Abstract

Objective: Lurasidone HCl is poorly water soluble drug. It should be come in to the BCS Class II drug. Hence oral Bioavailability of Lurasidone HCl is less (9-19%). To develop novel dosage foam of the self-Microemulsifying drug delivery systems (SMEDDS) for the Lurasidone HCl for enhancing its solubility hence the oral bioavailability. Methods: Solubility study was performed in different excipient and selected excipient on basis of solubility of Lurasidone HCl. Self microemulsion region was decided by preparing construction phase diagram. Drug excipient interaction study using FTIR. SMEDDS formulation was prepared in Capryol 90 (oil), Acrysol K-140(surfactant), and Transcutol P (co-surfactant) by simple mixing at 25°C. Parameters evaluated included: macroscopic evaluation, visual assessment, self-emulsification, transmittance test, particle size distribution, zeta potential and polydispersity index and In vitro dissolution. In-Vitro dissolution was carried in USP apparatus II using pH 1.2 HCl buffer at 37±0.5°C with 75 rpm rotating speed, drug release measured by spectroscopic method. Results: From the solubility study, better solubility was seen in Capryol 90(oil), Acrysol K 140(surfactant) and Transcutol P (co-surfactant). Optimized formulation F3 of SMEDDS was observed with smaller droplet size 57.35nm, PDI 0.288 and zeta potential -13.6mV5.Formulation was clear after dilution with water. SMEDDS formulations showed complete release in 60 minutes as compared with pure drug Lurasidone HCl (20mg).which showed a limited dissolution rate. Conclusion: SMEDDS Lurasidone HCl oral formulations were prepared that provides excellent drug solubilization and improved In-Vitro release of Lurasidone HCl.

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