CN106573002A - 布鲁顿氏酪氨酸激酶抑制剂的新型制剂 - Google Patents

布鲁顿氏酪氨酸激酶抑制剂的新型制剂 Download PDF

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Publication number
CN106573002A
CN106573002A CN201580043327.XA CN201580043327A CN106573002A CN 106573002 A CN106573002 A CN 106573002A CN 201580043327 A CN201580043327 A CN 201580043327A CN 106573002 A CN106573002 A CN 106573002A
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China
Prior art keywords
weight
compound
formulation
ibrutinib
solid dispersion
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Pending
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CN201580043327.XA
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English (en)
Chinese (zh)
Inventor
卡桑德拉·舒
哈里莎·阿特卢里
罗伯特·屈尔
珀尔·瑞-丘·泰
瑞安·米切尔·米尼基斯
詹姆斯·弗朗西斯·胡尔瓦特
亚历山大·雅各布·麦克维
宗清华
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Pharmacyclics LLC
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Pharmacyclics LLC
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Publication of CN106573002A publication Critical patent/CN106573002A/zh
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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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN201580043327.XA 2014-08-07 2015-08-07 布鲁顿氏酪氨酸激酶抑制剂的新型制剂 Pending CN106573002A (zh)

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 (1)

Publication Number Publication Date
CN106573002A true CN106573002A (zh) 2017-04-19

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CN201580043327.XA Pending CN106573002A (zh) 2014-08-07 2015-08-07 布鲁顿氏酪氨酸激酶抑制剂的新型制剂

Country Status (13)

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

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CN107014943A (zh) * 2017-06-07 2017-08-04 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
WO2019007317A1 (zh) * 2017-07-04 2019-01-10 江苏恒瑞医药股份有限公司 一种药物组合物及其制备方法
WO2019091438A1 (zh) * 2017-11-10 2019-05-16 苏州信诺维医药科技有限公司 作为btk抑制剂的5-氨基吡唑甲酰胺化合物的无定型固体分散体
CN110913840A (zh) * 2017-08-11 2020-03-24 默克专利股份公司 包含3-氟-4-[7-甲氧基-3-甲基-8-(1-甲基-1H-吡唑-4-基)-2-氧代-2,3-二氢-咪唑并[4,5-c]喹啉-1-基]-苄腈的药物制剂
CN111617028A (zh) * 2020-07-14 2020-09-04 扬子江药业集团江苏紫龙药业有限公司 一种含伊布替尼的口服制剂及制备方法
CN113194928A (zh) * 2018-07-31 2021-07-30 罗索肿瘤学公司 (s)-5-氨基-3-(4-((5-氟-2-甲氧基苯甲酰胺基)甲基)苯基)-1-(1,1,1-三氟丙-2-基)-1h-吡唑-4-甲酰胺的喷雾干燥的分散体和制剂
CN113509443A (zh) * 2021-07-14 2021-10-19 药源生物科技（启东）有限公司 一种含soluplus的固分体及其制备方法
CN114585362A (zh) * 2019-09-23 2022-06-03 生态有限公司 治疗制剂及其用途
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
CN115054603A (zh) * 2022-06-20 2022-09-16 上海宣泰医药科技股份有限公司 依鲁替尼药物组合物及其制备方法和药物制剂
CN115135308A (zh) * 2019-12-30 2022-09-30 德西费拉制药有限责任公司 非晶型激酶抑制剂制剂及其使用方法
US11793795B2 (en) 2019-12-30 2023-10-24 Deciphera Pharmaceuticals, Llc Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea
US11813251B2 (en) 2019-08-12 2023-11-14 Deciphera Pharmaceuticals, Llc Methods of treating gastrointestinal stromal tumors
US11986463B2 (en) 2018-01-31 2024-05-21 Deciphera Pharmaceuticals, Llc Combination therapy for the treatment of gastrointestinal stromal tumor
US12102620B2 (en) 2018-01-31 2024-10-01 Deciphera Pharmaceuticals, Llc Combination therapy for the treatment of mastocytosis
US12509456B2 (en) 2019-03-11 2025-12-30 Deciphera Pharmaceuticals, Llc Solid state forms of ripretinib

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JO3754B1 (ar) 2012-06-04 2021-01-31 Pharmacyclics Llc أشكال كريستالين لمثبط أنزيم كيناز تيروسين بروتون
CN104704129A (zh) 2012-07-24 2015-06-10 药品循环公司 与对布鲁顿酪氨酸激酶(btk)抑制剂的抗性相关的突变
SG11201700849XA (en) * 2014-08-07 2017-03-30 Pharmacyclics Llc Novel formulations of a bruton's tyrosine kinase inhibitor
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RS64653B1 (sr) 2015-04-06 2023-10-31 Janssen Pharmaceutica Nv Kompozicije koje sadrže ibrutinib
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CN110996913A (zh) * 2017-06-30 2020-04-10 欧恩科斯欧公司 新的贝利司他口服制剂
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CN111617028A (zh) * 2020-07-14 2020-09-04 扬子江药业集团江苏紫龙药业有限公司 一种含伊布替尼的口服制剂及制备方法
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
CN113509443A (zh) * 2021-07-14 2021-10-19 药源生物科技（启东）有限公司 一种含soluplus的固分体及其制备方法
CN113509443B (zh) * 2021-07-14 2023-04-11 药源生物科技（启东）有限公司 一种含soluplus的固分体及其制备方法
CN115054603A (zh) * 2022-06-20 2022-09-16 上海宣泰医药科技股份有限公司 依鲁替尼药物组合物及其制备方法和药物制剂

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