Quality evaluation of compounded capsules

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

Quality of fluoxetine hydrochloride capsules compounded in pharmacies

A possibilidade de adquirir medicamentos de menor custo tem feito os consumidores procurarem as farmácias de manipulação, que se tornaram uma importante alternativa para a aquisição rotineira de medicamentos. Porém, apesar das vantagens que o medicamento manipulado oferece em relação ao industrializado, a suposta ausência de um rígido controle de qualidade leva à preocupação quanto à qualidade das mesmas. Neste trabalho foram analisadas 3 formulações de cápsulas de cloridrato de fluoxetina 20 mg adquiridas em dezoito farmácias de manipulação e comparadas com o produto industrializado em relação aos testes de variação de peso, uniformidade de conteúdo e doseamento. Das formulações analisadas 63% cumpriram as especificações dos ensaios realizados.The possibility of purchasing medicines at a lower cost has made consumers search for compounding pharmacies and it has become an important alternative for the routine acquisition of medicines. However, although compounded medicine offers advantages when compared to industrialized medicines, the supposed absence of rigid quality control leads to the concern of their quality. In the present work, 3 formulations of 20 mg Fluoxetine hydrochloride capsules purchased in eighteen compounding pharmacies were analyzed. The results were compared to the industrialized product in the following parameters: weight variation, content uniformity and assay. Of all the samples, 63% met the tests specifications.Colegio de Farmacéuticos de la Provincia de Buenos Aire