Abstract

MATIZ MELO, Germán Eduardo  and  RODRIGUEZ CAVALLO, Erika. Comparative study of the biopharmaceutical quality of commercial and generic brands of captopril and losartan tablets in the Colombian market. Rev. colomb. cienc. quim. farm. [online]. 2014, vol.43, n.2, pp.217-233. ISSN 0034-7418.  https://doi.org/10.15446/rcciquifa.v43n2.54209.

Hypertension affects thousands of people around the world and in Colombia remains one of the leading causes of morbidity and mortality. The captopril and losartan drugs are the first choice for treatment. In order to assess the conformity of products and determine their biopharmaceutical equivalence, a total of 19 commercial brands available in drug stores and pharmacies in four major cities of the country (Bogotá, Cartagena, Cali and Barranquilla) were evaluated. To this end the physical, chemical and biopharmaceutical characteristics of the tablets, such as weight variation, hardness, disintegration, dissolution, dissolution profile, the dissolution efficiency and value of the active substance were evaluated. This latter from optimized and validated methodologies. Pharmacopeial assays were evaluated as provided in USP 35 NF 30. The results obtained allowed to establish that all models tested met the acceptance criteria in the Pharmacopoeia for each principle, and the biopharmaceutical behavior of brands is very similar for both types of molecule. The results of this work allows to propose the scientific community the determination of the biopharmaceutical equivalence as support in making purchasing decisions in the pharmaceutical service.

Keywords : captopril; losartan; biopharmaceutical; dissolution; similarity factor f2.

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