Process for making dry and stable hemostatic compositions

摘要

Described is a process for making a dry and stable hemostatic composition, said process comprising
a) providing a first component comprising a dry preparation of a coagulation inducing agent,b) providing a second component comprising a dry preparation of a biocompatible polymer suitable for use in hemostasis,c) mixing said first component and said second component under conditions effective to form a wet paste while essentially preventing degradation of the second component by said first component in a final container or transferring said wet paste into a final container,d) freezing and lyophilizing said paste in said container thereby obtaining a dry and stable hemostatic composition comprising said first and said second component in lyophilized form, ande) finishing said dry and stable hemostatic composition in said final container to a storable pharmaceutical device containing said first component and said second component in a combined form as a dry and stable hemostatic composition.

主权项

1. A process for making a dry and stable hemostatic composition, said process comprising:
a) providing a first component comprising a solution of a coagulation inducing agent; b) providing a second component comprising a dry preparation of a biocompatible polymer suitable for use in hemostasis; c) mixing said first component and said second component under conditions effective to form a wet paste while preventing degradation of the second component by said first component in a final container or mixing said first component and said second component under conditions effective to form the wet paste while preventing degradation of the second component by said first component and transferring said wet paste into a final container, wherein the wet paste is without a free liquid phase; d) freezing and lyophilizing said paste in said container thereby obtaining a dry and stable hemostatic composition comprising said first and said second component in lyophilized form; and e) finishing said dry and stable hemostatic composition in said final container to a storable pharmaceutical device containing said first component and said second component in a combined form as a finished dry and stable hemostatic composition, wherein: the first component comprises thrombin, the mixing step comprises mixing the first component and the second component at a temperature within a range from about 2° C. to about 15° C., and a contact time between the first component and the second component in the wet paste before lyophilizing is within a range from five minutes to six hours, 85% (weight/weight) or less of the wet paste is the solution of the coagulation inducing agent, the finishing step comprises sterilizing the dry and stable hemostatic composition in said final container, said thrombin has an initial activity prior to the lyophilizing step, and said finished dry and stable hemostatic composition has the capability to retain at least 90% of said thrombin activity after 24 months storage in dry form at room temperature.