Comparative Study of in vitro Quality Specifications of Yemeni Brand of Glimepiride Tablets Versus Foreign Brands Marketed in Yemen

Abstract

Background: Generic drug products are increasing in the market nowadays making it possible for people to select a particular generic drug from several equivalent products. Local pharmaceutical industry in Yemen has provided many Generic medicines to the Yemeni drug market. These medicines are cheaper alternatives to the high cost brands. Unfortunately, there is a wrong belief that generic medicines are inferior in quality compared to the original brands. Aim: To assess the quality specifications of a Yemeni brand of Glimepiride 2-mg tablets versus 2 foreign brands marketed in Yemen including one Arabian Brand and one innovator European brand. Methods: The quality physical specifications including tablet thickness, hardness, friability, and disintegration and weight variations were investigated for each of the three tested brands. In addition, the drug content and dissolution behavior of drug in those brands were also evaluated. Results: The results of quality specification testing of tablet thickness, friability, disintegration, weight variations and drug content of the three tested brands were within the accepted limits. With respect to other tests, the original and the Yemeni brands showed hardness within acceptable limit and also showed good dissolution similarity. However, the Arabian brand demonstrated high harness out of accepted limit and also showed dissolution dissimilarity with the original brand. Conclusion: The Yemeni brand of Glimepiride investigated in this study has equivalent quality specifications as that of the original brand