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Claims for Patent: 8,940,714

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Claims for Patent: 8,940,714

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:13/189,061
Patent Claims: 1. A method of administering cyanocobalamin, comprising infusing the nose of a subject in need thereof with an aqueous solution comprising a pharmaceutically effective amount of cyanocobalamin at a concentration of about 0.5% of total weight of solution, wherein the solution has a viscosity of less than 1000 cPs, and wherein the solution has a bioavailability of about 7% or more relative to the bioavailability of an intramuscular injection containing cyanocobalamin at a concentration of 0.1% of the total weight based on a same volume as the solution.

2. The method of claim 1 wherein the solution has a bioavailability of about 9% or more relative to the bioavailability of the intramuscular injection of cyanocobalamin.

3. The method of claim 1 wherein the solution has a bioavailability of about 10% or more relative to the bioavailability of the intramuscular injection of cyanocobalamin.

4. The method of claim 1 wherein the solution has a bioavailability of about 11% or more relative to the bioavailability of the intramuscular injection of cyanocobalamin.

5. The method of claim 1 wherein the solution has a bioavailability of about 12% or more relative to the bioavailability of the intramuscular injection of cyanocobalamin.

6. The method of claim 1, wherein the solution comprises cyanocobalamin, water, and one or more components selected from the group consisting of: a buffer, a preservative, and a humectant.

7. The method of claim 6, wherein the buffer is 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.

8. The method of claim 6, wherein the preservative is selected from the group consisting of: benzyl alcohol, parabens thimerosal, chlorobutanol, benzethonium chloride, and benzalkonium chloride.

9. The method of claim 6, wherein the humectant is selected from the group consisting of: sorbitol, propylene glycol, and glycerin.

10. A method of administering cyanocobalamin, comprising infusing the nose of a subject in need thereof with an aqueous solution comprising: a pharmaceutically effective amount of cyanocobalamin at a concentration of about 0.5% of total weight of solution, citric acid, sodium citrate, benzaikonium chloride, and glycerin, wherein the solution has a viscosity of less than 1000 cPs, and wherein the solution has a bioavailability of about 7% or more relative to the bioavailability of an intramuscular injection containing cyanocobalamin at a concentration of 0.1% of the total weight based on a same volume as the solution.

11. The method of claim 1 wherein the solution has a bioavailability of about 8% or more relative to the bioavailability of the intramuscular injection of cyanocobalamin.
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