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Last Updated: May 5, 2024

Claims for Patent: 11,154,498

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Summary for Patent: 11,154,498

Title:	Stabilized liquid formulation of levothyroxine
Abstract:	The present invention relates to stabilized liquid formulations of Levothyroxine or a pharmaceutically acceptable salt thereof, intended for parenteral administration. Further this invention also describes process of preparing such compositions.
Inventor(s):	Chandrashekhar; Kocherlakota (Secunderabad, IN), Nagaraju; Banda (Hyderabad, IN)
Assignee:	Leiutis Pharmaceuticals PVT. LTD. (Hyderabad, IN)
Application Number:	15/745,615
Patent Claims:	1. A stable, liquid parenteral pharmaceutical formulation of levothyroxine comprising: (i) levothyroxine sodium in a concentration of less than 0.1% w/v; (ii) a solubilizing agent comprising a cyclodextrin; (iii) optionally one or more stabilizing agents; (iv) arginine in a concentration of less than 0.20 M; and (v) one or more solvents, wherein the pH is between 5 and 7. 2. The liquid parenteral pharmaceutical formulation of claim 1, wherein the stabilizing agents are selected from one or both sodium iodide and potassium iodide. 3. The liquid parenteral pharmaceutical formulation of claim 1 wherein the cyclodextrin is sulfobutylether-.beta.-cyclodextrin (SBECD). 4. The liquid parenteral pharmaceutical formulation of claim 1, wherein the solvent is water. 5. The liquid parenteral pharmaceutical formulation of claim 1, wherein the solvent is propylene glycol. 6. The liquid parenteral pharmaceutical formulation of claim 1, wherein the pH of the formulation is 6. 7. The liquid parenteral pharmaceutical formulation of claim 1, wherein the cyclodextrin is selected from .alpha., .beta. and .gamma.-cyclodextrin and cyclodextrins modified with alkyl-, hydroxyalkyl-, dialkyl-, and sulfoalkyl-ether modified cyclodextrins. 8. A stable, liquid parenteral pharmaceutical formulation of levothyroxine comprising: (i) levothyroxine sodium; (ii) sulfobutylether-.beta.-cyclodextrin (SBECD) (iii) arginine in a concentration of less than 0.20 M; and (iv) one or more solvents, wherein the pH is between 5 and 7. 9. The liquid parenteral pharmaceutical formulation of claim 8, wherein the pH of the formulation is 6. 10. The liquid parenteral pharmaceutical formulation of claim 8, wherein arginine is in a concentration between approximately 0.06M to approximately 0.0001M.

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