Stabilised protein preparations for a tissue adhesive

A - Human Necessities – 61 – L

Patent

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A61L 24/10 (2006.01)

Patent

CA 2351544

A tissue adhesive is described, which contains three separate components, i.e., - a stabilized, essentially fibrinogen-free protein preparation that is of storage--quality in liquid state and contains the blood coagulation factor XIII - a stabilized protein preparation that is of storage-quality in liquid state and contains fibrinogen. A chaotropic substance of less than 0.28 mol/liter was added to said protein preparation to avoid or reduce the aggregation of fibrinogen, and - a preparation containing thrombin, which are provided in one packaging unit prepared to be used together. Furthermore, stabilized, frozen or lyophilized protein preparations containing fibrinogen and Factor XIII are described. Said protein preparations contain fibrinogen-- and Factor XIII which remains stable for more than four weeks after defrosting or reconstitution, as well as one or more added chaotropic substances in a quantity of less than 0.28 mol/liter which prevents or reduces the aggregation of fibrinogen and contain inorganic salts of < 100 mmol/liter, preferably < 50 mmol/liter.

L'invention concerne un adhésif tissulaire contenant trois composants séparés les uns des autres: une préparation protéique stabilisée, sensiblement dépourvue de fibrinogène, pouvant être stockée à l'état liquide et renfermant le facteur de coagulation XIII; une préparation protéique stabilisée, pouvant être stockée à l'état liquide, contenant du fibrinogène, à laquelle est ajoutée une substance chaotrope en une quantité inférieure à 0,28 mol/l, destinée à empêcher ou à diminuer l'agrégation du fibrinogène; et une préparation contenant de la thrombine. Ces trois composants se présentent sous la forme d'un emballage unitaire préparé en vue de leur utilisation simultanée. L'invention concerne également des préparations protéiques stabilisées, congelées ou lyophilisées, contenant du fibrinogène et du facteur XIII, dont la teneur en fibrinogène et en facteur XIII après décongélation ou reconstitution est stable pendant plus de quatre semaines, qui renferment une ou plusieurs substances chaotropes ajoutées empêchant ou diminuant l'agrégation du fibrinogène, en une quantité inférieure à 0,28 mol/l, et dont la teneur en sels inorganiques est inférieure à 100 mmol/l, de préférence à 50 mmol/l.

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