Stabilized thyroid hormone preparations and methods of making sa

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

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424465, 424479, 424480, A61K 920, A61K 936

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active

060569751

ABSTRACT:
Disclosed are thyroid hormone preparations useful in pharmaceutical applications. These preparations are disclosed to contain thyroxine drugs in combination with an inorganic salt, a carbohydrate having a molecular weight of greater than 500, and glycine. The preparations are also disclosed to have a free water content less than 4.5% by weight of the preparation. Also provided are compositions containing a reduced carbohydrate, a water soluble polysaccharide, or galactose. The preparations have improved stability wherein they are provided as being stable to the extent that substantially no potency loss is measured when the preparation is stored at 40.degree. C. and 75% relative humidity for 3 months.

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patent: 4851228 (1989-07-01), Zentner et al.
patent: 4871548 (1989-10-01), Edgren et al.
patent: 5102666 (1992-04-01), Acharya
patent: 5225204 (1993-07-01), Chen et al.
patent: 5275820 (1994-01-01), Chang
patent: 5324522 (1994-06-01), Krenning et al.
International Search Report--PCT/IB 96/01330, Apr. 16, 1997.

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