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

Document Type: Research article

Authors

1 Department of Pharmaceutics, Faculty of Pharmacy, Islamic Azad University, Pharmaceutical Sciences Branch (IAUPS), Tehran, Iran.

2 Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

3 Tehran Chemie Pharmaceutical Co., Tehran, Iran.

Abstract

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.

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