Vitamin B₁₂nasal spray and method of use

摘要

The present invention relates generally to vitamin B12 nasal spray compositions and methods of using the same in the treatment of vitamin B12 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.

主权项

1. A kit comprising:
A) a composition for nasal administration of a cobalamin compound, the composition comprising an aqueous solution containing about 0.02% w/w to about 1% w/w of a cobalamin compound and a pharmaceutically acceptable buffer, wherein the composition is sterile, wherein the composition is free of preservatives, wherein the composition has a pH of about 4 to about 6.5, and wherein the cobalamin compound is cyanocobalamin or hydroxocobalamin; and B) a container equipped with a pump adapted to deliver the composition into a patient's nostril, wherein the container is configured such that the dose of the cobalamin compound delivered with each administration is from about 5 μg to about 45 μg.