Claims for Patent: 8,324,157

Summary for Patent: 8,324,157

Title:	Preparation comprising insulin, nicotinamide and an amino acid
Abstract:	Insulin preparations comprising an insulin compound or a mixture of two or more insulin compounds, a nicotinic compound and an amino acid.
Inventor(s):	Olsen; Helle Birk (Bagsv.ae butted.rd, DK), Havelund; Svend (Bagsv.ae butted.rd, DK), Ribel-Madsen; Ulla (Bagsv.ae butted.rd, DK), Sturis; Jeppe (Bagsv.ae butted.rd, DK), Naver; Helle (Bagsv.ae butted.rd, DK), Schlein; Morten (Bagsv.ae butted.rd, DK), Ludvigsen; Svend (Bagsv.ae butted.rd, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	13/309,134
Patent Claims:	1. A pharmaceutical formulation comprising: B28Asp human insulin; a nicotinic compound; arginine; a preservative; and a buffer. 2. The pharmaceutical formulation of claim 1, wherein the buffer is a phosphate buffer. 3. A pharmaceutical formulation comprising: B28Asp human insulin; nicotinamide; zinc; arginine; a preservative; and a phosphate buffer. 4. The pharmaceutical formulation of claim 3, wherein the nicotinamide is present at a concentration ranging from about 1 mM to about 300 mM. 5. The pharmaceutical formulation of claim 4, wherein less than about 4 zinc ions are present per six B28Asp human insulin molecules. 6. The pharmaceutical formulation of claim 5, wherein the arginine is present in a concentration from about 10 mM to about 60 mM. 7. The pharmaceutical formulation of claim 6, wherein the arginine is present in a concentration ranging from about 10 mM to about 40 mM. 8. The pharmaceutical formulation of claim 7, wherein the preparation has a pH of about 7.4 or less. 9. The pharmaceutical formulation of claim 8, wherein the preparation has a pH of about 7.1. 10. The pharmaceutical formulation of claim 3, wherein the nicotinamide is present at a concentration ranging from about 80 mM to about 260 mM. 11. The pharmaceutical formulation of claim 10, wherein the arginine is present in a concentration ranging from about 10 mM to about 40 mM. 12. The pharmaceutical formulation of claim 11, wherein the preparation has a pH of about 7.4 or less. 13. The pharmaceutical formulation of claim 12, wherein less than about 4 zinc ions are present per six B28Asp human insulin molecules. 14. The pharmaceutical formulation of claim 11, wherein the preparation has a pH of about 7.1. 15. The pharmaceutical formulation of claim 14, wherein less than about 4 zinc ions are present per six B28Asp human insulin molecules. 16. An aqueous pharmaceutical formulation consisting essentially of: B28Asp human insulin; a nicotinic compound; arginine; a buffer; zinc; a preservative; and an isotonicity agent. 17. The aqueous pharmaceutical formulation of claim 16, wherein the buffer is a phosphate buffer. 18. The aqueous pharmaceutical formulation of claim 17, wherein the nicotinic compound is nicotinamide. 19. The aqueous pharmaceutical formulation of claim 18, wherein the nicotinamide is present at a concentration ranging from about 80 mM to about 260 mM. 20. The aqueous pharmaceutical formulation of claim 19, wherein the arginine is present in a concentration ranging from about 10 mM to about 40 mM. 21. The aqueous pharmaceutical formulation of claim 20, wherein the preservative is selected from the group consisting of phenol, cresol, and combinations thereof, and wherein the preparation has a pH of about 7.4 or less. 22. The aqueous pharmaceutical formulation of claim 21, wherein less than about 4 zinc ions are present per six B28Asp human insulin molecules. 23. The aqueous pharmaceutical formulation of claim 21, wherein the preparation has a pH of about 7.1. 24. The pharmaceutical formulation of claim 1, wherein the buffer consists of a phosphate buffer. 25. The pharmaceutical formulation of claim 1, wherein the nicotinic compound comprises nicotinamide. 26. The pharmaceutical formulation of claim 25, wherein the nicotinamide is present at a concentration ranging from about 80 mM to about 260 mM. 27. The pharmaceutical formulation of claim 26, wherein the arginine is present in a concentration ranging from about 10 mM to about 40 mM. 28. The pharmaceutical formulation of claim 5, wherein about 3 zinc ions are present per six B28Asp human insulin molecules. 29. The pharmaceutical formulation of claim 5, wherein less than about 3 zinc ions are present per six B28Asp human insulin molecules. 30. The pharmaceutical formulation of claim 29, wherein about 2.5 zinc ions are present per six B28Asp human insulin molecules. 31. The pharmaceutical formulation of claim 13, wherein about 3 zinc ions are present per six B28Asp human insulin molecules. 32. The pharmaceutical formulation of claim 13, wherein less than about 3 zinc ions are present per six B28Asp human insulin molecules. 33. The pharmaceutical formulation of claim 32, wherein about 2.5 zinc ions are present per six B28Asp human insulin molecules. 34. The pharmaceutical formulation of claim 15, wherein about 3 zinc ions are present per six B28Asp human insulin molecules. 35. The pharmaceutical formulation of claim 15, wherein less than about 3 zinc ions are present per six B28Asp human insulin molecules. 36. The pharmaceutical formulation of claim 35, wherein about 2.5 zinc ions are present per six B28Asp human insulin molecules. 37. The aqueous pharmaceutical formulation of claim 22, wherein about 3 zinc ions are present per six B28Asp human insulin molecules. 38. The aqueous pharmaceutical formulation of claim 22, wherein less than about 3 zinc ions are present per six B28Asp human insulin molecules. 39. The aqueous pharmaceutical formulation of claim 38, wherein about 2.5 zinc ions are present per six B28Asp human insulin molecules. 40. The aqueous pharmaceutical formulation of claim 23, wherein less than about 4 zinc ions are present per six B28Asp human insulin molecules. 41. The aqueous pharmaceutical formulation of claim 40, wherein about 3 zinc ions are present per six B28Asp human insulin molecules. 42. The aqueous pharmaceutical formulation of claim 40, wherein less than about 3 zinc ions are present per six B28Asp human insulin molecules. 43. The aqueous pharmaceutical formulation of claim 42, wherein about 2.5 zinc ions are present per six B28Asp human insulin molecules.