Quality evaluation of compounded capsules

Abstract

The aim of this study was to evaluate the quality of compounded capsules of different drugs for chronic diseases. It were assessed two samples, from two different pharmacies, for each of the following drugs: ranitidine 150 mg, methyldopa 250 mg, enalapril maleate 20 mg, fluoxetine hydrochloride 20 mg, propranolol hydrochloride 40 mg, and furosemide 40 mg. The assays of mean weight, content determination, content uniformity and dissolution were performed according to Brazilian Pharmacopoeia. All samples were approved in the assay of mean weight, and the samples M1 and Flu1 had failed in the assay of content determination. In the test of uniformity of dosage units the samples M1, Flu1, E1, E2 and Flu2 had failed. Only the samples M2, P1, P2, F1 and F2 were accepted in all pharmacopoeial tests, evidencing that the others did not achieve the minimum requirements to ensure safety, quality and efficacy of the drugs.Colegio de Farmacéuticos de la Provincia de Buenos Aire