Polymorphs of atomoxetine hydrochloride

Abstract

The present invention provides novel crystalline polymorph forms of atomoxetine hydrochloride denominated Forms B and C and methods for their preparation, as well as methods for the preparation of Form A. The present invention provides pharmaceutical compositions that comprise atomoxetine hydrochloride Form B, Form C, or mixtures thereof that can be used to treat attention deficit/hyperactivity disorder.

1 - 8 . (canceled) 
   
   
       1 . Atomoxetine hydrochloride prepared according to a process comprising the steps of:
 a) combining atomoxetine hydrochloride with water at a temperature of about 40° C. to about 60° C. to obtain a mixture;   b) cooling the mixture to about room temperature to obtain a precipitate; and   c) recovering atomoxetine hydrochloride.   
   
   
       2 . The process of  claim 1 , wherein the atomoxetine hydrochloride and water in step a) are combined at a temperature of about 50° C. 
   
   
       3 . The atomoxetine hydrochloride of  claim 1 , wherein said atomoxetine hydrochloride is crystalline. 
   
   
       4 . The crystalline atomoxetine hydrochloride of  claim 3 , wherein said crystalline is characterized by a powder x-ray diffraction pattern having peaks at about 13.7, 17.3, 18.7, 21.1, 22.6, 24.0, 27.3, 28.4 and 29.3±degrees two-theta.