Polymorphic forms of the sodium salt of 4-tert-butyl-N-[4-chloro-2-(1-oxy-pyridine-4-carbonyl)-phenyl]-benzene sulfonamide
Disclosed are novel polymorphic solvated and desolvated forms of the sodium salt of 4-tert-butyl-N-[4-chloro-2-(1-oxy-pyridine-4-carbonyl)phenyl]-benzenesulfonamide. One embodiment of the present invention is directed to a crystalline sodium salt of 4-tert-butyl-N-[4-chloro-2-(1-oxy-pyridine-4-carbonyl)-phenyl]benzenesulfonamide (hereinafter “Compound A-1,4-dioxane/water solvate”), wherein the crystalline form is characterized by an X-ray powder diffraction pattern comprising diffraction angles (° 28), when measured using Cu Ku radiation, at about 4.0, 8.1, 10.1, 14.2, 16.2, 18.6, 20.3, 24.7, 25.0, and 26.5.
1. A crystalline form of a sodium salt of 4-tert-butyl-N-[4-chloro-2-(1-oxy-pyridine-4-carbonyl)-phenyl]-benzenesulfonamide in the form of a solvate, wherein the solvate consists of one unit of water and one unit of 1,4-dioxane.
2. The crystalline form of claim 1 characterized by an X-ray powder diffraction pattern substantially in accordance with FIG. 1 .
3. The crystalline form of claim 1 , wherein the crystalline form provides a Raman spectrum containing peaks at about 668, 743, 804, 1125, 1154, 1162, 1286, 1544, 1587, 1597, 1611, 1657, and 1672 cm −1 .
4. The crystalline form of claim 1 , wherein the crystalline form provides a Raman spectrum substantially in accordance with FIG. 6 .
5. A pharmaceutical composition comprising the crystalline form according to claim 1 and a pharmaceutically acceptable carrier.
6. A method of preparing a pharmaceutical composition comprising admixing the crystalline form according to claim 1 and a pharmaceutically acceptable carrier.
7. The crystalline form of claim 1 , wherein the crystalline form differential scanning calorimetry themogram profile is substantially in accordance with FIG. 10 .
8. The pharmaceutical composition of claim 5 , further comprising a non-steroidal anti-inflammatory agent.
9. The pharmaceutical composition of claim 8 , wherein the composition is adapted for oral administration.
10. The composition of claim 8 wherein the composition is in the form of a tablet or capsule.
11. The composition of claim 5 , wherein the composition is in the form of a tablet or capsule.
12. The crystalline form of claim 1 characterized by an X-ray powder diffraction pattern containing diffraction angles, when measured using Cu K α radiation, at about 4.0, 8.1, 10.1, 14.2, 16.2, 18.6, 20.3, 24.7, 25.0, and 26.5 ° 2θ.
13. The crystalline form of claim 1 , wherein the crystalline form is prepared from contacting the sodium salt of 4-tert-butyl-N-[4-chloro-2-(1-oxy-pyridine-4-carbonyl)-phenyl]-benzenesulfonamide with water, 1,4-dioxane, and sodium hydroxide.
14. The crystalline form of claim 13 , characterized by an X-ray powder diffraction pattern containing diffraction angles, when measured using Cu K α radiation, at about 4.0, 8.1, 10.1, 14.2, 16.2, 18.6, 20.3, 24.7, 25.0, and 26.5 ° 2θ.
15. A pharmaceutical composition comprising the crystalline form according to claim 14 and a pharmaceutically acceptable carrier.