JP2017523206A - ブルトン型チロシンキナーゼ阻害剤の新規製剤 - Google Patents

ブルトン型チロシンキナーゼ阻害剤の新規製剤 Download PDF

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Publication number
JP2017523206A
JP2017523206A JP2017505606A JP2017505606A JP2017523206A JP 2017523206 A JP2017523206 A JP 2017523206A JP 2017505606 A JP2017505606 A JP 2017505606A JP 2017505606 A JP2017505606 A JP 2017505606A JP 2017523206 A JP2017523206 A JP 2017523206A
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formulation
ibrutinib
compound
polymer
solid dispersion
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Japanese (ja)
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JP2017523206A5 (enExample
Inventor
シュ，カサンドラ
アトゥルーリ，ハリシャ
キュール，ロバート
シュウェ−チョ タイ，パール
シュウェ−チョ タイ，パール
ミッチェル ミンキス，ライアン
ミッチェル ミンキス，ライアン
フランシス フルバット，ジェイムス
フランシス フルバット，ジェイムス
ジェイコブ マクベイ，アレキサンダー
ジェイコブ マクベイ，アレキサンダー
チョン，チン−ワ
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ファーマサイクリックス エルエルシー
ファーマサイクリックス エルエルシー
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Publication of JP2017523206A publication Critical patent/JP2017523206A/ja
Publication of JP2017523206A5 publication Critical patent/JP2017523206A5/ja
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    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • A61K9/14—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
    • A61K9/2022—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2017505606A 2014-08-07 2015-08-07 ブルトン型チロシンキナーゼ阻害剤の新規製剤 Pending JP2017523206A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462034353P 2014-08-07 2014-08-07
US62/034,353 2014-08-07
PCT/US2015/044258 WO2016022942A1 (en) 2014-08-07 2015-08-07 Novel formulations of a bruton's tyrosine kinase inhibitor

Publications (2)

Publication Number Publication Date
JP2017523206A true JP2017523206A (ja) 2017-08-17
JP2017523206A5 JP2017523206A5 (enExample) 2018-09-20

Family

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JP2017505606A Pending JP2017523206A (ja) 2014-08-07 2015-08-07 ブルトン型チロシンキナーゼ阻害剤の新規製剤

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Country Link
US (4) US9545407B2 (enExample)
EP (1) EP3193877A4 (enExample)
JP (1) JP2017523206A (enExample)
KR (1) KR20170033358A (enExample)
CN (1) CN106573002A (enExample)
AU (1) AU2015300798A1 (enExample)
BR (1) BR112017002231A2 (enExample)
CA (1) CA2955747A1 (enExample)
IL (1) IL250085A0 (enExample)
MX (1) MX2017001671A (enExample)
RU (1) RU2017106795A (enExample)
SG (1) SG11201700849XA (enExample)
WO (1) WO2016022942A1 (enExample)

Cited By (3)

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JP2021532159A (ja) * 2018-07-31 2021-11-25 ロクソ オンコロジー, インコーポレイテッドLoxo Oncology, Inc. （ｓ）−５−アミノ−３−（４−（（５−フルオロ−２−メトキシベンズアミド）メチル）フェニル）−１−（１，１，１−トリフルオロプロパン−２−イル）−１ｈ−ピラゾール−４−カルボキサミドの噴霧乾燥分散体および製剤
JP2022525797A (ja) * 2019-04-11 2022-05-19 ゴールドフィンチ バイオ，インク． ピリダジノンｔｒｐｃ５阻害剤の噴霧乾燥された製剤
JP2022533368A (ja) * 2019-05-17 2022-07-22 セルジーン シーエーアール エルエルシー Ｍｋ２媒介性障害の治療方法

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EA201492082A1 (ru) 2012-06-04 2015-03-31 Фармасайкликс, Инк. Кристаллические формы ингибитора тирозинкиназы брутона
KR20180088926A (ko) 2012-07-24 2018-08-07 파마싸이클릭스 엘엘씨 브루톤 티로신 키나제(btk)의 억제제에 대한 내성과 관련된 돌연변이
BR112017002231A2 (pt) * 2014-08-07 2018-07-17 Pharmacyclics Llc novas formulações de um inibidor de tirosina cinase de bruton
IL315294A (en) 2015-03-03 2024-10-01 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibitor
EP3280446A1 (en) * 2015-04-06 2018-02-14 Janssen Pharmaceutica, N.V. Compositions containing ibrutinib
MX2018008771A (es) * 2016-01-19 2018-11-09 Janssen Pharmaceutica Nv Formulaciones/composiciones que comprenden un inhibidor de btk.
KR20190138871A (ko) * 2017-04-24 2019-12-16 사무스 테라퓨틱스, 인코포레이티드 Hsp90 저해제 경구 제형 및 관련 방법
CN107014943B (zh) * 2017-06-07 2018-08-21 福建省微生物研究所 一种依鲁替尼对映异构体的检测方法
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WO2019058386A1 (en) 2017-09-19 2019-03-28 Cipla Limited COMPOSITIONS COMPRISING IBRUTINIB AND AN ALKALOID HAVING IMPROVED BIOAVAILABILITY
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CN114681424A (zh) * 2020-12-31 2022-07-01 鲁南制药集团股份有限公司 一种伊布替尼胶囊及其制备方法
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