Claims for Patent: 9,585,892
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Summary for Patent: 9,585,892
| Title: | Solid forms comprising N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, compositions thereof, and uses therewith |
| Abstract: | Solid forms comprising N-(5-tert-butyl-isoxazol-3-yl)-N′-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea, compositions comprising the solid forms, methods of making the solid forms and methods of their use for the treatment of various diseases and/or disorders are disclosed. |
| Inventor(s): | Shripad S. Bhagwat, Wei Lai, Stephan D. PARENT, Melanie J. Bevill, Alan Schwartz, Valeriya N. Smolenskaya |
| Assignee: | Ambit Bioscience Corp |
| Application Number: | US14/508,967 |
| Patent Claims: |
1. A method of treating leukemia in a patient comprising administering to the patient a therapeutically effective amount of a solid form comprising a salt of the compound of formula (I): wherein the salt is selected from the group consisting of: hydrobromide, besylate, esylate, edisylate, mesylate, napsylate, sulfate and tosylate salts. 2. The method of claim 1, wherein the solid form further comprises a solvent. 3. The method of claim 1, wherein the solid form further comprises water. 4. A method of treating leukemia in a patient comprising administering to the patient a therapeutically effective amount of a solid form of a bis-HCl salt of the compound of formula (I): 5. The method of claim 4, wherein the solid form further comprises solvent. 6. The method of claim 4, wherein the solid form further comprises water. 7. The method of claim 4, wherein the solid form is substantially free of solvent. 8. The method of claim 4, wherein the solid form is substantially free of water. 9. The method of claim 4, wherein the solid form is anhydrous. 10. The method of claim 4, wherein the solid form is the Form B crystal form of the bis-HCl salt of the compound of formula (I). 11. The method of claim 4, wherein the solid form has an XRPD pattern comprising peaks at approximately 6.98, 10.7, 20.82 and 27.6° 2θ when analyzed using copper Kα radiation. 12. The method of claim 4, wherein the solid form has an XRPD pattern which matches the XRPD patterns presented in FIG. 13 a. 13. The method of claim 4, wherein the solid form has an XRPD pattern which matches the XRPD pattern presented in FIG. 13 b. 14. The method of claim 4, wherein the solid form has a DSC thermogram comprising an endothermic event with an onset temperature of approximately 260° C. 15. The method of claim 4, wherein the solid form has unit cell parameters consistent with the following approximate unit cell parameters: a=15.6089 Å, b =11.9443 Å, c=16.9448 Å, β=101.249°, V=3098.5 Å3 and Z=4. 16. The method of claim 4, wherein the solid form which is physically stable at about 75% RH at about ambient temperature. 17. The method of claim 1, wherein the solid form is substantially pure. 18. The method of claim 1, wherein the solid form is substantially free of chemical impurities. 19. The method of claim 1, wherein the solid form is substantially free of physical impurities. 20. A method of treating leukemia in a patient having leukemia comprising administering to the patient a therapeutically effective amount of a crystal form of a compound of the following formula: which is selected from the group consisting of: a. Form A of the HCl salt; b. Form B of the HCl salt; c. Form C of the HCl salt, d. Form D of the HCl salt; e. Form E of the HCl salt; f. Form F of the HCl salt; g. Form G of the HCl salt; h. Form H of the HCl salt; i. Form I of the HCl salt; j. Form J of the HCl salt; k. Form K of the HCl salt; l. Form L of the HCl salt; m. Form N of the HCl salt; n. Form O of the HCl salt; o. Form A of the HBr salt; p. Form A of the sulfate salt; q. Form B of the sulfate salt; r. Form C of the sulfate salt; s. Form A of the mesylate salt; t. Form B of the mesylate salt; u. Form A of the esylate salt; v. Form B of the esylate salt; w. Form C of the esylate salt; x. Form A of the edisylate salt; y. Form A of the besylate salt; z. Form B of the besylate salt; aa. Form A of the tosylate salt; bb. Form B of the tosylate salt; cc. Form C of the tosylate salt; dd. Form A of the napsylate salt; and ee. Form B of the napsylate salt. |
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