Cyanocobalamin low viscosity aqueous formulations for intranasal delivery

  • US 9,415,007 B2
  • Filed: 09/12/2014
  • Issued: 08/16/2016
  • Est. Priority Date: 03/04/2003
  • Status: Active Grant
First Claim
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1. A method for elevating a level of vitamin B12 in a subject having vitamin B12 deficiency associated with gastric surgery, comprising:

  • administering an aqueous solution of cyanocobalamin to the subject having vitamin B12 deficiency associated with gastric surgery,wherein the aqueous solution of cyanocobalamin comprises;

    cyanocobalamin;

    water;

    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;

    optionally, a humectant selected from the group consisting of sorbitol, propylene glycol, and glycerin, and combinations thereof; and

    optionally, a preservative selected from the group consisting of benzyl alcohol, parabens thimerosal, chlorobutanol, benzethonium chloride, and benzalkonium chloride, and combinations thereof;

    wherein the aqueous solution of cyanocobalamin is suitable for intranasal administration, has a viscosity of less than about 1000 cPs, and a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin.

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