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Artículo

Preparation and characterization of polymorphs of the glucocorticoid deflazacort

Kassuha, Diego EnriqueIcon ; Aiassa, VirginiaIcon ; Bruno, Flavia PaolaIcon ; Cuadra, Gabriel R.Icon ; Sperandeo, Norma Rebeca
Fecha de publicación: 01/2014
Editorial: Taylor & Francis
Revista: Pharmaceutical Development and Technology
ISSN: 1083-7450
Idioma: Inglés
Tipo de recurso: Artículo publicado
Clasificación temática:
Otras Ciencias Químicas

Resumen

The polymorphism of new and old active pharmaceutical ingredients (APIs) is of great importance due to performance, stability and processability aspects. The objective of this study was to investigate the polymorphism of deflazacort (DEF), a glucocorticoid discovered >40 years ago, since this phenomenon has not been previously investigated for this API. Using different methods for solid form screening, it was determined for the first time that DEF is able to exist as three forms: a crystalline (DEF-1); a hydrated X-ray amorphous (DEF-t-bw) and an anhydrous amorphous phase (DEF-g) obtained from manually grinding DEF-1. The in vitro and in vivo dissolution rates (DRs) of DEF-1 and DEF-t-bw, which were measured using the rotating disk method in water at 37 °C and the pellet implantation technique in rats, respectively, indicated that DEF-t-bw exhibited slightly faster in vitro and in vivo DRs than those of the crystalline form, but the values were not significantly different. In addition, it was determined that DEF-t-bw devitrifies to DEF-1 by the effect of pressure, humidity and heat. It was concluded that DEF is glucorticoid with low tendency to exhibit different crystalline forms and that DEF-t-bw has no advantages over DEF-1 in terms of solubility, DRs and solid-state stability.
Palabras clave: Crystallization , Deflazacort , Disk Intrinsic/In Vivo Dissolution Rates , Polymorphism , Powder X-Ray Diffractometry
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info:eu-repo/semantics/openAccess Excepto donde se diga explícitamente, este item se publica bajo la siguiente descripción: Creative Commons Attribution-NonCommercial-ShareAlike 2.5 Unported (CC BY-NC-SA 2.5)
Identificadores
URI: http://hdl.handle.net/11336/25277
DOI: http://dx.doi.org/10.3109/10837450.2013.871033
URL: http://www.tandfonline.com/doi/full/10.3109/10837450.2013.871033
Colecciones
Articulos(CCT - CORDOBA)
Articulos de CTRO.CIENTIFICO TECNOL.CONICET - CORDOBA
Articulos(UNITEFA)
Articulos de UNIDAD DE INVESTIGACION Y DESARROLLO EN TECNOLOGIA FARMACEUTICA
Citación
Kassuha, Diego Enrique; Aiassa, Virginia; Bruno, Flavia Paola; Cuadra, Gabriel R.; Sperandeo, Norma Rebeca; Preparation and characterization of polymorphs of the glucocorticoid deflazacort; Taylor & Francis; Pharmaceutical Development and Technology; 20; 4; 1-2014; 401-409
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