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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Hauptverfasser: PROKAI, ALEX MARK, RINELLA, JOSEPH VINCENT JNR, SHARKNAS, ALBY DAVID, DOBBINS, MICHAEL ALLEN, DEFILIPPIS, MICHAEL ROSARIO
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creator PROKAI, ALEX MARK
RINELLA, JOSEPH VINCENT JNR
SHARKNAS, ALBY DAVID
DOBBINS, MICHAEL ALLEN
DEFILIPPIS, MICHAEL ROSARIO
description 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
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subjects HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
title Polypeptide compositions with improved stability
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