Estudio comparativo de las características físico-químicas y biofarmacéuticas de diferentes marcas comerciales de comprimidos de losartán 50 mg

Abstract

INTRODUCTION: Quality control of tablets is a crucial process to ensure drug quality, safety, and efficacy.

OBJECTIVE: To conduct a comparative study of the physicochemical and biopharmaceutical characteristics of losartan tablets from different commercial firms.

MATERIALS AND METHODS: The methodology applied was experimental, cross-sectional, and prospective in analyzing the quality control of five different brands of losartan 50 mg tablets obtained from pharmacies in Cuenca.

RESULTS: In the organoleptic characteristics tests, tablets were found without deformations, with uniform color, sui generis odor, and a diameter ranging from 7 to 10 mm, depending on the brand. In the mass uniformity testing, the following results were found; average 0.155 g, SD 0.0023%, CV 1.48% (Megalabs), average 0.187 g, SD 0.0042%, CV 2.24% (Genfar), average 0.157, SD 0.0025%, CV 1.59% (La Santé), average 0.272, SD 0.0044%, CV 1.61% (NIFA), average 0.167, SD 0.0014, CV 0.83 (Liomont). In the hardness testing, Megalabs 24.8 N, Genfar 24.6 N, La Santé 25 N, NIFA 24.6 N, and Liomont 24.6 N. Friability testing results were, Megalabs 0.032%, Genfar 0.030%, La Santé 0.031%, NIFA 0.015%, and Liomont 0.015%. As a result of the disintegration time assay, Megalabs 14'40'', Genfar 13'36'', La Santé 12'08'', NIFA 16'14'', and Liomont 24'21''.

CONCLUSION: The generic drugs concerning the innovator drug are different but comply with all the parameters established in the USP.