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1. (WO2016175192) STABILIZED PHARMACEUTICAL COMPOSITION
Latest bibliographic data on file with the International Bureau   

Pub. No.:    WO/2016/175192    International Application No.:    PCT/JP2016/063004
Publication Date: 03.11.2016 International Filing Date: 26.04.2016
IPC:
A61K 31/497 (2006.01), A61K 9/48 (2006.01), A61K 47/04 (2006.01), A61K 47/26 (2006.01), A61K 47/36 (2006.01), A61K 47/38 (2006.01), A61P 35/00 (2006.01)
Applicants: ASTELLAS PHARMA INC. [JP/JP]; 5-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 1038411 (JP)
Inventors: TASAKI Hiroaki; (JP).
YOSHIDA Mitsuru; (JP).
TSUNASHIMA Daisuke; (JP).
AZUMA Ryota; (JP)
Agent: MORITA Kenichi; (JP)
Priority Data:
2015-090702 27.04.2015 JP
2015-252958 25.12.2015 JP
Title (EN) STABILIZED PHARMACEUTICAL COMPOSITION
(FR) COMPOSITION PHARMACEUTIQUE STABILISÉE
(JA) 安定化されてなる医薬組成物
Abstract: front page image
(EN)Provided is a pharmaceutical composition which contains 5-{[(3R)-1-acryloylpyrrolidin-3-yl]oxy}-6-ethyl-3-({4-[4- (4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)- pyrazine-2-carboxamide (which is referred to as "compound A", hereinbelow) or a pharmaceutically acceptable salt thereof and is stabilized. The pharmaceutical composition comprises the compound A or a pharmaceutically acceptable salt thereof and a pharmaceutical additive having a difference in a water activity value of 0.1 or more, and is stabilized.
(FR)L'invention concerne une composition pharmaceutique qui contient du 5-{[(3R)-1-acryloylpyrrolidine-3-yl]oxy}-6-éthyl-3-({4-[4- (4-méthylpipérazine-1-yl)pipéridine-1-yl]phényl}amino)-pyrazine-2-carboxamide (ci-après appelé "composé A" ) ou un sel de qualité pharmaceutique de celui-ci, et qui est stabilisée. La composition pharmaceutique comprend le composé A ou un sel de qualité pharmaceutique de celui-ci, ainsi qu'un additif pharmaceutique présentant une différence de valeur d'activité aqueuse de 0,1 ou plus, et est stabilisée.
(JA)5-{[(3R)-1-アクリロイルピロリジン-3-イル]オキシ}-6-エチル-3-({4-[4-(4-メチルピペラジン-1-イル)ピペリジン-1-イル]フェニル}アミノ)ピラジン-2-カルボキサミド(以下、化合物A)又はその製薬学的に許容される塩を含有し、安定化されてなる医薬組成物を提供する。 前記医薬組成物は、化合物A又はその製薬学的に許容される塩、及び水分活性値の差分が0.1以上の医薬品添加物を含有し、安定化されてなる。
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, 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, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
African Regional Intellectual Property Organization (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG).
Publication Language: Japanese (JA)
Filing Language: Japanese (JA)