Claims for Patent: 9,345,772

Summary for Patent: 9,345,772

Title:	Liquid levothyroxine formulations
Abstract:	Embodiments of the present invention provide levothyroxine solutions that consist of from about 0.001% w/v to about 0.01% w/v of a levothyroxine; at least 70% w/w of a glycerol; less than 30% w/w of a water; and from about 0.01% w/w to about 1.5% w/w of an ethylenediaminetetraacetic acid (EDTA). Such levothyroxine solutions are characterized by exhibiting levothyroxine storage stability.
Inventor(s):	Parikh; Nilesh (Irvine, CA), Hite; William (Winchester, CA)
Assignee:
Application Number:	14/634,452
Patent Claims:	1. A pharmaceutical solution comprising: from 0.001% w/v to 0.01% w/v of a levothyroxine; from 75% w/w to 95% of glycerol; from 0.01% w/w to 1.5% w/w of an ethylenediaminetetraacetic acid (EDTA); and an amount of water sufficient to adjust the pharmaceutical solution to 100% w/w, and wherein the solution is storage stable. 2. The pharmaceutical solution of claim 1, wherein the levothyroxine is levothyroxine sodium. 3. The pharmaceutical solution of claim 2, wherein the EDTA is disodium EDTA. 4. The pharmaceutical solution of claim 3, wherein the solution comprises from 0.05% w/w to 1.0% w/w of the disodium EDTA. 5. The pharmaceutical solution of claim 4, wherein the solution comprises from 80% w/w to 95% w/w of the glycerol. 6. The pharmaceutical solution of claim 5, wherein the solution comprises from 85% w/w of 95% w/w glycerol. 7. The pharmaceutical solution of claim 6, wherein the solution comprises from 90% w/w to 95% w/w glycerol. 8. A pharmaceutical solution comprising: 0.002% w/v, 0.004% w/v, 0.006% w/v, 0.008% w/v, or 0.01% w/v of a levothyroxine; from 75% w/w to 95% w/w glycerol; from 0.05% w/w to 1.5% w/w of an EDTA; and an amount of water sufficient to adjust the pharmaceutical solution to 100% w/w, and wherein the solution is storage stable. 9. The pharmaceutical solution of claim 8, wherein the levothyroxine is levothyroxine sodium. 10. The pharmaceutical solution of claim 9, wherein the EDTA is disodium EDTA. 11. The pharmaceutical solution of claim 10, wherein the solution comprises from 80% w/w to 95% w/w glycerol. 12. The pharmaceutical solution of claim 11, wherein the solution comprises from 85% w/w to 95% w/w glycerol. 13. The pharmaceutical solution of claim 12, wherein the solution comprises from 90% w/w to 95% w/w glycerol. 14. A pharmaceutical solution comprising: 0.002% w/v or 0.004% w/v of a levothyroxine; from 75% w/w to 95% w/w glycerol; from 0.05% w/w to 1.0% w/w of an EDTA, an amount of water sufficient to adjust the pharmaceutical solution to 100% w/w, and wherein the solution is storage stable. 15. The pharmaceutical solution of claim 14, wherein the solution comprises from 80% w/w to 95% w/w glycerol. 16. The pharmaceutical solution of claim 15, wherein the solution comprises from 85% w/w to 95% w/w glycerol. 17. The pharmaceutical solution of claim 14, wherein the solution comprises from 90% w/w to 95% w/w glycerol. 18. A pharmaceutical solution comprising: from 0.002% w/v to 0.006% w/w of a levothyroxine sodium; from 90% w/w to 95% w/w glycerol; an amount of water sufficient to adjust the pharmaceutical solution to 100% w/w; and 0.08% w/w of an EDTA, and wherein the solution is storage stable. 19. The pharmaceutical solution of claim 18, wherein the levothyroxine is levothyroxine sodium, and wherein the EDTA is disodium EDTA.