Novel crystalline forms of selinexor and process for their preparation

Abstract

The present disclosure relates to solid state forms of Selinexor, processes for preparation thereof and pharmaceutical compositions thereof.

1 . A crystalline form of Selinexor designated as Form T17, characterized by data selected from one or more of the following:
 a. an X-ray powder diffraction pattern having peaks at 9.1, 14.3, 20.9, 22.2, and 26.0 degrees 2-theta±0.2 degrees 2-theta;   b. an XRPD pattern as depicted in  FIG. 17 ;   c. a combination of (a) and (b).   
     
     
         2 . The crystalline Form T17 of Selinexor according to  claim 1 , characterized by an XRPD pattern having peaks at 9.1, 14.3, 20.9, 22.2, and 26.0 degrees 2-theta±0.2 degrees 2-theta, and also having one, two, three, or four additional peaks selected from 10.4, 18.3, 19.3 and 24.7 degrees two theta±0.2 degrees two theta. 
     
     
         3 . The crystalline Form T17 of Selinexor according to  claim 1 , characterized as an acetic acid solvate and/or a hemi acetic acid solvate. 
     
     
         4 . The crystalline Form T17 of Selinexor according to  claim 1 , characterized as acetic acid solvate. 
     
     
         5 . The crystalline Form T17 of Selinexor according to  claim 1 , characterized as a hemi acetic acid solvate. 
     
     
         6 . A pharmaceutical composition comprising a crystalline form according to  claim 1 , optionally further comprising at least one pharmaceutically acceptable excipient. 
     
     
         7 . A process for preparing the pharmaceutical formulation according to  claim 5 , comprising combining the crystalline form with at least one pharmaceutically acceptable excipient. 
     
     
         8 . A method of treating a cancer that is treatable by the selective inhibition of nuclear export, comprising administering a therapeutically effective amount of the crystalline form according to  claim 1 , to a subject suffering from cancer, otherwise in need of the treatment.