Novel albumin-free factor VIII formulations - Patent Pending

United States Patent Application 20040116345
Kind Code A1
Besman, Marc ; et al. June 17, 2004
Novel albumin-free factor VIII formulations
Abstract
A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.
Inventors: Besman, Marc; (Studio City, CA) ; Bjornson, Erik; (Studio City, CA) ; Jameel, Feroz; (Covina, CA) ; Kashi, Ramesh; (Walnut, CA) ; Pikal, Michael; (Mansfield Center, CT) ; Tchessalov, Serguei; (Ashford, CT) ; Carpenter, John; (Littleton, CO)
Correspondence Name and Address: TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
Serial No.: 610723
Series Code: 10
Filed: July 1, 2003
U.S. Current Class: 514/12
U.S. Class at Publication: 514/012
Intern'l Class: A61K 038/37