Dry hemostatic compositions and methods for their preparation
AssigneesBaxter International Inc., Baxter Healthcare S.A.
InventorsZhen Qian, A. Edward Osawa, Cary J. Reich
Life of this patent
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Abstract
Dry cross-linked gelatin compositions are prepared that rapidly re-hydrate to produce gelatin hydrogels suitable as hemostatic sealants. Gelatin is cross-linked in the presence of certain re-hydration aids, such as polyethylene glycol, polyvinylprovidone, and dextran, in order to produce a dry cross-linked gelatin powder. The use of the re-hydration aids has been found to substantially increase the re-hydration rate in the presence of an aqueous re-hydration medium, typically thrombin-containing saline.
Claims17
A method for preparing a substantially dry cross-linked gelatin powder, said method comprising:
- providing an aqueous solution comprising a non-cross-linked gelatin and a re-hydration aid, wherein the rehydration aid in the aqueous solution comprises polyethylene glycol (PEG)in the range from 2.5% (w/w) to 20% (w/w) based on the weight of the gelatin, polyvinylpyrrolidone (PVP) in the range from 1.25% (w/w) to 20% (w/w) based on the weight of the gelatin, and dextran in the range from 1.25% (w/w) to 20% (w/w) based on the weight of the gelatin;
- cross-linking the gelatin in the presence of the re-hydration aid;
- removing at least 50% (w/w) of the re-hydration aid after the cross-linking step;
- and
- drying the cross-linked gelatin and grinding to produce a powder having a moisture content below 20% (w/w) and a re-hydration rate of at least 3 gm/gm in 30 seconds.
A method for preparing a substantially dry cross-linked gelatin powder, said method comprising:
- providing an aqueous solution comprising a non-cross-linked gelatin combined with a re-hydration aid, wherein the rehydration aid in the aqueous solution comprises polyethylene glycol (PEG)in the range from 2.5% (w/w) to 20% (w/w) based on the weight of the gelatin, polyvinylpyrrolidone (PVP) in the range from 1.25% (w/w) to 20% (w/w) based on the weight of the gelatin, and dextran in the range from 1.25% (w/w) to 20% (w/w) based on the weight of the gelatin;
- cross-linking the gelatin in the presence of the re-hydration aid;
- removing at least 50% (w/w) of the re-hydration aid after the cross-linking step;
- and
- drying the cross-linked gelatin and grinding to produce a powder having a moisture content below 20% (w/w).
A method for preparing a substantially dry cross-linked gelatin powder, said method comprising:
- providing an aqueous solution comprising a non-cross-linked gelatin combined with a re-hydration aid, wherein the rehydration aid in the aqueous solution comprises polyethylene glycol (PEG)in the range from 2.5% (w/w) to 20% (w/w) based on the weight of the gelatin, polyvinylpyrrolidone (PVP) in the range from 1.25% (w/w) to 20% (w/w) based on the weight of the gelatin, and dextran in the range from 1.25% (w/w) to 20% (w/w) based on the weight of the gelatin;
- cross-linking the gelatin in the presence of the re-hydration aid;
- removing at least 50% (w/w) of the re-hydration aid after the cross-linking step;
- and
- drying the cross-linked gelatin and grinding to produce a powder having a moisture content below 20% (w/w) and a re-hydration rate which is at least 5% higher than a re-hydration rate of a similar powder prepared without the re-hydration aid.
Dependencies are inferred from the claim text.