Pharmaceutical levothyroxine preparation

• US 6,491,946 B1
• Filed: 01/05/2001
• Issued: 12/10/2002
• Est. Priority Date: 07/07/1998
• 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): Spear, James M.
• Application Number:
  US09/743,114
• Time in Patent Office: 704 Days
• Field of Search: 424/464, 424/465, 424/489
• US Class Current: 424/465
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/18 Iodine; Compounds thereof

Abstract

The invention relates to a pharmaceutical preparation comprising levothyroxine sodium, potassium iodide, microcrystalline cellulose and binding agent, which is free of antioxidants or further auxiliaries, and processes for its production.

Claims

1. A pharmaceutical composition comprising levothyroxine sodium, potassium iodide, microcrystalline cellulose and hydroxypropylmethylcellulose or gelatine or both hydroxypropylmethylcellulose and gelatine, which is essentially free of antioxidants.

2. A pharmaceutical composition according to claim 1 comprising 5 to 400 μ

g of levothyroxine sodium and 5 to 400 μ

g of potassium iodide.

3. A pharmaceutical composition according to claim 1 wherein the levothyroxine sodium is in micronized form having a particle size of 5 to 25 μ

m.

4. A pharmaceutical composition according to claim 1, wherein the composition is solid in the form of tablets.

5. A process for the preparation of a pharmaceutical composition comprising levothyroxine sodium, potassium iodide, microcrystalline cellulose and a binding agent, which is essentially free of antioxidants, said process comprising spraying an aqueous hydroxypropylmethylcellulose and/or gelatine solution comprising levothyroxine sodium and potassium iodide which are present in suspended form in said solution onto microcrystalline cellulose in a fluidized bed granulation, admixing a disintegrating agent and a lubricant and compressing the resultant mixture to form tablets.

6. A process according to claim 5, wherein the disintegrating agent is croscarmellose sodium and the lubricant is magnesium stearate.