Stabilized thyroid hormone preparations and methods of...

Details Stabilized thyroid hormone preparations and methods of... Stabilized thyroid hormone preparations and methods of...

A - Human Necessities

61

K

A61K 31/195 (2006.01) A61K 9/14 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01)

Patent

CA 2235707

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 ~C and 75 % relative humidity for 3 months.

Cette invention concerne des préparations d'hormones thyroïdiennes qui s'avèrent utiles dans certaines applications pharmaceutiques. Ces préparations comportent des médicaments contenant de la thyroxine associée à un sel inorganique, un glucide de poids moléculaire supérieur à 500 et de la glycine. Ces préparations présentent également une teneur en eau libre inférieure à 4,5 % en poids de la préparation. L'invention concerne également des compositions contenant un glucide réduit, un polysaccharide soluble dans l'eau ou du galactose. Ces préparations présentent une stabilité accrue qui est telle que cette stabilité est assurée jusqu'au point qu'aucune perte d'activité n'est mesurée lorsqu'une telle préparation est stockée, pendant 3 mois, à 40 ·C et dans un environnement contenant 75 % d'humidité relative.

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