PROCESS FOR MAKING STERILE ARIPIPRAZOLE OF DESIRED MEAN PARTICLE SIZE

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Patent number: WO2005041970
Publication date: 2005-05-12
Inventor: GLEESON MARGARET (US); KIM SOOJIN (US); KIENTZLER DONALD (US); KIANG SAN (US)
Applicant: SQUIBB BRISTOL MYERS CO (US);; GLEESON MARGARET (US);; KIM SOOJIN (US);; KIENTZLER DONALD (US);; KIANG SAN (US)
Classification:
- international: A61K31/496; C07D401/00
- european:
Application number: WO2004US34634 20041020
Priority number(s): US20030513886P 20031023
Abstract of WO2005041970

A process is provided for making sterile aripiprazole having an average particle size less than 100 microns but preferably greater than 25 microns employing an impinging jet crystallization procedure. The resulting bulk aripiprazole of desired particle size may be used to form a sterile freeze-dried aripiprazole formulation, 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.
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