Pharmaceutical preparation

• US 20040063611A1
• Filed: 09/15/2003
• Published: 04/01/2004
• Est. Priority Date: 05/15/1998
• Status: Active Grant

• Current Assignee: Merck Patent GmbH (Merck & Co., Inc.)
• Original Assignee: Merck Patent GmbH (Merck & Co., Inc.)
• Inventors: Nischwitz, Marion, Schreder, Sven
• Granted Patent: US 8,008,349 B2
• Time in Patent Office: Days
• US Class Current: 514/2
• 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 9/2063 Proteins, e.g. gelatin
• CPC Class Codes: A61P 5/14 of the thyroid hormones, e.g. T3, T4
• CPC Class Codes: A61P 5/16 for decreasing, blocking or antagonising the activity of the thyroid hormones
• CPC Class Codes: A61P 5/18 of the parathyroid hormones

Abstract

The invention relates to a pharmaceutical preparation comprising levothyroxine sodium, gelatine and fillers, which is free of organic solvent residues, and to processes for its production.

Claims

1. Pharmaceutical preparation comprising levothyroxine sodium, gelatine and fillers and which is free of organic solvent residues.

2. Pharmaceutical preparation according to claim 1, characterized in that liothyronine sodium is optionally also contained.

3. Pharmaceutical preparation according to claim 1, characterized in that 5 to 400 μ

g of levothyroxine sodium are contained.

4. Pharmaceutical preparation according to claim 1, characterized in that levothyroxine sodium micronized with a particle size of between 5 μ

m and 25 μ

m is contained.

5. Pharmaceutical preparation according to claim 1, characterized in that fillers selected from the group consisting of lactose and/or maize starch and/or microcrystalline cellulose are contained.

6. Pharmaceutical preparation according to claim 1, 2 or 3, characterized in that it is a solid preparation in the form of tablets.

8. Process according to claim 5, characterized in that the disintegrant used is croscarmellose sodium and the lubricant used is magnesium stearate.

7. Process for the production of a pharmaceutical preparation, characterized in that levothyroxine sodium and optionally liothyronine sodium, which is/are present in suspended form in aqueous gelatine solution, are sprayed onto the filler(s) in a fluidized bed granulation, then a disintegrant and lubricant are admixed and the mixture is compressed to give tablets.