Kinase inhibitor salts and compositions thereof
The present invention relates to polymorphic forms of nilotinib lauryl sulfate salt.
1. A crystalline nilotinib lauryl sulfate salt characterized by an x-ray powder diffraction (XRPD) pattern with 2θ peaks at 5.6±0.2, 8.5±0.2 and one or more 2θ peaks selected from the group consisting of 9.4±0.2, 19.1±0.2, 21.5±0.2, and 24.9±0.2.
2. The crystalline nilotinib lauryl sulfate salt of claim 1 further characterized by an XRPD pattern with one or more 2θ peaks selected from the group consisting of 13.1±0.2, 20.2±0.2, 26.5±0.2, 27.7±0.2, and 29.0±0.2.
3. The crystalline nilotinib lauryl sulfate salt of claim 1 characterized by an XRPD pattern with 2θ peaks at 5.6±0.2, 8.5±0.2, 9.4±0.2, 19.1±0.2, 21.5±0.2, and 24.9±0.2.
4. The crystalline nilotinib lauryl sulfate salt of claim 3 further characterized by an XRPD pattern with one or more 2θ peaks selected from the group consisting of 13.1±0.2, 20.2±0.2, 26.5±0.2, 27.7±0.2 and 29.0±0.2.
5. The crystalline nilotinib lauryl sulfate salt of claim 1 characterized by an XRPD pattern with 2θ peaks at 5.6±0.2, 8.5±0.2, 9.4±0.2, 19.1±0.2, 20.2±0.2, 21.5±0.2, 24.9±0.2, 26.5±0.2 and 27.7±0.2 and one or more 2θ peaks selected from the group consisting of 9.2±0.2, 13.1±0.2, 13.7±0.2, 17.1±0.2, 17.8±0.2, 22.0±0.2, 25.8±0.2 and 29.0±0.2.
6. The crystalline nilotinib lauryl sulfate salt of claim 1 characterized by an XRPD pattern with 2θ peaks at 5.6±0.2, 8.5±0.2, 9.4±0.2, 13.1±0.2, 13.7±0.2, 17.1±0.2, 19.1±0.2, 20.2±0.2, 21.5±0.2, 24.9±0.2, 26.5±0.2 and 27.7±0.2.
7. An oral pharmaceutical composition comprising the crystalline nilotinib lauryl sulfate salt of claim 1 and at least one pharmaceutically acceptable excipient.
8. A crystalline nilotinib lauryl sulfate salt characterized by an x-ray powder diffraction (XRPD) pattern with 2θ peaks at 5.6±0.2, 8.5±0.2 and one or more 2θ peaks selected from the group consisting of 17.1±0.2, 20.2±0.2, 22.0±0.2, 22.8±0.2, 25.8±0.2, 26.1±0.2 and 26.6±0.2.
9. The crystalline nilotinib lauryl sulfate salt of claim 8 characterized by an XRPD pattern with 2θ peaks at 5.6±0.2, 8.5±0.2, 26.6±0.2, and one or more 2θ peaks selected from the group consisting of 9.4±0.2, 13.0±0.2, 13.6±0.2, 17.1±0.2, 19.1±0.2, 20.2±0.2, 21.5±0.2, 22.0±0.2, 24.8±0.2, 25.8±0.2, and 26.1±0.2.
10. The crystalline nilotinib lauryl sulfate salt of claim 8 characterized by an XRPD pattern with 2θ peaks at 5.6±0.2, 8.5±0.2, 9.4±0.2, 13.0±0.2, 13.6±0.2, 17.1±0.2, 19.1±0.2, 20.2±0.2, 21.5±0.2, 22.8±0.2, 24.8±0.2 and 26.6±0.2.
11. An oral pharmaceutical composition comprising the crystalline nilotinib lauryl sulfate salt of claim 8 and at least one pharmaceutically acceptable excipient.
12. A crystalline nilotinib lauryl sulfate salt characterized by an x-ray powder diffraction (XRPD) pattern with 2θ peaks at 5.6±0.2, 8.5±0.2 and one or more 2θ peaks selected from the group consisting of 9.1±0.2, 16.7±0.2, 17.9±0.2, 18.4±0.2, 19.6±0.2, 20.9±0.2, 23.0±0.2, 24.1±0.2, 25.8±0.2, 27.7±0.2, and 29.0±0.2.
13. The crystalline nilotinib lauryl sulfate salt of claim 12 further characterized by an XRPD pattern with one or more 2θ peaks selected from the group consisting of 9.6±0.2, 13.1±0.2, 13.9±0.2, 17.2±0.2, 19.1±0.2, 21.3±0.2 and 24.7±0.2.
14. The crystalline nilotinib lauryl sulfate salt of claim 12 characterized by an XRPD pattern with 2θ peaks at 5.6±0.2, 8.5±0.2, 9.6±0.2, 13.1±0.2, 13.9±0.2, 17.2±0.2, 19.1±0.2, 21.3±0.2, 23.0±0.2, 24.7±0.2, 27.7±0.2, and 29.0±0.2.
15. The crystalline nilotinib lauryl sulfate salt of claim 14 further characterized by an XRPD pattern with one or more 2θ peaks at 30.0±0.2, 30.7±0.2, 33.8±0.2, 34.6±0.2 and 38.7±0.2.
16. An oral pharmaceutical composition comprising the crystalline nilotinib lauryl sulfate salt of claim 12 and at least one pharmaceutically acceptable excipient.