DEVELOPMENT AND EVALUATION OF ORAL DISINTEGRATING TABLETS OF SPRAY-DRIED ARIPIPRAZOLE SOLID DISPERSIONS

Aripiprazole is a biopharmaceutics classification system (BCS) II drug used to treat schizophrenia and bipolar disorders. A fast-dissolving tablet will be an appropriate drug delivery route in these conditions. Therefore, the objective of the work was to convert aripiprazole into a solid dispersion via a spray drying process and further present it as an oral fast-dissolving tablet for improving patient compliance. The solid dispersion of the drug in mannitol from solvent evaporation via spray-drying forms porous amorphous solid dispersions. The spray drying trials were optimized using a custom design approach via Design Expert software version 13. Oral fast-disintegrating tablets containing optimized solid dispersions were evaluated for tableting properties, in-vitro drug release profile, and pharmacokinetic profile compared to aripiprazole. The optimized solid dispersion exhibited a 2-fold increase in solubility compared to pure aripiprazole. The tablet disintegrated in 27.1± 1.1seconds. The in-vitro drug dissolution showed a four-fold increase in drug release profile compared to pure aripiprazole in one h. The pharmacokinetic profile observed a two-fold increase in the bioavailability of solid dispersion in comparison to the pure drug suspension. The stability studies for six months assured the stability of the tablet. In conclusion, an orally disintegrating tablet of aripiprazole with improved solubility may increase the therapeutic efficacy of the drug.