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Claims for Patent: 8,552,025

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Claims for Patent: 8,552,025

Title:Stable methylnaltrexone preparation
Abstract: Stable pharmaceutical compositions useful for administering methylnaltrexone are described, as are methods for making the same. Kits, including these pharmaceutical compositions, also are provided.
Inventor(s): Sanghvi; Suketu P. (Kendall Park, NJ), Boyd; Thomas A. (Grandview, NY)
Assignee: Progenics Pharmaceuticals, Inc. (Tarrytown, NY)
Application Number:12/639,862
Patent Claims: 1. A stable pharmaceutical preparation comprising a solution of methylnaltrexone or a salt thereof, wherein the preparation comprises a pH between about 3.0 and about 4.0.

2. The pharmaceutical preparation of claim 1, wherein the pH is about 3.0 to about 3.5.

3. The pharmaceutical preparation of claim 1, wherein the concentration of methylnaltrexone or salt thereof ranges from 0.01 to 100 mg/ml.

4. The pharmaceutical preparation of claim 1, wherein the concentration of methylnaltrexone or salt thereof ranges from 1.0 to 50.0 mg/ml.

5. The pharmaceutical preparation of claim 1, wherein the concentration of methylnaltrexone or salt thereof is about 20 mg/ml.

6. The pharmaceutical preparation of claim 1, wherein the preparation is stable to storage for 6 months at about room temperature.

7. The pharmaceutical preparation of claim 1, wherein the preparation is stable to storage for 12 months at about room temperature.

8. The pharmaceutical preparation of claim 1, wherein the preparation is stable to storage for 24 months at about room temperature.

9. The pharmaceutical preparation of claim 1, further comprising a preservative.

10. The pharmaceutical preparation of claim 4, further comprising a preservative.

11. The pharmaceutical preparation of claim 1, further comprising an isotonicity agent.

12. The pharmaceutical preparation of claim 4, further comprising an isotonicity agent.

13. The pharmaceutical preparation of claim 1, wherein the preparation is suitable for parenteral administration.

14. The pharmaceutical preparation of claim 13, wherein the solution is provided in a vial with a septum or in a syringe.

15. The pharmaceutical preparation of claim 6, further comprising a preservative.

16. The pharmaceutical preparation of claim 6, further comprising an isotonicity agent.

17. The pharmaceutical preparation of claim 6, wherein the preparation is suitable for parenteral administration.

18. A pharmaceutical preparation comprising a solution of methylnaltrexone or a salt thereof, wherein the preparation has a pH ranging from 3.0 to 4.0, wherein the preparation is stable to storage for 6 months at about room temperature and wherein the preparation is suitable for parenteral administration.

19. The pharmaceutical preparation of claim 18, further comprising a preservative.

20. The pharmaceutical preparation of claim 18, further comprising an isotonicity agent.

21. The pharmaceutical preparation of claim 18, wherein the preparation has a pH of about 3.5.

22. The pharmaceutical preparation of claim 18, wherein the preparation has a pH of about 3.0 to about 3.5.

23. The pharmaceutical preparation of claim 1, wherein the preparation has a pH of about 3.5.
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