SOLUBILITY ENHANCEMENT OF LURASIDONE HYDROCHLORIDE BY PREPARING SMEDDS
Keywords:Lurasidone Hydrochloride, Solubility enhancement, SMEDDS, In-vitro dissolution, Ex-vivo diffusion
Objective: The objective of the study was to enhance solubility of Lurasidone HCl, an atypical antipsychotic drug, by formulating self-micro emulsifying drug delivery system (SMEDDS) and its characterization.
Methods: Solubility study of Lurasidone hydrochloride (LH) was carried out in various surfactants, co surfactants and oils. Pseudo ternary phase diagrams were constructed to identify the self-micro emulsification region. Screening was done so as to determine the proper combination of components. Based on this, LH SMEDDS were prepared using Cremophor RH40 (surfactant), Soluphor P (co-surfactant) and Capmul MCM (oil). The preconcentrate SMEDDS were evaluated for clarity(visual), precipitation, % transmittance, robustness to dilution, freeze thawing, particle size distribution and zeta potential and adsorbed SMEDDS were evaluated for drug content, flow properties, in-vitro dissolution and ex-vivo diffusion studies.
Results: The optimized LH SMEDDS composed of 14% Cremophor RH40, 68% Soluphor P, 18% Capmul MCM with a particle size of 3.95 Âµm and zeta potential of more than 50 mV showing 80% dissolution in 60 min.
Conclusion: The results of this study prove that SMEDDS help in improving the solubility, dissolution and bioavailability of lurasidone hydrochloride.
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