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Claims for Patent: 6,770,623

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Claims for Patent: 6,770,623

Title: Stabilized teriparatide solutions
Abstract:A stabilized pharmaceutical composition in the form of a solution for parenteral administration of a parathyroid hormone is described wherein the therapeutically active ingredient is stabilized with a buffer and a polyol. Preferred preparations contain in an aqueous solution human PTH(1-34), mannitol, an acetate or tartrate buffering agent and m-cresol or benzyl alcohol as a preservative.
Inventor(s): Chang; Chin-Ming (Fishers, IN), Havel; Henry A. (Indianapolis, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:09/555,476
Patent Claims: 1. A process for preparing a sealed vial or cartridge containing a liquid pharmaceutical formulation, comprising: a. combining human parathyroid hormone and a buffer to maintain a pH from greater than 3 to less than 7, thereby forming a solution, and b. sealing said solution in the vial or cartridge, from which a therapeutically effective dose of parathyroid hormone can be withdrawn for use by a patient.

2. A process for preparing a pharmaceutical composition in the form of a solution, comprising admixing human parathyroid hormone with a buffer to maintain a pH from greater than 3 to less than 7, wherein said solution does not undergo a step of freeze-drying or reconstitution prior to use by a patient.

3. The process of claim 2, wherein said buffer is selected from citrate, tartrate, or acetate.

4. The process of claim 2, said solution further comprising a stabilizer.

5. The process of claim 4, wherein said stabilizer is mannitol.

6. The process of claim 2, wherein said human parathyroid hormone is selected from the group consisting of PTH(1-31), PTH(1-34), PTH(1-37), PTH(1-38), PTH(1-41) and PTH(1-84).

7. The process of claim 6, wherein said human parathyroid hormone is PTH(1-84).

8. The process of claim 6, wherein said human parathyroid hormone is PTH(1-34).

9. A sealed vial containing a ready to administer pharmaceutical composition in the form of a solution suitable for administration by a patient, said composition comprising: a) human parathyroid hormone, and b) a buffer to maintain a pH from greater than 3 to less than 7.

10. The vial of claim 9 wherein said buffer is selected from citrate, tartrate, or acetate.

11. The vial of claim 9, said composition further comprising a stabilizer.

12. The vial of claim 11 wherein said stabilizer is mannitol.

13. The vial of claim 9, wherein said human parathyroid hormone is selected from the group consisting of PTH(1-31), PTH(1-34), PTH(1-37), PTH(1-38), PTH(1-41) and PTH(1-84).

14. The vial of claim 13, wherein said human parathyroid hormone is PTH(1-84).

15. The vial of claim 13, wherein said human parathyroid hormone is PTH(1-34).

16. The vial of claim 9 wherein said parathyroid hormone is at a concentration of 25 ug/ml to 1000 ug/ml.

17. A vial containing a stable liquid pharmaceutical formulation suitable for administration by a patient without being reconstituted by said patient prior to use, said formulation comprising: a) human parathyroid hormone (1-34) at a concentration of 250 ug/ml; b) glacial acetic acid at a concentration of 0.41 mg/ml, and sodium acetate (anhydrous) at a concentration of 0.10 mg/ml to maintain a pH from about 3 to 6; c) mannitol at a concentration of 45.4 mg/ml; d) metacresol at a concentration of 3.0 mg/ml; and e) water.

18. A method of treating osteoporosis comprising administration to a patient in need thereof of a formulated solution of human parathyroid hormone and a buffer to maintain a pH from greater than 3 to less than 7, said solution not having been reconstituted prior to administration to a patient.

19. The method according to claim 18 wherein said buffer is selected from citrate, tartrate, or acetate.

20. The method according to claim 18 said solution further comprising a stabilizer.

21. The method according to claim 20 wherein said stabilizer is mannitol.

22. The method according to claim 18 wherein said human parathyroid hormone is selected from the group consisting of PTH(1-31), PTH(1-34), PTH(1-37), PTH(1-38), PTH(1-41) and PTH(1-84).

23. The method according to claim 22 wherein said human parathyroid hormone is PTH(1-84).

24. The method according to claim 22 wherein said human parathyroid hormone is PTH(1-34).

25. The method according to claim 18 wherein said parathyroid hormone is at a concentration of 25 ug/ml to 1000 ug/ml.

26. The vial of claim 9 wherein said formulation further comprises a parenterally acceptable preservative.

27. A sealed cartridge containing a pharmaceutical composition in the form of a sterile solution ready for parenteral administration by a human patient, said formulation comprising: a. human parathyroid hormone, and b. a buffer to maintain a pH from greater than 3 to less than 7.

28. The cartridge of claim 27 wherein said buffer is selected from citrate, tartrate, or acetate.

29. The cartridge of claim 27, said formulation further comprising a stabilizer.

30. The cartridge of claim 29, wherein said stabilizer is mannitol.

31. The cartridge of claim 27, wherein said human parathyroid hormone is selected from the group consisting of PTH(1-31), PTH(1-34), PTH(1-37), PTH(1-38), PTH(1-41) and PTH(1-84).

32. The cartridge of claim 31, wherein said human parathyroid hormone is PTH(1-84).

33. The cartridge of claim 31, wherein said human parathyroid hormone is PTH(1-34).

34. The cartridge of claim 27 wherein said parathyroid hormone is at a concentration of 25 ug/ml to 1000 ug/ml.

35. A cartridge containing a pharmaceutical composition in the form of a solution suitable for administration by a patient, said formulation comprising: a) human parathyroid hormone (1-34) at a concentration of 250 ug/ml; b) glacial acetic acid at a concentration of 0.41 mg/ml, and sodium acetate (anhydrous) at a concentration of 0.10 mg/ml to maintain a pH from about 3 to 6; c) mannitol at a concentration of 45.4 mg/ml; d) metacresol at a concentration of 3.0 mg/ml; and e) water.

36. The vial of claim 15, further comprising a stabilizer, and wherein the buffer is selected from citrate, tartrate, or acetate.

37. A vial containing a liquid pharmaceutical formulation suitable for administration by a patient without being reconstituted by said patient prior to use, said formulation comprising: a) human parathyroid hormone (1-34) at a concentration of 25 ug/ml to 1000 ug/ml; b) a buffer to maintain a pH from about 3 to about 6; c) mannitol; d) metacresol; and e) water.

38. A cartridge containing a liquid pharmaceutical formulation suitable for administration by a patient, said formulation comprising: f) human parathyroid hormone (1-34) at a concentration of 25 ug/ml to 1000 ug/ml; g) a buffer to maintain a pH from about 3 to about 6; h) mannitol; i) metacresol; and j) water.

39. A sealed vial containing a pharmaceutical composition in the form of a solution suitable for administration by a patient, said composition comprising: a) human parathyroid hormone, and b) a buffer to maintain a pH from greater than 3 to less than 7, wherein said solution has not been reconstituted in the vial from a freeze-dried powder.

40. The vial of claim 39 wherein said buffer is selected from citrate, tartrate, or acetate.

41. The vial of claim 39, said formulation further comprising a stabilizer.

42. The vial of claim 41 wherein said stabilizer is mannitol.

43. The vial of claim 39, wherein said human parathyroid hormone is selected from the group consisting of PTH(1-31), PTH(1-34), PTH(1-37), PTH(1-38), PTH(1-41) and PTH(1-84).

44. The vial of claim 43, wherein said human parathyroid hormone is PTH(1-84).

45. The vial of claim 43, wherein said human parathyroid hormone is PTH(1-34).

46. The vial of claim 39 wherein said parathyroid hormone is at a concentration of 25 ug/ml to 1000 ug/ml.

47. The vial of claim 39 wherein said formulation further comprises a parenterally acceptable preservative.

48. The vial of claim 45, further comprising a stabilizer, and wherein the buffer is selected from citrate, tartrate, or acetate.
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