Improving the release rate of lurasidone hydrochloride from fast disintegrating tablets using green solvent evaporation technique

Abstract

Lurasidone hydrochloride (LRS HCl), an antipsychotic drug with low aqueous solubility, was dispersed in a matrix of polyethylene glycol (PEG) using the green solvent evaporation method. The green solvents used were water and ethanol. Solid dispersions and physical mixtures were prepared at various drug-to-polymer ratios, characterized by XRPD, FTIR, and DSC analyzes, and then used for the preparation of fast disintegrating tablets (FDTs). The tablets were analyzed for hardness, disintegration, and in vitro dissolution of LRS HCl. In vitro release profiles showed a significant improvement in the release rate of LRS HCl from tablets prepared with solid dispersions compared to those containing untreated LRS HCl or the physical mixture. The presented results confirm that the use of solid dispersions prepared by the green solvent evaporation method is a promising approach to enhance the in vitro dissolution of poorly soluble drugs such as LRS HCl. The applicability of mathematical models was tested to describe the release profiles of LRS HCl from FDTs. The diffusion process, following Fick’s law for drug release, appears to be the predominant release mechanism for this specific drug in FDTs.