Patent ID: 9669076
Date: 2017-06-06
CPC Classifications: A61K,A61P,Y10S

Claim:
1. A Factor VIII composition for use in treating a patient by reconstituting a lyophilised Factor VIII composition in a volume of a diluent to prepare a reconstituted Factor VIII composition and administering the reconstituted Factor VIII composition to the patient, wherein the lyophilised Factor VIII composition is obtainable by lyophilizing a volume of a liquid Factor VIII composition formulated without adding albumin to said composition, wherein the liquid Factor VIII composition comprises 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; and wherein the volume of the diluent is equal to or greater than the volume of the liquid Factor VIII composition.