Controlled release sterile injectable aripiprazole formulation comprising a particulate aripiprazole having a mean particle size of 1-10 microns, administered once or twice a month and comprising a freeze-dried formulation, method of their production and uses thereof in treating schizophrenia

摘要

A controlled release sterile freeze-dried aripiprazole formulation is provided which is formed of aripiprazole of a desired mean particle size and a vehicle thereof, which upon constitution with water and intramuscular injection releases aripiprazole over a period of at least about one week and up to about eight weeks. A method for preparing the controlled release freeze-dried aripiprazole formulation, and a method for treating schizophrenia employing the above formulation are also provided.