Author(s):

Jakia Akter, Arif Ullah and Md. Mehdi Hasan

Abstract: Glibenclamide Tablets are used to lower blood sugar levels and are used in the treatment of late-onset diabetes (type II diabetes mellitus) in patients whose blood sugar is not controlled by diet alone and who are not suitable for insulin injections. An effective, pleasant tasting formulation was found to have a good hardness of 3 kg/cm2, disintegration time of 27+1 seconds and in vitro drug release of not less than 95% within 30 minutes. The drug release was found to be comparable with the marketed dispersible tablet. Our drug meets all the criteria mentioned above. Specially formulation 5 is best among all the formulations. The brands of glibenclamide tablets complied with the official specification for hardness, friability, disintegration, and assay. Difference factor (f1) values were less than 15 and similarity factor (f2) values were greater than 50 for all products of glibenclamide. The hypoglycemic effect of different products of glibenclamide tablets was evaluated on normoglycemic mice. The in vivo studies indicated that there is no significant difference in percent reduction of blood glucose level between the brands of glibenclamide and the innovator product (p>0.05). Hence, based on the in vivo results and in vitro dissolution studies, the brands might be substituted with the innovator product in clinical practice.

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