Formulation Optimization and Assessment of Dexamethasone Orally Disintegrating Tablets Using Box-Behnken Design

摘要

The aim of this study was to prepare orally disintegrating tablets (ODTs) containing dexamethasone (DEX) by direct compression method with sufficient hardness and rapid disintegration time. In order to save time, money, and human resources in designing and improvement of formulation, the statistical software Design Expert is used. Box–Behnken response surface methodology was applied to evaluate and optimize the effects of concentrations of three excipients, Kollidon CL-SF (X1), Pearlitol SD200 (X2), and Prosolv SMCC (X3) as independent factors on four responses: percentage of drug released after 5 min, disintegrating time, hardness, and friability. Thirteen formulations offered by the Box–Behnken design were prepared by direct compression method and ultimate weight of 200 mg, while the amount of DEX was 4 mg. All formulations were characterized for parameters such as diameter, hardness, weight, thickness, friability, and disintegration time. Following the statistical results, the effects of independent variables on responses were evaluated and the optimum formulation regarding acceptable responses consisted of 15% Kollidon, 39.66% Pearlitol, and 7.5% Prosolv which showed 95.28% release of the drug after 5 min, disintegrating time of 30 sec, 6.1 kg hardness, and 0.12% of friability with an acceptable taste as the optimized formulation.