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1. (WO2009124586) AQUEOUS PHARMACEUTICAL FORMULATION
Latest bibliographic data on file with the International Bureau   

Pub. No.:    WO/2009/124586    International Application No.:    PCT/EP2008/054232
Publication Date: 15.10.2009 International Filing Date: 08.04.2008
IPC:
A61K 9/08 (2006.01), A61K 47/10 (2006.01), A61K 31/505 (2006.01)
Applicants: ACINO PHARMA AG [CH/CH]; Birsweg 2 CH-4253 Liesberg (CH) (For All Designated States Except US).
GILLESSEN, Dieter [CH/CH]; (CH) (For US Only).
JÄGER, Jürgen [DE/CH]; (CH) (For US Only)
Inventors: GILLESSEN, Dieter; (CH).
JÄGER, Jürgen; (CH)
Agent: Vossius & Partner; Siebertstrasse 4 81675 München (DE)
Priority Data:
Title (EN) AQUEOUS PHARMACEUTICAL FORMULATION
(FR) PRÉPARATION PHARMACEUTIQUE AQUEUSE
Abstract: front page image
(EN)The invention concerns a stable aqueous pharmaceutical composition comprising 5-[(2RS)-2-cyclopropyl-7,8-dimethoxy-2H-1-benzopyran-5-ylmethyl]-pyrimidine-2,4- diamine in form of the water soluble methanesulfonic acid salt, a physiological sodium chloride solution, ethanol and Povidone 12 PF, the liquid having a pH of over and above 4.8, but not higher than 5.2, and wherein the oxygen amount is controlled to be 0.8 ppm or less; which can be sterilized by filtration and/or by heated treatment, stored for longer time periods and which can be use for bolus injection or diluted for i.v. infusion.
(FR)La présente invention concerne une composition pharmaceutique aqueuse stable comprenant de la 5-[(2RS)-2-cyclopropyle-7,8-diméthoxy-2H-1-benzopyrane-5-ylméthyle]-pyrimidine-2,4- diamine sous forme de sel d'acide méthanésulfonique soluble dans l'eau, une solution de chlorure de sodium physiologique, d'éthanol et de Povidone 12 PF, le liquide ayant un pH supérieur à 4,8, mais inférieur à 5,2, et la quantité d'oxygène devant être inférieure ou égale à 0,8 ppm; cette composition peut être stérilisée par filtration et/ou traitement thermique, conservée à long terme et utilisée pour l'injection de bolus ou diluée pour injection par i.v.
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, 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)