Patent ID: 8728527
Filing Date: 2014-05-20
Classification: A61K,A61P

Abstract:
1. An injectable pharmaceutical composition comprising a substantially stable and sterile filterable dispersion of solid nanoparticles in an aqueous medium, wherein the solid nanoparticles comprise a microtubule inhibitor and have a mean particle size of less than 220 nm, wherein the composition is prepared by a process comprising: (a) combining an aqueous phase comprising water and a biocompatible polymer as emulsifier and an organic phase comprising the microtubule inhibitor, a water-immiscible organic solvent, optionally a water-miscible organic solvent as an interfacial lubricant and at least one Ostwald ripening inhibitor; (b) forming an oil-in-water emulsion using a high pressure homogenizer; and (c) removing the water-immiscible organic solvent and the water-miscible organic solvent from the oil-in water emulsion under vacuum; thereby forming a substantially stable dispersion of solid nanoparticles comprising the Ostwald ripening inhibitor, the biocompatible polymeric emulsifier and the microtubule inhibitor in the aqueous medium; wherein