Storage stable thyroxine active drug formulations and methods for their production
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United States of America Patent
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May 30, 2006
Grant Date -
Jan 22, 2004
app pub date -
May 20, 2003
filing date -
Nov 13, 2001
priority date (Note) -
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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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