Polymorphism evaluation in generic tablets containing mebendazole by dissolution tests

This study evaluates the incidence of the polymorphic forms of mebendazole (MBZ) in tablets within the Brazilian market by dissolution tests. The indicated dissolution medium by the USP 30 (United States Pharmacopoeia) and a proposed modified medium were duly compared in order to verify whether they...

Descripción completa

Detalles Bibliográficos
Autores: Honorato, Sara B., Farfan, Silvia Nora, Viana, Arnaldo, Filho, Josué M., Camarão, Gisela C., Fechine, Francisco V., Moraes, Maria E. A., Moraes, Manoel O., Ferro Seoane, Maribel, Dabbene, Viviana, Cuffini, Silvia Lucia, Ayala, Alejandro Pedro
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2012
País:Argentina
Institución:Consejo Nacional de Investigaciones Científicas y Técnicas
Repositorio:CONICET Digital (CONICET)
Idioma:inglés
OAI Identifier:oai:ri.conicet.gov.ar:11336/192720
Acceso en línea:http://hdl.handle.net/11336/192720
Access Level:acceso abierto
Palabra clave:MEBENDAZOLE
POLYMORPHISM
RAMAN SPECTROSCOPY
SOLUBILITY
X-RAY POWDER DIFFRACTION
https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
Descripción
Sumario:This study evaluates the incidence of the polymorphic forms of mebendazole (MBZ) in tablets within the Brazilian market by dissolution tests. The indicated dissolution medium by the USP 30 (United States Pharmacopoeia) and a proposed modified medium were duly compared in order to verify whether they are able to discriminate the polymorph A from polymorph C in commercial tablets. Dissolution assay tests of physical mixtures in raw materials of polymorph A and polymorph C, as well as of nine tablets of MBZ (available in the Brazilian market), were properly performed. For the dissolution tests, the USP 30 medium (I) and a modified medium (II) were used. The modified medium allowed a reproducible and reliable quality control of MBZ polymorphism in commercial tablets. © 2012 Sociedade Brasileira de Química.