Formulation and in Vitro Evaluation of Mouth Dissolving Tablets of Amisulpride Using Novel Super Disintegrants

Abstract

The present investigation was aimed at the formulation and in vitro evaluation of mouth dissolving tablets (MDTs) of Amisulpride using novel super disintegrants to enhance patient compliance and improve the drug’s onset of action. Amisulpride, an atypical antipsychotic agent, suffers from drawbacks such as delayed dissolution and swallowing difficulties in conventional dosage forms, making MDTs a suitable alternative. Various formulations were prepared by direct compression method using different concentrations of novel super disintegrants. The prepared tablets were evaluated for pre-compression parameters (angle of repose, bulk density, tapped density, Carr’s index, Hausner’s ratio) and post-compression parameters (hardness, friability, weight variation, wetting time, disintegration time, drug content, and in vitro dissolution studies).

The results revealed that all formulations complied with pharmacopeial limits. Among the developed batches, the optimized formulation exhibited a minimum disintegration time, rapid wetting time, and maximum drug release within a short period, demonstrating the effectiveness of the selected super disintegrants. The incorporation of novel super disintegrants significantly enhanced the dissolution profile of Amisulpride compared to conventional formulations.

In conclusion, the study established that mouth dissolving tablets of Amisulpride formulated with novel super disintegrants can serve as a promising dosage form, providing improved patient convenience, faster onset of therapeutic action, and enhanced bioavailability.