abstract |
A method for the production of an aripiprazole suspension is disclosed, wherein the aripiprazole has an average particle size of 1 to 10 µm with the process comprising the steps of: (a) combining wholesale aripiprazole and a vehicle to form a primary suspension; (b) subjecting the primary suspension to first pulverization, using, for example, a high shear pulverizer, a shearer exerting shear force on a material to be processed, a colloidal mill, an ultrasound dispersing machine, or a high pressure propulsion type emulsifying machine to form a secondary suspension; and (c) subjecting the secondary suspension to a second pulverization, using, e.g., a high pressure propulsion type emulsifying machine to sterile final suspension; and a method for producing a cold-dried formulation of aripiprazole suspension. |