IN VITRO RELEASE PERFORMANCE OF METFORMIN HYDROCHLORIDE FORMULATIONS USING THE FLOW-THROUGH CELL METHOD

  • José Raúl Medina-López Departamento Sistemas Biologicos Universidad Autonoma Metropolitana-Xochimilco
  • FRIDA IRIANA MEDINA-MORALES Departamento Sistemas Biologicos. Universidad Autonoma Metropolitana-Xochimilco, Mexico City, Mexico
  • Rafael Alonso Galvez-Lomelin Departamento Sistemas Biologicos. Universidad Autonoma Metropolitana-Xochimilco, Mexico City, Mexico
  • Juan Carlos Ruiz-Segura Departamento Sistemas Biologicos. Universidad Autonoma Metropolitana-Xochimilco, Mexico City, Mexico
  • Marcela Hurtado Departamento Sistemas Biologicos. Universidad Autonoma Metropolitana-Xochimilco, Mexico City, Mexico

Abstract

Objective: The objective of this work was to evaluate the in vitro 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).


Methods: 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 f2, mean dissolution time, dissolution efficiency, t50% and t63.2%. Dissolution data were adjusted to several mathematical models such as Makoid-Banakar, Peppas-Sahlin, Weibull and Logistic.


Results: 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 drug was found. Some generic formulations showed f2 > 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.


Conclusion: To demonstrate safe interchangeability between metformin hydrochloride generic formulations and reference bioequivalence studies should be performed. It is important a 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.

Keywords: diabetes type 2, flow-through cell method, generic drug products, metformin hydrochloride

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Medina-López, J. R., MEDINA-MORALES, F. I., Galvez-Lomelin, R. A., Ruiz-Segura, J. C., & Hurtado, M. (2020). IN VITRO RELEASE PERFORMANCE OF METFORMIN HYDROCHLORIDE FORMULATIONS USING THE FLOW-THROUGH CELL METHOD. International Journal of Applied Pharmaceutics, 12(6). Retrieved from https://innovareacademics.in/journals/index.php/ijap/article/view/39230
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