Sulcardine salts
Sulcardine salts other than sulfuric acid salts of sulcardine, including crystalline sulcardine salts, are provided herein. Pharmaceutical compositions comprising such salts and methods of treating arrhythmias comprising administering effective amounts of such salts are also provided.
1. A hydrate of an ethane-1,2-disulfonic acid salt of sulcardine.
2. The hydrate of claim 1 , wherein the hydrated ethane-1,2-disulfonic acid salt of sulcardine is crystalline.
3. The hydrate of claim 2 , wherein the hydrated ethane-1,2-disulfonic acid salt of sulcardine is a dihydrate.
4. The hydrate of claim 2 , wherein the crystalline salt is a monoedisylate salt of sulcardine.
5. The crystalline monoedisylate salt of claim 4 , wherein the salt is a dihydrate.
6. The crystalline monoedisylate salt of claim 4 , having an x-ray powder diffraction pattern comprising a peak at about 5.2° 2θ.
7. The crystalline monoedisylate salt of claim 6 , having an x-ray powder diffraction pattern further comprising one or more peaks at about 9.1° 2θ, about 10.2° 2θ, about 10.8° 2θ, about 11.3° 2θ, about 13.6° 2θ, and about 15.7° 2θ.
8. The crystalline monoedisylate salt of claim 6 , having an x-ray powder diffraction pattern further comprising peaks at about 15.7° 2θ, about 16.9° 2θ,and about 23.6° 2θ.
9. The crystalline monoedisylate salt of claim 6 , having an x-ray powder diffraction pattern further comprising peaks at about 9.1° 2θ and about 11.3° 2θ.
10. The crystalline monoedisylate salt of sulcardine of claim 4 , characterized by x-ray powder diffraction pattern presented in FIG. 28 .
11. The crystalline monoedisylate salt of claim 5 , wherein the salt provides an in vivo plasma profile comprising a median Cmax of higher than about 4,500 ng/mL with a Tmax of within about 0.5 hours post administration when orally administered to a subject.
12. The crystalline monoedisylate salt of claim 4 , wherein the salt is a monohydrate.
13. The crystalline monoedisylate salt of claim 4 , having an x-ray powder diffraction pattern comprising a peak at about 14.2° 2θ.
14. The crystalline monoedisylate salt of claim 13 , having an x-ray powder diffraction pattern further comprising two peaks between about 9.0° 2θ and about 9.8° 2θ.
15. The crystalline monoedisylate salt of claim 13 , having an x-ray powder diffraction pattern further comprising one or more peaks at about 9.2° 2θ, about 9.6° 2θ, about 10.4° 2θ, about 13.8° 2θ, and about 14.9° 2θ.
16. The crystalline monoedisylate salt of claim 13 , having an x-ray powder diffraction pattern further comprising peaks at about 18.8° 2θ, about 20.2° 2θ, and about 21.2° 2θ.
17. The crystalline monoedisylate salt of sulcardine of claim 4 , characterized by an x-ray powder diffraction pattern presented in FIG. 26 .
18. A solid salt of ethane-1,2-disulfonic acid and sulcardine.
19. A crystalline salt of ethane-1,2-disulfonic acid and sulcardine.