CRYSTALLINE FORMS OF AFATINIB DI-MALEATE
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Abstract
Crystalline forms of Afatinib di-maleate are described in the present application and processes for their preparation. The present invention also includes pharmaceutical compositions of such crystalline forms of Afatinib di-maleate, methods of their preparation and the use thereof hi the treatment of a patient in need thereof. The present invention also describes preparing Afatinib free base and salts of Afatinib, other than Afatibin di-maleate, and solid forms thereof.
1 Citation
22 Claims
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1-11. -11. (canceled)
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12. Crystalline Afatinib di-maleate Form D, characterized by data selected from:
- an X-ray powder diffraction pattern having peaks at 5.6, 9.5, 22.1, 26.3 and 29.5 degrees two theta±
0.2 degrees two theta;
an X-ray powder diffraction pattern substantially as depicted inFIG. 4 ; and
combinations thereof. - View Dependent Claims (13, 14, 15, 17, 19, 20, 21, 22)
- an X-ray powder diffraction pattern having peaks at 5.6, 9.5, 22.1, 26.3 and 29.5 degrees two theta±
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16. (canceled)
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18. (canceled)
Specification