Albumin-free Factor VIII formulations

US6586573B1 · kind B1 · utility

Assignees

• Baxter International Inc. · US
• UNIVERSITY OF CONNECTICUT · US

Inventors

• Marc Besman · Seattle, US
• Erik Bjornson · West Hollywood, US
• Feroz Jameel · Covina, US
• Ramesh Kashi · Walnut, US
• Michael Pikal · Mansfield Center, US
• Serguei Tchessalov · Andover, US
• John Carpenter · Littleton, US

Key dates

• Filing date: Feb 22, 2000
• Grant date: Jul 1, 2003
• Expiry date: Feb 22, 2020

Classification

• Technology area (CPC Y): Emerging Cross-Sectional Technologies
• CPC primary: Y10S530/829
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

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.