LEVOTHYROXINE FORMULATION WITH CARRAGEENAN

• US 20140179784A1
• Filed: 12/21/2012
• Published: 06/26/2014
• Est. Priority Date: 12/21/2012
• Status: Abandoned Application

• Current Assignee: Mylan Incorporated (Pfizer Inc.)
• Original Assignee: Mylan Incorporated (Pfizer Inc.)
• Inventors: Kirsch, John, Nallamothu, Ramakrishna, Polat, Baris E.
• Application Number:
  US13/723,500
• Publication Number:
  US 20140179784A1
• Time in Patent Office: Days
• US Class Current: 514/567
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/205 Polysaccharides, e.g. alginate, gums; Cyclodextrin

Abstract

A pharmaceutical composition comprising thyroxine and carrageenan. The pharmaceutical composition has an improved shelf life compared to other pharmaceutical compositions containing thyroxine. In one embodiment, the composition additionally comprises sucrose, microcrystalline cellulose, and mannitol. The pharmaceutical composition may be used for treating thyroid disorders by orally administering the composition to a patient in need thereof.

Claims

1. A pharmaceutical composition comprising thyroxine and carrageenan.

2. The composition of claim 1, wherein the composition comprises from about 0.1% to about 10% carrageenan.

3. The composition of claim 1, wherein the composition comprises from about 0.25% to about 4.0% carrageenan.

4. The composition of claim 1, wherein the composition comprises from about 0.5% to about 2.0% carrageenan.

5. The composition of claim 1, wherein the carrageenan is lambda carrageenan.

6. The composition of claim 1, wherein the thyroxine comprises levothyroxine sodium.

7. The composition of claim 1, wherein the composition comprises from about 0.1 μ

g to about 5000 μ

g thyroxine.

8. The composition of claim 7, wherein the composition comprises from about 0.25% to about 2.5% carrageenan, and the thyroxine comprises levothyroxine sodium.

9. The composition of claim 1, wherein the composition comprises sucrose, microcrystalline cellulose, and mannitol.

10. The composition of claim 8, wherein the composition comprises sucrose, microcrystalline cellulose, and mannitol.

11. The composition of claim 9, wherein the composition comprises from about 5% to about 70% sucrose, from about 5% to about 90% microcrystalline cellulose, and from about 5% to about 90% mannitol.

12. The composition of claim 1, wherein the decrease in potency, after 6 months at the accelerated conditions of 40°

C. and 75% relative humidity, is less than 5%.

13. The composition of claim 1, wherein the composition is a solid oral dosage form.

14. The composition of claim 13, wherein the composition is a tablet.

15. The composition of claim 10, wherein the composition is a solid oral dosage form.

16. The composition of claim 15, wherein the composition is a tablet.

17. The composition of claim 1, additionally comprising an antioxidant.

18. The composition of claim 17, wherein the antioxidant is selected from butylated hydroxyanisole, butylated hydroxytoluene, and propyl gallate.

19. A method for treating thyroid disorders comprising orally administering the composition of claim 1 to a patient in need thereof.

20. The method of claim 19, wherein 25 to 300 μ

g of thyroxine is administered once daily.