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Claims for Patent: 4,724,231

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Claims for Patent: 4,724,231

Title: Nasel compositions containing vitamin B.sub.12
Abstract:This invention is directed to compositions for nasal administration of a vitamin B.sub.12 to a human suffering a vitamin B.sub.12 deficiency. It is also directed to such compositions in dosage unit form and with methods of administering such compositions.
Inventor(s): Wenig; Jeffrey (Dix Hills, NY)
Assignee: Nastech Pharmaceutical, Inc. (Hauppauge, NY)
Application Number:06/848,690
Patent Claims: 1. A therapeutic composition for nasal administration comprising a therapeutically effective amount of a vitamin B.sub.12, a pharmaceutically acceptable isotonic aqueous buffer to provide a pH of from about 4 to 6 and sufficient pharmaceutically acceptable thickening agent so that the viscosity of the composition is from about 2500 to 10,000 cps.

2. A therapeutic composition of claim 1 wherein the vitamin B.sub.12 is cyanocobalamin.

3. A composition as in claim 1 or 2 additionally containing from about 1% to 10% by weight of a humectant.

4. A composition as in claim 1 or 2 additionally containing from about 0.2% to 2% by weight of a surfactant.

5. A composition as in claim 1 or 2 additionally containing from about 1% to 10% by weight of a humectant and from about 0.2% to 2% by weight of a surfactant.

6. A therapeutic composition as in claim 1 wherein the thickening agent is methyl cellulose.

7. A therapeutic composition of claim 6 wherein the vitamin B.sub.12 is cyanocobalamin.

8. A therapeutic composition of claim 6 or 7 additionally containing from about 1% to 10% by weight of a humectant and from about 0.2% to 2% by weight of a surfactant.

9. A therapeutic composition for nasal administration in dosage unit form comprising from 50 to 1000 micrograms of a vitamin B.sub.12, a pharmaceutically acceptable isotonic aqueous buffer to provide a pH of from about 4 to 6 and sufficient pharmaceutically acceptable thickening agent so that the viscosity of the composition is from about 2500 to 10,000 cps.

10. A therapeutic composition as in claim 9 wherein the vitamin B.sub.12 is cyanocobalamin.

11. A therapeutic composition as in claim 9 or 10 additionally containing from about 1% to 10% by weight of a humectant.

12. A therapeutic composition as in claim 9 or 10 additionally containing from about 0.2% to 2% by weight of a surfactant.

13. A therapeutic composition as in claim 9 or 10 additionally containing from about 1% to 10% by weight of a surfactant.

14. A therapeutic composition as in claim 9 wherein the thickening agent is methyl cellulose.

15. A therapeutic composition as in claim 14 wherein the vitamin B.sub.12 is a cyanocobalamin.

16. A therapeutic composition as in claim 14 or 15 additionally containing from about 1% to 10% by weight of a humectant and from about 0.2% to 2% by weight of a surfactant.

17. A method of treating a human for vitamin B.sub.12 deficiency which comprises nasal administering to a human in need of such treatment a composition comprising a therapeutically effective amount of a vitamin B.sub.12, a pharmaceutically acceptable isotonic aqueous buffer to provide a pH of from about 4 to 6 and sufficient pharmaceutically acceptable thickening agent so that the viscosity of the composition is from about 2500 to 10,000 cps.

18. A method as in claim 17 wherein the vitamin B.sub.12 is cyanocobalamin.

19. A method as in claim 17 or 18 wherein the composition additionally contains from about 1% to 10% by weight of a humectant.

20. A method as in claim 17 or 18 wherein the composition additionally contains from about 0.2% to 2% by weight of a surfactant.

21. A method as in claim 17 or 18 wherein the composition additionally contains from about 1% to 10% by weight of a humectant and from about 0.2% to 2% by weight of a surfactant.

22. A method as in claim 17 wherein the thickening agent is methyl cellulose.

23. A method as in claim 22 wherein the vitamin B.sub.12 is cyanocobalamin.

24. A method as in claim 22 or 23 wherein the composition additionally contains from about 1% to 10% by weight of a humectant and from about 0.2% to 2% by weight of a surfactant.

25. A composition as in claim 1 wherein the viscosity is from 2500 to 6500 cps.

26. A composition as in claim 9 wherein the viscosity is from 2500 to 6500 cps.

27. A method as in claim 17 wherein the viscosity of the composition is from 2500 to 6500 cps.
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