Storage stable thyroxine active drug formulations and...

Details Storage stable thyroxine active drug formulations and... Storage stable thyroxine active drug formulations and...

2007-03-27

2007-03-27

Hartley, Michael G. (Department: 1618)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S400000, C424S464000, C424S468000, C424S489000, C424S499000, C424S502000, C514S567000

Reexamination Certificate

active

11143645

ABSTRACT:
This invention provides a storage-stable dosage form of a thyroxine active drug composition which exhibits an improved stability. The formulation contains a thyroxine active drug substance, an alditol, and a saccharide, and, optionally, additional pharmaceutically accepted excipients. Levothyroxine sodium is the preferred active drug substance, mannitol is the preferred alditol, and sucrose is the9 preferred saccharide. Additional preferred excipients include, for example, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and sodium lauryl sulfate.

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