Solid pharmaceutical preparation containing levothyroxine and/or liothyronine salts

• US 8,293,272 B2
• Filed: 05/03/2004
• Issued: 10/23/2012
• Est. Priority Date: 05/03/2004
• Status: Active Grant

• Current Assignee: Globopharm Pharmazeutische Produktions-Und HandelsGmbH
• Original Assignee: Globopharm Pharmazeutische Produktions-Und HandelsGmbH
• Inventors: Burghart, Walter, Raneburger, Johannes, Burghart, Kurt
• Primary Examiner(s): Westerberg, Nissa
• Application Number:
  US10/555,354
• Publication Number:
  US 20070014851A1
• Time in Patent Office: 3,095 Days
• Field of Search: None
• US Class Current: 424/464
• 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 9/1623 Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/205 Polysaccharides, e.g. alginate, gums; Cyclodextrin

Abstract

In a solid pharmaceutical preparation containing water-soluble salts of levothyroxine and/or liothyronine as active ingredients, the water activity of said pharmaceutical preparation is adjusted to values of below 0.4 and, preferably, 0.1 to 0.3, measured at room temperature.

Claims

1. A solid pharmaceutical preparation comprising water-soluble salts of levothyroxine as an active ingredient,

wherein water activity of said pharmaceutical preparation is adjusted to values of below 0.4 and above 0.1, measured at a room temperature of 25°

C.

2. The pharmaceutical preparation according to claim 1, wherein the water activity of said pharmaceutical preparation is adjusted to values ranging from 0.1 to 0.3, measured at a room temperature of 25°

C.

3. The pharmaceutical preparation according to claim 1, wherein a methanolic or ethanolic solution of said active ingredient is homogenously applied on a carrier.

4. The pharmaceutical preparation according to claim 3, wherein the carrier is a water-soluble carrier.

5. The pharmaceutical preparation according to claim 4, wherein mannitol is used as said water-soluble carrier.

6. The pharmaceutical preparation according to claim 3, wherein the carrier is treated with an amount of EDTA-Na substantially corresponding to a Ca⁺⁺-content of the carrier.

7. The pharmaceutical preparation according to claim 1, wherein the preparation is in the form of tablets and is confectioned with non-hygroscopic adjuvants.

8. The pharmaceutical preparation according to claim 3, wherein said carrier is mixed with starch, guar or granulation aids.

9. The pharmaceutical preparation according to claim 3, wherein the carrier is treated with an amount of EDTA-Na substantially corresponding to a Ca⁺⁺-content of the carrier, and citric acid.

10. The pharmaceutical preparation according to claim 1, wherein the preparation is in the form of tablets and is confectioned in a package with little or no water-vapor permeability.