JP2016531151A - レファメチニブを含有する医薬組成物 - Google Patents

レファメチニブを含有する医薬組成物 Download PDF

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JP2016531151A
JP2016531151A JP2016542319A JP2016542319A JP2016531151A JP 2016531151 A JP2016531151 A JP 2016531151A JP 2016542319 A JP2016542319 A JP 2016542319A JP 2016542319 A JP2016542319 A JP 2016542319A JP 2016531151 A JP2016531151 A JP 2016531151A
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weight
coating
coated tablet
refametinib
tablet according
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Pending
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JP2016542319A
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Japanese (ja)
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JP2016531151A5 (enExample
Inventor
ストロイヤー，アンケ
スクラブス，ズザンネ
フオルメル，ミヒヤエル
ヴインター，ガブリエーレ
キツセンベツク，ローゼマリー
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バイエル ファーマ アクチエンゲゼルシャフト
バイエル ファーマ アクチエンゲゼルシャフト
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Priority claimed from EP13184229.6A external-priority patent/EP2848246A1/en
Application filed by バイエル ファーマ アクチエンゲゼルシャフト, バイエル ファーマ アクチエンゲゼルシャフト filed Critical バイエル ファーマ アクチエンゲゼルシャフト
Publication of JP2016531151A publication Critical patent/JP2016531151A/ja
Publication of JP2016531151A5 publication Critical patent/JP2016531151A5/ja
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/18—Sulfonamides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2016542319A 2013-09-13 2014-09-11 レファメチニブを含有する医薬組成物 Pending JP2016531151A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP13184229.6A EP2848246A1 (en) 2013-09-13 2013-09-13 Pharmaceutical compositions containing refametinib
EP13184229.6 2013-09-13
EP13184539 2013-09-16
EP13184539.8 2013-09-16
PCT/EP2014/069453 WO2015036512A1 (en) 2013-09-13 2014-09-11 Pharmaceutical compositions containing refametinib

Publications (2)

Publication Number Publication Date
JP2016531151A true JP2016531151A (ja) 2016-10-06
JP2016531151A5 JP2016531151A5 (enExample) 2017-10-19

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JP2016542319A Pending JP2016531151A (ja) 2013-09-13 2014-09-11 レファメチニブを含有する医薬組成物

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US (1) US20160220494A1 (enExample)
EP (1) EP3043778B1 (enExample)
JP (1) JP2016531151A (enExample)
CN (1) CN105658209A (enExample)
CA (1) CA2923990A1 (enExample)
DK (1) DK3043778T3 (enExample)
ES (1) ES2648267T3 (enExample)
HU (1) HUE035877T2 (enExample)
NO (1) NO3043778T3 (enExample)
PL (1) PL3043778T3 (enExample)
TW (1) TW201542245A (enExample)
UY (1) UY35734A (enExample)
WO (1) WO2015036512A1 (enExample)

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US10058630B2 (en) 2012-10-22 2018-08-28 Concievalve, Llc Methods for inhibiting stenosis, obstruction, or calcification of a stented heart valve or bioprosthesis
JP6433085B2 (ja) 2013-04-09 2018-12-05 ボストン バイオメディカル， インコーポレイテッド がんの処置に使用するための２−アセチルナフト［２，３−ｂ］フラン−４，９−ジオン
DK3105226T3 (da) 2014-02-13 2019-10-14 Incyte Corp Cyclopropylaminer som lsd1-inhibitorer
PT3105218T (pt) 2014-02-13 2019-12-05 Incyte Corp Ciclopropilaminas como inibidores de lsd1
WO2016007722A1 (en) 2014-07-10 2016-01-14 Incyte Corporation Triazolopyridines and triazolopyrazines as lsd1 inhibitors
EP3626720A1 (en) 2015-04-03 2020-03-25 Incyte Corporation Heterocyclic compounds as lsd1 inhibitors
KR102710120B1 (ko) 2015-08-12 2024-09-27 인사이트 홀딩스 코포레이션 Lsd1 저해제의 염
EP3359157A4 (en) 2015-10-06 2019-05-15 The Wistar Institute Of Anatomy And Biology METHOD AND COMPOSITIONS FOR THE TREATMENT OF METASTASIVE AND REFRACTORY CANCER DISEASES AND TUMORS
CN107224438B (zh) * 2016-03-25 2021-04-06 江苏豪森药业集团有限公司 富马酸沃诺拉赞药物组合物
US10939164B2 (en) * 2016-05-10 2021-03-02 Rovi Guides, Inc. Method and system for transferring an interactive feature to another device
KR101796684B1 (ko) * 2016-05-19 2017-11-10 건국대학교 산학협력단 케라틴 8 인산화 억제제를 포함하는 황반변성 예방 또는 치료용 약학 조성물 및 황반변성 치료제의 스크리닝 방법
US11299469B2 (en) 2016-11-29 2022-04-12 Sumitomo Dainippon Pharma Oncology, Inc. Naphthofuran derivatives, preparation, and methods of use thereof
CA3058162A1 (en) * 2017-03-30 2018-10-04 Boston Biomedical, Inc. Compositions for treating and/or preventing cancer
WO2018213424A1 (en) 2017-05-17 2018-11-22 Boston Biomedical, Inc. Methods for treating cancer
JP7166754B2 (ja) * 2017-11-22 2022-11-08 沢井製薬株式会社 ダサチニブ無水物含有製剤
US10968200B2 (en) 2018-08-31 2021-04-06 Incyte Corporation Salts of an LSD1 inhibitor and processes for preparing the same
CN115487186B (zh) * 2022-09-29 2024-04-16 北京朗瑞邦科技有限公司 一种具有mTOR抑制活性的药物制剂及其制备方法

Citations (10)

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Publication number Priority date Publication date Assignee Title
JP2002515074A (ja) * 1994-07-12 2002-05-21 バーウィンド・ファーマスーティカル・サーヴィスィーズ・インコーポレーテッド 防湿性フィルム被覆材組成物、方法および被覆成形物
JP2003509339A (ja) * 1999-07-09 2003-03-11 バーウィンド・ファーマスーティカル・サーヴィスィーズ・インコーポレーテッド フィルムコーティングおよびポリビニルアルコールをベースとするフィルムコーティング組成物
JP2004051506A (ja) * 2002-07-17 2004-02-19 Nichiko Pharmaceutical Co Ltd 経時的な変色を抑制した医薬組成物
JP2004300138A (ja) * 2003-03-18 2004-10-28 Takeda Chem Ind Ltd 安定化された経口固形製剤
JP2011518786A (ja) * 2008-04-14 2011-06-30 アルデア バイオサイエンシズ，インコーポレイティド 調製及び使用のための組成物及び方法
JP2011162531A (ja) * 2010-02-10 2011-08-25 Takada Seiyaku Kk フェキソフェナジン含有フイルムコーテイング経口製剤
JP2011236188A (ja) * 2010-05-06 2011-11-24 Takada Seiyaku Kk パロキセチン含有フイルムコ−テイング経口製剤
JP2012520321A (ja) * 2009-03-11 2012-09-06 アルデア バイオサイエンシズ，インコーポレイティド 特定の癌の治療のためのｒｄｅａ１１９／ｂａｙ８６９７６６を含む組み合わせ医薬
WO2012120364A2 (en) * 2011-03-09 2012-09-13 Ideal Cures Pvt. Ltd. Novel immediate release film coating compositions
JP2015527395A (ja) * 2012-09-06 2015-09-17 バイエル・ヘルスケア・エルエルシーＢａｙｅｒ ＨｅａｌｔｈＣａｒｅＬＬＣ レゴラフェニブを含有する被覆医薬組成物

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JP2002515074A (ja) * 1994-07-12 2002-05-21 バーウィンド・ファーマスーティカル・サーヴィスィーズ・インコーポレーテッド 防湿性フィルム被覆材組成物、方法および被覆成形物
JP2003509339A (ja) * 1999-07-09 2003-03-11 バーウィンド・ファーマスーティカル・サーヴィスィーズ・インコーポレーテッド フィルムコーティングおよびポリビニルアルコールをベースとするフィルムコーティング組成物
JP2004051506A (ja) * 2002-07-17 2004-02-19 Nichiko Pharmaceutical Co Ltd 経時的な変色を抑制した医薬組成物
JP2004300138A (ja) * 2003-03-18 2004-10-28 Takeda Chem Ind Ltd 安定化された経口固形製剤
JP2011518786A (ja) * 2008-04-14 2011-06-30 アルデア バイオサイエンシズ，インコーポレイティド 調製及び使用のための組成物及び方法
JP2012520321A (ja) * 2009-03-11 2012-09-06 アルデア バイオサイエンシズ，インコーポレイティド 特定の癌の治療のためのｒｄｅａ１１９／ｂａｙ８６９７６６を含む組み合わせ医薬
JP2011162531A (ja) * 2010-02-10 2011-08-25 Takada Seiyaku Kk フェキソフェナジン含有フイルムコーテイング経口製剤
JP2011236188A (ja) * 2010-05-06 2011-11-24 Takada Seiyaku Kk パロキセチン含有フイルムコ−テイング経口製剤
WO2012120364A2 (en) * 2011-03-09 2012-09-13 Ideal Cures Pvt. Ltd. Novel immediate release film coating compositions
JP2015527395A (ja) * 2012-09-06 2015-09-17 バイエル・ヘルスケア・エルエルシーＢａｙｅｒ ＨｅａｌｔｈＣａｒｅＬＬＣ レゴラフェニブを含有する被覆医薬組成物

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PL3043778T3 (pl) 2018-04-30
TW201542245A (zh) 2015-11-16
UY35734A (es) 2015-04-30
DK3043778T3 (da) 2017-11-27
NO3043778T3 (enExample) 2018-02-03
WO2015036512A1 (en) 2015-03-19
CN105658209A (zh) 2016-06-08
EP3043778B1 (en) 2017-09-06
HUE035877T2 (en) 2018-05-28
EP3043778A1 (en) 2016-07-20
ES2648267T3 (es) 2017-12-29
US20160220494A1 (en) 2016-08-04
CA2923990A1 (en) 2015-03-19

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