Dry hemostatic compositions and methods for their preparation
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61F-013/00
A61F-002/00
A61K-009/14
A61K-009/50
출원번호
US-0468316
(2009-05-19)
등록번호
US-8092820
(2012-01-10)
발명자
/ 주소
Qian, Zhen
Osawa, A. Edward
Reich, Cary J.
출원인 / 주소
Baxter International Inc.
대리인 / 주소
Kilpatrick Townsend & Stockton LLP
인용정보
피인용 횟수 :
0인용 특허 :
119
초록▼
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
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.
대표청구항▼
1. A method for preparing a substantially dry cross linked gelatin powder, the method comprising: providing an aqueous solution comprising a non-cross-linked gelatin and at least one re-hydration aid, wherein the non-cross-linked gelatin is present in the aqueous solution in the range from 5% (w/w)
1. A method for preparing a substantially dry cross linked gelatin powder, the method comprising: providing an aqueous solution comprising a non-cross-linked gelatin and at least one re-hydration aid, wherein the non-cross-linked gelatin is present in the aqueous solution in the range from 5% (w/w) to 15% (w/w) and the re-hydration aid is present in the aqueous solution in the range from 5% to 30% (w/w) based on the weight of the non-cross-linked gelatin present in the aqueous solution;cross-linking the non-cross-linked gelatin in the presence of the at least one re-hydration aid so as to produce a cross-linked gelatin;removing at least 50% (w/w) of the at least one re-hydration aid from the aqueous solution after the cross-linking step; anddrying the cross-linked gelatin and grinding the cross-linked gelatin to produce the substantially dry cross linked gelatin powder, wherein the re-hydration aid is present in the dry cross linked gelatin powder at below 0.1% (w/w), and wherein the substantially dry cross linked gelatin powder has a moisture content below 20% (w/w) and a re-hydration rate of at least 3 gm/gm in 30 seconds. 2. A method as in claim 1, wherein the at least one re-hydration aid comprises at least one material selected from the group consisting of glycerol, polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), and dextran. 3. A method as in claim 1, wherein the at least one re-hydration aid comprises at least one material selected from the group consisting of polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), and dextran. 4. A method as in claim 1, wherein the at least one re-hydration aid comprises at least two materials selected from the group consisting of polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), and dextran. 5. A method as in claim 1, wherein the at least one re-hydration aid comprises polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), and dextran. 6. A method as in claim 1, wherein the at least one re-hydration aid comprises PEG at from 2.5% to 20% by weight, PVP at from 1.25% to 20% by weight, and dextran at from 1.25% to 20% by weight. 7. A method as in claim 1, wherein the cross-linking step comprises adding a cross-linking agent to the aqueous solution. 8. A method as in claim 7, wherein the cross-linking agent comprises glutaraldehyde. 9. A method for preparing a substantially dry cross linked gelatin powder, the method comprising: providing an aqueous solution comprising a non-cross-linked gelatin and at least one re-hydration aid;cross-linking the non-cross-linked gelatin in the presence of the at least one re-hydration aid so as to produce a cross-linked gelatin;removing at least 50% (w/w) of the at least one re-hydration aid from the aqueous solution after the cross-linking step; anddrying the cross-linked gelatin and grinding the cross-linked gelatin to produce the substantially dry cross-linked gelatin powder, wherein the re-hydration aid is present in the dry cross-linked gelatin powder at below 0.1% (w/w), and wherein the substantially dry cross-linked gelatin powder has a moisture content below 20% (w/w) and a re-hydration rate of at least 3 gm/gm. 10. A method as in claim 9, wherein the step of removing at least 50% (w/w) of the at least one re-hydration aid comprises filtering the aqueous solution containing the cross-linked gelatin in a solvent followed by filtration of the cross-linked gelatin to produce a filter cake and washing the filter cake to remove the at least 50% (w/w) of the at least one re-hydration aid. 11. A method as in claim 10, wherein the step of washing the filter cake removes at least 90% (w/w) of the at least one re-hydration aid originally present in the aqueous solution. 12. A method as in claim 10, wherein the step of drying comprises drying the filter cake after the washing step. 13. A method for preparing a substantially dry cross-linked gelatin powder, the method comprising: providing an aqueous solution comprising a non-cross-linked gelatin and at least one re-hydration aid;cross-linking the non-cross-linked gelatin in the presence of the at least one re-hydration aid so as to produce a cross-linked gelatin;removing at least 50% (w/w) of the at least one re-hydration aid from the aqueous solution after the cross-linking step; anddrying the cross-linked gelatin and grinding the cross-linked gelatin to produce the substantially dry cross-linked gelatin powder, wherein the substantially dry cross-linked gelatin powder has a moisture content below 20% (w/w) and a re-hydration rate of at least 3 gm/gm. 14. A method as in claim 13, wherein the substantially dry cross linked gelatin powder has a re-hydration rate of at least 3.5 gm/gm. 15. A method as in claim 13, wherein the substantially dry cross linked gelatin powder has a re-hydration rate of at least 3.75 gm/gm. 16. A method as in claim 13, wherein the substantially dry cross-linked gelatin powder has a re-hydration rate which is at least 5% higher than a re-hydration rate of a cross linked gelatin powder similarly prepared without the at least one re-hydration aid. 17. A method as in claim 13, wherein the at least one re-hydration aid comprises PEG in the range from 2.5% (w/w) to 20% (w/w) based on the weight of the gelatin. 18. A method as in claim 13, wherein the at least one re-hydration aid comprises PVP in the range from 1.25% (w/w) to 20% (w/w) based on the weight of the gelatin. 19. A method as in claim 13, wherein the at least one re-hydration aid comprises dextran in the range from 1.25% (w/w) to 20% (w/w) based on the weight of the gelatin. 20. A method as in claim 13,wherein the at least one re-hydration aid comprises PEG in the range from 2.5% (w/w) to 20% (w/w) based on the weight of the gelatin, 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.
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