Abstract: 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.
Type:
Grant
Filed:
December 5, 2000
Date of Patent:
April 4, 2006
Assignee:
Eli Lilly and Company
Inventors:
Michael Rosario DeFelippis, Michael Allen Dobbins, Alby David Sharknas, Alex Mark Prokai, Joseph Vincent Rinella
Abstract: Novel human protein C derivatives are described. These derivatives have increased anti-coagulation activity and resistance to inactivation by serpins, compared to wild-type protein C and retain the biological activity of the wild-type human protein D. These derivatives will require either less frequent administration and/or smaller dosage than wild-type human protein C in the treatment of acute coronary syndromes, vascular occlusive disorders, hyper coagulable states, thrombotic disorders and disease states predisposing to thrombosis.
Type:
Grant
Filed:
January 19, 2001
Date of Patent:
January 11, 2005
Assignee:
Eli Lilly and Company
Inventors:
Bruce Edward Gerlitz, Bryan Edward Jones
Abstract: The present invention provides a method of treatment of viral hemorrhagic fever with protein C. The claimed invention provides a needed therapy for a serious and debilitating disorder while avoiding complications such as bleeding tendency, toxicity and general side effects of currently available anti-coagulant agents.