Crystalline forms of (r)-8-chloro-1-methyl- 2,3,4,5-tetrahydro-1h-3-benzazepine hydrochloride

Abstract

The present invention is directed to crystalline forms of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine, compositions containing the same and uses thereof.

1 .- 40 . (canceled) 
     
     
         41 . A crystal form of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride (Form I). 
     
     
         42 . A composition comprising the crystal form of  claim 41 . 
     
     
         43 . A composition comprising the crystal form of  claim 41  and a pharmaceutically acceptable carrier. 
     
     
         44 . A method of treatment of obesity comprising administering to an individual in need of such treatment a therapeutically effective amount of the crystal form of  claim 41 . 
     
     
         45 . A method of decreasing food intake comprising administering to an individual in need of such administration a therapeutically effective amount of the crystal form of  claim 41 . 
     
     
         46 . A method of inducing satiety comprising administering to an individual in need of such administration a therapeutically effective amount of the crystal form of  claim 41 . 
     
     
         47 . A method of controlling weight gain comprising administering to an individual in need of such administration a therapeutically effective amount of the crystal form of  claim 41 . 
     
     
         48 . A process for preparing a crystal form of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride (Form I) comprising the step of:
 heating crystalline (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride, where the crystalline (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride contains one or more crystalline forms other than Form I.   
     
     
         49 . The process of  claim 48 , wherein the crystalline (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride comprises (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride (Form II). 
     
     
         50 . The process of  claim 48 , wherein the crystalline (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride comprises (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate (Form III). 
     
     
         51 . The process of  claim 48 , wherein the crystalline (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride comprises a mixture of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride (Form II) and (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate (Form III). 
     
     
         52 . The process of  claim 48 , wherein the crystalline (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride is heated at a temperature of at least about 60° C. 
     
     
         53 . A crystal form of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride (Form I) prepared by the process of  claim 48 . 
     
     
         54 . A method of preparing a pharmaceutical composition comprising mixing (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride (Form I) with a pharmaceutically acceptable carrier. 
     
     
         55 . The method of claim  14 , wherein the (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride (Form I) is prepared by a method of  claim 48 . 
     
     
         56 . A method according to  claim 54 , further comprising forming the pharmaceutical composition into a tablet, a pill, a powder, a soft or hard gelatin capsule, or a sterile packaged powder. 
     
     
         57 . A solid pharmaceutical composition prepared by the method of  claim 54 . 
     
     
         58 . A solid pharmaceutical composition prepared by the method of  claim 56 , wherein the pharmaceutical composition is in a form chosen from a tablet, a pill, a powder, a soft or hard gelatin capsule, or a sterile packaged powder.