Stabilised Compositions of Factor VII Polypeptides

摘要

The invention relates to chemically as well as physically stable kits and compositions comprising polypeptides, in particular Factor VII or Factor VII-related polypeptides, such that these compositions can be stored, handled and used at room temperature.

主权项

1. A kit containing a pharmaceutical medicament, said kit comprising
a) a composition comprising (i) a blood coagulation factor polypeptide and (ii) at least one stabilizing agent selected from the group consisting of: surfactants, antioxidants, saccharides, polyols, and combinations of any of the foregoing, wherein the composition has a moisture content of not more than about 3%, in a first unit form, and container means for containing said first unit form; and, b) in a second unit form, an administration vehicle comprising (i) a solvent for reconstitution of said composition and (ii) at least one component selected from the group consisting of:
1) an agent suitable for keeping the pH of said composition in the range of 3 to 9 when dissolved in aqueous solvent, wherein the agent is present in an amount of from about 0.1 mM to 100 mM and2) a tonicity modifying agent in an amount sufficient to make essentially isotonic the reconstituted solution resulting from dissolving the composition of the first unit form in the administration vehicle of the second unit form; and container means for containing said second unit form.