Non-granulated levothyroxine pharmaceutical compositions

• US 20030185885A1
• Filed: 08/10/2002
• Published: 10/02/2003
• 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:
  US10/216,036
• Publication Number:
  US 20030185885A1
• Time in Patent Office: Days
• US Class Current: 424/465
• 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. A non-granulated sugar-free, starch-free pharmaceutical composition comprising levothyroxine and a pharmaceutically acceptable carrier, in tablet form.

2. The composition of claim 1, wherein the composition further comprises microcrystalline β

-cellulose.

3. The composition of claim 2, wherein the microcrystalline β

-cellulose has a bulk density of between from about 0.10 g/cm³ to about 0.35 g/cm³.

4. The composition of claims 2, wherein the microcrystalline 3-cellulose has a bulk density of between from about 0.15 g/cm³ to about 0.25 g/cm³.

5. The composition of claim 2, wherein the microcrystalline β

-cellulose has a conductivity of less than about 200 μ

S/cm.

6. The composition of claim 2, wherein the microcrystalline β

-cellulose has a conductivity of between from about 0.5 μ

S/cm to 50 μ

S/cm.

7. The composition of claim 1, wherein tablet has a total hardness of between from about 6 to about 14 KP as determined by a standard hardness test.