Pharmaceutical Equivalence of Losartan Potassium Tablets in Argentina

Abstract

Losartan potassium (LOK) is an antihypertensive agent from the group of selective angiotensin AT1 receptor antagonists, widely used in the form of tablets for oral administration. The available data for BCS classification are confusing, though class III or IV are most likely. The quality attributes of solid oral dosage forms of LOK immediate-release tablets (50 mg) available in the Argentine pharmaceutical market were evaluated according to the Argentine Pharmacopoeia and United States Pharmacopeia (i.e., storage conditions information, price per tablet, average weight, assay, uniformity of dosage units, hardness, disintegration time, and in vitro dissolution). The dissolution efficiency (DE) results were compared using one way analysis of variance. All evaluated samples were within the acceptable limits for disintegration time, hardness, assay, uniformity of dosage units, and in vitro dissolution (in Stage 1). A statistically significant difference in DE was recorded for samples C, D, E, F, and G compared to the reference formulation (sample H). These samples had higher DE values than the reference; there were no statistically significant differences between the samples. Therefore, the evaluated samples of LOK from the Argentine market can be considered pharmaceutical equivalents.