Resumen

SARAVIA GUTIERREZ, Giovana Ximena  y  DAZA CALDERON, María Luisa. In vitro Bioequivalence study of immediate release tablets of 850 mg of Metformin marketed in Bolivia  . Rev.Cs.Farm. y Bioq [online]. 2020, vol.8, n.2, pp.77-92. ISSN 2310-0265.

Abstract Introduction: Bioequivalence studies demonstrate the equivalence in biopharmaceutical quality between the multi-source pharmaceutical product and the reference medicine, allowing the establishment of bridges between preclinical tests and clinical trials associated with the reference medicine. Metformin hydrochloride is the drug of first choice for the diabetes mellitus II treatment and belongs to class 3 of the Biopharmaceutical Classification System. Objective: Establish by in vitro dissolution tests, whether 4 multisource pharmaceutical products of immediate release and peroral administration, with Metformin hydrochloride, marketed in Bolivia are bioequivalent in relation to the reference product, through an experimental design, with statistical significance. Method: Dissolution profiles were prepared for each product, taking into account the conditions of the dissolution test method established in the "Metformin, tablets" monograph of USP 39, considering six sampling times. The kinetic analysis of the accumulated dissolved percentage data of the dissolution profiles versus time was performed. The independent model method was used to compare the dissolution profiles of the products by calculating the difference factor (f1) and similarity factor (f2) recommended for Biowaiver studies, by the World Health Organization. Results: All the products taken into account in the investigation, satisfactorily fulfilled the Quality Control analysis. The results of the Bioequivalence study showed that there are statistically significant differences between the products of the study. Conclusion: In this study the in vitro bioequivalence of the products B, C, D and E in relation to the reference product A was not demonstrated, based on in vitro dissolution tests

Palabras clave : In vitro Bioequivalence; Metformin; Multisource; Biowaiver.

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