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AssigneeEli Lilly and Company
InventorsMichael Rosario DeFelippis, Michael Allen Dobbins, Alby David Sharknas, Alex Mark Prokai, Joseph Vincent Rinella
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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.
An aqueous, parenteral pharmaceutical composition for improving stability of a polypeptide comprising the polypeptide and glycerin, wherein the glycerin comprises propane-1,2,3-triol and reactive aldehyde impurities, the glycerin is derived from a non-animal source, the concentration of propane-1,2,3-triol is less than 500 mg/mL, and the content of reactive aldehyde impurities is less than 33 ppm.
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