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US 2010/0168018 A1Published application
Factor viii formulations
AssigneesBaxter International Inc., University of Connecticut
InventorsMichael Pikal, Serguei Tchessalov, Erik Bjornson, Feroz Jameel, Marc Besman
Life of this patent
Estimating the term…
Abstract
A Factor VIII (FVIII) composition formulated such that NaCl is not present in the final formulation or is present in trace amounts, which allows for a concomitant reduction in the lyophilization cycle time and increased stability of the lyophilized FVIII.
Claims21
A stable lyophilized pharmaceutical formulation of Factor VIII (FVIII) comprising:
- (a) a FVIII;
- (b) one or more buffering agents;
- (c) one or more antioxidants;
- (d) one or more stabilizing agents;
- and (e) one or more surfactants;
- said FVIII comprising a polypeptide selected from the group consisting of:
- a) a recombinant FVIII polypeptide;
- b) a biologically active analog, fragment or variant of a);
- said buffer is comprising of a pH buffering agent in a range of about 0.1 mM to about 500 mM and said pH is in a range of about 2.0 to about 12.0;
- said antioxidant is at a concentration of about 0.005 to about 1.0 mg/ml;
- said stabilizing agent is at a concentration of about 0.005 to about 20%;
- said surfactant is at a concentration of about 0.001% to about 1.0%;
- and
- said formulation excluding sodium chloride (NaCl) or including only trace amount of NaCl.
11 more elements
The formulation of claim 16 wherein the surfactant is TWEEN-80 at about 0.03%.
A stable lyophilized pharmaceutical formulation of Factor VIII (FVIII) comprising:
- (a) a FVIII;
- (b) one or more buffering agents;
- (c) one or more antioxidants;
- (d) one or more stabilizing agents;
- and (e) one or more surfactants;
- said FVIII comprising a polypeptide selected from the group consisting of:
- a) a recombinant FVIII polypeptide;
- b) a biologically active analog, fragment or variant of a);
- said buffer is comprising of a pH buffering agent in a range of about 0.1 mM to about 500 mM and said pH is in a range of about 2.0 to about 12.0;
- said antioxidant is at a concentration of about 0.005 to about 1.0 mg/ml;
- said stabilizing agent is at a concentration of about 0.005 to about 20%;
- and
- said surfactant is at a concentration of about 0.001% to about 1.0%.
10 more elements
Dependencies are inferred from the claim text.