Steven E Springer-Wilson

US Patent:

20020193440, Dec 19, 2002

Filed:

Feb 20, 2002

Appl. No.:

10/079375

Inventors:

Steven Ritter - Canton MI, US
Steven Springer-Wilson - Dearborn MI, US
Robert Gault - Grosse Pointe Woods MI, US

International Classification:

A61K031/198

US Classification:

514/567000

Abstract:

Novel formulations useful for thyroid hormone replacement and suppression therapy are described herein. While dosage formulations containing iodinated thyronines, levothyroxine sodium (T4) or liothyronine sodium (T3), as the active pharmaceutical ingredient (API) dispersed in a polymeric solid are known, manufacturing such formulations with acceptable dose content uniformity is difficult due to the high biological activity of T4 and T3. Described herein is the preparation of a single API formulation containing both T4 and T3 in a pharmaceutically effective ratio, wherein the dose content uniformity is the same for T3 as for T4 even if the T3 dose is extremely low. The present invention provides a method for the preparation of an API wherein T3 is uniformly distributed within the crystal lattice of T4 to form a solid solution by cooling suitable solutions of levothyroxine sodium and liothyronine sodium, a pharmaceutical composition containing such an API, and a method to use such an API in the treatment of thyroactive disorders.