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Claims for Patent: 8,568,793

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Claims for Patent: 8,568,793

Title:Sodium nitrite-containing pharmaceutical compositions
Abstract: 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.
Inventor(s): Sherman; Craig (Scottsdale, AZ), Lepine; Anthony James (Greendale, WI), Smith; Catherine Marie (Grafton, WI), Wirtz; Kevin Robert (Belgium, WI), Schulze; Erich (Mission Viejo, CA)
Assignee: Hope Medical Enterprises, Inc. (Scottsdale, AZ)
Application Number:12/703,448
Patent Claims: 1. Solid 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 sodium nitrite 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. A pharmaceutical composition comprising sodium nitrite and one or more pharmaceutically acceptable carriers or excipients, wherein the sodium nitrite 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.

4. The sodium nitrite of claim 2, wherein the sodium nitrite contains no less than about 98% by weight of sodium nitrite.

5. The sodium nitrite of claim 2, wherein the sodium nitrite contains no less than about 99.8% by weight of sodium nitrite as measured by Ion Chromatography analysis.

6. The sodium nitrite of claim 4, wherein the sodium nitrite is a white to off-white solid.

7. The sodium nitrite of claim 6, wherein a 10% aqueous solution of the sodium nitrite at 25.degree. C. has a pH value between about 8 and about 9.

8. The sodium nitrite of claim 7, which 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.

9. The pharmaceutical composition of claim 3, wherein the sodium nitrite contains no less than about 97% by weight and no greater than about 101% by weight of sodium nitrite.

10. The pharmaceutical composition of claim 9, wherein the sodium nitrite is a white to off-white solid.

11. The pharmaceutical composition of claim 10, wherein a 10% aqueous solution of the sodium nitrite at 25.degree. C. has a pH value between about 8 and about 9.

12. The pharmaceutical composition of claim 11, which 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.

13. The pharmaceutical composition of claim 3, wherein the composition is formulated for oral, parenteral, inhalation, nasal, intravesical, vaginal, rectal, sublingual, ophthalmic, or topical administration.

14. The pharmaceutical composition of claim 13, wherein the composition is formulated as a single dosage form.

15. The pharmaceutical composition of any of claim 14, wherein the pharmaceutically acceptable excipient is water.

16. The pharmaceutical composition of claim 15, further comprising an isotonic agent and one or more pH adjusting agents.

17. A sterile aqueous solution intended for intravenous injection, comprising the sodium nitrite of claim 1 and water for injection or another pharmaceutically acceptable vehicle.

18. A method for treating cyanide poisoning, comprising sequentially administering intravenously to a subject having cyanide poisoning: (1) a therapeutically effective amount of a sterile aqueous solution comprising pharmaceutical grade sodium nitrite of claims 1; and (2) a therapeutically effective amount of a sterile aqueous solution comprising pharmaceutical grade sodium thiosulfate pentahydrate.

19. A kit that includes: (1) a single unit dosage form comprising pharmaceutical grade sodium nitrite, wherein said pharmaceutical grade sodium nitrite 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; and (2) a single unit dosage form comprising sodium thiosulfate pentahydrate, wherein said sodium thiosulfate pentahydrate contains no greater than about 10 ppm of non-purgeable organic carbon, contains no greater than about 0.01% by weight of carbonate, contains no greater than about 0.05 ppm of mercury, contains no greater than about 2 ppm of aluminum, contains no greater than about 0.003% by weight of selenium, contains no less than about 98% by weight and no greater than about 102% by weight of sodium thiosulfate on an anhydrous basis measured by ion chromatography, has a water content between 32% and 37% by weight, has a heavy metal content of no greater than about 10 ppm, contains no greater than about 200 ppm of chloride, contains no greater than about 0.001% by weight of sulfide, contains no greater than about 0.002% 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 0.1% of sulfite, contains no greater than about 0.5% of sulfate, contains no greater than about 3 ppm of arsenic, contains no greater than about 0.001% by weight of lead, has total aerobic count of microbial load of no greater than about 100 CFU/g, has total yeast and mold count of no greater than about 20 CFU/g, contains no greater than about 0.02 EU/mg of bacterial endotoxins, contains no greater than about 0.002% by weight of nitrogen compounds, contains no greater than about 0.005% by weight of insoluble matter, and contains no greater than 0.01% by weight of residual anti-caking agent.
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