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Claims for Patent: 7,879,349

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Claims for Patent: 7,879,349

Title:Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Abstract: A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum.times.100) to at least about 1.1 comprising intranasally administering an aqueous solution of a cyanocobalamin, wherein said solution of cyanocobalamin has a bioavailability of at least 7% relative to an intramuscular injection of a cyanocobalamin.
Inventor(s): Quay; Steven C. (Edmonds, WA), Aprile; Peter C. (East Northport, NY), Go; Zenaida O. (Clifton, NJ), Sileno; Anthony P. (Brookhaven Hamlet, NY)
Assignee: Par Pharmaceutical, Inc. (Woodcliff Lake, NJ)
Application Number:12/079,875
Patent Claims: 1. A stable pharmaceutical aqueous solution of cyanocobalamin comprised of cyanocobalamin and water, a preservative selected from the group consisting of benzyl alcohol, parabens, chlorobutanol, benzethonium chloride, and benzalkonium chloride, and combinations thereof, and a buffer selected from the group consisting of citric acid, sodium citrate, monopotassium phosphate, disodium phosphate, potassium biphthalate, sodium hydroxide, sodium acetate, acetic acid, and combinations thereof, wherein said solution of cyanocobalamin is suitable for intranasal administration, and has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin, with the proviso that the solution contains no mercury or mercury compounds.

2. The aqueous solution of claim 1, wherein the pH of the solution is about 4-6.

3. The aqueous solution of claim 2, wherein the pH of the solution is about 5.

4. The aqueous solution of claim 1, wherein the preservative is benzyl alcohol.

5. The aqueous solution of claim 1, wherein the preservative is benzalkonium chloride.

6. The aqueous solution of claim 1, wherein the buffer is sodium hydroxide.

7. The aqueous solution of claim 1, wherein the preservatives are benzyl alcohol and benzalkonium chloride and the buffer is sodium hydroxide.

8. The aqueous solution of claim 1, wherein the cyanocobalamin is present at a concentration of about 0.5% of the total weight of the aqueous solution.

9. A method for administering cyanocobalamin comprised of infusing the nose with an aqueous solution of claim 1.

10. The method of claim 9, wherein the pH of the aqueous solution is about 4-6.

11. The method of claim 9, wherein the pH of the aqueous solution is about 5.

12. The method of claim 9, wherein the preservative is benzyl alcohol.

13. The method of claim 9, wherein the preservative is benzalkonium chloride.

14. The method of claim 9, wherein the buffer is sodium hydroxide.

15. The method of claim 9, wherein the preservatives are benzyl alcohol and benzalkonium chloride and the buffer is sodium hydroxide.

16. The method of claim 9, wherein the cyanocobalamin is present at a concentration of about 0.5% of the total weight of the aqueous solution.

17. A method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally an aqueous solution of claim 1.
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