62-67 Cervera LAJP 1395
نویسندگان
چکیده
At present, meprobamate is not a drug with a broad commercial spectrum. In order to get an optimal pharmaceutical formulation for this kind of drug or others more competitive, experimental design methodology is a statistical tool very useful for reach them. The principal aim of this work was to apply D-Optimal mixture design for optimization of meprobamate (400 mg) fast released tablets manufactured by wet granulation. The excipients included in this study were maize starch (filler), Kollidom K25 (binder), sodium lauryl sulfate (surfactant) and Acdisol (disintegrant). Different granulate and tablet properties were modeled as functions of the four ingredient percentages. The optimization criteria for this medicament were a maximum percentage of drug dissolution and a high granulate flowability. The proportions of the optimal mixture were 10.4% maize starch, 6.0% Kollidon K25, 1.02% sodium lauryl sulfate, and 5.0% Acdisol. RESUMEN. “Optimización de tabletas de liberación rápida de meprobamato usando diseños con mezclas”. Actualmente, el meprobamato no es un fármaco de amplio espectro comercial. Con el objetivo de obtener una formulación farmacéutica óptima para este fármaco u otros más competitivos, la metodología de diseños experimentales es una herramienta estadística muy útil para lograrlo. El propósito principal de este trabajo fue aplicar un diseño con mezcla D-Optimal para la optimización de tabletas de liberación rápida de meprobamato (400 mg), elaboradas por granulación húmeda. Los excipientes incluidos en este estudio fueron: almidón de maiz (relleno), Kollidom K25 (aglutinante), lauril sulfato de sodio (surfactante) y Acdisol (desintegrante). Diferentes propiedades de los granulados y las tabletas fueron modeladas en función de los porcentajes de los cuatro ingredientes. Los criterios de optimización para esta formulación farmacéutica fueron una máxima disolución del fármaco y una alta fluidez del granulado. Las proporciones de la mezcla óptima fueron: almidón de maíz, 10,4%; Kollidon K25, 6,0%; lauril sulfato de sodio, 1,02% y Acdisol, 5,0%.
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