Hemostatic compositions containing sterile thrombin

Abstract

The present invention includes sterilized hemostatic compositions that contain a continuous, biocompatible liquid phase having a solid phase of particles of a biocompatible polymer suitable for use in hemostasis and that is substantially insoluble in the liquid phase, and sterile thrombin, each of which is substantially homogenously dispersed throughout the continuous liquid phase, and methods for making such compositions,

Description

FIELD OF THE INVENTION [0001] The present invention relates to hemostatic compositions containing sterile thrombin and to methods of making such hemostatic compositions. BACKGROUND OF THE INVENTION [0002] Gelatin-based hemostats, both in solid sponge or powder form, are commercially available and are used in surgical procedures. Gelatin powder, when mixed with fluid, can be prepared in various forms depending on the contemplated end-use and the ratio of fluid to powder. For example, where higher concentrations of fluid are employed, a paste or slurry that is useful as a flowable, extrudable and injectable hemostat may be prepared for use in diffuse bleeding, particularly from uneven surfaces or hard to reach areas. Such conventional slurries are prepared at the point of use by mechanical agitation and mixing of the powder and liquid to provide uniformity of the composition. The paste then is placed into a delivery means or applicator, e.g. a syringe, and applied to the wound. In oth...

AI Technical Summary

Benefits of technology

[0005] The present invention is directed to sterilized hemostatic compositions comprising a continuous, biocompatible liquid phase, a solid phase comprising porous or non-porous particles of a biocompatible polymer suitable for use in hemostasis and which are substantially insoluble in the liquid phase, and sterile thrombin. The continuous liquid phase comprises the solid particulate phase and sterile thrombin substantially homogenously dispersed there through. The ratio of the liquid phase, the solid particulate phase and thrombin is effective to provide the composition with hemostatic properties, both prior to and after sterilization. Sterile compositions of the present invention may be prepared well in advance of the time of use while maintaining thrombin enzymatic activity even after being subjected to sterilizing radiation. The present invention also includes methods of making the hemostatic compositions.

Problems solved by technology

Gelatin powders are sterilized prior to preparing such compositions but mixing of the powders and fluids may compromise the sterility of the hemostatic composition due to handling of the materials at the site of use, or in general by exposure to the environment for relatively extended periods of time during mixing and the like.

Proteins such as thrombin are prepared aseptically and thus there is a risk that nonsterilized proteins such as thrombin, when used in hemostatic compositions, may compromise the sterility of the previously-sterilized materials, such as sterilized gelatin powder.

However, as thrombin is known to be denatured by exposure to sterilizing condition such as ionizing radiation conventionally used to sterilize the powders, which denaturing destroys all enzymatic activity of the thrombin, thrombin has not been reported to be incorporated into the hemostatic compositions and then terminally sterilized prior to use to ensure a sterile composition.