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Caracterizaci??n y estudio de solubilidad de mezclas binarias de flunarizina / polietilenglicol 4000

By Mar??a Teresa Mar??n Bosc??, Mar??a Victoria Margarit Bellver and Daniel Mart??n-Ramos

Abstract

En este trabajo estudiamos las interacciones de la flunarizina con polietilenglicol 4000 en dispersiones s??lidas preparadas\ud siguiendo el m??todo de disoluci??n propuesto por Sekiguchi y Obi. Como elementos de comparaci??n se han\ud utilizado mezclas f??sicas de ambos componentes, preparados en las mismas proporciones de f??rmaco/pol??mero: 10/\ud 90, 20/80, 30/70, 40/60, 50/50,60/40 y 80/20.\ud Las propiedades fisicoqu??micas de las dispersiones s??lidas y mezclas f??sicas se investigan mediante espectroscop??a\ud infrarroja,difracci??n de rayos X, calorimetr??a diferencial de barrido y solubilidad en equilibrio. Los espectros de\ud infrarrojo indican que no ha habido interacci??n qu??mica entre la flunarizina y el PEG. Los difractogramas muestran\ud que a determinadas proporciones, el PEG se introduce en la estructura de la flunarizina y los estudios t??rmicos\ud parecen indicar la formaci??n de una mezcla eut??ctica a la proporci??n 28,96% de flunarizina y 71,04% de PEG 4000.\ud Todas las muestras presentan una solubilidad superior a la del f??rmaco puro y en ambos tipos de muestras el\ud incremento es mayor al aumentar la proporci??n de pol??mero. El an??lisis de comparaci??n m??ltiple aplicado independientemente\ud a las dispersiones s??lidas y mezclas f??sicas, indica que no existe diferencia estad??sticamente significativa\ud (p<0,05) entre las muestras de proporciones 30/70, 40/60, 50/50 y 60/40, pero s?? hay diferencias entre ??stas y las de\ud proporciones 10/90, 20/80 y 80/20.In this report interactions of flunarizine and polyethylene glycol 4000 in solid dispersions prepared according to the\ud dissolution method proposed by Sekiguchi and Obi, have been investigated. For purposes of comparison, physical\ud mixtures were prepared at the same drug/polymer percentage proportions: 10/90, 20/80, 30/70, 40/60, 50/50, 60/40 and\ud 80/20.\ud The physicochemical properties of both kinds of sample were investigated with infrared spectroscopy, X-Ray diffraction,\ud differential scanning calorimetry and solubility in equilibrium. Infrared spectra suggested that no chemical interaction\ud between flunarizine and polyethylene glycol 4000 had taken place. X-Ray patterns have shown that at certain proportions,\ud polyethylene glycol is bonded within the flunarizine structure. Differential scanning calorimetry indicated that the\ud formation of an eutectic mixture becomes apparent at a drug/polymer ratio of 28.96/71.04.\ud Equilibrium solubility studies showed that drug solubility was enhanced as the polymer content in the samples increased.\ud The Multiple range test (LSD) applied independently to solid dispersions, and to physical mixtures, revealed that the\ud samples of drug/polymer proportions of 30/70, 40/60, 50/50 and 60/40 did not produce statistically significant differences\ud (p<0.05). However, differences were detected between these proportions and samples with a drug/polymer ratio of 10/\ud 90, 20/80 and 80/20

Topics: Flunarizina, Flunarizine, Polietilenglicol 4000, Polyethylene glycol 4000, Dispersiones s??lidas, Solid dispersions, Solubilidad, Solubility
Publisher: Universidad de Granada, Facultad de Farmacia
Year: 2002
OAI identifier: oai:digibug.ugr.es:10481/28243
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