In vitro Bioequivalence Analysis of Generic Metformin Hydrochloride Film-coated Tablets

This study demonstrates that most generic metformin HCl film-coated tablets available in the Philippine market meet the United States Pharmacopeia (USP) quality control requirements and exhibit <i>in vitro</i> bioequivalence with the innovator drug. However, the failure of three brands to meet the hardness specifications and the lack of bioequivalence in one brand highlight the need for stringent quality assurance and regulatory oversight. Ensuring compliance with these standards is critical to maintaining the safety, efficacy, and therapeutic interchangeability of generic drugs. These findings emphasize the importance of continuous post-market surveillance to uphold the quality of generic medications in the market, to safeguard public health.

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Publication Details

Journal
Acta Medica Philippina
Published
2025-01-01
DOI
https://doi.org/10.47895/amp.vi0.10375
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
Field-Weighted Citation Impact
0.00
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article

In vitro Bioequivalence Analysis of Generic Metformin Hydrochloride Film-coated Tablets

Acta Medica Philippina
Analytical Methods in Pharmaceuticals
article

In vitro Bioequivalence Analysis of Generic Metformin Hydrochloride Film-coated Tablets

article en

Abstract

This study demonstrates that most generic metformin HCl film-coated tablets available in the Philippine market meet the United States Pharmacopeia (USP) quality control requirements and exhibit <i>in vitro</i> bioequivalence with the innovator drug. However, the failure of three brands to meet the hardness specifications and the lack of bioequivalence in one brand highlight the need for stringent quality assurance and regulatory oversight. Ensuring compliance with these standards is critical to maintaining the safety, efficacy, and therapeutic interchangeability of generic drugs. These findings emphasize the importance of continuous post-market surveillance to uphold the quality of generic medications in the market, to safeguard public health.

Acta Medica PhilippinaVol. 60(2)
Adamson University (PH), University of Connecticut (US), Centro Escolar University (PH)
Openalex Percentile: Top 87%
Analytical Methods in Pharmaceuticals
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