Levothyroxine compositions having unique triiodothyronine Cmax properties

• US 20030194437A1
• Filed: 08/14/2002
• Published: 10/16/2003
• Est. Priority Date: 08/14/2001
• Status: Abandoned Application

• Current Assignee: Elaine A. Strauss, Franz G. Andrew, Philip A. Dimenna, Rocco L. Gemma
• Original Assignee: Elaine A. Strauss, Franz G. Andrew, Philip A. Dimenna, Rocco L. Gemma
• Inventors: Gemma, Rocco L., Franz, G. Andrew, Strauss, Elaine A., DiMenna, Philip A.
• Application Number:
  US10/218,999
• Publication Number:
  US 20030194437A1
• Time in Patent Office: Days
• US Class Current: 424/468
• 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. An immediate release pharmaceutical composition comprising a levothyroxine salt, wherein the composition exhibits a triiodothyronine (T3) plasma Cmax of between from about 0.1 ng/ml to about 10 ng/ml as determined by the standard Cmax test.

2. The composition of claim 1, wherein the composition exhibits a triiodothyronine (T3) plasma Cmax of between from about 0.5 ng/ml to about 2 ng/ml as determined by the standard Cmax test.

3. The composition of claims 1-2, wherein the In(Cmax) is between from about 0.01 to about 5.

4. The composition of claims 1-2, wherein the In(Cmax) is between from about 0.01 to about 5.