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1. (WO2009065918) STABILISATION OF LIQUID-FORMULATED FACTOR VII(A) POLYPEPTIDES BY ALDEHYDE-CONTAINING COMPOUNDS
Latest bibliographic data on file with the International Bureau   

Pub. No.:    WO/2009/065918    International Application No.:    PCT/EP2008/065959
Publication Date: 28.05.2009 International Filing Date: 21.11.2008
IPC:
A61K 9/08 (2006.01), A61K 38/36 (2006.01), A61K 47/08 (2006.01), A61P 7/04 (2006.01)
Applicants: NOVO NORDISK HEALTH CARE AG [CH/CH]; Andreasstraase 15, CH-8050 Zürich (CH) (For All Designated States Except US).
DÖRWALD, Florencio, Zaragoza [DE/CH]; (CH) (For US Only).
STENNICKE, Henning, Ralf [DK/DK]; (DK) (For US Only).
OLSEN, Ole, Hvilsted [DK/DK]; (DK) (For US Only)
Inventors: DÖRWALD, Florencio, Zaragoza; (CH).
STENNICKE, Henning, Ralf; (DK).
OLSEN, Ole, Hvilsted; (DK)
Priority Data:
07121310.2 22.11.2007 EP
Title (EN) STABILISATION OF LIQUID-FORMULATED FACTOR VII(A) POLYPEPTIDES BY ALDEHYDE-CONTAINING COMPOUNDS
(FR) STABILISATION DE POLYPEPTIDES DU FACTEUR VII(A) FORMULÉS SOUS FORME LIQUIDE PAR DES COMPOSÉS CONTENANT DES ALDÉHYDES
Abstract: front page image
(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 R-CHO motif, e.g. Benzaldehyde, 3-hydroxybenzaldehyde, 4- hydroxybenzaldehyde, or 5-formyl-4- methylimidazole.
(FR)La présente invention concerne des compositions pharmaceutiques aqueuses liquides stabilisées envers la dégradation chimique et/ou physique, qui contiennent des polypeptides du facteur VII, ainsi que des procédés de préparation et d'utilisation de telles compositions, ainsi que des fioles contenant de telles compositions, et l'utilisation de telles compositions pour le traitement d'un syndrome sensible au facteur VII. Le mode de réalisation principal est représenté par une composition pharmaceutique aqueuse liquide qui comprend au moins 0,01 mg/mL d'un polypeptide du facteur VII (i) ; un tampon (ii) approprié pour maintenir le pH dans la plage allant d'environ 4,0 à environ 9,0 ; et au moins un stabilisateur (iii) qui comprend un motif R-CHO, p. ex. benzaldéhyde, 3-hydroxybenzaldéhyde, 4- hydroxybenzaldéhyde ou 5-formyl-4-méthylimidazole.
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
African Regional Intellectual Property Organization (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MT, NL, NO, 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)