Pharmaceutical composition comprising pde9 inhibitor

Abstract

The present invention provides a pharmaceutical composition comprising a PDE9 inhibitor. Specifically, the PDE9 inhibitor is (S)-7-(2-methoxy-3,5-dimethylpyridin-4-yl)-1-(tetrahydrofuran-3-yl)-1H-pyrazolo[4,3-c]quin olin-4(5H)-one or pharmaceutically acceptable salts thereof.

1 .- 9 . (canceled) 
     
     
         10 . A method of treating Alzheimer's disease, comprising administering orally to a human subject in need thereof a dosage form comprising a therapeutically effective amount of Compound A or a pharmaceutically acceptable salt thereof, wherein said therapeutically effective amount is a single daily dose to achieve a mean Cmax of from about 1.8 ng/mL to about 7.6 ng/mL for each 1 mg of Compound A after administration to the human subject, and said Compound A is (S)-7-(2-methoxy-3,5-dimethylpyridin-4-yl)-1-(tetrahydrofuran-3-yl)-1H-pyrazolo[4,3-c]quinolin-4(5H)-one represented by Formula (1): 
       
         
           
           
               
               
           
         
       
     
     
         11 . The method of  claim 10 , wherein said single daily dose is from about 25 mg to about 400 mg. 
     
     
         12 . The method of  claim 10 , wherein said therapeutically effective amount is a single daily dose to achieve a mean AUC(0-inf) of from about 72.6 to about 217.0 ng*hr/mL for each 1 mg of Compound A after administration to the human subject. 
     
     
         13 . The method of  claim 10 , wherein said therapeutically effective amount is a single daily dose to achieve a mean AUC(0-t) of from about 71.0 to about 210.0 ng*hr/mL for each 1 mg of Compound A after administration to the human subject. 
     
     
         14 . A method of treating Lewy body dementia, comprising administering orally to a human subject in need thereof a dosage form comprising a therapeutically effective amount of Compound A or a pharmaceutically acceptable salt thereof, wherein said therapeutically effective amount is a single daily dose to achieve a mean Cmax of from about 1.8 ng/mL to about 7.6 ng/mL for each 1 mg of Compound A after administration to the human subject, and said Compound A is (S)-7-(2-methoxy-3,5-dimethylpyridin-4-yl)-1-(tetrahydrofuran-3-yl)-1H-pyrazolo[4,3-c]quinolin-4(5H)-one represented by Formula (1): 
       
         
           
           
               
               
           
         
       
     
     
         15 . The method of  claim 14 , wherein said single daily dose is from about 25 mg to about 400 mg. 
     
     
         16 . The method of  claim 14 , wherein said therapeutically effective amount is a single daily dose to achieve a mean AUC(0-inf) of from about 72.6 to about 217.0 ng*hr/mL for each 1 mg of Compound A after administration to the human subject. 
     
     
         17 . The method of  claim 14 , wherein said therapeutically effective amount is a single daily dose to achieve a mean AUC(0-t) of from about 71.0 to about 210.0 ng*hr/mL for each 1 mg of Compound A after administration to the human subject. 
     
     
         18 . A method of treating Parkinson's disease with dementia, comprising administering orally to a human subject in need thereof a dosage form comprising a therapeutically effective amount of Compound A or a pharmaceutically acceptable salt thereof, wherein said therapeutically effective amount is a single daily dose to achieve a mean Cmax of from about 1.8 ng/mL to about 7.6 ng/mL for each 1 mg of Compound A after administration to the human subject, and said Compound A is (S)-7-(2-methoxy-3,5-dimethylpyridin-4-yl)-1-(tetrahydrofuran-3-yl)-1H-pyrazolo[4,3-c]quinolin-4(5H)-one represented by Formula (1): 
       
         
           
           
               
               
           
         
       
     
     
         19 . The method of  claim 18 , wherein said single daily dose is from about 25 mg to about 400 mg. 
     
     
         20 . The method of  claim 18 , wherein said therapeutically effective amount is a single daily dose to achieve a mean AUC(0-inf) of from about 72.6 to about 217.0 ng*hr/mL for each 1 mg of Compound A after administration to the human subject. 
     
     
         21 . The method of  claim 18 , wherein said therapeutically effective amount is a single daily dose to achieve a mean AUC(0-t) of from about 71.0 to about 210.0 ng*hr/mL for each 1 mg of Compound A after administration to the human subject.