EA031190B1 - Фармацевтические составы ингибитора киназ семейства raf, способы их получения и способы их применения - Google Patents

Фармацевтические составы ингибитора киназ семейства raf, способы их получения и способы их применения Download PDF

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Publication number
EA031190B1
EA031190B1 EA201691918A EA201691918A EA031190B1 EA 031190 B1 EA031190 B1 EA 031190B1 EA 201691918 A EA201691918 A EA 201691918A EA 201691918 A EA201691918 A EA 201691918A EA 031190 B1 EA031190 B1 EA 031190B1
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EA
Eurasian Patent Office
Prior art keywords
pharmaceutical composition
pharmaceutically acceptable
cancer
amount
extrudate
Prior art date
Application number
EA201691918A
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English (en)
Russian (ru)
Other versions
EA201691918A1 (ru
Inventor
Рейчел Л. Брейк
Вивиана Бозон
Чинг-куо Дз. Чоу
Джеймс К. Динунцио
Кэтрин М. Гелвин
Каруппиах Каннан
Юки Кодоно
Циньли Сюй
Original Assignee
Милленниум Фармасьютикалз, Инк.
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Application filed by Милленниум Фармасьютикалз, Инк. filed Critical Милленниум Фармасьютикалз, Инк.
Publication of EA201691918A1 publication Critical patent/EA201691918A1/ru
Publication of EA031190B1 publication Critical patent/EA031190B1/ru

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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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/541—Non-condensed thiazines containing further 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C12Q1/6886—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Pathology (AREA)
  • Genetics & Genomics (AREA)
  • Analytical Chemistry (AREA)
  • Oncology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Hospice & Palliative Care (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
EA201691918A 2014-03-26 2015-03-26 Фармацевтические составы ингибитора киназ семейства raf, способы их получения и способы их применения EA031190B1 (ru)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201461970595P 2014-03-26 2014-03-26
US201462048527P 2014-09-10 2014-09-10
PK16215 2015-03-25
UY0001036046A UY36046A (es) 2014-03-26 2015-03-25 Formulaciones farmacéuticas, procesos para la preparación y métodos de uso
PCT/US2015/022792 WO2015148828A1 (en) 2014-03-26 2015-03-26 Pharmaceutical formulations of a pan-raf kinase inhibitor, processes for their preparation, and methods of use

Publications (2)

Publication Number Publication Date
EA201691918A1 EA201691918A1 (ru) 2017-02-28
EA031190B1 true EA031190B1 (ru) 2018-11-30

Family

ID=57215543

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201691918A EA031190B1 (ru) 2014-03-26 2015-03-26 Фармацевтические составы ингибитора киназ семейства raf, способы их получения и способы их применения

Country Status (17)

Country Link
US (1) US10426782B2 (enExample)
EP (1) EP3122334B1 (enExample)
JP (1) JP6571105B2 (enExample)
CN (1) CN106456787B (enExample)
BR (1) BR112016022219B1 (enExample)
CA (1) CA2943808C (enExample)
CO (1) CO2016003340A2 (enExample)
CR (1) CR20160483A (enExample)
DO (1) DOP2016000254A (enExample)
EA (1) EA031190B1 (enExample)
EC (1) ECSP16084317A (enExample)
ES (1) ES2744298T3 (enExample)
GE (1) GEP20186932B (enExample)
MA (1) MA39765A (enExample)
PE (1) PE20170773A1 (enExample)
UY (1) UY36046A (enExample)
WO (1) WO2015148828A1 (enExample)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190117652A1 (en) * 2014-12-23 2019-04-25 Millennium Pharmaceuticals, Inc. Combination of raf inhibitors and taxanes
WO2017066664A1 (en) * 2015-10-16 2017-04-20 Millennium Pharmaceuticals, Inc. Combination therapy including a raf inhibitor for the treatment of colorectal cancer
MA44483A (fr) 2016-03-24 2019-01-30 Millennium Pharm Inc Procédés pour traiter des événements indésirables gastro-intestinaux d'origine immunitaire dans des traitements oncologiques immunitaires
WO2017165491A1 (en) * 2016-03-24 2017-09-28 Millennium Pharmaceuticals, Inc. Use of a pd-1 antagonist and a raf inhibitor in the treatment of cancer
TW201735949A (zh) 2016-03-24 2017-10-16 千禧製藥公司 治療抗ctla4及抗pd-1組合治療中的胃腸道免疫相關不良事件之方法
US12122787B2 (en) 2019-09-20 2024-10-22 Shanghai Jemincare Pharmaceuticals Co., Ltd Fused pyridone compound, and preparation method therefor and use thereof
EP4065122A4 (en) * 2019-11-27 2023-12-27 Day One Biopharmaceuticals, Inc. SOLID DISPERSION OF PAN-RAF KINASE INHIBITOR
CN117042772A (zh) * 2020-11-06 2023-11-10 首日生物制药公司 用于治疗低级别胶质瘤的raf抑制剂
AU2021376286A1 (en) * 2020-11-06 2023-06-22 Dana-Farber Cancer Institute, Inc. Raf inhibitor for treating low grade glioma
CA3211167A1 (en) * 2021-02-19 2022-08-25 Samuel C. BLACKMAN Combination of raf inhibitor and mek inhibitor
WO2023049807A2 (en) * 2021-09-22 2023-03-30 Sirnaomics, Inc. Improved methods for preparing nanoparticle compositions containing histidine-lysine copolymers

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009006389A2 (en) * 2007-06-29 2009-01-08 Sunesis Pharmaceuticals, Inc. Pyrimidine derivatives useful as raf kinase inhibitors
WO2013144923A1 (en) * 2012-03-30 2013-10-03 Takeda Pharmaceutical Company Limited Administration of a raf inhibitor and a mek inhibitor in the treatment of melanoma

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4843155A (en) 1987-11-19 1989-06-27 Piotr Chomczynski Product and process for isolating RNA
US5346994A (en) 1992-01-28 1994-09-13 Piotr Chomczynski Shelf-stable product and process for isolating RNA, DNA and proteins
DE19509807A1 (de) * 1995-03-21 1996-09-26 Basf Ag Verfahren zur Herstellung von Wirkstoffzubereitungen in Form einer festen Lösung des Wirkstoffs in einer Polymermatrix sowie mit diesem Verfahren hergestellte Wirkstoffzubereitungen
US20050220865A1 (en) 2004-04-02 2005-10-06 Koleng John J Compressed composition comprising magnesium salt
RU2403013C2 (ru) 2005-12-16 2010-11-10 Ханми Фарм. Ко., Лтд. Твердая дисперсия, содержащая активный ингредиент с низкой температурой плавления, и содержащая ее таблетка для перорального введения
KR100767349B1 (ko) * 2006-08-01 2007-10-17 삼천당제약주식회사 페노피브레이트를 함유하는 경구용 약제 조성물 및 그의제조방법
CA2669094A1 (en) 2006-11-08 2008-05-29 Novavax,Inc. Method of preparing solid dosage forms of multi-phasic pharmaceutical compositions
JPWO2008114859A1 (ja) * 2007-03-22 2010-07-08 アステラス製薬株式会社 ピラゾール誘導体を含有する医薬組成物
AU2009292615B2 (en) 2008-09-17 2015-12-03 Mylan Inc. Granulates, process for preparing them and pharmaceutical products containing them
US20130172375A1 (en) * 2011-12-13 2013-07-04 Hoffmann-La Roche Inc. Pharmaceutical composition

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009006389A2 (en) * 2007-06-29 2009-01-08 Sunesis Pharmaceuticals, Inc. Pyrimidine derivatives useful as raf kinase inhibitors
WO2013144923A1 (en) * 2012-03-30 2013-10-03 Takeda Pharmaceutical Company Limited Administration of a raf inhibitor and a mek inhibitor in the treatment of melanoma

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
MACAULEY D; FERNANDEZ R; COLOMBO A: "American Association for Cancer Research (AACR) 103<rd> Annual Meeting Chicago, Illinois, USA - March 31-April 4, 2012", DRUGS OF THE FUTURE, J.R. PROUS, vol. 37, no. 6, 1 June 2012 (2012-06-01), pages 451 - 455, XP009173753, ISSN: 0377-8282, DOI: 10.1358/dof.2012.37.6.1820866 *
ZIAI JAMES; HUI PEI: "BRAF mutation testing in clinical practice.", EXPERT REVIEW OF MOLECULAR DIAGNOSTICS, EXPERT REVIEWS LTD., GB, vol. 12, no. 2, 1 March 2012 (2012-03-01), GB, pages 127 - 138, XP008176589, ISSN: 1744-8352, DOI: 10.1586/erm.12.1 *

Also Published As

Publication number Publication date
JP2017511313A (ja) 2017-04-20
CR20160483A (es) 2017-04-27
CN106456787B (zh) 2020-12-18
US20170173033A1 (en) 2017-06-22
WO2015148828A1 (en) 2015-10-01
ES2744298T3 (es) 2020-02-24
EP3122334B1 (en) 2019-06-26
CA2943808A1 (en) 2015-10-01
UY36046A (es) 2015-10-30
US10426782B2 (en) 2019-10-01
EA201691918A1 (ru) 2017-02-28
DOP2016000254A (es) 2017-02-15
ECSP16084317A (es) 2018-05-31
GEP20186932B (en) 2018-12-10
JP6571105B2 (ja) 2019-09-04
CO2016003340A2 (es) 2017-02-17
PE20170773A1 (es) 2017-07-04
CN106456787A (zh) 2017-02-22
MA39765A (fr) 2017-02-01
BR112016022219A2 (pt) 2018-07-10
BR112016022219B1 (pt) 2022-09-27
CA2943808C (en) 2022-08-16
EP3122334A1 (en) 2017-02-01

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ BY KZ KG TJ TM RU