Unique levothyroxine aqueous materials

• US 20030199586A1
• Filed: 08/14/2002
• Published: 10/23/2003
• Est. Priority Date: 08/14/2001
• 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: Gemma, Rocco L., Franz, G. Andrew, Strauss, Elaine A., DiMenna, Phillip A.
• Application Number:
  US10/218,835
• Publication Number:
  US 20030199586A1
• Time in Patent Office: Days
• 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 9/2054 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 pharmaceutical composition, comprising the product of dissolution of a preparation comprising levothyroxine salt, cross-linked sodium carboxymethylcellulose, and β

-form microcrystalline cellulose, in an aqueous medium.

2. The composition of claim 1, wherein the preparation comprises about 0.001 to 1% by weight levothyroxine, about 5 to about 40% by weight cross-linked sodium carboxymethylcellulose, and at least about 50% by weight of β

-form microcrystalline cellulose.