Formulation and Evaluation of Aripiprazole Oral Disintegrating Tablets

Abstract

Aim: This work aims to develop oral disintegrating tablets from solid dispersion of aripiprazole that are capable of enhancing solubility. Methodology: Aripiprazole an antipsychotic is a BCS class IV drug with Oral bioavailability of 87%. To enhance the solubility of this drug the solid dispersions were prepared by using a combination of β-Cyclodextrin and PVP K30 in 1:1, 1:2 by using a physical mixture and solvent evaporation method. The prepared solid dispersions were analyzed for all the physical parameters and drug excipient interactions. The solid dispersion was optimized for the preparation of oral disintegrating tablets by direct compression technique using different concentrations of various natural super disintegrants namely Tapioca starch, Amorphophallus campanulactus, and synthetic super disintegrants namely Sodium starch glycolate, crospovidone. Results: FTIR showed that the drug and excipients are compatible with each other. Among all the solid dispersion formulations SCD6 (Drug: β-cyclodextrin) shows a high percentage of drug release i.e., 98.58±0.28% for 45 min, and solubility was found to be 0.954±0.32mg/ml. Percentage practical yield was found to be 98.36±0.14% and drug content was found to be 97.31±0.04%. SCD6 formulation was optimized for the preparation of oral disintegrating tablets. The post-compression parameters of all the prepared tablets were within the limits. Among all, F3 formulations containing tapioca starch, 7.5% were found to possess a better disintegration time (28±1.52sec) and in-vitro dissolution (98.64±0.29% for 45min). Conclusion: It can be concluded that solid dispersions of Aripiprazole incorporated in oral disintegrating tablets are a very useful approach for better release of Aripiprazole in an efficient manner.