Process for making sterile aripiprazole of desired mean...

A - Human Necessities – 61 – K

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A61K 31/496 (2006.01) C07D 401/00 (2006.01)

Patent

CA 2543248

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.

Procédé de préparation d'aripiprazole stérile ayant une taille moyenne des particules inférieure à 100 microns, mais de préférence supérieure à 25 microns, à l'aide d'un processus de cristallisation par jets opposés. L'aripiprazole en vrac résultant à taille désirée des particules peut être utilisé pour former une composition d'aripiprazole stérile lyophilisée, qui, lorsqu'elle est reconstituée avec de l'eau et injectée en injection intramusculaire, libère de l'aripiprazole sur une période d'au moins environ une semaine et allant jusqu'à environ huit semaines.

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