Patent ID: 7780988

Claim:
A process for producing a pharmaceutical composition comprising the steps: (a) forming a feed solution comprising a drug and a concentration-enhancing polymer dissolved in a solvent, wherein said drug is a low-solubility drug having an aqueous solubility of less than 1 mg/mL; (b) directing said feed solution to a spray-drying apparatus comprising a drying chamber, atomizing means for atomizing said feed solution into droplets in said drying chamber, a source of heated drying gas for drying said droplets and dried product collection means wherein said atomizing means is a pressure nozzle capable of producing droplets of said feed solution having an average droplet diameter of at least 50 μm and wherein 90 vol % of said droplets have a diameter greater than 10 μm; (c) atomizing said feed solution into droplets in said drying chamber by said atomizing means to produce droplets having an average diameter of at least 50 μm and wherein 90 vol % of said droplets have a diameter greater than 10 μm; (d) contacting said droplets with said heated drying gas to form particulates of a solid amorphous dispersion of said drug and said concentration-enhancing polymer, wherein the amount of drug in crystalline form does not exceed 10% and said dispersion is substantially homogeneous; and (e) collecting said particulates wherein said concentration-enhancing polymer is present in said solution in a sufficient amount so that said solid amorphous dispersion provides concentration enhancement of said drug in a use environment relative to a control composition consisting essentially of an equivalent amount of said drug alone.