HIV/AIDS treatment and physicochemical quality control of medicines: evaluation of non-generic lamivudine + zidovudine tablets manufactured in Brazil

• Autor(a) principal: Beck,Ruy Carlos Ruver
• Data de Publicação: 2007
• Outros Autores: Athayde,Margareth Linde, Cardoso,Simone Gonçalves
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Brazilian Journal of Infectious Diseases
• Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1413-86702007000600003
• topic: Antiretroviral therapy; quality control; lamivudine; public health; tablets; zidovudine

In this work it was evaluated the physicochemical quality of lamivudine + zidovudine tablets, whose association belongs to the list of drugs distributed by the Brazil's National Program on Sexually Transmitted Diseases and AIDS. Four non-generic products (lamivudine + zidovudine tablets) were analyzed. They were obtained from different Brazilian manufacturers, besides a reference product. The quality was evaluated by physicochemical tests described in the official codes. A validated reversed-phase high performance liquid chromatography (HPLC) method was used for the assay of the active substances. All samples were in accordance to the requisites in relation to their physicochemical characteristics. Dissolution studies showed similar drug percentual dissolved among all samples. The results reflect the interest of the national pharmaceutical industry to ensure the delivery of safer and cheaper drugs to the Brazilian people, with particular importance in the National Program on Sexually Transmitted Diseases and AIDS.