Title:
NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS
Document Type and Number:
Japanese Patent JP2017125076
Kind Code:
A
Abstract:
PROBLEM TO BE SOLVED: To provide therapeutic Factor VIII formulations which are stable in the absence of albumin or other proteins.SOLUTION: A Factor VIII composition formulated without adding albumin 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.SELECTED DRAWING: None
Inventors:
BESMAN MARC
BJORNSON ERIK
JAMEEL FEROZ
KASHI RAMESH
PIKAL MICHAEL
TCHESSALOV SERGUEI
CARPENTER JOHN
BJORNSON ERIK
JAMEEL FEROZ
KASHI RAMESH
PIKAL MICHAEL
TCHESSALOV SERGUEI
CARPENTER JOHN
Application Number:
JP2017088289A
Publication Date:
July 20, 2017
Filing Date:
April 27, 2017
Export Citation:
Assignee:
BAXALTA INC
BAXALTA GMBH
UNIV CONNECTICUT
BAXALTA GMBH
UNIV CONNECTICUT
International Classes:
A61K38/37; A61K9/19; A61K38/43; A61K47/02; A61K47/10; A61K47/18; A61K47/20; A61K47/22; A61K47/26; A61K47/34; A61K47/36; A61K47/42; A61P7/04
Attorney, Agent or Firm:
Hidesaku Yamamoto