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.
Institutions
- Adamson University (PH)
- University of Connecticut (US)
- Centro Escolar University (PH)
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