Fabrication et contrôle qualité physico-chimique et microbiologique d'un comprimé générique anti-hémorragique "OPTISYLATE 250 mg"

Abstract

This study focuses on the manufacturing and quality testing of Optisylate 250 mg, an oral anti-hemorrhagic medication in the form of a film-coated tablet. It was produced in the solid dosage form production unit of the SARL OPTIPHARM laboratory, located in Guidjel, with the aim of verifying whether the finished product complies with the standards of the European Pharmacopoeia. Physico-chemical and microbiological tests were carried out in the company's quality control laboratory. Physical examination showed that the tablets are white, film-coated, round, biconvex, with smooth surfaces on both sides and free of visible defects. The uniformity of mass test gave an average tablet weight of 324.73 mg, which falls within the accepted range. The hardness test indicated an average breaking force of 88.01 N, while the friability test showed a weight loss of only 0.36 %, which is well below the maximum allowed limit of 1 %. The blisters demonstrated perfect sealing with no leakage, indicating high-quality packaging that protects the product from moisture and external aggressions. The mass variation and content uniformity tests revealed an average active ingredient content of 102.66 %, with an acceptance value (AV) of 4.68, which is below the limit of 15 set by the European Pharmacopoeia at level 1. This means that the tablets are consistent in their active substance content. Chemical analyses confirmed the product's quality. The dissolution test showed an average percentage of 105.92 % of etamsylate released, and the assay confirmed a content of 102.66 %. The identification test gave a specific absorbance of 150.3 l·g⁻¹·cm⁻¹, consistent with the expected value for etamsylate. Related substances were tested by HPLC and remained within acceptable limits. From a microbiological test, the tablets contained only 3 colonyforming units per gram (CFU/g) of aerobic bacteria. No yeasts or molds were detected, and the test for Escherichia coli was negative. In conclusion, all the results indicate that Optisylate 250 mg complies with the quality standards of the European Pharmacopoeia.