Levothyroxine compositions having unique triidothyronine plasma AUC properties

• US 20030198672A1
• 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:
  US10/219,009
• Publication Number:
  US 20030198672A1
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence

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 features a triiodothyronine (T3) AUC (0-t) of between from about 10 ng-hour/mlL to about 100 ng-hour/mlL

2. The composition of claim 1, wherein the composition features a triiodothyronine (T3) AUC (0-t) of between from about 20 ng-hour/ml to about 60 ng-hour/ ml.

3. The composition of claims 1, wherein the In[AUC(0-t)] is between from about 1 to about 5.

4. The composition of claims 2, wherein the In[AUC(0-t)] is between from about 1 to about 5.

5. The composition of claims 2, wherein the In(Cmax) of the levothyroxine (T4) plasma level is between from about 1 to about 3.