Stabilized medicaments containing thyroid hormones

• US 5,958,979 A
• Filed: 04/08/1998
• Issued: 09/28/1999
• Est. Priority Date: 10/27/1995
• Status: Expired due to Term

• Current Assignee: Henning Berlin GmbH
• Original Assignee: Henning Berlin GmbH
• Inventors: Weickgenannt, Guido, Lahr, Wolfgang, Friese, Andrea
• Primary Examiner(s): Raymond, Richard L.
• Application Number:
  US09/051,376
• Time in Patent Office: 538 Days
• Field of Search: 424/451, 424/464, 424/484, 424/486, 424/488, 514/567, 562/447
• US Class Current: 514/567
• 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 47/02 Inorganic compounds
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/14 of the thyroid hormones, e.g. T3, T4

Abstract

The present invention relates to stabilized medicaments containing thyroid hormone the stabilizing component of which is sodium thiosulfate in a mass ratio of thyroid hormone to sodium thiosulfate of 1:0.1 to 1:50 and processes for preparing such medicaments.

Claims

1. Stable medicaments containing thyroid hormones, wherein said medicaments comprise sodium thiosulfate as the stabilising component in a ratio of thyroid hormones to sodium thiosulfate of 1:

0.1 to 1;

50 by weight.

2. The medicaments according to claim 1, wherein the medicaments further comprise an alkaline component an amount of which can be adjusted in such a manner that the medicament slurried or dissolved in water has a pH of 5.5 to 9.

3. The medicaments according to claim 2, wherein the alkaline component is an alkali salt or a lye.

4. The medicaments according to claim 3, wherein the alkali salt is sodium carbonate.

5. The medicaments according to claim 1, the thyroid hormone is levothyroxin.

6. The medicaments according to claim 1, wherein the thyroid hormone is liothyronin.

7. The medicaments according to claim 1, wherein the thyroid hormone is diiodothyrosin.

8. The medicaments according to claim 1, wherein the medicaments contain at least two thyroid hormones.

9. The medicaments according to claim 1, wherein the medicaments contain a further active ingredient in addition to at least one thyroid hormone.

10. A method for preparing medicaments comprising:

adding sodium thiosulfate in a dissolved state to a matrix mixture containing thyroid hormones, wherein the ratio of the thyroid hormones to sodium thiosulfate is 1;

0.1 to 1;

50 by weight.

11. The method of claim 10 further comprising:

adding an alkaline component to the matrix mixture, wherein the alkaline component is added in an amount such that the matrix mixture slurried or dissolved in water has a pH of 5.5 to 9.

12. The method of claim 11, wherein the alkaline component is either one of an alkali salt and a lye.

13. The method of claim 12, wherein the alkali salt is sodium carbonate.

14. The method of claim 12, wherein the thyroid hormone is levothyroxin.

15. The method of claim 10, wherein the thyroid hormone is liothyronin.

16. The method of claim 10, wherein the thyroid hormone is diiodothyrosin.

17. The method of claim 10, wherein the medicament contains at least two thyroid hormones.

18. The method of claim 10 further comprising:

adding a further active ingredient in addition to at least one thyroid hormone.