Levothyroxine formulations

A levothyroxine composition includes levothyroxine sodium and mannitol. The composition is a lyophilized solid. The composition may include from 100 to 500 micrograms levothyroxine sodium and from 2 to 4 milligrams mannitol.

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30 Claims

1. A lyophilized solid composition, comprising:
- about 100 micrograms of levothyroxine sodium;
  
  a buffer; and
  
  between 2 and 4 milligrams of mannitol.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
- - 2. The lyophilized solid composition of claim 1, wherein, when the lyophilized solid composition is stored at 25°
    - C. for a predetermined time period, less than 0.20% of the levothyroxine sodium is converted to liothyronine.
  - 3. The lyophilized solid composition of claim 2, wherein the predetermined time period is 12 months.
  - 4. The lyophilized solid composition of claim 1, wherein about 3 milligrams of mannitol is in the lyophilized solid composition.
  - 5. A pharmaceutical solution, comprising:
    - the lyophilized solid composition of claim 1; and
      
      a pharmaceutically acceptable liquid carrier.
  - 6. The pharmaceutical solution of claim 5, wherein a concentration of the levothyroxine sodium in the pharmaceutical solution is between 5 and 500 μ
    - g/mL.
  - 7. A method of providing levothyroxine to a patient in need thereof, the method comprising:
    - administering the pharmaceutical solution of claim 5 to the patient in need thereof.
  - 8. The method of claim 7, wherein the pharmaceutical solution is administered to the patient in need thereof such that between about 50 to 500 micrograms of levothyroxine sodium is administered to the patient in need thereof.
  - 9. The method of claim 8, wherein the pharmaceutical solution is administered to the patient in need thereof such that between about 50 to 100 micrograms or about 300 to 500 micrograms of levothyroxine sodium is administered to the patient in need thereof.
  - 10. The lyophilized solid composition of claim 1, wherein the buffer is a phosphate buffer.

11. A lyophilized solid composition, comprising:
- about 200 micrograms of levothyroxine sodium;
  
  a buffer; and
  
  between 2 and 4 milligrams of mannitol.
- View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
- - 12. The lyophilized solid composition of claim 11, wherein, when the lyophilized solid composition is stored at 25°
    - C. for a predetermined time period, less than 0.20% of the levothyroxine sodium is converted to liothyronine.
  - 13. The lyophilized solid composition of claim 12, wherein the predetermined time period is 12 months.
  - 14. The lyophilized solid composition of claim 11, wherein about 3 milligrams of mannitol is in the lyophilized solid composition.
  - 15. A pharmaceutical solution, comprising:
    - the lyophilized solid composition of claim 11; and
      
      a pharmaceutically acceptable liquid carrier.
  - 16. The pharmaceutical solution of claim 15, wherein a concentration of the levothyroxine sodium in the pharmaceutical solution is between 5 and 500 μ
    - g/mL.
  - 17. A method of providing levothyroxine to a patient in need thereof, the method comprising:
    - administering the pharmaceutical solution of claim 15 to the patient in need thereof.
  - 18. The method of claim 17, wherein the pharmaceutical solution is administered to the patient in need thereof such that between about 50 to 500 micrograms of levothyroxine sodium is administered to the patient in need thereof.
  - 19. The method of claim 18, wherein the pharmaceutical solution is administered to the patient in need thereof such that between about 50 to 100 micrograms or about 300 to 500 micrograms of levothyroxine sodium is administered to the patient in need thereof.
  - 20. The lyophilized solid composition of claim 11, wherein the buffer is a phosphate buffer.

21. A lyophilized solid composition, comprising:
- about 500 micrograms of levothyroxine sodium;
  
  a buffer; and
  
  between 2 and 4 milligrams of mannitol.
- View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30)
- - 22. The lyophilized solid composition of claim 21, wherein, when the lyophilized solid composition is stored at 25°
    - C. for a predetermined time period, less than 0.20% of the levothyroxine sodium is converted to liothyronine.
  - 23. The lyophilized solid composition of claim 22, wherein the predetermined time period is 12 months.
  - 24. The lyophilized solid composition of claim 21, wherein about 3 milligrams of mannitol is in the lyophilized solid composition.
  - 25. A pharmaceutical solution, comprising:
    - the lyophilized solid composition of claim 21; and
      
      a pharmaceutically acceptable liquid carrier.
  - 26. The pharmaceutical solution of claim 25, wherein a concentration of the levothyroxine sodium in the pharmaceutical solution is between 5 and 500 μ
    - g/mL.
  - 27. A method of providing levothyroxine to a patient in need thereof, the method comprising:
    - administering the pharmaceutical solution of claim 25 to the patient in need thereof.
  - 28. The method of claim 27, wherein the pharmaceutical solution is administered to the patient in need thereof such that between about 50 to 500 micrograms of levothyroxine sodium is administered to the patient in need thereof.
  - 29. The method of claim 28, wherein the pharmaceutical solution is administered to the patient in need thereof such that between about 50 to 100 micrograms or about 300 to 500 micrograms of levothyroxine sodium is administered to the patient in need thereof.
  - 30. The lyophilized solid composition of claim 21, wherein the buffer is a phosphate buffer.

Specification

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Litigation Data

Current Assignee
Fresenius KABI USA LLC (Fresenius SE & Co. KGaA)
Original Assignee
Fresenius KABI USA LLC (Fresenius SE & Co. KGaA)
Inventors
Jiang, John Zhiqiang, Usayapant, Arunya, Monen, George
Primary Examiner(s)
MCMILLIAN, KARA RENITA

Application Number

US14/641,426
Publication Number

US 20150174246A1
Time in Patent Office

233 Days
Field of Search
US Class Current

1/1
CPC Class Codes

A61K 31/197   the amino and the carboxyl ...

A61K 31/198   Alpha-amino acids, e.g. ala...

A61K 47/02   Inorganic compounds

A61K 47/10   Alcohols; Phenols; Salts th...

A61K 47/26   Carbohydrates, e.g. sugar a...

A61K 9/0019   Injectable compositions; In...

A61K 9/19   lyophilised , i.e. freeze-d...

Levothyroxine formulations

First Claim

2 Assignments

Litigations

1 Petition

Accused Products

Abstract

9 Citations

30 Claims

Specification

Solutions

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Levothyroxine formulations

First Claim

2 Assignments

Subscription Required

Subscription Required

Litigations

1 Petition

Subscription Required

Accused Products

Subscription Required

Abstract

9 Citations

30 Claims

Specification

Subscription Required

Solutions

Use Cases

Quick Links