Pharmaceutical equivalence of metformin tablets with various binders
作者： T. M.B. Bresolin , A. G. Couto , L. C. Block , L. O. Schemling , S. C. MOURãO
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摘要: Metformin hydrochloride is a high-dose drug widely used as an oral anti-hyperglycemic agent. As it highly crystalline and has poor compaction properties, difficult to form tablets by direct compression. The aim of this study was develop adequate metformin tablets, pharmaceutically equivalent the reference product, Glucophage ® (marketed Glifage in Brazil). 500mg were produced wet granulation with various binders (A = starch, B starch 1500 , C PVP K30 D K90 ). analyzed for their hardness, friability, disintegration, dissolution, content uniformity dissolution profile (basket apparatus at 50 rpm, pH 6.8 phosphate buffer). 4 formulations, F1 (5% A 5% C), F2 F3 (10% C) F4 D), demonstrated content, disintegration total after 30 minutes (F1, F4), 60 (F3). release time profiles fitted Higuchi model F3), similarly pharmaceutical reference, or zero order (F4). efficiency all formulations 75%, except (45%). thus . Keywords: dissolution; metformin; tablet; binder; equivalence
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