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 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.