Comparative Evaluation of the Quality Control Parameters and Hypoglycemic Drug Effect of Some Brands of Glibenclamide Tablet

Abstract

Drug release profile and bioavailability indices have been well correlated with the quality of drug products. A comparative evaluation of the quality control parameters and hypoglycaemic drug performance check of some brands of glibenclamide tablets was studied. The physicochemical parameters of the brands were evaluated through uniformity of weight, friability and hardness tests along with disintegration and dissolution profile in phosphate buffer (pH 8). The hypoglycaemic drug performance of the brands was evaluated by twice daily oral dosing of 5mg glibenclamide tablet under controlled evening meal and fasting blood sugar (FBS) determinations. The statistical inferences about the groups’ mean fasting blood sugar (MFBS) were compared with a postulated/expected population MFBS of 5.0 mmol/L and the hypothesis that there was no difference in the population from which the MFBS was obtained for each group treatment, was tested. The brands complied with the USP specifications for tablet hardness, weight uniformity, and friability and disintegration tests. There was no significant difference in the chemical content among the brands at CI=95%. The assay gave a chemical content between 92.4% and 102.5%w/w for the drug brands. The dissolution profiles in phosphate buffer revealed satisfactory C45 and T70 of ≥ 70% and ≤ 45 min respectively. The MFBS for each brand laid beyond 2xSE of the postulated population MFBS. The investigated brands were of comparable quality standards and can be regarded as pharmaceutical and therapeutic equivalent. The hypoglycaemic drug effect of the drug products at the twice a day dosing could not achieve the postulated MFBS level. The method can be applied as a performance check for different brands of oral hypoglycaemic dugs emanating from the possible differences in the quality/production factors.