Sertraline hydrochloride polymorphs

Abstract

The present invention is directed to forms II, III, V, VI, VII, VIII, IX and X of sertraline hydrochloride and novel methods for their preparation. According to the present invention, sertraline hydrochloride polymorph II may be produced by slurrying sertraline hydrochloride polymorph VI in aprotic organic solvent. Sertraline hydrochloride polymorphic form III may be produced by heating sertraline hydrochloride polymorphs V and VI. Sertraline hydrochloride forms V and VI may be produced from either sertraline hydrochloride or sertraline base by crystallization. Sertraline hydrochloride Form VII may be produced by suspending sertraline chloride polymorph V in water, followed by filtration. Sertraline hydrochloride Forms VIII and IX may be produced by suspending sertraline base in water followed by acidification and filtration. Sertraline hydrochloride Form X may be produced by suspending sertraline hydrochloride in benzyl alcohol with heating, followed by filtration.

1 - 23 . (canceled) 
     
     
         24 . A pharmaceutical composition comprising a therapeutically effective amount of sertraline hydrochloride Form V and a pharmaceutically acceptable carrier. 
     
     
         25 - 90 . (canceled) 
     
     
         91 . Sertraline hydrochloride Form V. 
     
     
         92 . Sertraline hydrochloride Form V characterized by an x-ray powder diffraction pattern comprising peaks at about 5.2°±0.2, 10.4°±0.2, 11.0°±0.2, 14.3°±0.2, 16.5°±0.2, 17.3°±0.2, 18.4°±0.2, 19.1°±0.2, 19.7°±0.2, 20.9°±0.2, 22.0°±0.2, 23.2°±0.2, 23.6°±0.2, 25.5°±0.2, 26.0°±0.2, and 29.1°±0.2 degrees 2 theta. 
     
     
         93 . A method for the treatment of depression, comprising the step of administering to a human subject in need of such treatment the pharmaceutical composition of  claim 24 . 
     
     
         94 . A tablet comprising the pharmaceutical composition of  claim 24 . 
     
     
         95 . A method for the treatment of depression, comprising the step of administering to a human subject in need of such treatment the tablet of  claim 94 . 
     
     
         96 . Crystalline sertraline hydrochloride having a powder XRD pattern as substantially depicted in  FIG. 1 . 
     
     
         97 . A pharmaceutical composition comprising a therapeutically effective amount of the sertraline hydrochloride of  claim 96  and a pharmaceutically acceptable carrier. 
     
     
         98 . A tablet comprising the pharmaceutical composition of  claim 97 . 
     
     
         99 . Sertraline hydrochloride having an IR spectrum with bands at 773 cm −1 , 822 cm −1 , 1012 cm −1 , 1032 cm −1 , 1054 cm −1 , 1133 cm −1 , 1328 cm −1 , 1562 cm −1  and 1590 cm −1 . 
     
     
         100 . A pharmaceutical composition comprising a therapeutically effective amount of the sertraline hydrochloride of  claim 99  and a pharmaceutically acceptable carrier.