Loading patent…
AssigneeEli Lilly and Company
InventorsMichael Rosario DeFelippis, Michael Allen Dobbins, Alby David Sharknas, Alex Mark Prokai, Joseph Vincent Rinella
Estimating the term…
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 comprising a polypeptide and glycerin, wherein the glycerin is derived from a non-animal source.
An aqueous, parenteral pharmaceutical composition comprising a polypeptide and glycerin, wherein the glycerin has a reactive aldehyde content of less than 8 ppm.
A process for lowering the level of reactive aldehydes in glycerin comprising, contacting glycerin with a solid drying agent and a polymeric resin comprising free amino groups.
Dependencies are inferred from the claim text.