Development and optimization of aripiprazole ODT by using box-behnken design

Abstract

The main objective of the study is to develop and optimize the potential variables which influence aripiprazole oral disintegration tablets (ODTs) formulation. Aripiprazole ODTs were prepared by using a direct compression method. Three factors with three levels of Box-Behnken design were used to optimize and develop the aripiprazole ODT formulation. The design recommended 20 formulations of different independent variables such as Microcrystalline cellulose (MCC) (Xi), Crospovidone (CP) (X2), and Cascarmellose sodium (CCS) (X3) and their effect was monitored on dependent variables such as tablet weight (Yi), Thickness (Y2), Hardness (Y3), Dissolution (Y4), Disintegration (Y5). Agreeable flow properties which are ranged from good to excellent were demonstrated by all powder blends. The disintegration time (Y5) was directly related to the lubricant concentration and mixing of time which intern had a direct effect on tablet thickness, hardness and compression force these interns had a direct impact on friability. The Box-Behnken design recommended an optimized formula of 20mg (Xi), 3mg (X2) and 3mg (X3) of the selected independent variables. Finally, the prediction error percentage responses of dependent variables Yi, Y2, Y3, Y4, and Y5 were found to be 0.38, 0.59, 2.43, 4.06, and 3.67% respectively. The 2, 4, and 10 formulas achieved more than 90% of drug release within the seven min of dissolution test time. The optimized formulation of aripiprazole ODT was successfully developed using box Behnken design and the same was prepared efficiently by using the direct compression method.