Comparative analysis of eighteen brands of glimepiride tablets collected from certain arab countries

الملخص EN

Purpose: The aim of the present study is to investigate the physicochemical equivalence of eighteen brands of Glimepiride tablets (ant hyperglycemic) collected from retail pharmacies in certain Arab capital markets include (Yemen, Saudi Arabia, Syria, and Egypt).

Also to obtaining baseline data towards the establishment of bioequivalence of the tablets dosage forms. Method: The quality and physicochemical equivalence of eighteen different brands of Glimepiride tablets were assessed.

The assessment included the evaluation of uniformity of weight, friability, crushing strength, disintegration and dissolution tests as well as chemical assay of the tablets. Results: All the eighteen brands of the tablets passed the British Pharmacopoeia (BP) standards for uniformity of weight, disintegration and friability and one of the eighteen brands failed the hardness test.

There were significant differences in the dissolution profiles of the eighteen brands.

All the brands except C and F released >60% of Glimepiride within 30 min.

Only eight of the brands complied with the standard assay of active ingredients content for Glimepiride tablets while other brand did not comply. Conclusion: Eight out of the eighteen brands of Glimepiride tablets that were analyzed passed all the BP or USP quality specifications and were physically and chemically equivalent.

This study highlights the need for constant market monitoring of new products to ascertain their equivalency to the innovator product.