Optimization and characterization of direct coating for ibuprofen particles using a composite fluidized bed

Abstract

Ibuprofen particles (mean particle size, 27 μm and melting point, 76 °C) as core materials were directly coated with a water-soluble polymer. The primary particles were preserved using a composite fluidized bed with a dispersing mechanism at the bottom of the fluidized bed apparatus. Coated primary particles were obtained under the following 3 conditions: (1) Setting the spray air flow rate at 10 L/min from the initial to 2% coating, (2) adding the low-viscosity water-soluble polymer macrogol 6000 to the hypromellose coating solution, and (3) changing the spray air flow rate to 15 L/min from 2% coating. The particles obtained were confirmed to be coated primary particles by scanning electron microscopy of their cross sections prepared by the cryo-focused ion beam method. The dissolution test showed a marked improvement in the solubility of ibuprofen from the coated primary particles compared with that of a physical mixture. In conclusion, the optimization of the direct coating process made it possible to undertake primary particle coating of a raw material that has a low melting point and a particle size of not more than 50 μm. Primary particle coating contributes to improvements in the physicochemical properties of drugs.