A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 38/48 (2006.01) A61K 47/16 (2006.01) A61K 47/18 (2006.01)
Patent
CA 2534028
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 Z1 R1) NH Z2 R2 motif, e.g. benzamidine compounds and guanidine compounds such as arginine.
L'invention concerne des compositions pharmaceutiques liquides aqueuses stabilisées contre la dégradation chimique et/ou physique et contenant des polypeptides du facteur VII, des méthodes servant à préparer et à utiliser ces compositions, ainsi que des flacons contenant ces compositions et l'utilisation de ces compositions pour traiter un syndrome sensible aux facteurs VII. Le mode de réalisation principal consiste en une composition pharmaceutique liquide aqueuse contenant au moins 0,01 mg/mL d'un polypeptide du facteur VII (i); un agent tampon (ii) permettant de conserver le pH dans une plage située entre 4 et 9 ; au moins un agent stabilisant (iii) contenant un motif de -C(=N-Z?1¿-R?1¿)-NH-Z?2¿-R?2¿, par exemple, des composés de benzamidine et des composés de guanidine, tels qu'arginine.
Bowler Andrew Neil
Jensen Michael Bech
Petersen Anders Klarskov
Dimock Stratton Llp
Novo Nordisk Health Care Ag
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