LEVOTHYROXINE LIQUID FORMULATIONS
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 a cyclodextrin 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.
1 - 15 . (canceled)
16 . A pharmaceutical product comprising an aqueous formulation for parenteral administration, the formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof, an amine, and a cyclodextrin, wherein the formulation has a pH of about 9.0 to about 11.5, and wherein the formulation contains not more than about 5% total impurities.
17 . The pharmaceutical product of claim 16 , wherein the formulation comprises levothyroxine sodium at a concentration of from about 5 mcg/mL to about 100 mcg/mL.
18 . The pharmaceutical product of claim 16 , wherein the cyclodextrin is hydroxypropyl-β-cyclodextrin or sulfobutylether β-cyclodextrin.
19 . (canceled)
20 . The pharmaceutical product of claim 16 , wherein the formulation contains not more than 2.0% liothyronine (T3).
21 . The pharmaceutical product of claim 16 , wherein the total impurities are determined after storage for one week at 55° C.
22 . The pharmaceutical product of claim 16 , wherein the total impurities are determined after storage for two months at 40° C.
23 . The pharmaceutical product of claim 16 , wherein the formulation retains at least about 95% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for at least 12 months at room temperature.
24 - 30 . (canceled)
31 . A pharmaceutical product comprising an aqueous formulation for parenteral administration, the formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof and sulfobutylether β-cyclodextrin, wherein the formulation has a pH of about 9.0 to about 11.5, and wherein the formulation contains not more than about 5% total impurities.
32 . The pharmaceutical product of claim 31 , wherein the formulation comprises an amine.
33 . The pharmaceutical product of claim 31 , wherein the formulation comprises levothyroxine sodium at a concentration of from about 5 mcg/mL to about 100 mcg/mL.
34 . The pharmaceutical product of claim 31 , wherein the formulation contains not more than 2.0% liothyronine (T3).
35 . The pharmaceutical product of claim 31 , wherein the total impurities are determined after storage for one week at 55° C.
36 . The pharmaceutical product of claim 31 , wherein the total impurities are determined after storage for two months at 40° C.
37 . The pharmaceutical product of claim 31 , wherein the formulation retains at least about 95% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for at least 12 months at room temperature.
38 . The pharmaceutical formulation of claim 31 , wherein the formulation is contained within a clear glass vial.
39 . The pharmaceutical formulation of claim 16 , wherein the formulation is contained within a clear glass vial.