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Claims for Patent: 7,144,861

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Claims for Patent: 7,144,861

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:10/055,509
Patent Claims: 1. An aqueous pharmaceutical solution, which comprises: human parathyroid hormone (1 34) in a concentration of about 100 500 ug/ml; an acetate buffer to maintain the pH range of the solution from 3 to 6; a stabilizing agent selected from the group consisting of glucose, trehalose, raffinose, sucrose, mannitol, sorbitol, inositol, glycerine, propylene glycol, and mixtures thereof; a parenterally acceptable preservative; and water; wherein said solution is sterile and ready for parenteral administration to a human patient.

2. The pharmaceutical solution of claim 1 wherein the preservative is selected from m-cresol or benzyl alcohol.

3. The pharmaceutical solution of claim 2 wherein the preservative is m-cresol at a concentration range of about 0.3 to about 1.0% by weight of the solution.

4. The pharmaceutical solution of claim 1, 2, or 3, wherein the stabilizing agent is mannitol at a concentration of about 3% to 10% by weight of the total solution.

5. The pharmaceutical solution of claim 1, 2, or 3 wherein the concentration of the buffer is in the range of about 2 mM to 100 mM.

6. The pharmaceutical solution of claim 5 wherein the buffer includes acetic acid and sodium acetate.

7. The pharmaceutical solution of claim 1, 2, 3, or 4, wherein said parathyroid hormone concentration is 250 ug/ml.

8. An aqueous pharmaceutical solution, which comprises: 0.25 mg human parathyroid hormone (1 34), 50 mg mannitol, 2.5 mg m-cresol, 0.52 mg acetic acid and 0.12 mg sodium acetate mixed per 1 ml of water, wherein the solution is sterile and ready for parenteral administration to a human patient.

9. A method for preparing a sterile, ready to administer pharmaceutical solution for parenteral administration comprising human parathyroid hormone (1 34), said method comprising the steps of: a) admixing human parathyroid hormone (1 34) with: an acetate buffer to maintain a pH range from greater than 3 to less than 7; a stabilizing agent selected from the group consisting of glucose, trehalose, raffinose, sucrose, mannitol, sorbitol, inositol, glycerine, propylene glycol, and mixtures thereof; a parenterally acceptable preservative; and water wherein said parathyroid hormone is at a concentration of about 100 500 ug/ml; and b) sterilizing the solution for parenteral administration without undergoing a step of freeze-drying or reconstitution prior to use by a patient.

10. The method of claim 9, wherein the preservative is m-cresol in a range of about 0.3 to about 1.0% by weight of the solution; the stabilizing agent is about 3 to 10% by weight of the total solution; and the concentration of the buffer system is in the range of about 2 mM to 100 mM.

11. The method of claim 10, wherein about 0.25 mg human parathyroid hormone (1 34), 50 mg mannitol, 2.5 mg m-cresol, 0.52 mg acetic acid and 0.12 mg sodium acetate are mixed per 1 ml of water.

12. A sealed vial comprising: a sterile, aqueous pharmaceutical solution ready for parenteral administration to a patient, said solution comprising human parathyroid hormone (1 34) in a concentration range from 100 ug/ml to 500 ug/ml; an acetate or tartrate buffer system to maintain the pH range of the solution from 3 to 6; a stabilizing agent selected from glucose, trehalose, raffinose, sucrose, mannitol, sorbitol, inositol, glycerin, and propylene glycol, or mixtures thereof; a parenterally acceptable preservative; and water; wherein said solution has not been reconstituted in the vial from a powder.

13. The sealed vial of claim 12 wherein the stabilizer is mannitol.

14. The sealed vial of claim 13 wherein the parathyroid hormone (1 34) is at a concentration of 250 ug/ml, the mannitol is at a concentration of about 1% to about 20% by weight of the solution, and the preservative is at a concentration of about 0.1% to about 2% by weight of the solution.

15. A sealed vial as in claim 14 wherein said preservative is selected from m-cresol or benzyl alcohol and the mannitol is at a concentration of about 3 to 10% by weight of the solution.
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