Claims for Patent: 11,135,190
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Summary for Patent: 11,135,190
| Title: | Levothyroxine liquid formulations |
| Abstract: | The present invention is directed to a pharmaceutical product which includes a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes tromethamine, sodium iodide, and water and has a pH of about 9.0 to about 11.5. The liquid formulation according to the invention is stable and ready-to-use. |
| Inventor(s): | Usayapant; Arunya (Mundelein, IL), Ibrahim; Basma M. (Lincolnshire, IL) |
| Assignee: | Fresenius Kabi USA, LLC (Lake Zurich, IL) |
| Application Number: | 16/511,220 |
| Patent Claims: |
1. A pharmaceutical product comprising a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof, a stabilizing agent comprising an
amine selected from one or more of tromethamine, bis(2-hydroxyethyl)-imino-tris(hydroxymethyl)methane, monoethanolamine, diethanolamine, triethanolamine, 2-amino-2-methyl-1,3-propanediol, 2-dimethylamino-2-methyl-1-propanediol, 2-amino-2-ethylpropanol,
2-amino-1-butanol, and 2-amino-2-methyl-1-propanol, and water, wherein the formulation retains at least 95% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for two months at 40.degree. C. and
retains at least 95% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for at least 12 months at room temperature.
2. The pharmaceutical product of claim 1, wherein the levothyroxine or a pharmaceutically acceptable salt thereof is levothyroxine sodium. 3. The pharmaceutical product of claim 2, wherein levothyroxine sodium is present at a concentration of from about 5 mcg/mL to about 500 mcg/mL. 4. The pharmaceutical product of claim 1, wherein the amine is tromethamine which is present at a concentration of about 1 mg/mL to about 50 mg/mL. 5. The pharmaceutical product of claim 1, wherein the stabilizing agent further comprises a salt of iodine. 6. The pharmaceutical product of claim 5, wherein the salt of iodine is sodium iodide or potassium iodide. 7. The pharmaceutical product of claim 6, wherein the salt of iodine is sodium iodide which is present at a concentration of about 10 mcg/mL to about 500 mcg/mL. 8. The pharmaceutical product of claim 1, wherein the formulation has a pH of from about 9.0 to about 11.5. 9. The pharmaceutical product of claim 8, wherein the formulation has a pH of from about 9.8 to about 10.8. 10. The pharmaceutical product of claim 1, wherein the formulation contains not more than 2.0% liothyronine (T3). 11. The pharmaceutical product of claim 1, wherein the formulation contains not more than 5.0% total impurities. 12. The pharmaceutical product of claim 1, wherein the formulation retains at least about 90% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for at least 18 months at room temperature. 13. The pharmaceutical product of claim 1, wherein the formulation does not contain a buffer. 14. The pharmaceutical product of claim 1, wherein the formulation is contained within a clear glass container. 15. The pharmaceutical product of claim 14, wherein the clear glass container is a flint colored, molded vial, ampoule, cartridge, or syringe. 16. The pharmaceutical product of claim 14, wherein the clear glass container is not treated with ammonium sulfate. |
