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Abstract

A stable dosage form of levothyroxine sodium which includes a stable complex of levothyroxine sodium and a cellulose compound, polyvinylpyrrolidone or a Poloxamer, which complex is adsorbed on the surface of a cellulose compound carrier. In a first embodiment the stable complex of levothyroxine sodium is prepared by mixing the levothyroxine sodium with a complexing agent such as polyvinylpyrrolidone or a Poloxamer, dissolving the resulting mixture in a polar organic solvent such as water, methanol, ethanol, propanol, isopropyl alcohol, methylene dichloride or butanol, adding a cellulose carrier to the liquid and subsequently drying the resulting mixture to obtain a powdery, stabilized complex of levothyroxine sodium and polyvinylpyrrolidone or Poloxamer adsorbed on the cellulose carrier. In a second embodiment the levothyroxine sodium is at least partially dissolved directly in the polar organic solvent and a cellulose carrier is added to the solution to produce the stabilized levothyroxine sodium complex. In a third embodiment the levothyroxine sodium is dry mixed with a cellulose complexing agent and a cellulose carrier to produce the stabilized levothyroxine sodium complex. The complexes can be mixed with pharmaceutically acceptable excipients for compression into tablets or placed in capsules to define stable levothyroxine sodium dosage formulations.

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First Claim