Vol. 8, Issue 6 (2019)

Author(s):
Shammi Akhter, Md. Moksadul Amin, Md. Ruhul Amin, Simom Hasan, Md. Mehdi Hasan and Dr. Hasan Mahamud Reza

Abstract:
Glyburide belongs to class II drugs, that is, characterized by low solubility and high permeability therefore, the enhancement of its solubility and dissolution profile is expected to significantly improve its bioavailability and reduce its side effects. The precompression blend of Glyburide soild dispersions were characterized with respect to angle of repose, bulk density, tapped density, Carr’s index and Hausner’s ratio. The precompression blend of all the batches indicates well to fair flow ability and compressibility. The formulated tablets were evaluated for various quality control parameters. 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. In vitro and in vivo methods. Friability, disintegration, dissolution, and assay for the content of active ingredients were evaluated using the methods described in the British Pharmacopeia (2009) and United States Pharmacopeia (2007).