APPLICATION OF FREEZE-DRYING TECHNIQUE IN THE DEVELOPMENT AND EVAULATION OF NANOSUSPENSION LOADED ODF OF ANTIPSYCHOTIC DRUG

Lurasidone HCl is antipsychotic drug belonging to BCS class II drug used for the treatment of schizophrenia. It was initially approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with schizophrenia. Our study was aimed at increasing the solubility of Lurasidone HCl by formulating nanosuspension and then incorporating it into oral dissolving films which were prepared by freeze drying technique to enhance Solubility and stability of film, Bioavailability and patient compliance. Reducing of particle size is achieved by formulating nanosuspension by High Pressure Homogenization Technique in which different stabilizers were screened for stabilizing agent in which Poloxamer 407 were selected based on the particle size and PDI.And the obtained nanosuspension is loaded into the ODF. The polymer is selected by the screening technique based on appearance, film forming, DT, and Folding endurance HPMC E15 is selected as a polymer and glycerine as a plasticizer. Optimization studies were carried out using 3² Central Composite Design. By considering all the evaluation parameters Optimized F7 formulation was the best among all the formulations with the DT 47secs, %Drug content 96.64, and folding endurance of 163.The F7 formulation was evaluated further by carrying out In-vitro dissolution studies and comparison with the In-vitro release profile of film prepared by solvent casting method. The F7 Freeze dried resulted in higher and increased drug release than the heat dried that is 96.11% at the 15th minute for freeze dried film whereas for heat dried 73.78 at 15^th min. The drug release of the Marketed formulation was found to be 81.18% at the 120th minute.

Keywords: Lurasidone HCl, Nanosuspension, ODFs, Freeze dried, solvent casting.