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Research Gate: Pharmaceutical Science
The Research Gate: Pharmaceutical Science provides a resource content dealing with the Pharmaceutical industry starting from drug discovery process to drug distribution system to patients.
The Research Gate: Pharmaceutical Science aims to publish all the recent and exceptional research articles and reviews in all areas of modern Pharmaceutical industry like drug discovery including in-silico drug design, combinatorial chemistry, new drug targets, Bioinformatics and chemoinformatics, Genomics and proteomics, medicinal chemistry, SAR, high-throughput screening, advances in ADME, drug delivery and Biopharmaceuticals, phytochemistry and pharmacognosy.
Formulation Development of Uncoated Metformin Tablet and it’s in vitro Bioequivalence Study for Biowaiver
Abstract
The purpose of this research work is to prepare metformin hydrochloride immediate release tablets by wet granulation technique and study the possibility of biowaiver by in-vitro dissolution studies by comparing the marketed formulation. In order to obtain the best, optimized product eight different formulations were developed by varying the concentration of binder and disintegrants. Weight variation, thickness, hardness, friability, and in-vitro release, were studied as response variables. The formulations F2 and F3 were selected as optimized formulation for comparing with the reference product. The in-vitro release profile in different media like 0.01 N hydrochloric acid (pH 2), phosphate buffer (pH 4.5), and phosphate buffer (pH 6.8)werestudies, the results shows that both the formulation had shown the similarity factor (f2) more than 50% but it does not satisfy the WHO criteria for biowaiver because none of the formulation including the marketed formulation had not shown 85% or more dissolved within 15 min in standard dissolution media at pH 1.2, 4.5, and 6.8.