Abstract
The objective of the present study was to determine the quality of six different brands of nimodipine 30 mg film coated tablets which are commercially available in the local market of Karachi, Pakistan. We performed different physico-chemical tests which were weight variation test, thickness, diameter, disintegration, hardness, dissolution and assay tests. All the brands (NimoA to NimoF) have passed all these tests and the results were within the adequate limits. Also release profiles of all brands were compared at pH 1.2, phosphate buffer pH 4.5 and pH 6.8 and in order to determine the surfactant effects on dissolution profiles, sodium dodecyl sulfate (SDS) was used in 0.3 % concentration in above mentioned dissolution media, also drug release profile was also evaluated by using acetate buffer pH 4.5 with SDS which was recommended as a official method for nimodipine film coated tablets. In the present study various statistical approaches were used for the data analysis which was recommended by FDA such as One way ANOVA, model dependent and in-dependent method. Results of the ANOVA showed that no significant variation was found within and between different brands as p-values were less than 0.05, similarly results of drug release was best fitted to Weibull model (r(2) = 0.997).
RESUMEN. El objetivo del presente estudio fue determinar la calidad de seis marcas diferentes de comprimidos recubiertos de 30 mg de nimodipina que estan comercialmente disponibles en el mercado local de Karachi, Pakistan. Se realizaron diferentes pruebas fisico-quimicas tales como variacion de peso, espesor, diametro, desintegracion, dureza y disolucion. Todas las marcas (NimoA a NimoF) pasaron todas las pruebas y los resultados se encontraron dentro de los limites adecuados. Tambien se compararon los perfiles de liberacion a pH 1,2, tampon fosfato pH 4,5 y pH 6,8; con el fin de determinar los efectos de agente tensioactivo sobre los perfiles de disolucion se uso dodecilsulfato de sodio (SDS) en concentracion de 0,3 % en los medios de disolucion mencionados anteriormente; tambien se evaluo el perfil de liberacion del farmaco mediante el uso de acetato de pH 4,5 con SDS, recomendado como metodo oficial para comprimidos de nimodipina. En el presente estudio se utilizaron varios metodos estadisticos para el analisis de datos recomendados por la FDA, tal como One way ANOVA, asi como modelos independiente y dependiente. Los resultados del ANOVA mostraron que no hay ninguna variacion significativa dentro de y entre las diferentes marcas, ya que los valores de p fueron menores que 0,05; de manera similar los resultados de liberacion de farmaco mostraron modelos de Weibull y Higuchi debido a sus altos valores de r(2).