Sodium nitrite-containing pharmaceutical compositions
Provided herein are pharmaceutically acceptable sodium nitrite and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-volatile organic carbon in a sodium nitrite-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium nitrite. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium nitrite.
1. A method for treating a cardiovascular disease with a decrease in blood flow comprising administering to a subject having a cardiovascular disease a therapeutically effective amount of sodium nitrite which contains no greater than about 0.02% by weight of sodium carbonate, contains no greater than about 10 ppm of an anti-caking agent, has a loss on drying of no greater than about 0.25% by weight, wherein the water content is no greater than about 0.5% by weight, wherein the heavy metal content is no greater than about 10 ppm, contains no greater than about 0.4% by weight of sodium nitrate, contains no greater than about 0.005% by weight of insoluble matter, contains no greater than about 0.005% by weight of chloride, contains no greater than about 0.01% by weight of sulfate, contains no greater than about 0.001% by weight of iron, contains no greater than about 0.01% by weight of calcium, contains no greater than about 0.005% by weight of potassium, contains no greater than about 0.05 ppm of mercury, contains no greater than about 2 ppm of aluminum, contains no greater than about 3 ppm of arsenic, contains no greater than about 0.003% by weight of selenium, contains no greater than about 5000 ppm of ethanol, contains no greater than about 3000 ppm methanol, wherein the total non-volatile organic carbon content is no greater than about 10 ppm, and contains no greater than about 0.25 EU/mg of bacterial endotoxins.
2. The method of claim 1 , wherein the sodium nitrite contains no less than about 97% by weight and no greater than about 101% by weight of sodium nitrite.
3. The method of claim 1 , wherein the sodium nitrite contains no less than about 98% by weight of sodium nitrite.
4. The method of claim 1 , wherein the sodium nitrite contains no less than about 99.8% by weight of sodium nitrite as measured by Ion Chromatography analysis.
5. The method of claim 1 , wherein the sodium nitrite is a white to off-white solid.
6. The method of claim 1 , wherein a 10% aqueous solution of the sodium nitrite at 25° C. has a pH value between about 8 and about 9.
7. The method of claim 1 , wherein the sodium nitrite has total aerobic count of microbial load of no greater than about 100 CFU/g and has total yeast and mold count of no greater than about 20 CFU/g.
8. The method of claim 1 , wherein the cardiovascular disease is cerebral vasospasm.
9. The method of claim 1 , wherein the cardiovascular disease is an ischemic central nervous system event.
10. The method of claim 1 , wherein the cardiovascular disease is ischemia-reperfusion injury.
11. The method of claim 1 , wherein the cardiovascular disease is angina.
12. The method of claim 1 , wherein the cardiovascular disease is systemic hypertension.
13. The method of claim 1 , wherein the cardiovascular disease is claudication.
14. The method of claim 1 , wherein the cardiovascular disease is high blood pressure.
15. The method of claim 1 , wherein the cardiovascular disease is peripheral artery disease.
16. The method of claim 1 , wherein the cardiovascular disease is critical limb ischemia.
17. The method of claim 1 , wherein the cardiovascular disease is tissue ischemia-reperfusion injury.
18. The method of claim 1 , wherein the cardiovascular disease is pulmonary hypertension.
19. The method of claim 1 , wherein the cardiovascular disease is cutaneous ulceration.