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Claims for Patent: 8,003,353

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Claims for Patent: 8,003,353

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:12/142,240
Patent Claims: 1. A method for administering cyanocobalamin comprised of providing an aqueous solution of cyanocobalamin wherein said aqueous solution of cyanocobalamin is comprised of cyanocobalamin at a concentration of about 0.5% of total weight of solution, citric acid at a concentration of about 0.12%, sodium citrate at a concentration of about 0.32%, glycerin at a concentration of about 2.23%, benzalkonium chloride at concentration of about 0.02% and water, wherein said solution of cyanocobalamin is suitable for intranasal administration and has a viscosity less than about 1000 cPs, with the proviso that the solution of cyanocobalamin contains no mercury or mercury-containing compounds, and wherein the cyanocobalamin solution is administered into a nose of an individual through an actuator tip as a spray, wherein the spray has a spray pattern ellipticity ratio of from about 1.0 to about 1.4 when measured at a height of 3.0 cm from the actuator tip.

2. The method of claim 1 wherein the cyanocobalamin spray produces droplets of the solution, wherein less than 5% of the droplets are less than 10 .mu.m in size.

3. The method of claim 1 wherein the cyanocobalamin spray produces droplets of the solution, and wherein 50% of the droplets are 26.9 .mu.m or less in size.

4. The method of claim 1 wherein the cyanocobalamin spray produces droplets of the solution, and wherein 90% of the droplets are 55.3 .mu.m or less in size.

5. The method of claim 1 wherein the cyanocobalamin spray produces droplets of the solution, and wherein 10% of the droplets are 12.5 .mu.m or less in size.

6. The method of claim 1 wherein the spray has a spray pattern major axis and a minor axis of about 25-40 mm each.
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