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    Protein stabilization in solution
    1.
    发明申请
    Protein stabilization in solution 有权

    公开(公告)号：US20060160720A1

    公开(公告)日：2006-07-20

    申请号：US11284709

    申请日：2005-11-22

    申请人： Michael Jensen ,  Birthe Hansen ,  Troels Kornfelt ,  Kirsten Jakobsen

    发明人： Michael Jensen ,  Birthe Hansen ,  Troels Kornfelt ,  Kirsten Jakobsen

    IPC分类号： A61K38/37 ,  B65D85/42 ,  B65D83/04

    CPC分类号： A61K38/4846

    摘要： Provided are storage containers for proteinaceous pharmaceutical compositions which are characterized in, among other things, comprising (i) a wall portion, wherein an inner wall material thereof is selected from silica-coated glass, silicone-coated glass, polymers of non-cyclic olefins, cycloolefin polymers and cycloolefin/linear olefin copolymers and (ii) one or more closure portions not constituting part of the wall portion, and which contains a formulation of a protein. Also provided are new methods of storing proteinaceous compositions. In one aspect, the stored protein is characterized as having an amino-terminal γ-carboxyglutamic acid (Gla) domain with 9-12 Gla residues.

    Liquid, aqueous, pharmaceutical compositions of factor VII polypeptides
    2.
    发明申请
    Liquid, aqueous, pharmaceutical compositions of factor VII polypeptides 审中-公开
    液体，水性，因子VII多肽的药物组合物

    公开(公告)号：US20060063714A1

    公开(公告)日：2006-03-23

    申请号：US11229427

    申请日：2005-09-15

    申请人： Michael Jensen ,  Birthe Hansen ,  Troels Kornfelt ,  Kirsten Jakobsen ,  Janus Krarup ,  Egon Persson ,  Anders Petersen ,  Andrew Bowler

    发明人： Michael Jensen ,  Birthe Hansen ,  Troels Kornfelt ,  Kirsten Jakobsen ,  Janus Krarup ,  Egon Persson ,  Anders Petersen ,  Andrew Bowler

    IPC分类号： A61K38/36

    CPC分类号： A61K38/4846 ,  A61K9/0019 ,  A61K47/02 ,  A61K47/12 ,  A61K47/18 ,  A61K47/183 ,  A61K47/186

    摘要： The invention relates to a liquid, aqueous pharmaceutical composition comprising a Factor VII polypeptide (e.g. human Factor VIIa) and a buffering agent; wherein the molar ratio of non-complexed calcium ions (Ca2+) to the Factor VII polypeptide is lower than 0.5. The composition may further comprise a stabilizing agent (e.g. copper or magnesium ions, benzamidine, or guanidine), a non-ionic surfactant, a tonicity modifying agent, an antioxidant and a preservative. The composition is useful for treating a Factor VII-responsive syndrome, such as bleeding disorders, including those caused by clotting Factor deficiencies (e.g. haemophilia A, haemophilia B, coagulation Factor XI deficiency, 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.

    摘要翻译： 本发明涉及包含因子VII多肽（例如人因子VIIa）和缓冲剂的液体含水药物组合物; 其中非络合钙离子（Ca 2+ 2 +）与因子VII多肽的摩尔比低于0.5。 组合物还可以包含稳定剂（例如铜或镁离子，苯甲脒或胍），非离子表面活性剂，张力调节剂，抗氧化剂和防腐剂。 该组合物可用于治疗因子VII反应性综合征，例如出血性疾病，包括由凝血因子缺乏引起的出血性疾病（例如血友病A，血友病B，凝血因子XI缺乏症，凝血因子VII缺乏症）。 血小板减少症或维勒布兰氏病，或凝血因子抑制剂，脑内出血或任何原因引起的过度出血。 制剂也可以与外科手术或其他创伤相关的患者或接受抗凝治疗的患者给予。

    Liquid composition of modified factor VII polypeptides
    4.
    发明申请
    Liquid composition of modified factor VII polypeptides 审中-公开
    修饰因子VII多肽的液体组成

    公开(公告)号：US20070049523A1

    公开(公告)日：2007-03-01

    申请号：US11473387

    申请日：2006-06-21

    申请人： Birthe Hansen ,  Michael Jensen ,  Troels Kornfelt

    发明人： Birthe Hansen ,  Michael Jensen ,  Troels Kornfelt

    IPC分类号： A61K38/36

    CPC分类号： A61K38/36 ,  A61K9/0019

    摘要： The invention provides a liquid, aqueous composition, comprising (i) a modified factor VII polypeptide; (ii) an agent suitable for keeping pH in the range of from about 4.0 to about 8.0; (iii) an antioxidant; and (iv) an agent selected from the list of: a calcium salt, a magnesium salt, or a mixture thereof.

    摘要翻译： 本发明提供一种液体含水组合物，其包含（i）修饰的因子VII多肽; （ii）适于将pH保持在约4.0至约8.0范围内的试剂; （iii）抗氧化剂; 和（iv）选自以下列表的试剂：钙盐，镁盐或其混合物。

    Liquid composition of factor VII polypeptides
    6.
    发明申请
    Liquid composition of factor VII polypeptides 审中-公开
    因子VII多肽的液体组成

    公开(公告)号：US20060183683A1

    公开(公告)日：2006-08-17

    申请号：US11304429

    申请日：2005-12-15

    申请人： Birthe Hansen ,  Michael Jensen ,  Troels Kornfelt

    发明人： Birthe Hansen ,  Michael Jensen ,  Troels Kornfelt

    IPC分类号： A61K38/36 ,  A61K31/19

    CPC分类号： A61K47/02 ,  A61K9/0019 ,  A61K31/19 ,  A61K47/183

    摘要： The invention concerns 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 9.0; (iii) an agent selected from the group consisting of: a calcium salt, a magnesium salt, or a mixture thereof; wherein the concentration of (iii) is less than 15 mM; and (iv) An ionic strength modifying agent; wherein the ionic strength of the composition is at least 200 mM.

    摘要翻译： 本发明涉及一种液体含水组合物，其包含（i）因子VII多肽，（ii）适于将pH保持在约4.0至约9.0范围内的试剂; （iii）选自以下的试剂：钙盐，镁盐或其混合物; 其中（iii）的浓度小于15mM; 和（iv）离子强度改性剂; 其中所述组合物的离子强度为至少200mM。

    Liquid, aqueous pharmaceutical composition of Factor VII polypeptides
    7.
    发明申请
    Liquid, aqueous pharmaceutical composition of Factor VII polypeptides 审中-公开
    因子VII多肽的液体，水性药物组合物

    公开(公告)号：US20060166882A1

    公开(公告)日：2006-07-27

    申请号：US11304427

    申请日：2005-12-15

    申请人： Michael Jensen ,  Birthe Hansen ,  Troels Kornfelt ,  Kirsten Jakobsen

    发明人： Michael Jensen ,  Birthe Hansen ,  Troels Kornfelt ,  Kirsten Jakobsen

    IPC分类号： A61K38/36 ,  A61K33/34 ,  A61K33/26

    CPC分类号： A61K33/24 ,  A61K9/0019 ,  A61K33/26 ,  A61K33/32 ,  A61K33/34 ,  A61K38/4846 ,  A61K45/06 ,  A61K47/02 ,  A61K47/10 ,  A61K47/183 ,  A61K2300/00

    摘要： 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).

    摘要翻译： 本发明涉及含有因子VII多肽的液体含水药物组合物，以及用于制备和使用这些组合物的方法以及含有这种组合物的小瓶，以及这些组合物在治疗因子VII应答综合征中的用途， 例如出血性疾病，包括由凝血因子缺乏引起的出血性疾病（如血友病A，血友病B，凝血因子VII缺乏症）; 血小板减少症或维勒布兰氏病，或凝血因子抑制剂，脑内出血或任何原因引起的过度出血。 制剂也可以与外科手术或其他创伤相关的患者或接受抗凝治疗的患者给予。 更具体地说，本发明涉及防止化学和/或物理降解稳定的液体组合物。 主要实施方案由包含因子VII多肽（i）的液体，水性药物组合物表示; 适于将pH保持在约4.0至约9.0范围内的缓冲剂（ii）; 至少一种含金属的试剂（iii），其中所述金属选自氧化态+ II的第一过渡系列金属，除了锌，如铬，锰，铁，钴，镍和铜之外; 和非离子表面活性剂（iv）。