Controlled release sterile injectable aripiprazole formulation and method

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 therefor, 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.

主权项

1. A sterile frozen controlled release aripiprazole formulation which comprises:
(a) aripiprazole having a mean particle size of about 1 to 10 microns, and (b) one or more suspending agents, wherein said sterile frozen controlled release aripiprazole formulation is obtained by freezing a homogeneous aqueous suspension comprising (a) and (b), and wherein upon drying to form a cake and reconstitution, which comprises adding water to said cake, a sterile injectable formulation is obtained which is a homogeneous suspension and which contains from about 0.1 to about 600 mg of aripiprazole per mL, and wherein upon injection into a subject, said sterile injectable formulation releases aripiprazole over a period of at least about two weeks from the date of administration.