US 11,883,394 B2
Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia
Wilfredo Morales, Morrow, OH (US); Tarek A. Zeidan, Lexington, MA (US); Renato A. Chiarella, Cambridge, MA (US); Steven G. Wright, Madeira, OH (US); and Jason M. Perry, Cambridge, MA (US)
Assigned to ALKERMES PHARMA IRELAND LIMITED, Dublin (IE)
Filed by ALKERMES PHARMA IRELAND LIMITED, Dublin (IE)
Filed on Mar. 24, 2021, as Appl. No. 17/211,352.
Application 17/211,352 is a continuation of application No. 16/595,608, filed on Oct. 8, 2019, granted, now 10,973,816.
Application 16/595,608 is a continuation of application No. 16/043,721, filed on Jul. 24, 2018, granted, now 10,478,434, issued on Nov. 19, 2019.
Application 16/043,721 is a continuation of application No. 14/833,638, filed on Aug. 24, 2015, granted, now 10,064,859, issued on Sep. 4, 2018.
Claims priority of provisional application 62/041,341, filed on Aug. 25, 2014.
Prior Publication US 2021/0205302 A1, Jul. 8, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/496 (2006.01); C07D 401/12 (2006.01); A61K 31/00 (2006.01)
CPC A61K 31/496 (2013.01) [A61K 31/00 (2013.01); C07D 401/12 (2013.01)] 20 Claims
 
1. A process for making a compound of Formula (I) in crystal form:

OG Complex Work Unit Chemistry
the process comprising the steps of:
(a) dissolving the compound of Formula (I) or a salt or solvate thereof in a first solvent to form a homogeneous drug solution;
(b) optionally combining the drug solution with a second solvent;
(c) cooling the solution; and
(d) further homogenizing the solution to induce formation of the compound of Formula (I) in crystal form.