In vitro Bioequivalence Analysis of Generic Metformin Hydrochloride Film-coated Tablets
Abstract
Background and objectives: The in vitro bioequivalence assessment using a dissolution apparatus, as specified by the United States Pharmacopeia (USP), is a critical parameter in the formulation and development of generic pharmaceutical products. This study is crucial for evaluating the interchangeability of generic drugs with their reference innovator counterparts. Post-market surveillance of generic drugs ensures consistent quality after distribution in the market. Metformin hydrochloride, a widely prescribed oral hypoglycemic agent for managing type 2 diabetes, is among the most utilized medications globally.In the Philippines, there is a growing need to assess the bioequivalence of various generic formulations of metformin HCl film coated tablets to ensure compliance with regulatory requirements. The Philippine Food and Drug Administration (FDA) mandates in vivo or in vitro bioequivalence including, dissolution profile comparison, as a prerequisite for the registration of generic drugs. This study aims to evaluate the quality and in vitro bioequivalence of metformin HCl film-coated tablets available in the Philippine market by comparing their dissolution profiles against the innovator, Glucophage. This research seeks to provide insights into the interchangeability, therapeutic equivalence, and overall quality of these generic formulations, thus contributing to public health and regulatory standards.
Methods: Generic metformin HCl film-coated tablets were subjected to…
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