled us to ensure therapeutic equivalence between tablets from batch E001 and the reference.