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Machine translation
1. (WO2005016365) LIQUID, AQUEOUS PHARMACEUTICAL COMPOSITION OF FACTOR VII POLYPEPTIDES
Latest bibliographic data on file with the International Bureau   

Pub. No.: WO/2005/016365 International Application No.: PCT/DK2004/000537
Publication Date: 24.02.2005 International Filing Date: 12.08.2004
IPC:
A61K 38/48 (2006.01) ,A61K 47/16 (2006.01) ,A61K 47/18 (2006.01)
Applicants: JENSEN, Michael, Bech[DK/DK]; DK (UsOnly)
PETERSEN, Anders, Klarskov[DK/DK]; DK (UsOnly)
BOWLER, Andrew, Neil[GB/DK]; DK (UsOnly)
NOVO NORDISK HEALTH CARE AG[CH/CH]; Andreasstrasse 15 CH-8050 Zurich, CH
Inventors: JENSEN, Michael, Bech; DK
PETERSEN, Anders, Klarskov; DK
BOWLER, Andrew, Neil; DK
Common
Representative:
NOVO NORDISK A/S; Corporate Patents Novo Allé DK-2880 Bagsvaerd, DK
Priority Data:
60/496,44320.08.2003US
PA 2003 0116114.08.2003DK
PCT/DK04/00018118.03.2004DK
Title (EN) LIQUID, AQUEOUS PHARMACEUTICAL COMPOSITION OF FACTOR VII POLYPEPTIDES
(FR) COMPOSITION PHARMACEUTIQUE LIQUIDE AQUEUSE DE POLYPEPTIDES DU FACTEUR VII
Abstract:
(EN) 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.
(FR) 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-Z1-R1)-NH-Z2-R2, par exemple, des composés de benzamidine et des composés de guanidine, tels qu'arginine.
Designated States: AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NA, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RU, SC, SD, SE, SG, SK, SL, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, YU, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (EPO) (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IT, LU, MC, NL, PL, PT, RO, SE, SI, SK, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)