Stable pharmaceutical preparation comprising levothyroxine sodium, gelatin and fillers and which is free of organic solvent residues

• US 8,008,349 B2
• Filed: 09/15/2003
• Issued: 08/30/2011
• Est. Priority Date: 05/15/1998
• Status: Expired due to Fees

• Current Assignee: Merck Patent GmbH (Merck & Co., Inc.)
• Original Assignee: Merck Patent GmbH (Merck & Co., Inc.)
• Inventors: Nischwitz, Marion, Schreder, Sven
• Primary Examiner(s): Spivack; Phyllis G.
• Application Number:
  US10/661,588
• Publication Number:
  US 20040063611A1
• Time in Patent Office: 2,906 Days
• Field of Search: 514/567
• 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 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.

Claims

1. A pharmaceutical preparation comprising active compound, 5 mg gelatin as a binder and fillers and which is free of organic solvent, wherein the active compound is levo-thyroxine sodium, and which preparation is in tablet form.

2. The pharmaceutical preparation according to claim 1, containing 5 to 400 μ

g of levothyroxine.

3. The pharmaceutical preparation according to claim 1, containing levothyroxine sodium micronized with a particle size of between 5 μ

m and 25 μ

m.

4. The pharmaceutical preparation according to claim 1, wherein the filler is lactose, maize starch or microcrystalline cellulose.

5. A pharmaceutical preparation comprising levo-thyroxine sodium, 5 mg gelatin as a binder and fillers which is free of organic solvent and which is in solid form.

6. The pharmaceutical preparation according to claim 5, containing 5 to 400 μ

g of levothyroxine.

7. The pharmaceutical preparation according to claim 5, containing levothyroxine sodium micronized with a particle size of between 5 μ

m and 25 μ

m.

8. The pharmaceutical preparation according to claim 5, wherein the filler is lactose, maize starch or microcrystalline cellulose.

9. The pharmaceutical preparation according to claim 5, comprising levothyroxine sodium, lactose, starch, gelatin, croscarmellose sodium, and magnesium stearate.

10. The pharmaceutical preparation according to claim 9, further comprising liothyronine sodium.

11. A pharmaceutical preparation comprising active compound, 5 mg gelatin as a binder and fillers and which is free of organic solvent wherein the active compound consists essentially of levo-thyroxine sodium and liothyronine sodium, and which preparation is in solid form.

12. The pharmaceutical preparation according to claim 11, containing 5 to 400 μ

g of levothyroxine.

13. The pharmaceutical preparation according to claim 11, containing levothyroxine sodium micronized with a particle size of between 5 μ

m and 25 μ

m.

14. The pharmaceutical preparation according to claim 11, wherein the filler is lactose, maize starch or microcrystalline cellulose.