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Claims for Patent: 7,550,434

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Claims for Patent: 7,550,434

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:11/541,862
Patent Claims: 1. A process for preparing a sealed vial or sealed cartridge containing a sterile pharmaceutical solution, comprising: a) combining human PTH (1-34) at a concentration of 100 .mu.g/ml to 500 .mu.g/ml, a polyol stabilizing agent, a buffering system to maintain the pH range of the solution from greater than 3 to 6, and a parenterally acceptable preservative; and b) sealing said solution in a vial or cartridge from which a therapeutically effective dose of PTH can be withdrawn for parenteral administration by a human patient; wherein the solution does not undergo a step of lyophilization prior to use by the patient.

2. The process of claim 1, wherein said polyol stabilizing agent is present in the solution at 3 to 10 wt-% of the total solution.

3. The process of claim 1, wherein said polyol stabilizing agent is mannitol.

4. The process of claim 1, wherein said buffering system is selected from citrate, tartrate or acetate.

5. The process of claim 1, wherein said buffering system is acetate.

6. The process of claim 1, wherein said preservative is selected from the cresols, benzyl alcohol, phenol, benzalkonium chloride, benzethonium chloride, chlorobutanol, phenylethyl alcohol, methyl paraben, propyl paraben, thimerosal, phenylmercuric nitrate and phenylmercuric acetate.

7. The process of claim 1, wherein said preservative is m-cresol.

8. The process of claim 3, wherein said buffering system is selected from citrate, tartrate or acetate.

9. The process of claim 3, wherein said buffering system is acetate.

10. The process of claim 8, wherein said preservative is selected from the cresols, benzyl alcohol, phenol, benzalkonium chloride, benzethonium chloride, chlorobutanol, phenylethyl alcohol, methyl paraben, propyl paraben, thimerosal, phenylmercuric nitrate and phenylmercuric acetate.

11. The process of claim 8, wherein said preservative is m-cresol.

12. A sealed vial or sealed cartridge containing a pharmaceutical solution comprising: a) human parathyroid hormone (1-34) at a concentration of 100 .mu.g/ml to 500 .mu.g/ml; b) a buffering system to maintain the pH range of the solution from greater than 3 to 6; c) a polyol stabilizing agent; and d) and a parenterally acceptable preservative; wherein the solution is sterile and ready for parenteral administration by a human patient without undergoing a step of lyophilization prior to use by the patient.

13. The vial or cartridge of claim 12, wherein said polyol stabilizing agent is present in the solution at 3 to 10 wt-% of the total solution.

14. The vial or cartridge of claim 12, wherein said polyol stabilizing agent is mannitol.

15. The vial or cartridge of claim 12, wherein said buffering system is selected from citrate, tartrate or acetate.

16. The vial or cartridge of claim 12, wherein said buffering system is acetate.

17. The vial or cartridge of claim 12, wherein said preservative is selected from the cresols, benzyl alcohol, phenol, benzalkonium chloride, benzethonium chloride, chlorobutanol, phenylethyl alcohol, methyl paraben, propyl paraben, thimerosal, phenylmercuric nitrate and phenylmercuric acetate.

18. The vial or cartridge of claim 12, wherein said preservative is m-cresol.

19. The vial or cartridge of claim 14, wherein said buffering system is selected from citrate, tartrate or acetate.

20. The vial or cartridge of claim 14, wherein said buffering system is acetate.

21. The vial or cartridge of claim 19, wherein said preservative is selected from the cresols, benzyl alcohol, phenol, benzalkonium chloride, benzethonium chloride, chlorobutanol, phenylethyl alcohol, methyl paraben, propyl paraben, thimerosal, phenylmercuric nitrate and phenylmercuric acetate.

22. The vial or cartridge of claim 19, wherein said preservative is m-cresol.

23. A sealed vial or sealed cartridge containing a pharmaceutical solution comprising a) human parathyroid hormone (1-34) at a concentration of 250 .mu.g/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 the pH range of the solution from greater than 3 to 6; c) mannitol at a concentration of 45 .4 mg/ml; and d) m-cresol at a concentration of 3.0 mg/ml; wherein the solution is sterile and ready for parenteral administration by a human patient without undergoing a step of lyophilization prior to use by the patient.

24. A method of treating osteoporosis comprising parenteral administration to a patient in need thereof of a pharmaceutical solution comprising human PTH(1-34) in a concentration of 100-500 .mu.g/ml, a buffering system to maintain the pH range of the solution from greater than 3 to 6, a polyol stabilizing agent, and a parenterally acceptable preservative; wherein said solution is sterile and ready for parenteral administration by a human patient; and wherein the solution is withdrawn from a sealed vial or sealed cartridge without undergoing a step of lyophilization prior to use by the patient.

25. The method of claim 24, wherein said polyol stabilizing agent is present in the solution at 3 to 10 wt-% of the total solution.

26. The method of claim 24, wherein said polyol stabilizing agent is mannitol.

27. The method of claim 24, wherein said buffering system is selected from citrate, tartrate or acetate.

28. The method of claim 24, wherein said buffering system is acetate.

29. The method of claim 24, wherein said preservative is selected from the cresols, benzyl alcohol, phenol, benzalkonium chloride, benzethonium chloride, chlorobutanol, phenylethyl alcohol, methyl paraben, propyl paraben, thimerosal, phenylmercuric nitrate and phenylmercuric acetate.

30. The method of claim 24, wherein said preservative is m-cresol.

31. The method of claim 26, wherein said buffering system is selected from citrate, tartrate or acetate.

32. The method of claim 26, wherein said buffering system is acetate.

33. The method of claim 31, wherein said preservative is selected from the cresols, benzyl alcohol, phenol, benzalkonium chloride, benzethonium chloride, chlorobutanol, phenylethyl alcohol, methyl paraben, propyl paraben, thimerosal, phenylmercuric nitrate and phylmercuric acetate.

34. The method of claim 31, wherein said preservative is m-cresol.
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