TY - JOUR AU - MEDINA-LĂ“PEZ, JOSE RAUL AU - MEDINA-MORALES, FRIDA IRIANA AU - GALVEZ LOMELIN, RAFAEL ALONSO AU - RUIZ SEGURA, JUAN CARLOS AU - HURTADO, MARCELA PY - 2020/11/07 Y2 - 2024/03/29 TI - IN VITRO RELEASE PERFORMANCE OF METFORMIN HYDROCHLORIDE FORMULATIONS USING THE FLOW-THROUGH CELL METHOD JF - International Journal of Applied Pharmaceutics JA - Int J App Pharm VL - 12 IS - 6 SE - Original Article(s) DO - 10.22159/ijap.2020v12i6.39230 UR - https://journals.innovareacademics.in/index.php/ijap/article/view/39230 SP - 76-82 AB - <p><strong>Objective: </strong>The objective of this work was to evaluate the <em>in vitro</em> release performance of metformin hydrochloride formulations (500-mg tablets) using the hydrodynamic environment of the flow-through cell method. Results were compared with those generated by the official dissolution test (USP basket apparatus).</p><p><strong>Methods: </strong>The reference drug product and three generic formulations were tested with phosphate buffer pH 6.8 as dissolution medium. Dissolution profiles were carried out with an automated flow-through cell apparatus using laminar flow at 16 ml/min. Drug was quantified at 233 nm during 45 min. Dissolution profiles were compared with the calculation of f<sub>2</sub> similarity factor, mean dissolution time, dissolution efficiency, t<sub>50%</sub> and t<sub>63.2%</sub>. Dissolution data were adjusted to several mathematical models such as Makoid-Banakar, Peppas-Sahlin, Weibull and Logistic.</p><p><strong>Results: </strong>With the flow-through cell method and at 45 min less than 60% of metformin hydrochloride dissolved was found, while with the USP basket apparatus, less than 75% of the drug was found. Some generic formulations showed f<sub>2</sub>&gt;50 with both USP apparatuses, but statistical comparisons of parameters indicated significant differences between their dissolution profiles and reference. Due to variability obtained no dissolution profiles were compared by model-dependent approach.</p><p><strong>Conclusion: </strong>To demonstrate safe interchangeability between metformin hydrochloride generic formulations and reference bioequivalence studies should be performed. It is important post-marketing monitoring of the commercial formulations because health regulatory agencies of each country must ensure drug products with quality, safety, and efficacy at the lowest possible cost.</p> ER -