Vitamin B12 nasal spray and method of use

a technology of vitamin b12 and composition, applied in the field of vitamin b12 nasal spray composition, can solve the problems of inconvenient and pain associated with the injection that typically must be administered by medical personnel, the inability of medical personnel to adequately absorb cobalamin compositions orally, and the inability to effectively absorb cobalamin compositions in patients. , to achieve the effect of improving the effect of reducing the risk of infection, improving the effect of anti-inflammatory effect, and improving the effect of anti-

Inactive Publication Date: 2007-05-17
ENDO PHARMA INC
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AI Technical Summary

Problems solved by technology

Use of vitamin B12 injections for maintenance therapy has obvious disadvantages, including the inconvenience and pain associated with the injection that typically must be administered by medical personnel.
Orally administered cobalamin compositions may fail to be adequately absorbed in the patient, particularly in those in which secretion or utilization of intrinsic factor is inadequate.
Although maintenance therapy with vitamin B12 nasal compositions has proven generally effective, those undergoing such therapy may experience some irritation of the nasal mucosa and discomfort due, in part, to the high dosage of the cobalamin compound typically administered as well as preservatives and other additives often present in these compositions.

Method used

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[0046] The study comprised twenty-five subjects, ages 18-85, with a history of documented vitamin B12 deficiency who had previously been receiving maintenance intramuscular (IM) injections of B12. The purpose of this study was to determine whether as an alternative to IM injections, one daily administration of a 0.025% by weight cobalamin composition is sufficient to sustain an efficacious level of B12 in place of IM therapy and, thereby, maintain a serum B12 level within the therapeutic range of greater than about 200 ng / L.

[0047] As an alternative to an IM injection, an aqueous isotonic composition containing a cobalamin compound was provided to the subjects to allow them to dose themselves at home with one daily intranasal (IN) administration comprising two puffs or sprays of B12 (cobalamin). The intranasal cobalamin composition used in this study is listed in Table 1.

TABLE 1Cobalamin Containing Composition Used in StudyQuantity Required perDescription% w / wBatchMolaritySodium C...

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Abstract

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application Ser. No. 60 / 709,200 filed Aug. 17, 2005, the entire content of which is hereby incorporated herein by reference.FIELD OF THE INVENTION [0002] 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. BACKGROUND [0003] Vitamin B12 is a water soluble vitamin that plays a role in mammalian growth, hematopoiesis, production of epithelial cells, and maintenance of the nervous system. It was firs...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/714
CPCA61K9/0043A61K31/714A61K47/02A61P1/02A61P7/06A61K47/10A61K47/12A61M11/006A61M15/08
Inventor FELLER, THEODORE H.SUTTERER, ANGELAFLEMING, THOMAS E.ARNALL, PATRICK J.
Owner ENDO PHARMA INC
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