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 PDFInfo
- 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
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- ibrutinib
- compound
- polymer
- solid dispersion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
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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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dispersion Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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 (OSRAM) | 2018-09-20 |
Family
ID=55264642
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 |
Country Status (13)
| Country | Link |
|---|---|
| US (4) | US9545407B2 (OSRAM) |
| EP (1) | EP3193877A4 (OSRAM) |
| JP (1) | JP2017523206A (OSRAM) |
| KR (1) | KR20170033358A (OSRAM) |
| CN (1) | CN106573002A (OSRAM) |
| AU (1) | AU2015300798A1 (OSRAM) |
| BR (1) | BR112017002231A2 (OSRAM) |
| CA (1) | CA2955747A1 (OSRAM) |
| IL (1) | IL250085A0 (OSRAM) |
| MX (1) | MX2017001671A (OSRAM) |
| RU (1) | RU2017106795A (OSRAM) |
| SG (1) | SG11201700849XA (OSRAM) |
| WO (1) | WO2016022942A1 (OSRAM) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Families Citing this family (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ604040A (en) | 2010-06-03 | 2015-02-27 | Pharmacyclics Inc | The use of inhibitors of bruton’s tyrosine kinase (btk) |
| EA201492082A1 (ru) | 2012-06-04 | 2015-03-31 | Фармасайкликс, Инк. | Кристаллические формы ингибитора тирозинкиназы брутона |
| KR20150032340A (ko) | 2012-07-24 | 2015-03-25 | 파마시클릭스, 인코포레이티드 | 브루톤 티로신 키나제(btk)의 억제제에 대한 내성과 관련된 돌연변이 |
| EP3193877A4 (en) * | 2014-08-07 | 2018-04-04 | Pharmacyclics LLC | Novel formulations of a bruton's tyrosine kinase inhibitor |
| IL315294A (en) | 2015-03-03 | 2024-10-01 | Pharmacyclics Llc | Pharmaceutical formulations of bruton's tyrosine kinase inhibitor |
| MA54411B1 (fr) * | 2015-04-06 | 2023-11-30 | Janssen Pharmaceutica Nv | Compositions contenant de l'ibrutinib |
| KR20180101521A (ko) * | 2016-01-19 | 2018-09-12 | 얀센 파마슈티카 엔.브이. | Btk 저해제를 포함하는 제형/조성물 |
| EP3615008A4 (en) * | 2017-04-24 | 2021-05-05 | Samus Therapeutics, Inc. | ORAL HSP90 INHIBITOR FORMULATIONS AND RELATED PROCESSES |
| 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 |
| IL271658B2 (en) * | 2017-06-30 | 2023-09-01 | Onxeo | New oral formulations of belinostat |
| UA127413C2 (uk) * | 2017-07-04 | 2023-08-16 | Джянгсу Хенгруй Медісін Ко., Лтд. | Фармацевтична композиція та спосіб її отримання |
| AU2018314837A1 (en) * | 2017-08-11 | 2020-03-26 | Merck Patent Gmbh | Pharmaceutical preparation comprising 3-Fluoro-4-(7-methoxy-3-methyl-8-(1-methyl-1 H-pyrazol-4-yl)-2-oxo-2,3-dihydro-imidazo(4,5-c)quinolin-1 -yl)-benzonitrile |
| EP3684367A1 (en) | 2017-09-19 | 2020-07-29 | Cipla Limited | Compositions comprising ibrutinib and an alkaloid having enhanced bioavailability |
| WO2019070698A1 (en) | 2017-10-02 | 2019-04-11 | Johnson Matthey Public Limited Company | Novel forms of ibrutinib |
| CN111212644B (zh) * | 2017-11-10 | 2021-01-15 | 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 |
| CZ2017787A3 (cs) * | 2017-12-08 | 2019-06-19 | Zentiva, K.S. | Farmaceutické kompozice obsahující ibrutinib |
| US11576917B2 (en) | 2018-01-20 | 2023-02-14 | Natco Pharma Limited | Pharmaceutical compositions comprising Ibrutinib |
| JP7523351B2 (ja) | 2018-01-31 | 2024-07-26 | デシフェラ・ファーマシューティカルズ,エルエルシー | 肥満細胞症の治療のための併用療法 |
| JP2021512105A (ja) | 2018-01-31 | 2021-05-13 | デシフェラ・ファーマシューティカルズ,エルエルシー | 消化管間質腫瘍の治療のための併用療法 |
| WO2019195827A1 (en) | 2018-04-06 | 2019-10-10 | Johnson Matthey Public Limited Company | Novel form of ibrutinib |
| US20210121466A1 (en) | 2018-05-03 | 2021-04-29 | Juno Therapeutics, Inc. | Combination therapy of a chimeric antigen receptor (car) t cell therapy and a kinase inhibitor |
| CN112292117B (zh) | 2018-06-15 | 2024-06-07 | 詹森药业有限公司 | 包含依鲁替尼的配制品/组合物 |
| NZ784949A (en) | 2019-08-12 | 2025-09-26 | Deciphera Pharmaceuticals Llc | Ripretinib for treating gastrointestinal stromal tumors |
| CN118319863A (zh) * | 2019-09-23 | 2024-07-12 | 生态有限公司 | 治疗制剂及其用途 |
| AU2020419197B2 (en) * | 2019-12-30 | 2023-08-31 | Deciphera Pharmaceuticals, Llc | Amorphous kinase inhibitor formulations and methods of use thereof |
| NZ789199A (en) | 2019-12-30 | 2025-07-25 | 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 |
| CA3181361A1 (en) * | 2020-04-30 | 2021-11-04 | Nanocopoeia, Llc | Orally disintegrating tablet comprising amorphous solid dispersion of nilotinib |
| 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 |
| EP4281047A1 (en) * | 2021-01-21 | 2023-11-29 | XSpray Pharma AB (publ) | Fast dissolving pharmaceutical compositions of dasatinib |
| US20240024248A1 (en) * | 2021-01-21 | 2024-01-25 | Xspray Pharma Ab | Fast dissolving pharmaceutical compositions |
| MX2023010196A (es) * | 2021-03-03 | 2023-09-11 | Oakwood Laboratories LLC | Formulaciones de microesferas que comprenden inhibidores de btk y metodos para fabricar y usar las mismas. |
| 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 |
| WO2023104808A1 (en) * | 2021-12-10 | 2023-06-15 | Synthon B.V. | Pharmaceutical composition comprising ibrutinib |
| WO2023220655A1 (en) | 2022-05-11 | 2023-11-16 | Celgene Corporation | Methods to overcome drug resistance by re-sensitizing cancer cells to treatment with a prior therapy via treatment with a t cell therapy |
| 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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- 2015-08-07 SG SG11201700849XA patent/SG11201700849XA/en unknown
- 2015-08-07 CA CA2955747A patent/CA2955747A1/en not_active Abandoned
- 2015-08-07 KR KR1020177004064A patent/KR20170033358A/ko not_active Withdrawn
- 2015-08-07 AU AU2015300798A patent/AU2015300798A1/en not_active Abandoned
- 2015-08-07 BR BR112017002231-1A patent/BR112017002231A2/pt not_active Application Discontinuation
- 2015-08-07 CN CN201580043327.XA patent/CN106573002A/zh active Pending
- 2015-08-07 JP JP2017505606A patent/JP2017523206A/ja active Pending
- 2015-08-07 MX MX2017001671A patent/MX2017001671A/es unknown
- 2015-08-07 WO PCT/US2015/044258 patent/WO2016022942A1/en not_active Ceased
- 2015-08-07 RU RU2017106795A patent/RU2017106795A/ru not_active Application Discontinuation
- 2015-08-07 US US14/821,290 patent/US9545407B2/en active Active
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2016
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2017
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- 2017-03-17 US US15/462,444 patent/US20180028537A1/en active Granted
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2018
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| JP7286755B2 (ja) | 2018-07-31 | 2023-06-05 | ロクソ オンコロジー, インコーポレイテッド | (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 |
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| BR112017002231A2 (pt) | 2018-07-17 |
| IL250085A0 (en) | 2017-03-30 |
| US20190282578A1 (en) | 2019-09-19 |
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| CA2955747A1 (en) | 2016-02-11 |
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| EP3193877A4 (en) | 2018-04-04 |
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| US20170079981A1 (en) | 2017-03-23 |
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| SG11201700849XA (en) | 2017-03-30 |
| AU2015300798A1 (en) | 2017-02-02 |
| US20160038496A1 (en) | 2016-02-11 |
| WO2016022942A1 (en) | 2016-02-11 |
| US20180028537A1 (en) | 2018-02-01 |
| EP3193877A1 (en) | 2017-07-26 |
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