Formulation and Evaluation of Orally Disintegrating Tablets of Aripiprazole Using 3 2 Full Factorial Design

Orally Disintegrating Tablets (ODTs) have the unique property of disintegrating in the mouth in seconds without chewing and the need of water which is advantageous mainly for paediatric, geriatrics, mentally challenged, bed ridden, uncooperative patients and patients having difficulty in swallowing tablets. The current study was aimed to formulate and evaluate orally disintegrating tablets of Aripiprazole commonly used as an atypical antipsychotic. Drug excipients compatibility study checked by DSC showed no interaction between drug and excipients. The tablets were prepared by sublimation technique. The experimental trials were taken using menthol as a sublimating agent and kyron T-314 as a superdisintegrant in different concentrations. A 3 2 full factorial design was applied to investigate the combined effect of two formulation independent variables: amount of Menthol (X1) and Kyron T-314 (X2). The disintegration time (Y1) and wetting time (Y2) were selected as dependent variables. The prepared tablets were evaluated for post compression parameters like diameter, thickness, weight variation, hardness, friability, hygroscopicity, disintegration time, wetting time, drug content and invitro drug release. The results indicated that concentration of Menthol (X1) and Kyron T-314 (X2) significantly affected the disintegration time (Y1) and wetting time (Y2). Batch F9 containing Menthol (14 mg) and Kyron T-314 (8.25 mg) shows less disintegration time (10 Sec.), less wetting time (22 Sec.) and good drug release (99.66%) compared to other batches. Hence it was selected as optimized batch. Stability study conducted as per ICH guidelines and the optimized batch F9 was found to be stable.