Hemostatic compositions

Abstract

The invention discloses a hemostatic composition comprising crosslinked gelatin in particulate form suitable for use in hemostasis, wherein the composition is present in paste form containing 15.0 to 19.5% (w/w), preferably 16.0 to 19.5% (w/w), 16.5 to 19.5% (w/w), 17.0 to 18.5% (w/w) or 17.5 to 18.5% (w/w), more preferred 16.5 to 19.0% (w/w) or 16.8 to 17.8% (w/w), especially preferred 16.5 to 17.5% (w/w), and wherein the composition comprises an extrusion enhancer.

1 . A hemostatic composition comprising crosslinked gelatin in particulate form suitable for use in hemostasis, wherein the composition is present in paste form containing 15.0 to 19.5% (w/w) crosslinked gelatin, and wherein the composition comprises an extrusion enhancer. 
     
     
         2 . The hemostatic composition according to  claim 1 , wherein the extrusion enhancer is albumin in an amount of between 0.5 to 5.0% (w/w). 
     
     
         3 . The hemostatic composition according to  claim 1 , wherein the crosslinked gelatin is glutaraldehyde-crosslinked gelatin or genipin-crosslinked gelatin. 
     
     
         4 . The hemostatic composition according to  claim 1 , wherein the crosslinked gelatin is type B gelatin. 
     
     
         5 . The hemostatic composition according to  claim 1 , wherein the crosslinked gelatin is present as granular material. 
     
     
         6 . The hemostatic composition according to  claim 1 , wherein the crosslinked gelatin has a particle size of 100 to 1000 μm. 
     
     
         7 . The hemostatic composition according to  claim 1 , wherein the composition contains thrombin. 
     
     
         8 . The hemostatic composition to  claim 1  for use in the treatment of an injury selected from the group consisting of a wound, a hemorrhage, a damaged tissue, a bleeding tissue, and a bone defect. 
     
     
         9 . A method of treating an injury selected from the group consisting of a wound, a hemorrhage, a damaged tissue, and a bleeding tissue, comprising administering a hemostatic composition according to  claim 1  to the injury. 
     
     
         10 . A kit for making a flowable paste of crosslinked gelatin for the treatment of an injury selected from the group consisting of a wound, a hemorrhage, a damaged tissue, and a bleeding tissue, comprising:
 a) a dry hemostatic composition comprising crosslinked gelatin in particulate form to be reconstituted to a flowable paste containing 15.0 to 19.5% (w/w) crosslinked gelatin; and   b) a pharmaceutically acceptable diluent for reconstitution of the hemostatic composition,   wherein either the composition or the diluent comprises albumin in an amount which leads to an albumin concentration in the reconstituted paste of between 0.5 to 5.0% (w/w).   
     
     
         11 . The kit according to  claim 10 , wherein the pharmaceutically acceptable diluent comprises a buffer or buffer system. 
     
     
         12 . The kit according to  claim 10 , wherein the pharmaceutically acceptable diluent comprises thrombin. 
     
     
         13 . The kit according to  claim 10 , wherein the pharmaceutically acceptable diluent contains a substance selected from the group consisting of NaCl, CaCl 2 , and sodium acetate. 
     
     
         14 . A method for providing a ready to use form of a hemostatic composition according to  claim 1 , wherein the hemostatic composition is provided in a first syringe and a diluent for reconstitution is provided in a second syringe, the first and the second syringe are connected to each other, and the fluid is brought into the first syringe to produce a flowable form of the hemostatic composition. 
     
     
         15 . The method according to  claim 14 , wherein the flowable form of the hemostatic composition contains particles that are more than 50% (w/w) with a size of 100 to 1000 μm. 
     
     
         16 . The hemostatic composition according to  claim 1 , wherein the composition contains 16.0 to 19.5% (w/w) crosslinked gelatin. 
     
     
         17 . The hemostatic composition according to  claim 1 , wherein the composition contains 16.5 to 19.5% (w/w) crosslinked gelatin. 
     
     
         18 . The hemostatic composition according to  claim 1 , wherein the composition contains 16.5 to 19.0% (w/w) crosslinked gelatin. 
     
     
         19 . The hemostatic composition according to  claim 1 , wherein the composition contains 17.0 to 18.5% (w/w) crosslinked gelatin. 
     
     
         20 . The hemostatic composition according to  claim 1 , wherein the composition contains 16.5 to 17.5% (w/w) crosslinked gelatin.