Claims for Patent: 4,724,231

Summary 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.