Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula

• Autor(a) principal: Chorilli, Marlus [UNESP]
• Data de Publicação: 2010
• Outros Autores: Souza, A. A., Corrêa, F., Salgado, Hérida Regina Nunes [UNESP]
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Repositório Institucional da UNESP
• Texto Completo: http://serv-bib.fcfar.unesp.br/seer/index.php/Cien_Farm/article/view/1296; http://hdl.handle.net/11449/72218
• topic: Cephalexin; Dissolution profile; Generic medicine; Reference medicine; Similar medicine; cefalexin; generic drug; capsule endoscope; drug delivery system; drug dosage form; drug release; drug research; drug solubility; in vitro study; medical literature

With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the percentage of the drug dissolved in a standard time. The dissolution profile indicated that this medicine, in this pharmaceutical form, dissolves readily (85% of the drug dissolved in 15 minutes) and the curves showed great similarity, suggesting that the 3 brands are pharmaceutically equivalent.