Avaliação do perfil de dissolução de comprimidos de losartan potássico 50 mg comercializados no Brasil

Abstract

The comparison of the dissolution profile among two or more drugs may be an indication of equivalence or bioequivalence, but not a guarantee. This article studies the dissolution profiles of tablets of losartan potassium 50 mg in purified water and in three other media, in the physiological range of pH 1.2; 4.5 and 6.8. Three drugs were evaluated: reference (R), similar (S) and generic (G). The drug was analyzed by UV spectrophotometry and data were submitted to calculation of the similarity factor (f2), according to RDC 31/2010. The results showed that the dissolution profile of the generic drug achieved similarity to that of the reference drug in purified water and buffer (pH 6.8) only, and the profile of the similar drug was similar to that of the reference drug in hydrochloric acid (pH 1.2) only. The conclusion is that the differences observed among the dissolution profiles may suggest a possible impairment of the bioavailability of these products. However, in order to check the bioequivalence of both generic and similar drugs, in vivo tests are required.