A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 38/37 (2006.01) A61K 47/02 (2006.01) A61K 47/18 (2006.01) A61K 47/26 (2006.01) A61P 7/04 (2006.01)
Patent
CA 2634674
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; 1 mM to 5 mM calcium salt; and a buffering agent.
Besman Marc
Bjornson Erik
Carpenter John
Jameel Feroz
Kashi Ramesh
Baxter International Inc.
Sim & Mcburney
University Of Connecticut
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