FORMULATIONS FOR WOUND THERAPY
The present invention relates to novel formulations comprising a dry powder fibrin sealant comprised of a mixture of fibrinogen and/or thrombin, for use in the treatment of wounds or injuries, in particular for use as a topical hemostatic composition or for surgical intervention.
1 . A method of treating a wound or reducing bleeding at a haemorrhaging site, comprising administering to the wound or haemorrhaging site a pharmaceutical composition comprising an absorbable carrier of a biocompatible, biodegradable polymer and microparticles comprising fibrinogen in an amount of from about 0.1-15 mg/cm 2 and/or microparticles comprising thrombin in an amount of from about 0.01 to 500 IU/cm 2 , wherein the microparticles further comprise a glassy carrier, and wherein the microparticles are attached to said absorbable carrier.
2 . The method of claim 1 , wherein said treatment results in a time to hemostasis of less than about 10 minutes when administered to a wound or haemorrhaging site which exhibits a bleeding rate of greater than about 30 g/minute.
3 . The method of claim 1 , wherein the absorbable carrier consists essentially of a biocompatible, biodegradable polymer selected from a cellulose, polyurethane, gelatin or collagen, such as a collagen-sponge, or a chitosan, and amorphous fibrinogen or amorphous thrombin, and the treatment is for tissue sealing, tissue gluing or hemostasis.
4 . The method of claim 3 , wherein the amorphous fibrinogen or amorphous thrombin exhibit a degree of crystallinity of at most about 10% by weight of the microparticle population in the carrier.
5 . The method of claim 3 wherein the treatment is for the topical treatment of a wound, and the wound is selected from the group consisting of a) minor abrasions, cuts, scrapes, scratches, burns, sunburns, ulcers, internal venous bleeding, external venous bleeding, and b) surgical interventions selected from gastrointestinal surgery, surgery on parenchymal organs; surgical interventions in the ear, nose and throat area (ENT), cardiovascular surgery, aesthetic surgery, spinal surgery, neurological surgery; lymphatic, biliary, and cerebrospinal (CSF) fistulae, air leakages during thoracic and pulmonary surgery, thoracic surgery, orthopaedic surgery; gynaecological surgical procedures; vascular surgery and emergency surgery, liver resection, and soft tissue injury or surgery.
6 . The method of claim 5 , wherein the pharmaceutical composition is topically applied to a traumatic injury in the battle field, a wound or during or after surgery.
7 . A method of making a pharmaceutical composition comprising:
(i) suspending microparticles comprising fibrinogen and/or microparticles comprising thrombin, which microparticles further comprise a glassy carrier, in a vehicle in which they are not soluble;
(ii) applying the resulting suspension to an absorbable carrier; and
(iii) optionally removing the vehicle.
8 . The method of claim 7 , wherein the composition further comprises a plasticizer, binder or viscosifying agent.