5ht2c receptor modulator compositions and methods of use

Abstract

The present invention relates to a composition comprising phentermine and a selective 5HT-2C receptor agonist. In addition, the invention relates to a composition comprising phentermine and a selective 5HT-2C receptor agonist having Formula (I): or a pharmaceutically acceptable salt, solvate or hydrate thereof. These compositions are useful in pharmaceutical compositions whose use includes the treatment of obesity.

1 .- 41 . (canceled) 
     
     
         42 . A method of decreasing food intake in a mammal comprising the step of:
 administering to said mammal 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof.   
     
     
         43 . The method of  claim 42 , wherein each of the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof is formulated for oral administration. 
     
     
         44 . The method of  claim 42 , wherein each of the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof is formulated as a solid dosage form. 
     
     
         45 . The method of  claim 42 , wherein each of the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof is formulated as a liquid dosage form. 
     
     
         46 . The method of  claim 42 , wherein the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof are present in a combined preparation for simultaneous, separate or sequential use. 
     
     
         47 . A method of decreasing food intake in a mammal comprising the step of:
 administering to said mammal 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine.   
     
     
         48 . The method of  claim 47 , wherein each of the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine is formulated for oral administration. 
     
     
         49 . The method of  claim 47 , wherein each of the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine is formulated as a solid dosage form. 
     
     
         50 . The method of  claim 47 , wherein each of the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine is formulated as a liquid dosage form. 
     
     
         51 . The method of  claim 47 , wherein the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine are present in a combined preparation for simultaneous, separate or sequential use. 
     
     
         52 . A method for preparing a composition comprising 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof, said method comprising combining 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof. 
     
     
         53 . A method for preparing a composition comprising 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof, said method comprising combining 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable carriers. 
     
     
         54 . A method for preparing a composition comprising 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof, said method comprising combining 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof to form a tablet or capsule. 
     
     
         55 . A method of preparing a composition comprising 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof, said method comprising uniformly mixing 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof with one or more liquid excipients and/or solid excipients. 
     
     
         56 . A method of preparing a composition comprising 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof, comprising uniformly mixing compound 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine or a pharmaceutically acceptable salt thereof with a liquid or a finely divided solid carrier, or both.