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1. (WO2018079570) STABLE PHARMACEUTICAL COMPOSITION
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Pub. No.: WO/2018/079570 International Application No.: PCT/JP2017/038416
Publication Date: 03.05.2018 International Filing Date: 25.10.2017
IPC:
A61K 31/497 (2006.01) ,A61K 9/20 (2006.01) ,A61K 47/02 (2006.01) ,A61P 35/00 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
33
Heterocyclic compounds
395
having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
495
having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
4965
Non-condensed pyrazines
497
containing further heterocyclic rings
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
20
Pills, lozenges or tablets
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
02
Inorganic compounds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35
Antineoplastic agents
Applicants:
アステラス製薬株式会社 ASTELLAS PHARMA INC. [JP/JP]; 東京都中央区日本橋本町二丁目5番1号 5-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 1038411, JP
Inventors:
櫻井 敦司 SAKURAI Atsushi; JP
吉田 允 YOSHIDA Mitsuru; JP
冨永 哲夫 TOMINAGA Tetsuo; JP
Agent:
山口 健次郎 YAMAGUCHI Kenjiro; JP
森田 憲一 MORITA Kenichi; JP
鈴木 ▲頼▼子 SUZUKI Yoriko; JP
濱井 康丞 HAMAI Kosuke; JP
森平 浩一郎 MORIHIRA Koichiro; JP
川濱 周弥 KAWAHAMA Shuya; JP
Priority Data:
2016-20912726.10.2016JP
Title (EN) STABLE PHARMACEUTICAL COMPOSITION
(FR) COMPOSITION PHARMACEUTIQUE STABLE
(JA) 安定な医薬組成物
Abstract:
(EN) Provided is a stable pharmaceutical composition containing 5-{[(3R)-1-acryloylpyrrolidin-3-yl]oxy}-6-ethyl-3-({4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)pyrazine-2-carboxamide or a pharmaceutically acceptable salt thereof. The pharmaceutical composition contains potassium chloride and/or sodium chloride, and inhibits an increase in related substances.
(FR) L'invention concerne une composition pharmaceutique stable contenant de 5-{[(3R)-1-acryloylpyrrolidin-3-yl]oxy}-6-éthyl-3-({4-[4-(4-méthylpipérazin-1-yl)pipéridin-1-yl]phényl}amino)pyrazine-2-carboxamide ou un sel pharmaceutiquement acceptable de celui-ci. La composition pharmaceutique contient du chlorure de potassium et/ou du chlorure de sodium, et inhibe une augmentation de substances apparentées.
(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-カルボキサミド又はその製薬学的に許容される塩を含む安定な医薬組成物を提供する。前記医薬組成物は、塩化カリウム、及び/又は塩化ナトリウムを含み、類縁物質の増加を抑制する。
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, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, 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 (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (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)