Dry hemostatic compositions and methods for their preparation
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.
1. A composition comprising cross-linked gelatin powder having a moisture content of 20% (w/w) or less and a re-hydration rate of at least 3 gm/gm in 30 seconds, wherein the composition further comprises a re-hydration aid, the re-hydration aid selected from the group consisting of:
polyethylene glycol (PEG) having an average molecular weight of about 1000, polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000, and dextran having an average molecular weight of about 40,000;
polyethylene glycol (PEG) having an average molecular weight of about 1000 and polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000;
polyethylene glycol (PEG) having an average molecular weight of about 1000 and dextran having an average molecular weight of about 40,000;
polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000 and dextran having an average molecular weight of about 40,000;
polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000; and
dextran having an average molecular weight of about 40,000.
2. A composition as in claim 1 , wherein the powder has a mean particle size in the range from 150 μm to 750 μm.
3. A composition as in claim 2 , wherein the powder has an equilibrium swell in the range from 400% to 1000%.
4. A composition as in claim 1 , wherein the powder has a moisture content in the range from 5% (w/w) to 15% (w/w).
5. A composition comprising cross-linked gelatin powder having a moisture content of 20% (w/w) or less and a re-hydration rate of at least 3 gm/gm in 30 seconds, wherein the composition further comprises a re-hydration aid, the re-hydration aid selected from the group consisting of:
polyethylene glycol (PEG) having an average molecular weight of about 1000, polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000, and dextran having an average molecular weight of about 40,000;
polyethylene glycol (PEG) having an average molecular weight of about 1000 and polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000;
polyethylene glycol (PEG) having an average molecular weight of about 1000 and dextran having an average molecular weight of about 40,000;
polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000 and dextran having an average molecular weight of about 40,000;
polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000; and
dextran having an average molecular weight of about 40,000 and
wherein the powder has a mean particle size in the range from 150 μm to 750 μm, and wherein the powder has an equilibrium swell in the range from 400% to 1000%.
6. A composition as in claim 5 , wherein the powder has a moisture content in the range from 5% (w/w) to 15% (w/w).
7. A composition as in claim 1 , wherein the re-hydration aid is polyethylene glycol (PEG) having an average molecular weight of about 1000, polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000, and dextran having an average molecular weight of about 40,000.
8. A composition as in claim 1 , wherein the re-hydration aid is polyethylene glycol (PEG) having an average molecular weight of about 1000 and polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000.
9. A composition as in claim 1 , wherein the re-hydration aid is polyethylene glycol (PEG) having an average molecular weight of about 1000 and dextran having an average molecular weight of about 40,000.
10. A composition as in claim 1 , wherein the re-hydration aid is polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000 and dextran having an average molecular weight of about 40,000.
11. A composition as in claim 1 , wherein the re-hydration aid is polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000.
12. A composition as in claim 1 , wherein the re-hydration aid is dextran having an average molecular weight of about 40,000.
13. A composition as in claim 1 , wherein the re-hydration rate is between 3 and 3.79 gm/gm in 30 seconds.
14. A composition as in claim 1 , wherein the re-hydration aid is present at below 0.1% of the composition.
15. A composition as in claim 5 , wherein the re-hydration aid is polyethylene glycol (PEG) having an average molecular weight of about 1000, polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000, and dextran having an average molecular weight of about 40,000.
16. A composition as in claim 5 , wherein the re-hydration aid is polyethylene glycol (PEG) having an average molecular weight of about 1000 and polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000.
17. A composition as in claim 5 , wherein the re-hydration aid is polyethylene glycol (PEG) having an average molecular weight of about 1000 and dextran having an average molecular weight of about 40,000.
18. A composition as in claim 5 , wherein the re-hydration aid is polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000 and dextran having an average molecular weight of about 40,000.
19. A composition as in claim 5 , wherein the re-hydration aid is polyvinylpyrrolidone (PVP) having an average molecular weight of about 50,000.
20. A composition as in claim 5 , wherein the re-hydration aid is dextran having an average molecular weight of about 40,000.
21. A composition as in claim 5 , wherein the re-hydration rate is between 3 and 3.79 gm/gm in 30 seconds.
22. A composition as in claim 5 , wherein the re-hydration aid is present at below 0.1% of the composition.