Preparación de comprimidos de desintegración rápida de clorhidrato de ondansetrón mediante el método de compresión directa

Abstract

To make rapidly disintegrating tablets containing 8 mg ondansetron hydrochloride with suffi cient mechanical integrityas well as a pleasant taste, microcrystalline cellulose (MCC), lactose anhydrous, mannitol and croscarmellose wereformulated. Tablets were prepared by a direct compression method. Tablets properties such as tensile strength, disintegrationtime, wetting time and friability were determined. The two-factor spherical second order composite experimentaldesign was used for the preparation of preliminary batches and the desirability function was employed for theoptimization of preliminary batches. For preparation of the rapidly disintegrating tablets, simplex lattice design withconstraints on the proportion of excipients was utilized. In later design, tensile strength and disintegration time wereselected as dependent variables and concentration of microcrystalline cellulose, concentration of lactose anhydrous andconcentration of mannitol were selected as controlling factors. Mathematical equations and contour plots were usedto relate independent variables with tensile strength and disintegration time. Furthermore, the composite index which considers a positive or negative deviation from an ideal value was calculated for the optimization of the formulation.Contour plots of tensile strength and disintegration time were superimposed to fi nd out the optimized region at whichtablets with an acceptable crushing strength and disintegration time can be produced. The concept of similarity factorsf2 and Sd were used to prove similarity of dissolution in distilled water and simulated saliva (pH 6.8). Rapidly disintegratingtablets with durable structure and desirable taste could be prepared by selecting proper level of MCC, lactoseanhydrous, mannitol, croscarmellose and compression force.