Development of a simple and rapid Formulation and evaluation of Metformin HCl extended-release tablets in comparison with Glucophage® XR

Abstract

Metformin HCl is the first-line therapy for type 2 diabetes. It is available in both immediate-release and extended-release tablet forms, with the extended-release tablet being more beneficial. In this study, 34 formulations using five sustained-release agents, alone or in combination, were evaluated. The granular flowability, angle of repose, bulk Density, tapped Density, compressibility index, and Hausner ratio were assessed. Furthermore, the compressed tablets were tested for appearance, hardness, friability, and in-vitro drug release. Eleven formulations were evaluated for dissolution profiles according to the standards specified in the United States Pharmacopeia. After calculating the similarity factor (f1) and difference factor (f2), eight formulations were identified for further investigation. The combination of xanthan gum and hypromellose (HPMC K100) demonstrated superior results regarding the sustained-release agent amount and tablet appearance. This noteworthy finding led to continuing the study to explore further formulations with different amounts of xanthan gum and Hypromellose K100. As a result, formulation F34 was identified as the optimal choice because of its higher drug-to-polymer ratio. In conclusion, the final formulation is a rapid, cost-effective, and straightforward method due to the less time required for drying, the amount of sustained-release agents, and the number of components.