Polypeptide compositions with improved stability

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...

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Bibliographische Detailangaben
Hauptverfasser: PROKAI, ALEX MARK, RINELLA, JOSEPH VINCENT JNR, SHARKNAS, ALBY DAVID, DOBBINS, MICHAEL ALLEN, DEFILIPPIS, MICHAEL ROSARIO
Format: Patent
Sprache:eng ; fre ; ger
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Beschreibung
Zusammenfassung: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