Storage stable thyroxine active drug formulations and...

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills

Reexamination Certificate

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C424S465000

Reexamination Certificate

active

07052717

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 and an antioxidant, and, optionally, additional pharmaceutically accepted excipients. Levothyroxine sodium is the preferred active drug substance, butylated hydroxyanisole is the preferred antioxidant. Additional preferred excipients include, for example, microcrystalline cellulose, sucrose, mannitol, crospovidone, magnesium stearate, colloidal silicon dioxide, and sodium lauryl sulfate.

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