The present invention relates generally to vitamin B 12 nasal spray compositions and methods of using the same in the treatment of vitamin B 12 deficiency and various disorders that are related to such deficiency. In particular embodiments, the present invention is directed to treatment methods comprising intranasal administration of a cobalamin composition according to a particular dosing and frequency schedule and to a preservative-free nasal spray composition comprising a cobalamin compound useful in the practice of such treatment methods.
1. A method for maintaining vitamin B12 blood serum levels in a subject, the method comprising intranasally administering to the subject in need thereof a composition such that a dose of from about 5 μg to about 45 μg of cyanocobalamin is administered, wherein the composition comprises an aqueous solution containing about 1% w/w cyanocobalamin, a pharmaceutically acceptable buffer, a humectant, and a preservative, and wherein:
the buffer comprises a citrate buffer;
the humectant comprises glycerin;
the preservative comprises benzalkonium chloride;
the composition has a pH of about 4 to about 6.5, and
the composition is provided in a container equipped with a pump adapted to deliver the composition into a patient's nostril.
2. The method according to claim 1 , comprising administering the dose of cyanocobalamin in a plurality of metered sprays of the composition.
3. The method according to claim 1 , comprising administering the dose of cyanocobalamin in a single metered spray of the composition.
4. The method of claim 1 , wherein the composition is administered to provide a weekly dosage of from about 100 μg to about 1000 μg of cyanocobalamin.
5. The method of claim 1 , wherein the composition is administered to provide a weekly dosage of from about 100 μg to about 800 μg of cyanocobalamin.
6. The method of claim 1 , wherein the composition is administered to provide a weekly dosage of from about 100 μg to about 500 μg of cyanocobalamin.
7. The method of claim 1 , wherein the dose is administered once daily.
8. A method for maintaining normal hematologic status in a pernicious anemia patient following intramuscular vitamin B12 injection therapy, said method comprising intranasally administering to the patient a composition such that a dose of from about 5 μg to about 45 μg of cyanocobalamin is administered, wherein the composition comprises an aqueous solution containing about 1% w/w cyanocobalamin, a pharmaceutically acceptable buffer, a humectant, and a preservative, and wherein:
the buffer comprises a citrate buffer;
the humectant comprises glycerin;
the preservative comprises benzalkonium chloride;
the composition has a pH of about 4 to about 6.5, and
the composition is provided in a container equipped with a pump adapted to deliver the composition into a patient's nostril.
9. The method according to claim 8 , comprising administering the dose of cyanocobalamin in a plurality of metered sprays of the composition.
10. The method according to claim 8 , comprising administering the dose of cyanocobalamin in a single metered spray of the composition.
11. The method of claim 8 , wherein the composition is administered to provide a weekly dosage of from about 100 μg to about 1000 μg of cyanocobalamin.
12. The method of claim 8 , wherein the composition is administered to provide a weekly dosage of from about 100 μg to about 800 μg of cyanocobalamin.
13. The method of claim 8 , wherein the composition is administered to provide a weekly dosage of from about 100 μg to about 500 μg of cyanocobalamin.