Kinase inhibitor salts, and compositions thereof
The present invention relates to polymorphic forms of dasatinib lauryl sulfate salt.
1. A crystalline dasatinib lauryl sulfate salt characterized by an x-ray powder diffraction (XRPD) pattern with four or more 2θ peaks selected from the group consisting of 6.5±0.2, 9.5±0.2, 10.2±0.2, 12.7±0.2, 17.1±0.2, 18.1±0.2, 19.1±0.2, 21.1±0.2, 22.2±0.2, 24.1±0.2, 24.7±0.2 and 28.5±0.2.
2. The crystalline dasatinib lauryl sulfate salt of claim 1 further characterized by an XRPD pattern with one or more 2θ peaks selected from the group consisting of 7.9±0.2, 12.3±0.2, 14.4±0.2, 14.9±0.2, 16.0±0.2, 16.8±0.2, 19.8±0.2, 23.2±0.2, 25.6±0.2, 26.6±0.2, 27.6±0.2, 28.1±0.2, 28.9±0.2, 31.3±0.2, 34.2±0.2 and 37.2±0.2.
3. The crystalline dasatinib lauryl sulfate salt of claim 1 characterized by an XRPD pattern with 20 peaks at 12.7±0.2, 18.1±0.2, 19.1±0.2, 21.1±0.2, 22.2±0.2 and 24.7±0.2.
4. The crystalline dasatinib lauryl sulfate salt of claim 3 further characterized by an XRPD pattern with one or more 2θ peaks selected from the group consisting of 5.9±0.2, 6.5±0.2, 9.5±0.2, 10.2±0.2, 12.3±0.2, 14.9±0.2, 16.8±0.2, 17.1±0.2, 19.8±0.2, 23.2±0.2, 24.1±0.2, 26.6±0.2, and 28.5±0.2.
5. The crystalline dasatinib lauryl sulfate salt of claim 1 characterized by an XRPD pattern with 20 peaks at 6.5±0.2, 9.5±0.2, 10.2±0.2, 12.3±0.2, 12.7±0.2, 17.1±0.2, 18.1±0.2, 19.1±0.2, 21.1±0.2, 22.2±0.2, 23.2±0.2, 24.1±0.2 and 24.7±0.2.
6. An oral pharmaceutical composition comprising the crystalline dasatinib lauryl sulfate salt of claim 1 and at least one pharmaceutically acceptable excipient.
7. A crystalline dasatinib lauryl sulfate salt characterized by an x-ray powder diffraction (XRPD) pattern with four or more 2θ peaks selected from the group consisting of 6.6±0.2, 12.4±0.2, 17.1±0.2, 18.2±0.2, 19.0±0.2, 21.3±0.2, 22.3±0.2, 24.1±0.2, 24.8±0.2, and 27.5±0.2.
8. The crystalline dasatinib lauryl sulfate salt of claim 7 further characterized by an XRPD pattern with one or more 2θ peaks selected from the group consisting of 9.6±0.2, 10.2±0.2, 10.7±0.2, 12.8±0.2, 14.4±0.2, 15.5±0.2, 16.0±0.2, 19.8±0.2, 20.5±0.2, 23.2±0.2, 25.8±0.2, 26.1±0.2, 26.7±0.2, 27.2±0.2, 28.4±0.2, 28.8±0.2, 31.4±0.2, 33.3±0.2 and 34.4±0.2.
9. The crystalline dasatinib lauryl sulfate of claim 7 characterized by an XRPD pattern with 20 peaks at 6.6±0.2, 17.1±0.2, 18.2±0.2, 19.0±0.2, 21.3±0.2, 22.3±0.2, 24.1±0.2 and 24.8±0.2.
10. An oral pharmaceutical composition comprising the crystalline dasatinib lauryl sulfate salt of claim 7 and at least one pharmaceutically acceptable excipient.
11. A crystalline dasatinib lauryl sulfate salt characterized by an x-ray powder diffraction (XRPD) pattern with four or more 2θ peaks selected from the group consisting of 6.3±0.2, 9.5±0.2, 12.7±0.2, 15.9±0.2, 17.0±0.2, 19.0±0.2, 21.0±0.2, 22.2±0.2, 24.6±0.2 and 31.2±0.2.
12. The crystalline dasatinib lauryl sulfate salt of claim 11 further characterized by an XRPD pattern with one or more 2θ peaks selected from the group consisting of 10.1±0.2, 12.2±0.2, 16.7±0.2, 18.0±0.2, 23.1±0.2, 23.9±0.2, 25.6±0.2, 28.5±0.2, 28.7±0.2, 37.2±0.2 and 38.7±0.2.
13. The crystalline dasatinib lauryl sulfate salt of claim 11 characterized by an XRPD pattern with 20 peaks at 9.5±0.2, 10.1±0.2, 12.7±0.2, 18.0±0.2, 19.0±0.2, 21.0±0.2, 22.2±0.2, 23.9±0.2, 24.6±0.2 and 31.2±0.2.
14. An oral pharmaceutical composition comprising the crystalline dasatinib lauryl sulfate salt of claim 11 and at least one pharmaceutically acceptable excipient.
15. A crystalline dasatinib lauryl sulfate salt characterized by an x-ray powder diffraction (XRPD) pattern with four or more 2θ peaks selected from the group consisting of 6.9±0.2, 9.9±0.2, 10.5±0.2, 13.1±0.2, 17.1±0.2, 17.4±0.2, 18.4±0.2, 19.4±0.2, 21.5±0.2, 22.6±0.2, 24.4±0.2, and 25.0±0.2.
16. The crystalline dasatinib lauryl sulfate salt of claim 15 further characterized by an XRPD pattern with one or more 2θ peaks selected from the group consisting of 12.6±0.2, 14.7±0.2, 16.3±0.2, 17.2±0.2, 20.1±0.2, 23.5±0.2, 26.0±0.2, 26.5±0.2, 26.9±0.2, 27.4±0.2, 27.8±0.2, 28.7±0.2, 29.1±0.2, and 31.6±0.2.
17. The crystalline dasatinib lauryl sulfate salt of claim 15 characterized by an XRPD pattern with 2θ peaks at 13.1±0.2, 17.4±0.2, 18.4±0.2, 19.4±0.2, 21.5±0.2, 22.6±0.2, 24.4±0.2, and 25.0±0.2.
18. An oral pharmaceutical composition comprising the crystalline dasatinib lauryl sulfate salt of claim 15 and at least one pharmaceutically acceptable excipient.