Stabilized pharmaceutical compositions

• US 20030180353A1
• Filed: 08/10/2002
• Published: 09/25/2003
• Est. Priority Date: 08/10/2001
• Status: Abandoned Application

• Current Assignee: Elaine A. Strauss, Franz G. Andrew, Phillip A. Dimenna, Rocco L. Gemma
• Original Assignee: Elaine A. Strauss, Franz G. Andrew, Phillip A. Dimenna, Rocco L. Gemma
• Inventors: DiMenna, Phillip A., Gemma, Rocco L., Franz, G. Andrew, Strauss, Elaine A.
• Application Number:
  US10/215,902
• Publication Number:
  US 20030180353A1
• Time in Patent Office: Days
• US Class Current: 424/465
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

The present invention generally relates to stable pharmaceutical compositions, and methods of making and administering such compositions. In one aspect, the invention features stabilized pharmaceutical compositions that include pharmaceutically active ingredients such as levothyroxine (T4) sodium and liothyronine (T3) sodium (thyroid hormone drugs), preferably in an immediate release solid dosage form. Also provided are methods for making and using such immediate release and stabilized compositions.

Claims

1. A stabilized solid pharmaceutical composition comprising a levothyroxine salt and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition loses less than about 0.7% of its activity per month for up to 18 months.

2. The composition of claim 1, wherein the pharmaceutical composition loses less than about 0.5% of its activity per month for up to 18 months.

3. The composition of claim 1, wherein the pharmaceutical composition loses less than about 0.3% of its activity per month for up to 18 months.

4. A pharmaceutical composition in solid form comprising a pharmaceutically active ingredient and a β

-sheet form of microcrystalline cellulose.

5. The pharmaceutical composition of claim 4, wherein at least about 50 weight % of the composition weight is β

-sheet form of microcrystalline cellulose.

6. The pharmaceutical composition of claims 4, wherein the active ingredient is levothyroxine sodium.

7. The pharmaceutical composition of claims 5, wherein the active ingredient is levothyroxine sodium.