Concentrated liquid thyroid hormone composition
This invention is directed generally to a liquid pharmaceutical composition comprising at least one thyroid hormone (particularly a composition further comprising at least one cyclodextrin compound), a process for making such a composition, and a method of using such a composition to treat a condition associated with impaired thyroid hormone function.
1. A pharmaceutical composition comprising:
from 0.1 mg/ml to 0.2 mg/ml levothyroxine or a pharmaceutically acceptable salt thereof,
from about 10% to about 50% (by weight) hydroxypropyl-β-cyclodextrin,
at least one buffer having a pKa of at least about 9.5,
at least 5% (by weight) water,
a preservative at a concentration of no greater than about 30% (by weight),
from about 5% to about 20% (by weight) ethanol, and
a pharmaceutically acceptable antioxidant at a concentration of no greater than about 5% (by weight);
wherein the pharmaceutical composition is liquid and has a pH of from about 10 to about 10.5.
2. The pharmaceutical composition of claim 1 , wherein the pH of the composition is from about 10.1 to about 10.3.
3. The pharmaceutical composition of claim 1 , wherein the composition further comprises NaOH.
4. The pharmaceutical composition of claim 1 , wherein the buffer comprises sodium bicarbonate.
5. A method of treating a disorder associated with impaired thyroid hormone function in an animal, wherein the method comprises administering a therapeutically effective amount of a pharmaceutical composition of claim 1 to the animal.
6. The method of claim 5 , wherein the animal is a dog.
7. The method of claim 5 , wherein the condition comprises hypothyroidism.