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Saccharide free, storage stable thyroid hormone active drug formulations and methods for their production

  • US 8,779,000 B1
  • Filed: 07/20/2013
  • Issued: 07/15/2014
  • Est. Priority Date: 07/20/2013
  • Status: Active Grant
First Claim
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1. A pharmaceutical composition in unit dosage form that comprises:

  • a therapeutically effective amount of a levothyroxine sodium;

    an antioxidant in an amount sufficient to stabilize the levothyroxine sodium against oxidation;

    an amount of an alditol sufficient to stabilize the levothyroxine sodium; and

    at least two excipients selected from the group consisting of a filler, a binder, and a lubricant, wherein;

    the alditol is at least one member selected from the group consisting of a mannitol, a sorbitol, a maltitol, and a xylitol;

    the composition is free of added saccharide selected from the group consisting of a monosaccharide, a disaccharide, and an oligosaccharide; and

    the composition is storage stable.

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