ABSTRACT

Introduction: The use of fast disintegrating tablets is on the increase especially by pediatric and geriatric patients who suffer from difficulty in swallowing (dysphagia) as it disintegrates rapidly upon contact with saliva in the oral cavity without chewing and without water.

Objective: The objective of this study was to develop and evaluate fast disintegrating tablets of diclofenac potassium prepared by disintegrant addition method and to optimise the concentration of the disintegrants using Box-Behnken Design.

Method: Various batches (B1-B13) of diclofenac tablets were prepared by direct compression using Box-Behnken modelled-combinations of three disintegrants (sodium starch glycolate, microcrystalline cellulose and maize starch). The tablets were subjected to disintegration and hardness tests and seven optimal batches were selected. Powder blends and tablets of the selected batches were mass produced and subjected to pre-compression (bulk and tapped densities, angle of repose, Hausner’s ratio and Carr’s index) and post compression (hardness, friability, disintegration and dissolution) evaluations.

Results: The powder mixtures of batches had angle of repose between 23.11-53.55°, Hausner’s ratio ranging from 1.21-1.31, Carr’s index between 17.17-25.04 as well as bulk and tapped densities ranging between 0.460-0.523 g/ml and 0.598-0.683 g/ml respectively. The optimized batches disintegrated within 3 minutes, had optimal hardness values (> 4.0 kp) and released 78% of their drug content within 30 minutes.

Conclusion: Fast disintegrating diclofenac tablets were successfully formulated using a blend of disintegrants. Batch B10 with disintegration time of 60.67 ± 3.0 seconds, tablet hardness of 11.4 ± 0.51 kp and percentage drug release of 93.1% in 30 minutes was superior to the others