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Claims for Patent: 5,834,422

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Claims for Patent: 5,834,422

Title: Asp.sup.B28 insulin compositions
Abstract:The present invention relates to insulin crystals comprising ASP.sup.B28 and protamine, and pharmaceutical preparations containing same, The crystals and preparations exhibit rapid onset and prolonged activity when administered in vivo.
Inventor(s): Balschmidt; Per (Esper.ae butted.rde, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:08/763,851
Patent Claims: 1. A pharmaceutical formulation comprising:

(A) crystals comprising Asp.sup.B28 human insulin and protamine; and

(B) a solution comprising Asp.sup.B28 human insulin, zinc, and water.

2. A pharmaceutical formulation as defined in claim 1, wherein said crystals are suspended in said solution.

3. A pharmaceutical formulation as defined in claim 2, wherein said crystals further comprise zinc.

4. A pharmaceutical formulation as defined in claim 2, further comprising a member selected from the group consisting of an isotonic agent, a buffer, and a combination thereof.

5. A pharmaceutical formulation as defined in claim 3, further comprising a member selected from the group consisting of an isotonic agent, a buffer, or a combination thereof.

6. A pharmaceutical formulation as defined in claim 5, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate.

7. A pharmaceutical formulation as defined in claim 5, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate.

8. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical formulation as defined in claim 2.

9. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical formulation as defined in claim 3.

10. A pharmaceutical formulation comprising

(1) crystals comprising Asp.sup.B28 human insulin, protamine, and a member selected from the group comprising of phenol, m-cresol, and a combination thereof; and

(2) a solution comprising Asp.sup.B28 human insulin, zinc, water, and a member selected from the group comprising of phenol, m-cresol, and a combination thereof.

11. A pharmaceutical formulation as defined in claim 10, wherein said crystals are suspended in said solution.

12. A pharmaceutical formulation as defined in claim 11, wherein said crystals further comprise zinc.

13. A pharmaceutical formulation as defined in claim 11, further comprising a member selected from the group consisting of an isotonic agent, a buffer, and a combination thereof.

14. A pharmaceutical formulation as defined in claim 12, further comprising a member selected from the group consisting of an isotonic agent, a buffer, and a combination thereof.

15. A pharmaceutical formulation as defined in claim 13, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate.

16. A pharmaceutical formulation as defined in claim 14, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate.

17. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical formulation as defined in claim 11.

18. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical formulation as defined in claim 12.

19. A pharmaceutical formulation comprising:

(A) crystals comprising Asp.sup.B28 human insulin and protamine; and

(B) a solution comprising water and a hexameric human insulin analog complex comprising Asp.sup.B28 human insulin and zinc.

20. A pharmaceutical formulation as defined in claim 19, wherein said crystals are suspended in said solution.

21. A pharmaceutical formulation as defined in claim 20, wherein said crystals further comprise zinc.

22. A pharmaceutical formulation as defined in claim 20, wherein said hexameric human insulin analog complex comprises six molecules of Asp.sup.B28 human insulin and at least two zinc ions.

23. A pharmaceutical formulation as defined in claim 21, wherein said hexameric human insulin analog complex comprises six molecules of Asp.sup.B28 human insulin and at least two zinc ions.

24. A pharmaceutical formulation as defined in claim 20, further comprising an isotonic agent, a buffer, and a combination thereof.

25. A pharmaceutical formulation as defined in claim 21, further comprising an isotonic agent, a buffer, and a combination thereof.

26. A pharmaceutical formulation as defined in claim 24, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate.

27. A pharmaceutical formulation as defined in claim 25, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate.

28. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical formulation as defined in claim 20.

29. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical formulation as defined in claim 21.

30. A pharmaceutical formulation comprising:

(A) crystals comprising Asp.sup.B28 human insulin, protamine, and a member selected from the group consisting of phenol, m-cresol, and a combination thereof; and

(B) a solution comprising water and a hexameric human insulin analog complex comprising Asp.sup.B28 insulin, zinc, and a member selected from the group consisting of phenol, m-cresol, and a combination thereof.

31. A pharmaceutical formulation as defined in claim 30, wherein said crystals are suspended in said solution.

32. A pharmaceutical formulation as defined in claim 31, wherein said crystals further comprise zinc.

33. A pharmaceutical formulation as defined in claim 31, wherein said hexameric human insulin analog complex comprises six molecules of Asp.sup.B28 human insulin and at least two zinc ions.

34. A pharmaceutical formulation as defined in claim 32, wherein said hexameric human insulin analog complex comprises six molecules of Asp.sup.B28 human insulin and at least two zinc ions.

35. A pharmaceutical formulation as defined in claim 31, further comprising a member selected from the group consisting of an isotonic agent, a buffer, and a combination thereof.

36. A pharmaceutical formulation as defined in claim 32, further comprising a member selected from the group consisting of an isotonic agent, a buffer, and a combination thereof.

37. A pharmaceutical formulation as defined in claim 35, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate.

38. A pharmaceutical formulation as defined in claim 36, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate.

39. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical formulation as defined in claim 31.

40. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical formulation as defined in claim 32.

41. A pharmaceutical formulation comprising:

(A) crystals comprising Asp.sup.B28 human insulin and protamine; and

(B) a solution prepared by combining water; zinc and Asp.sup.B28 human insulin in a molar ratio of at least 1:6; and a member selected from the group consisting of phenol, m-cresol, and a combination thereof.

42. A pharmaceutical formulation as defined in claim 41, wherein said crystals are suspended in said solution.

43. A pharmaceutical formulation as defined in claim 41, wherein said molar ratio is about 1:6.

44. A pharmaceutical formulation comprising:

(A) crystals comprising Asp.sup.B28 human insulin and protamine; and

(B) a solution prepared by dissolving Asp.sup.B28 human insulin in a diluent, and adding zinc so that the molar ratio of zinc to Asp.sub.B28 human insulin is at least 1:6; and a member selected from the group consisting of phenol, m-cresol, and a combination thereof to said analog dissolved in said diluent.

45. A pharmaceutical formulation as defined in claim 44, wherein said crystals are suspended in said solution.

46. A pharmaceutical formulation as defined in claim 44, wherein said molar ratio is about 1:6.

47. A pharmaceutical formulation as defined in claim 41, wherein said complex comprises a hexamer.

48. A pharmaceutical formulation as defined in claim 44, wherein said complex comprises a hexamer.

49. A pharmaceutical formulation as defined in claim 42, further comprising a member selected from the group consisting of an isotonic agent, a buffer, and a combination thereof.

50. A pharmaceutical formulation as defied in claim 45, further comprising a member selected from the group consisting of an isotonic agent, a buffer, and a combination thereof.

51. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical formulation as defined in claim 42.
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