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US 10,479,987 B2Granted
Thrombin solution and methods of use thereof
AssigneeOmrix Biopharmaceuticals Ltd.
InventorsRoberto Meidler, Oleg Belyaev, Liliana Bar, Israel Nur
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Abstract
Provided are methods for lyophilization of an aqueous thrombin solution, thrombin solutions for use in such lyophilization methods, and solid thrombin compositions produced by such methods.
Claims9
A solid composition comprising thrombin, obtained by lyophilization of an aqueous thrombin solution, the method comprising:
- providing the aqueous thrombin solution comprising about 1 to less than about 4.6% w/v of a single saccharide or sugar alcohol;
- at least 0.7 to lower than about 1.75% w/v sodium chloride;
- about 0.2 to about 3% w/v albumin;
- calcium chloride;
- and sodium acetate, wherein the aqueous thrombin solution is devoid of polyethylene glycol;
- and lyophilizing the aqueous thrombin solution, wherein a height of the aqueous thrombin solution in a lyophilization vessel is in the range of 6 mm to 10 mm, and wherein a total lyophilization time is no greater than about 35 hours;
- wherein the obtained solid composition is devoid of polyethylene glycol, comprises thrombin, a single saccharide or sugar alcohol, and sodium chloride, and wherein the solid composition has a water content of less than 3%, by total weight of the composition.
4 more elements
Dependencies are inferred from the claim text.