Polypeptide compositions with improved stability

Details Polypeptide compositions with improved stability Polypeptide compositions with improved stability

A - Human Necessities

61

K

A61K 47/10 (2006.01) A61K 38/22 (2006.01) A61K 38/28 (2006.01) A61P 5/50 (2006.01)

Patent

CA 2394213

The present invention provides means to improve the chemical stability of aqueous, parenteral pharmaceutical compositions comprising a polypeptide and glycerin. Reactive aldehydes are identified in commercial glycerins, and means for reducing such are provided. Convenient means are provided to assay for reactive aldehydes in glycerin, and a strong linear correlation between the level of reactive aldehydes in glycerin and chemical stability of compositions comprising a polypeptide and glycerin is demonstrated. The invention includes aqueous compositions comprising a polypeptide and glycerin having improved chemical stability compared to compositions previously known.

L'invention concerne des moyens permettant d'améliorer la stabilité chimique de compositions pharmaceutiques, parentérales et aqueuses comprenant un polypeptide et de la glycérine. En outre, l'invention concerne des aldéhydes réactifs présents dans les glycérines commerciales, et des moyens permettant de déterminer la quantité d'aldéhydes réactifs dans la glycérine. L'invention concerne une démonstration selon laquelle il existe une corrélation linéaire importante entre la quantité d'aldéhydes réactifs contenus dans la glycérine et la stabilité chimique des compositions comprenant un polypeptide et de la glycérine. L'invention concerne des compositions aqueuses comprenant un polypeptide et de la glycérine qui présentent une stabilité chimique améliorée par rapport aux compositions déjà connues.

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