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US 2016/0101163 A1Published application
Stabilised Compositions of Factor VII Polypeptides
AssigneeNovo Nordisk Healthcare AG
InventorsBirthe Lykkegaard Hansen, Michael Bech Jensen, Troels Kornfelt
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Abstract
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.
Claims18
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 and
- 2) 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.
4 more elements
A composition comprising (i) a Factor VII polypeptide and (ii) at least one stabilizing agent selected from the group consisting of
- a) a combination of an antioxidant and mannitol;
- b) a combination of methionine and a polyol;
- c) a combination of a saccharide and mannitol;
- d) a combination of sucrose and a polyol;
- e) methionine;
- and
- f) a polysorbate surfactant in an amount of from about 0.06 to 0.08 mg/mL;
- said composition having a moisture content of not more than about 3%.
5 more elements
Dependencies are inferred from the claim text.