5ht2c receptor modulator compositions

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 dosage form of 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, 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 and 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 provided in amounts effective to induce satiety in a mammal. 
     
     
         43 . The dosage form of  claim 42 , wherein the dosage form is formulated for oral administration. 
     
     
         44 . The dosage form of  claim 42 , wherein the dosage form is formulated as a solid dosage form. 
     
     
         45 . The dosage form of  claim 42 , wherein the dosage form is formulated as a liquid dosage form. 
     
     
         46 . The dosage form of  claim 42 , further comprising a pharmaceutically acceptable carrier. 
     
     
         47 . A dosage form of a composition comprising 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 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 and 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 provided in amounts effective to induce satiety in a mammal. 
     
     
         48 . The dosage form of  claim 47 , wherein the dosage form is formulated for oral administration. 
     
     
         49 . The dosage form of  claim 47 , wherein the dosage form is formulated as a solid dosage form. 
     
     
         50 . The dosage form of  claim 47 , wherein the dosage form is formulated as a liquid dosage form. 
     
     
         51 . The dosage form of  claim 47 , further comprising a pharmaceutically acceptable carrier. 
     
     
         52 . A dosage form of a composition comprising 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and a hydrate of a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine wherein the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrate of a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine thereof are present in a combined preparation for simultaneous, separate or sequential use and wherein the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrate of a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine are provided in amounts effective to induce satiety in a mammal. 
     
     
         53 . The dosage form of  claim 51 , wherein the dosage form is formulated for oral administration. 
     
     
         54 . The dosage form of  claim 51 , wherein the dosage form is formulated as a solid dosage form. 
     
     
         55 . The dosage form of  claim 51 , wherein the dosage form is formulated as a dosage form. 
     
     
         56 . The dosage form of  claim 51 , further comprising a pharmaceutically acceptable carrier. 
     
     
         57 . A dosage form of 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, 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 and 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 provided in amounts effective to control weight gain in a mammal. 
     
     
         58 . The dosage form of  claim 57 , wherein the dosage form is formulated for oral administration. 
     
     
         59 . The dosage form of  claim 57 , wherein the dosage form is formulated as a solid dosage form. 
     
     
         60 . The dosage form of  claim 57 , wherein the dosage form is formulated as a liquid dosage form. 
     
     
         61 . The dosage form of  claim 57 , further comprising a pharmaceutically acceptable carrier. 
     
     
         62 . A dosage form of a composition comprising 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 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 and 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 provided in amounts effective to control weight gain in a mammal. 
     
     
         63 . The dosage form of  claim 62 , wherein the dosage form is formulated for oral administration. 
     
     
         64 . The dosage form of  claim 62 , wherein the dosage form is formulated as a solid dosage form. 
     
     
         65 . The dosage form of  claim 62 , wherein the dosage form is formulated as a liquid dosage form. 
     
     
         66 . The dosage form of  claim 62 , further comprising a pharmaceutically acceptable carrier. 
     
     
         67 . A dosage form of a composition comprising 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and a hydrate of a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine wherein the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrate of a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine thereof are present in a combined preparation for simultaneous, separate or sequential use and wherein the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrate of a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine are provided in amounts effective to control weight gain in a mammal. 
     
     
         68 . The dosage form of  claim 67 , wherein the dosage form is formulated for oral administration. 
     
     
         69 . The dosage form of  claim 67 , wherein the dosage form is formulated as a solid dosage form. 
     
     
         70 . The dosage form of  claim 67 , wherein the dosage form is formulated as a liquid dosage form. 
     
     
         71 . The dosage form of  claim 67 , further comprising a pharmaceutically acceptable carrier. 
     
     
         72 . A dosage form of 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, 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 and 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 provided in amounts effective to treat obesity in a mammal. 
     
     
         73 . The dosage form of  claim 72 , wherein the dosage form is formulated for oral administration. 
     
     
         74 . The dosage form of  claim 72 , wherein the dosage form is formulated as a solid dosage form. 
     
     
         75 . The dosage form of  claim 72 , wherein the dosage form is formulated as a liquid dosage form. 
     
     
         76 . The dosage form of  claim 72 , further comprising a pharmaceutically acceptable carrier. 
     
     
         77 . A dosage form of a composition comprising 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 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 and 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 provided in amounts effective to treat obesity in a mammal. 
     
     
         78 . The dosage form of  claim 77 , wherein the dosage form is formulated for oral administration. 
     
     
         79 . The dosage form of  claim 77 , wherein the dosage form is formulated as a solid dosage form. 
     
     
         80 . The dosage form of  claim 77 , wherein the dosage form is formulated as a liquid dosage form. 
     
     
         81 . The dosage form of  claim 77 , further comprising a pharmaceutically acceptable carrier. 
     
     
         82 . A dosage form of a composition comprising 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and a hydrate of a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine wherein the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrate of a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine thereof are present in a combined preparation for simultaneous, separate or sequential use and wherein the 1,1-dimethyl-2-phenyl-ethylamine, or a pharmaceutically acceptable salt thereof, and the hydrate of a hydrochloric acid salt of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine are provided in amounts effective to treat obesity in a mammal. 
     
     
         83 . The dosage form of  claim 82 , wherein the dosage form is formulated for oral administration. 
     
     
         84 . The dosage form of  claim 82 , wherein the dosage form is formulated as a solid dosage form. 
     
     
         85 . The dosage form of  claim 82 , wherein the dosage form is formulated as a liquid dosage form. 
     
     
         86 . The dosage form of  claim 82 , further comprising a pharmaceutically acceptable carrier.