Formulation et détermination de qualité d’un produit pharmaceutique par une méthode d’analyse

Abstract

The pharmaceutical industry is a strategic economic sector that manages the development, production and marketing of well-monitored, well-controlled pharmaceutical products that comply with national and international standards. The objective of this work placement was to review the various pharmacotechnical tests (hardness, friability, uniformity of mass, disaggregation, dissolution), physicochemical (assay) and microbiological (DLMT, DGAT, research of E. coli) existing for the quality control of mébévérine-saidal 100mg. The generic mébévérine-saidal 100mg is a film-coated tablet, white in color and has no breakage or stain, the mean mass of this tablet is within [Mt ± 5%] of the theoretical mass, that is to say In the range 255mg ± 5% [242.25mg - 267.75mg]. For the mass uniformity test, a single tablet among the tablets tested deviates ± 5% from the mean mass and no tablets deviate by ± 10%. On the other hand, all the tablets disintegrate completely at a time less than 30 minutes, have hardness greater than 3.5kg and the loss of their mass during the friability test is less than 1%. For the control of the active principle, it was found that the hydrochloric mébévérine dissolved in the dissolution medium in a percentage greater than 70% and exists in the tablets tested at an average level of between 95mg and 105mg. The microbiological control of the tablet based on the total aerobic count, thus the count of total yeasts and molds and the search for E. coli shows an absence of microbial development on all the culture media, with the exception of the sabouraud medium -glucose-agar where there appears a colony of mold. Referring mainly to the European Pharmacopoeia 8th Edition, the British Pharmacopoeia and the company's internal monograph, trials have shown that mébévérine-saidal 100mg tablets are of satisfactory quality.