Polymorphs of sorafenib acid addition salts
The present invention provides amorphous and crystalline forms of acid addition salts of sorafenib, pharmaceutical compositions comprising them and their use for the treatment of cancer. The present invention also provides processes for the preparation of acid addition salts of sorafenib.
1. Crystalline sorafenib hydrochloride of Formula III
characterized by X-ray diffraction peaks having d-spacing values at about 3.69, 3.63, 3.42, 3.39 and 3.05 Å.
2. Crystalline sorafenib hydrochloride of claim 1 further characterized by X-ray diffraction peaks having d-spacing values at about 6.40, 4.22, 4.06 and 3.60 Å.
3. Crystalline sorafenib hydrochloride of claim 1 characterized by DSC thermogram having endotherms at about 68[0.33]° C., 115[0.21]° C. and 152[0.74]° C.
4. Crystalline sorafenib hydrochloride of claim 1 characterized by X-ray diffraction spectrum, DSC thermogram, TGA and IR spectrum as depicted in FIGS. 1 , 2 , 3 and 4 , respectively.
5. A pharmaceutical composition comprising crystalline sorafenib hydrochloride of Formula III.