PE20170773A1 - Formulaciones farmaceuticas, procesos para la preparacion, y metodos de uso - Google Patents

Formulaciones farmaceuticas, procesos para la preparacion, y metodos de uso

Info

Publication number
PE20170773A1
PE20170773A1 PE2017000171A PE2017000171A PE20170773A1 PE 20170773 A1 PE20170773 A1 PE 20170773A1 PE 2017000171 A PE2017000171 A PE 2017000171A PE 2017000171 A PE2017000171 A PE 2017000171A PE 20170773 A1 PE20170773 A1 PE 20170773A1
Authority
PE
Peru
Prior art keywords
preparation
processes
methods
pharmaceutical formulations
pharmaceutically acceptable
Prior art date
Application number
PE2017000171A
Other languages
English (en)
Inventor
Rachael L Brake
Viviana Bozon
Chingkuo J Chow
James C Dinunzio
Katherine M Galvin
Karuppiah Kannan
Yuki Kodono
Qunli Xu
Original Assignee
Millennium Pharm Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Millennium Pharm Inc filed Critical Millennium Pharm Inc
Publication of PE20170773A1 publication Critical patent/PE20170773A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54Heterocyclic 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
    • A61K31/541Non-condensed thiazines containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate 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
    • A61K9/146Intimate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C12Q1/6886Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/106Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/156Polymorphic or mutational markers

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • Hospice & Palliative Care (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Oncology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La invencion se refiere a una composicion farmaceutica que comprende (1) un extruido de dispersion solida que comprende (R)-2-(1-(6-amino-5-cloropirimidina-4-carboxamido)etil)-N-(5-cloro-4-(trifluorometil)piridina-2-il)tiazol-5-carboxamida o una sal farmaceuticamente aceptable del mismo y un copolimero de acetato de vinilpirrolidinona-vinilo y (2) uno o mas excipientes farmaceuticamente aceptables, para el tratamiento de cancer y un proceso para su preparacion. la invencion tambien se refiere a la administracion de la composicion farmaceutica a un paciente segun un regimen de dosificacion intermitente
PE2017000171A 2014-03-26 2015-03-26 Formulaciones farmaceuticas, procesos para la preparacion, y metodos de uso PE20170773A1 (es)

Applications Claiming Priority (4)

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

Publications (1)

Publication Number Publication Date
PE20170773A1 true PE20170773A1 (es) 2017-07-04

Family

ID=57215543

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2017000171A PE20170773A1 (es) 2014-03-26 2015-03-26 Formulaciones farmaceuticas, procesos para la preparacion, y metodos de uso

Country Status (17)

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

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016106359A1 (en) * 2014-12-23 2016-06-30 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
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
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
EP3433275A1 (en) 2016-03-24 2019-01-30 Millennium Pharmaceuticals, Inc. Methods of treating gastrointestinal immune-related adverse events in immune oncology treatments
EP4065122A4 (en) * 2019-11-27 2023-12-27 Day One Biopharmaceuticals, Inc. SOLID DISPERSION OF PAN-RAF KINASE INHIBITOR
WO2022099074A1 (en) * 2020-11-06 2022-05-12 Dot Therapeutics-1, Inc. Raf inhibitor for treating low grade glioma
EP4294400A1 (en) * 2021-02-19 2023-12-27 Day One Biopharmaceuticals, Inc. 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

Family Cites Families (12)

* 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
CN101330904B (zh) 2005-12-16 2012-04-18 韩美控股株式会社 含有低熔点活性成分的固体分散体以及含有它的口服给药片剂
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
CL2008001933A1 (es) * 2007-06-29 2009-09-25 Millennium Pharm Inc Compuestos derivados de pirimidina, inhibidores de la raf quinasa; compuestos intermediarios; procedimiento de preparacion; composicion farmaceutica; y su uso para tratar trastornos proliferativos, cardiacos, neurodegenerativos, inflamatorios, oseos, inmunologicos enfermedad viral, entre otros.
US20100209495A1 (en) 2008-09-17 2010-08-19 Mylan Laboratories, 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
CA2868954A1 (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

Also Published As

Publication number Publication date
EA201691918A1 (ru) 2017-02-28
CN106456787B (zh) 2020-12-18
WO2015148828A1 (en) 2015-10-01
US10426782B2 (en) 2019-10-01
JP2017511313A (ja) 2017-04-20
US20170173033A1 (en) 2017-06-22
EP3122334A1 (en) 2017-02-01
JP6571105B2 (ja) 2019-09-04
ES2744298T3 (es) 2020-02-24
CO2016003340A2 (es) 2017-02-17
DOP2016000254A (es) 2017-02-15
ECSP16084317A (es) 2018-05-31
UY36046A (es) 2015-10-30
CA2943808A1 (en) 2015-10-01
BR112016022219B1 (pt) 2022-09-27
BR112016022219A2 (pt) 2018-07-10
EA031190B1 (ru) 2018-11-30
CR20160483A (es) 2017-04-27
MA39765A (fr) 2017-02-01
GEP20186932B (en) 2018-12-10
CA2943808C (en) 2022-08-16
CN106456787A (zh) 2017-02-22
EP3122334B1 (en) 2019-06-26

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