US2023212137A1PendingUtilityA1

Solid forms of 2-(4-chlorophenyl)-n-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide, and their pharmaceutical compositions and uses

Assignee: CELGENE CORPPriority: Jan 8, 2016Filed: Jun 23, 2022Published: Jul 6, 2023
Est. expiryJan 8, 2036(~9.5 yrs left)· nominal 20-yr term from priority
A61K 9/0014C07D 401/04A61K 9/19C07K 16/00A61K 31/454A61K 45/06A61K 31/513A61K 2039/505A61K 9/08A61K 9/0019A61K 39/395A61P 35/00A61P 35/02A61P 43/00C07B 2200/13
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Claims

Abstract

Solid forms comprising 2-(4-chlorophenyl)-N-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide, compositions comprising the solid forms, methods of making the solid forms and methods of their uses are disclosed.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A solid form of 2-(4-chlorophenyl)-N-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide or a tautomer thereof:
                       wherein the solid form is selected from:   Form D having an X-ray powder diffraction pattern comprising peaks at about 14.1, 14.3, 18.8 or 19.1 degrees 2θ; and   Form E having an X-ray powder diffraction pattern comprising peaks at about 16.1, 17.0, 21.2 or 22.9 degrees 2θ.   
     
     
         2 . The solid form of  claim 1 , which is anhydrous. 
     
     
         3 . The solid form of  claim 1 , which is Form D having an X-ray powder diffraction pattern comprising peaks at about 14.1, 14.3, 18.8 or 19.1 degrees 2θ. 
     
     
         4 . The solid form of  claim 3 , having an X-ray powder diffraction pattern comprising peaks at about 14.1, 14.3, 18.8, 19.1, 23.6 or 24.0 degrees 2θ. 
     
     
         5 . The solid form of  claim 3 , having an X-ray powder diffraction pattern substantially as shown in  FIG.  23   . 
     
     
         6 . The solid form of  claim 3 , having a thermal gravimetric analysis plot comprising a mass loss of about 14.1% up to about 140° C. 
     
     
         7 . The solid form of  claim 3 , having a thermal gravimetric analysis plot substantially as shown in  FIG.  24   . 
     
     
         8 . The solid form of  claim 3  which is substantially pure. 
     
     
         9 . The solid form of  claim 3  which is a DMSO solvate. 
     
     
         10 . The solid form of  claim 1 , which is Form E having an X-ray powder diffraction pattern comprising peaks at about 16.1, 17.0, 21.2 or 22.9 degrees 2θ. 
     
     
         11 . The solid form of  claim 10 , having an X-ray powder diffraction pattern comprising peaks at about 10.5, 12.5, 16.1, 17.0, 18.5, 21.2, 21.7, 22.6, 22.9, 23.4, 23.8, 24.1, 25.1 or 26.7 degrees 2θ. 
     
     
         12 . The solid form of  claim 10 , having an X-ray powder diffraction pattern substantially as shown in  FIG.  25   . 
     
     
         13 . The solid form of  claim 10 , having a thermal gravimetric analysis plot comprising a mass loss of about 19.4% up to about 120° C. 
     
     
         14 . The solid form of  claim 10 , having a thermal gravimetric analysis plot substantially as shown in  FIG.  26   . 
     
     
         15 . The solid form of  claim 10  which is substantially pure. 
     
     
         16 . The solid form of  claim 10  which is a DMSO solvate. 
     
     
         17 . An amorphous form of 2-(4-chlorophenyl)-N-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide or a tautomer thereof: 
       
         
           
           
               
               
           
         
       
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         18 . The amorphous form of  claim 17  having a differential scanning calorimetry plot substantially as shown in  FIG.  27   . 
     
     
         19 . The amorphous form of  claim 17  having an X-ray powder diffraction pattern substantially as shown in  FIG.  28   . 
     
     
         20 . A pharmaceutical composition comprising the solid form of  claim 1  and a pharmaceutically acceptable carrier, diluent or excipient. 
     
     
         21 . A pharmaceutical composition comprising the amorphous form of  claim 20  and a pharmaceutically acceptable carrier, diluent or excipient. 
     
     
         22 . The pharmaceutical composition of  claim 21 , wherein the composition is formulated for parenteral or intravenous administration. 
     
     
         23 . The pharmaceutical composition of  claim 22 , wherein the composition is formulated as a single unit dosage form.

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