Dissolution testing is used to evaluate the performance of pharmaceutical products. This study compared the dissolution profiles of seven immediate-release metformin 500-mg formulations, including two products with the trade name Glucophage, in simulated intestinal fluid (SIF) at pH 6.8 buffer without enzymes. Other characteristics investigated were absolute weight and drug content. These formulations were marketed in Trinidad and Tobago and are categorized as Class 3 drugs by the Biopharmaceutics Classification System (BCS). The paddle apparatus was used at 75 rpm in 900 mL of SIF at 37 ± 0.5 °C. Samples of 1.25 mL were removed at 10, 15, 20, 30, 45, and 60 min without replacement, of which 100 µL was diluted with fresh medium and then analyzed spectrophotometrically at 233 nm. Data were analyzed statistically using one-way analysis of variance and DDSolver Add-In to Excel. The weights were significantly different (p ≤ 0.05), and each of the formulations demonstrated drug content between 99% and 103%. Only one of the formulations showed <85% drug release in 15 min and a calculated f 2 value less than 50, which deviates from the acceptance criteria recommended by the World Health Organization (WHO).
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.