Optimization of Superdisintegrants Concentration in Designing of Mouth Dissolving Tablets of Solid Dispersion of Domperidone by Using response surface methodology

Abstract

This research involves preparation of mouth dissolving tablets of solid dispersions of Domperidone by direct compression method using various concentrations of superdisintegrants in combination i.e. Croscarmellose Sodium and crospovidone. For optimization, a 32 (two-factor three-level) factorial design is being used in which 2 factors were evaluated, each at 3 levels and experimental trials were performed at all 9 possible combinations for every four selected solid dispersion batches (9x4=36 formulations + one blank). The amount of Croscarmellose Sodium (X1) and crospovidone (X2) was selected as independent variables. The disintegration time, percentage friability and percent drug release were selected as dependent variables. All the active powder blends were evaluated for precompression parameters (viz. angle of repose, Carr’s index, Hausner ratio, etc.) and the tablets were evaluated for post-compression parameters (viz. weight variation, hardness, and friability, wetting time, disintegration time, water absorption ratio, and in vitro drug release studies). Optimization was done using the software (Design Expert® 11.0.4), predicted responses of which were validated.