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Claims for Patent: 9,006,289

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Claims for Patent: 9,006,289

Title:Levothyroxine formulations
Abstract: A levothyroxine composition includes levothyroxine sodium and mannitol. The composition is a solid. The composition may include from 100 to 500 micrograms levothyroxine sodium and from 1 to 5 milligrams mannitol. The composition may include from 100 to 200 micrograms levothyroxine sodium, and the mass ratio of mannitol to levothyroxine sodium in the composition may be at most 40:1. The composition may include about 500 micrograms levothyroxine sodium, and the mass ratio of mannitol to levothyroxine sodium in the composition may be at most 10:1.
Inventor(s): Jiang; Zhi-Qiang (Skokie, IL), Usayapant; Arunya (Mundelein, IL), Monen; George (Woodridge, IL)
Assignee: Fresenius Kabi USA, LLC (Lake Zurich, IL)
Application Number:13/597,884
Patent Claims: 1. A composition, comprising: about 100 or about 200 micrograms of levothyroxine sodium; a phosphate buffer; and from 2 to 4 milligrams of mannitol, where the composition is a lyophilized solid.

2. The composition of claim 1, where the amount of levothyroxine sodium is about 100 micrograms and the amount of mannitol is about 3 milligrams.

3. The composition of claim 1, where the amount of levothyroxine sodium is about 200 micrograms and the amount of mannitol is about 3 milligrams.

4. The composition of claim 2, where the phosphate buffer is dibasic sodium phosphate in an amount from 400 to 600 micrograms.

5. The composition of claim 4, where the composition is formed by forming a liquid mixture by combining the levothyroxine sodium, the mannitol, dibasic sodium phosphate, and a solvent comprising water; and lyophilizing the liquid mixture.

6. The composition of claim 1, where when the composition is stored at 25 .degree. C., at most 0.20% of the levothyroxine sodium is converted to liothyronine over a period of 12 months.

7. The composition of claim 1, where when the composition is stored at 40 .degree. C., at most 0.20% of the levothyroxine sodium is converted to liothyronine over a period of 3 months.

8. The composition of claim 4, where when the composition is stored at 25 .degree. C., at most 0.20% of the levothyroxine sodium is converted to liothyronine over a period of 12 months.

9. The composition of claim 3, where the phosphate buffer is dibasic sodium phosphate in an amount from 400 to 600 micrograms.

10. The composition of claim 9, where the composition is formed by forming a liquid mixture by combining the levothyroxine sodium, the mannitol, dibasic sodium phosphate, and a solvent comprising water; and lyophilizing the liquid mixture.

11. The composition of claim 4, where when the composition is stored at 40 .degree. C., at most 0.20% of the levothyroxine sodium is converted to liothyronine over a period of 3 months.

12. The composition of claim 9, where when the composition is stored at 25 .degree. C., at most 0.20% of the levothyroxine sodium is converted to liothyronine over a period of 12 months.

13. The composition of claim 9, where when the composition is stored at 40 .degree. C., at most 0.20% of the levothyroxine sodium is converted to liothyronine over a period of 3 months.

14. A composition, comprising: about 500 micrograms of levothyroxine sodium; a phosphate buffer; and from 2 to 4 milligrams of mannitol, where the composition is a lyophilized solid.

15. The composition of claim 14, where the amount of mannitol is about 3 milligrams.

16. The composition of claim 15, where the phosphate buffer is dibasic sodium phosphate in an amount from 400 to 600 micrograms.

17. The composition of claim 16, where the composition is formed by forming a liquid mixture by combining the levothyroxine sodium, the mannitol, dibasic sodium phosphate, and a solvent comprising water; and lyophilizing the liquid mixture.

18. The composition of claim 14, where when the composition is stored at 25 .degree. C., at most 0.15% of the levothyroxine sodium is converted to liothyronine over a period of 12 months.

19. The composition of claim 16, where when the composition is stored at 25 .degree. C., at most 0.15% of the levothyroxine sodium is converted to liothyronine over a period of 12 months.

20. The composition of claim 16, where when the composition is stored at 40 .degree. C., at most 0.15% of the levothyroxine sodium is converted to liothyronine over a period of 3 months.

21. The composition of claim 14, where when the composition is stored at 40 .degree. C., at most 0.15% of the levothyroxine sodium is converted to liothyronine over a period of 3 months.
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