Methods of administering levothyroxine pharmaceutical compositions

• US 7,101,569 B2
• Filed: 08/14/2002
• Issued: 09/05/2006
• Est. Priority Date: 08/14/2001
• Status: Expired due to Term

• 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.
• Primary Examiner(s): Kunz, Gary
• Assistant Examiner(s): Haghighatian, Mina
• Application Number:
  US10/218,718
• Publication Number:
  US 20030194422A1
• Time in Patent Office: 1,483 Days
• Field of Search: 424/439, 424/442, 424/484, 424/451, 424/464, 424/465, 424/466, 514/2, 514/561, 514/567
• US Class Current: 424/439
• 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. A method of administering a levothyroxine pharmaceutical composition to a patient, comprising placing an immediate release levothyroxine pharmaceutical tablet that loses less than about 0.7% potency per month for up to 18 months in an aqueous medium, dispersing the levothyroxine composition in the aqueous medium for less than ten minutes, and administering the aqueous medium to the patient.

2. The method of claim 1, wherein the aqueous medium is selected from water, saline, soft drinks and milk.

3. The method of claim 2, wherein the dispersion step is conducted for less than five minutes.