Novel methods

Abstract

The disclosure provides the use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals for the treatment of residual symptoms of psychosis or schizophrenia. The disclosure also provides novel long acting injectable formulations of particular substituted heterocycle fused gamma-carboline compounds and use of such long acting injectable formulations for the treatment of residual symptoms of psychosis or schizophrenia.

1 - 30 . (canceled) 
     
     
         31 . A sustained or delayed release pharmaceutical composition comprising an effective amount of Compound of Formula I: 
       
         
           
           
               
               
           
         
         wherein X is —N(CH 3 )— and Y is —O—, in free base form, and a polymeric matrix, wherein the Compound of Formula I is dispersed or dissolved in the polymeric matrix, and wherein the polymeric matrix comprises poly(d,l-lactide) or poly(d,l-lactide-co-glycolide) polymer with either carboxylic acid or carboxylic ester end groups. 
       
     
     
         32 . The pharmaceutical composition according to  claim 31 , wherein the composition is a long-acting injectable composition. 
     
     
         33 . The pharmaceutical composition according to  claim 31 , wherein the polymeric matrix comprises poly(d,l-lactide) polymer. 
     
     
         34 . The pharmaceutical composition according to  claim 31 , wherein the polymeric matrix comprises poly(d,l-lactide-co-glycolide) polymer, wherein the ratio of lactide to glycolide monomeric units is from 50:50 to 75:25. 
     
     
         35 . The pharmaceutical composition according to  claim 34 , wherein the poly(d,l-lactide-co-glycolide) polymer has a weight average molecular weight of 24,000 to 38,000 Daltons. 
     
     
         36 . The pharmaceutical composition according to  claim 31 , wherein the polymeric matrix is not composed in microparticles or microspheres. 
     
     
         37 . The pharmaceutical composition of  claim 31 , wherein the composition degrades and releases the Compound of Formula I over a period of about 30 days. 
     
     
         38 . The pharmaceutical composition of  claim 31 , wherein the composition is formulated for intramuscular, intraperitoneal, intrathecal, epidural or subcutaneous injection. 
     
     
         39 . The pharmaceutical composition of  claim 31 , further comprising an antioxidant. 
     
     
         40 . The pharmaceutical composition according to  claim 31 , wherein the effective amount of the compound of Formula I is from 100 mg to 600 mg per month. 
     
     
         41 . The pharmaceutical composition according to  claim 31 , wherein the effective amount of the compound of Formula I is from 150 to 300 mg per month. 
     
     
         42 . A method for the treatment of bipolar disorder I and/or bipolar II disorder comprising administering to a patient in need thereof an effective amount of the pharmaceutical composition according to  claim 31 . 
     
     
         43 . The method according to  claim 42 , wherein the bipolar disorder is bipolar I disorder. 
     
     
         44 . The method according to  claim 42 , wherein the bipolar disorder is bipolar II disorder. 
     
     
         45 . A method for the treatment of the negative symptoms of schizophrenia comprising administering to a patient in need thereof an effective amount of the pharmaceutical composition according to  claim 31 .