US 12,280,048 B2
Amorphous solid dispersions
Peng Li, New Milford, NJ (US)
Assigned to INTRA-CELLULAR THERAPIES, INC., Bedminster, NJ (US)
Filed by INTRA-CELLULAR THERAPIES, INC., New York, NY (US)
Filed on Oct. 17, 2023, as Appl. No. 18/488,513.
Application 18/488,513 is a division of application No. 17/659,063, filed on Apr. 13, 2022, granted, now 11,826,367.
Application 17/659,063 is a continuation of application No. 16/341,806, granted, now 11,331,316, issued on May 17, 2022, previously published as PCT/US2017/054962, filed on Oct. 3, 2017.
Claims priority of provisional application 62/407,285, filed on Oct. 12, 2016.
Prior Publication US 2024/0115565 A1, Apr. 11, 2024
Int. Cl. A61K 31/4985 (2006.01); A61K 9/00 (2006.01); A61K 9/10 (2006.01); A61K 9/16 (2006.01); A61K 9/20 (2006.01); A61K 9/48 (2006.01); A61K 47/38 (2006.01); A61P 3/04 (2006.01); A61P 25/06 (2006.01); A61P 25/18 (2006.01); A61P 25/22 (2006.01); A61P 25/24 (2006.01); A61P 25/28 (2006.01); C07D 471/16 (2006.01)
CPC A61K 31/4985 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0024 (2013.01); A61K 9/0053 (2013.01); A61K 9/1617 (2013.01); A61K 9/1635 (2013.01); A61K 9/1641 (2013.01); A61K 9/1652 (2013.01); A61K 9/2013 (2013.01); A61K 9/2027 (2013.01); A61K 9/2031 (2013.01); A61K 9/2054 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 47/38 (2013.01); A61P 3/04 (2018.01); A61P 25/06 (2018.01); A61P 25/18 (2018.01); A61P 25/22 (2018.01); A61P 25/24 (2018.01); A61P 25/28 (2018.01); A61K 9/10 (2013.01); C07D 471/16 (2013.01)] 24 Claims
 
1. A method for the treatment of a human suffering from a disease or disorder selected from the group consisting of obesity, anorexia, bulimia, depression, anxiety, psychosis, schizophrenia, migraine, obsessive-compulsive disorder, sexual disorders, attention deficit disorder, attention deficit hyperactivity disorder, sleep disorders, conditions associated with cephalic pain, social phobias, and dementia, comprising administering to a patient in need thereof a therapeutically effective amount of an amorphous solid dispersion comprising 1-(4-fluoro-phenyl)-4-((6bR, 10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one (ITI-007) free base, in combination or association with a pharmaceutically acceptable diluent or carrier, wherein the pharmaceutically acceptable diluent or carrier comprises cellulose acetate excipient in a weight ratio of 5:95 to 50:50 ITI-007 free base to cellulose acetate, wherein the X-ray diffraction pattern of the amorphous solid dispersion is free of peaks characteristic of the excipient.