Title:
第VII因子ポリペプチドの液体水性薬学的組成物
Document Type and Number:
Japanese Patent JP2007507419
Kind Code:
A
Abstract:
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).
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Inventors:
Jensen, Michael Beck
Hansen, Birse Rickegard
Kornfeld, Troels
Jacobsen, Kirsten Kramer
Hansen, Birse Rickegard
Kornfeld, Troels
Jacobsen, Kirsten Kramer
Application Number:
JP2006515737A
Publication Date:
March 29, 2007
Filing Date:
June 30, 2004
Export Citation:
Assignee:
Novo Nordisk Health Care Akchen Gesell Shaft
International Classes:
A61K33/24; A61K38/43; A61K9/08; A61K38/48; A61K47/02; A61K47/26; A61P7/04
Domestic Patent References:
| JP2003531862A | 2003-10-28 | |||
| JP2001515460A | 2001-09-18 | |||
| JP2001515460A | 2001-09-18 | |||
| JP2003531862A | 2003-10-28 |
Foreign References:
| WO2003006054A1 | 2003-01-23 | |||
| WO2003006054A1 | 2003-01-23 |
Attorney, Agent or Firm:
Takehiko Suzue
Satoshi Kono
Makoto Nakamura
Kurata Masatoshi
Takashi Mine
Yoshihiro Fukuhara
Toshio Shirane
Sadao Muramatsu
Nobuhisa Nogawa
Ryo Hashimoto
Tetsuya Kazama
Satoshi Kono
Makoto Nakamura
Kurata Masatoshi
Takashi Mine
Yoshihiro Fukuhara
Toshio Shirane
Sadao Muramatsu
Nobuhisa Nogawa
Ryo Hashimoto
Tetsuya Kazama