Good quality drugs fulfilling the regulatory parameters and produced per the current good manufacturing (CGMP) standards\nare very critical for best therapeutic outcome in patient therapy. Hence, this study assesses quality as well as physicochemical\nbioequivalence of five brands of glibenclamide tablets marketed in Addis Ababa using in vitro and in vivo methods. Friability,\ndisintegration, dissolution, and assay for the content of active ingredients were evaluated using the methods described in theBritish\nPharmacopeia (2009) and United States Pharmacopeia (2007). All the brands of glibenclamide tablets complied with the official\nspecification for hardness, friability, disintegration, and assay.Difference factor (f1) values were less than 15 and similarity factor (f2)\nvalues were greater than 50 for all products of glibenclamide.The hypoglycemic effect of different products of glibenclamide tablets\nwas evaluated on normoglycemic mice.The in vivo studies indicated that there is no significant difference in percent reduction of\nblood glucose level between the brands of glibenclamide and the innovator product (p > 0.05). Hence, based on the in vivo results\nand in vitro dissolution studies, the brands might be substituted with the innovator product in clinical practice.
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