Levothyroxine compositions having unique plasma AUC properties

• US 20030198671A1
• Filed: 08/10/2002
• Published: 10/23/2003
• 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: Gemma, Rocco L., Franz, G. Andrew, Strauss, Elaine A., DiMenna, Phillip A.
• Application Number:
  US10/216,034
• Publication Number:
  US 20030198671A1
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61K 31/195 having an amino group
• 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
• 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 levothyroxine (T4) plasma AUC (0-t) of between from about 450 μ

g-hour/dl to about 600 μ

g-hour/dl.

2. The composition of claim 1, wherein the composition features a levothyroxine (T4) AUC (0-t) of between from about 500 μ

g-hour/dlL to about 550 μ

g-hour/dlL.

3. The composition of claims 1, wherein the In[AUC(0-t)] is between from about 1 to about 10.

4. The composition of claims 2, wherein the In[AUC(0-t)] is between from about 1 to about 10.