Concentrated fenofibrate nanoparticle suspensions from melt emulsification for enhanced drug dissolution

Concentrated fenofibrate (FNB) nanoparticle suspensions are produced via an oil/water melt emulsification process from the micronized drug particles dispersed in water above the drug melting point. Sonication energy enables forming nanosized melt droplets, and nanosized solid particles upon subsequent cooling. Stabilization achieved via surface-active molecules is necessary to prevent coalescence of the droplets or agglomeration of the solid nanoparticles. Judicious selection of stabilizer and concentration resulted in 150-nm drug particles with solid loading up to 30%. The hydrophilic-lipophilic-balance concept is applicable, facilitating selection of surfactants based on their chemical structure. The strong in vitro dissolution rate enhancement suggests improved FNB bioavailability.