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.
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