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Type: Journal article
Title: Use of in vitro dissolution testing to assess multiple generic metformin tablets
Author: Ngo, S.
Wong, S.
Citation: Journal of Pharmaceutical Research International, 2018; 21(4):JPRI.39508-1-JPRI.39508-9
Publisher: SCIENCEDOMAIN international
Issue Date: 2018
ISSN: 2456-9119
Statement of
Sze S. Wong and Suong N. T. Ngo
Abstract: Aims: Metformin is a high-solubility and low-permeability drug that is widely used as an oral antidiabetic medication. In many countries, metformin is available as multiple generic formulations, with over 10 registered products, which are approved to be dispensed interchangeable. The aims of this study were to assess the in vitro dissolution profiles of a range of commercial brands of metformin hydrochloride tablets under a range of in vitro conditions and to determine whether differences in in vitro dissolution can be detected under a range of conditions. Methodology: Single and multiple (2 or 4) tablets from all brands were tested in both pH 6.8 and 0.1M HCl (gastric pH) dissolution medium and collected samples were analysed by highperformance liquid chromatography. Results: At least three distinct dissolution profiles were seen, designated slow, medium and fast released profiles. The innovator product, Glucophage® exhibited a medium released profile while Glucohexal® (G1) and Diaformin® (G3) displayed a fast released and a slow released profile respectively. The differences in the dissolution profiles were more apparent in the 0.1M HCl medium and a higher degree of disparity between the dissolution profiles was observed when the number of tablets in each dissolution flask increased. Conclusion: The results indicated that multiple registered versions of metformin have different dissolution profiles that can be detected even under standard in vitro conditions. However, all formulations were extensively dissolved within 45 minutes, suggesting that the in vivo performance of the different brands are not likely to differ to a clinically significant extent.
Keywords: Metformin; bioequivalence; dissolution testing; HPLC
Description: Published 13th March 2018
Rights: © 2018 Wong and Ngo; This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI: 10.9734/JPRI/2018/39508
Published version: http://http/
Appears in Collections:Animal and Veterinary Sciences publications
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