Formulation and evaluation of spherical crystal agglomerates of Lurasidone Hydrochloride

The main objective of the study was to improve aqueous solubility of poorly water soluble drug. Lurasidone Hydrochloride is a BCS class II drug and has low solubility. To enhance solubility Spherical Crystal Agglomerates of Lurasidone Hydrochloride were formulated using solvent exchange method. Different process parameter like good solvent, bad solvent, agitation time, speed and bad solvent volume were successfully optimized on the basis of various evolution parameters. Polymers were screened on basic of saturation solubility and it was found PVA and PEG4000 mixture giving higher saturation solubility and better morphology of spherical crystal. To optimized concentration of PVA and PEG 4000 factorial design was adopted. It was found increase amount of PVA and PEG 4000 enhance saturation solubility and percentage drug release. Formulation was s successfully characterized by FTIR, DSC, XRD and particle size. Saturation solubility shows increase in solubility of formulation as compare pure drug. In vitro dissolution study of formulation performed and observed improvement in dissolution. Tablet of formulation was prepared using direct compression method and evaluated by various parameters. Dissolution of prepared and marketed tablet was compared; it was found that improvement in dissolution profile. Prepared tablet showed stability after one month. Results showed improvement in solubility by Spherical Crystal Agglomerates approach.