Concentrated liquid thyroid hormone composition

• US 8,318,712 B2
• Filed: 01/05/2007
• Issued: 11/27/2012
• Est. Priority Date: 01/06/2006
• Status: Active Grant

• Current Assignee: Intervet International BV (Merck & Co., Inc.)
• Original Assignee: Intervet International BV (Merck & Co., Inc.)
• Inventors: Pierrès, Cécile, Gaugain-Hamidi, Atimad
• Primary Examiner(s): Fetterolf, Brandon
• Assistant Examiner(s): Stone, Christopher R
• Application Number:
  US12/160,292
• Publication Number:
  US 20090270507A1
• Time in Patent Office: 2,153 Days
• Field of Search: 514/183
• US Class Current: 514/183
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 47/08 containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 47/40 Cyclodextrins; Derivatives thereof
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61P 5/14 of the thyroid hormones, e.g. T3, T4

Abstract

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.

Claims

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.