Levothyroxine liquid formulations
AssigneeFresenius Kabi USA, LLC
InventorsArunya Usayapant, Basma M. Ibrahim
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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, water, and an amine, and has a pH above the buffering range of the amine. The liquid formulation of the invention is stable and ready-to-use.
Claims32
A pharmaceutical product comprising a liquid formulation comprising about 5 mcg/mL to about 100 mcg/mL of levothyroxine sodium, a stabilizing agent comprising an alkanolamine and a salt of iodine, and water, wherein the formulation has a pH of from about 9.0 to about 11.5 and retains about least about 95% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for two months at 40° C. and is stable for at least 12 months at room temperature.
A method of preparing a pharmaceutical product comprising:
- (a) filling purified water into a container,
- (b) dissolving a stabilizing agent comprising an alkanolamine and a salt of iodine in the water to form a solution,
- (c) adjusting the pH of the solution to 9.0 to 11.5 with sodium hydroxide and/or hydrochloric acid to form a pH adjusted solution,
- (d) adding levothyroxine sodium to the pH adjusted solution to form an initial drug solution,
- (e) adding purified water to the drug solution to form a final drug solution,
- (f) filtering the final drug solution through a 0.22 mm filter to form a filtered final drug solution, and
- (g) filling the filtered final drug solution into one or more clear glass containers and sealing the containers, thereby preparing the pharmaceutical product.
A pharmaceutical product comprising a liquid formulation comprising about 5 mcg/mL to about 100 mcg/mL of levothyroxine sodium, glycerol, and water, wherein the formulation has a pH of from about 7.0 to about 9.0.
Dependencies are inferred from the claim text.