Patent application number | Description | Published |
20090111751 | Method of Removing a Non-Metallic Protein Inhibitor From a Liquid Pharmaceutical Preparation - The invention relates to a method for removing a protein inhibitor from a liquid pharmaceutical preparation, said method comprising the steps of: (a) providing a sealed container comprising an initial liquid pharmaceutical preparation comprising (i) a protein belonging to the group of serine proteases/Vitamin K-dependent proteins and (ii) a non-metallic inhibitor for said protein; (b) contacting said pharmaceutical preparation with a solid phase polymeric material capable of retaining at least a substantial portion of said inhibitor; and (c) separating said liquid pharmaceutical preparation from said solid phase polymeric material so as to obtain a resulting liquid pharmaceutical preparation having a reduced concentration of said inhibitor compared to the initial liquid pharmaceutical preparation. | 04-30-2009 |
20100166730 | Liquid, Aqueous Pharmaceutical Composition of Factor VII Polypeptides - The present invention is directed to liquid, aqueous pharmaceutical compositions containing Factor VII polypeptides, and methods for preparing and using such compositions, as well as vials containing such compositions, and the use of such compositions in the treatment of a Factor VII-responsive syndrome, e.g., bleeding disorders, including those caused by clotting Factor deficiencies (e.g. haemophilia A, haemophilia B, coagulation Factor VII deficiency); by thrombocytopenia or von Willebrand's disease, or by clotting Factor inhibitors, and intra cerebral haemorrhage, or excessive bleeding from any cause. The preparations may also be administered to patients in association with surgery or other trauma or to patients receiving anticoagulant therapy. More particularly, the invention relates to liquid compositions stabilised against chemical and/or physical degradation. The main embodiment is represented by a liquid, aqueous pharmaceutical composition comprising a Factor VII polypeptide (i); a buffering agent (ii) suitable for keeping pH in the range of from about 4.0 to about 9.0; at least one metal-containing agent (iii), wherein said metal is selected from the group consisting of first transition series metals of oxidation state +II, except zinc, such as chromium, manganese, iron, cobalt, nickel, and copper; and a non-ionic surfactant (iv). | 07-01-2010 |
20100294677 | High Concentration Factor VII Polypeptide Formulations Comprising an Aromatic Preservative and an Antioxidant - The present invention relates to pharmaceutical compositions comprising at least 10 mg/mL of a Factor VII polypeptide (i); a buffering agent (ii) suitable for keeping pH in the range of from about 5.0 to about 9.0; at least one aromatic preservative (iii) in a concentration of at least 0.1 mg/mL; and at least one antioxidant (iv) in a concentration of at least 0.1 mg/mL; the composition optionally comprising further components, with the proviso that none of such further components are Factor VII polypeptide stabilizing agents selected from (a) metal-containing agents, wherein said metal is selected from the group consisting of first transition series metals of oxidation state +II, except zinc; and (b) stabilising agent comprising a —C(═N—Z1-R1)-NH—Z2-R2 motif. | 11-25-2010 |
20110104142 | FORMULATIONS OF PEG-FUNCTIONALISED SERINE PROTEASES WITH HIGH CONCENTRATIONS OF AN AROMATIC PRESERVATIVE - The invention relates to a liquid, aqueous pharmaceutical composition comprising a Factor VII polypeptide (i) functionalised with one or more polyethylene glycol (PEG) moieties, said PEG moieties having a molecular weight of at least 300 Da; a buffering agent (ii) suitable for keeping pH in the range of from about 5.0 to about 9.0; and at least one aromatic preservative (iii) in a concentration of at least 0.1 mg/mL. | 05-05-2011 |
20120003206 | LIQUID, AQUEOUS PHARMACEUTICAL COMPOSITIONS OF FACTOR VII POLYPEPTIDES - The present invention is directed to liquid, aqueous pharmaceutical compositions stabilised against chemical and/or physical degradation containing Factor VII polypeptides, and methods for preparing and using such compositions, as well as vials containing such compositions, and the use of such compositions in the treatment of a Factor VII-responsive syndrome. The main embodiment is represented by a liquid, aqueous pharmaceutical composition comprising at least 0.01 mg/mL of a Factor VII polypeptide (i); a buffering agent (ii) suitable for keeping pH in the range of from about 4.0 to about 9.0; and at least one stabilising agent (iii) comprising a —C(═N—Z | 01-05-2012 |
20120004176 | Liquid Composition of Factor VII Polypeptides - A liquid aqueous composition comprising (i) a factor VII polypeptide, (ii) an agent suitable for keeping pH in the range of from about 4.0 to about 8.0; (iii) an agent selected from the list of: a calcium salt, a magnesium salt, or a mixture thereof; wherein the concentration of (iii) is at least 15 mM. | 01-05-2012 |
20130017184 | Stabilised solid compositions of factor VII polypeptides - The invention relates to chemically as well as physically stable compositions comprising Factor VII or a Factor VII-related polypeptide such that these compositions can be stored, handled and used at room temperature. | 01-17-2013 |