AVALIAÇÃO DA QUALIDADE FÍSICO-QUÍMICA E DAS CARACTERÍSTICAS ORGANOLÉPTICAS DE COMPRIMIDOS DE LOSARTANA POTÁSSICA: ESTUDO COMPARATIVO ENTRE MEDICAMENTOS DE REFERÊNCIA, GENÉRICO E SIMILAR

Abstract

Losartan potassium is an antihypertensive drug belonging to the class of angiotensin II receptor antagonists, and it ranked second in the ranking of the 20 most marketed substances and combinations by presentations in 2019. Quality control, meanwhile, aims to evaluate medicines, ensuring a good pharmacological effect. The aim of this study was to evaluate the physicochemical and organoleptic quality of coated tablets of losartan potassium (50 mg). To this end, a comparative study was carried out using the physicochemical tests of medium weight and disintegration. In addition, the organoleptic characteristics of the samples were compared with the characteristics described in the medicines' package leaflets. The samples were designated as G (generic medicine), S (similar medicine) and R (reference medicine). The results obtained were in accordance with the specifications of the Brazilian Pharmacopoeia 6th edition and the package leaflets, therefore, all the samples were approved. Non-conformity with pharmacopoeial specifications can result in losses for consumers and medicine manufacturers, thus, it is important to evaluate the physicochemical quality of pharmaceutical formulations.