JP6679578B2 - セリチニブ製剤 - Google Patents

セリチニブ製剤 Download PDF

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Publication number
JP6679578B2
JP6679578B2 JP2017514990A JP2017514990A JP6679578B2 JP 6679578 B2 JP6679578 B2 JP 6679578B2 JP 2017514990 A JP2017514990 A JP 2017514990A JP 2017514990 A JP2017514990 A JP 2017514990A JP 6679578 B2 JP6679578 B2 JP 6679578B2
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JP
Japan
Prior art keywords
ceritinib
tablet
pharmaceutical composition
weight percent
tablets
Prior art date
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Active
Application number
JP2017514990A
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English (en)
Japanese (ja)
Other versions
JP2017520619A (ja
JP2017520619A5 (OSRAM
Inventor
ブリューレス,セバスチャン
エンスリン,シモン
Original Assignee
ノバルティス アーゲー
ノバルティス アーゲー
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=53298568&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP6679578(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by ノバルティス アーゲー, ノバルティス アーゲー filed Critical ノバルティス アーゲー
Publication of JP2017520619A publication Critical patent/JP2017520619A/ja
Publication of JP2017520619A5 publication Critical patent/JP2017520619A5/ja
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Classifications

    • 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
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/14—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
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2063—Proteins, e.g. gelatin
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cephalosporin Compounds (AREA)
JP2017514990A 2014-05-29 2015-05-27 セリチニブ製剤 Active JP6679578B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462004359P 2014-05-29 2014-05-29
US62/004,359 2014-05-29
PCT/IB2015/053966 WO2015181739A1 (en) 2014-05-29 2015-05-27 Ceritinib formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2020046475A Division JP7084955B2 (ja) 2014-05-29 2020-03-17 セリチニブ製剤

Publications (3)

Publication Number Publication Date
JP2017520619A JP2017520619A (ja) 2017-07-27
JP2017520619A5 JP2017520619A5 (OSRAM) 2018-07-05
JP6679578B2 true JP6679578B2 (ja) 2020-04-15

Family

ID=53298568

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2017514990A Active JP6679578B2 (ja) 2014-05-29 2015-05-27 セリチニブ製剤
JP2020046475A Active JP7084955B2 (ja) 2014-05-29 2020-03-17 セリチニブ製剤
JP2022034913A Withdrawn JP2022078236A (ja) 2014-05-29 2022-03-08 セリチニブ製剤

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2020046475A Active JP7084955B2 (ja) 2014-05-29 2020-03-17 セリチニブ製剤
JP2022034913A Withdrawn JP2022078236A (ja) 2014-05-29 2022-03-08 セリチニブ製剤

Country Status (27)

Country Link
US (4) US20170112834A1 (OSRAM)
EP (1) EP3148513B1 (OSRAM)
JP (3) JP6679578B2 (OSRAM)
KR (1) KR20170008239A (OSRAM)
CN (1) CN106456640B (OSRAM)
AR (1) AR100625A1 (OSRAM)
AU (3) AU2015265470A1 (OSRAM)
BR (1) BR112016027580A8 (OSRAM)
CA (1) CA2948291A1 (OSRAM)
CL (1) CL2016003047A1 (OSRAM)
DK (1) DK3148513T3 (OSRAM)
EA (1) EA036922B1 (OSRAM)
EC (1) ECSP16096826A (OSRAM)
ES (1) ES2792574T3 (OSRAM)
HU (1) HUE048950T2 (OSRAM)
IL (1) IL248835B (OSRAM)
MX (1) MX373624B (OSRAM)
PE (1) PE20170313A1 (OSRAM)
PH (1) PH12016502272A1 (OSRAM)
PL (1) PL3148513T3 (OSRAM)
PT (1) PT3148513T (OSRAM)
SG (1) SG11201609208UA (OSRAM)
SI (1) SI3148513T1 (OSRAM)
TN (1) TN2016000484A1 (OSRAM)
TW (1) TWI721946B (OSRAM)
UY (1) UY36140A (OSRAM)
WO (1) WO2015181739A1 (OSRAM)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2015265470A1 (en) 2014-05-29 2016-11-24 Novartis Ag Ceritinib formulation
CN106176752B (zh) * 2015-05-07 2020-06-23 石药集团中奇制药技术(石家庄)有限公司 色瑞替尼药物组合物
CN109381440A (zh) * 2018-11-15 2019-02-26 威海贯标信息科技有限公司 一种艾乐替尼组合物
CN113244236B (zh) * 2021-06-01 2023-02-03 上海市第一人民医院 色瑞替尼在制备治疗甲状腺相关眼病的药物中的应用

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3632778A (en) * 1970-06-10 1972-01-04 Hoffmann La Roche Tablets containing l-dopa
PE20071315A1 (es) * 2006-03-06 2008-02-14 Wyeth Corp Formulaciones de compuestos derivados de fenilo y procesos de preparacion para tabletas que contienen dichos compuestos
US20090239920A1 (en) 2006-11-21 2009-09-24 Wyeth Pharmaceutical formulations of an anhydrate crystal form of 2-(3-fluoro-4-hydroxyphenyl)-7-vinyl-1,3-benzoxazol-5-ol
US20080175901A1 (en) 2006-11-21 2008-07-24 Wyeth Pharmaceutical formulations of a crystal form of 2-(3-fluoro-4-hydroxyphenyl)-7-vinyl-1,3-benzoxazol-5-ol
BRPI0722383A2 (pt) * 2006-12-08 2012-06-05 Irm Llc compostos inibidores de proteìna quinase, composições contendo os mesmos bem como seus usos
WO2008073687A2 (en) * 2006-12-08 2008-06-19 Irm Llc Compounds and compositions as protein kinase inhibitors
EP2090297A1 (en) 2008-02-13 2009-08-19 Boehringer Ingelheim International GmbH Formulations of flibanserin
SI2334202T1 (sl) 2008-09-04 2012-04-30 Cargill Inc Tabletiranje eritritola
JO3635B1 (ar) 2009-05-18 2020-08-27 Millennium Pharm Inc مركبات صيدلانية صلبة وطرق لانتاجها
BR112012003631A2 (pt) 2009-08-18 2015-09-01 Gargill Inc "produção de comprimidos de eritritol e isomalte."
JP5596799B2 (ja) 2010-05-11 2014-09-24 田辺三菱製薬株式会社 カナグリフロジン含有錠剤
JP2013536694A (ja) 2010-09-07 2013-09-26 カーギル インコーポレイテッド 凝固糖アルコール混合物
AU2015265470A1 (en) 2014-05-29 2016-11-24 Novartis Ag Ceritinib formulation

Also Published As

Publication number Publication date
US20200009141A1 (en) 2020-01-09
AU2018203007B2 (en) 2019-07-18
CN106456640B (zh) 2021-05-14
US11000523B2 (en) 2021-05-11
JP2022078236A (ja) 2022-05-24
JP2020114834A (ja) 2020-07-30
IL248835B (en) 2020-05-31
TW201613580A (en) 2016-04-16
ECSP16096826A (es) 2018-04-30
PT3148513T (pt) 2020-05-27
MX373624B (es) 2020-05-22
CL2016003047A1 (es) 2017-04-07
BR112016027580A8 (pt) 2021-06-29
DK3148513T3 (da) 2020-05-25
US20210154194A1 (en) 2021-05-27
HUE048950T2 (hu) 2020-09-28
JP2017520619A (ja) 2017-07-27
PE20170313A1 (es) 2017-04-18
WO2015181739A1 (en) 2015-12-03
EP3148513A1 (en) 2017-04-05
EA201692310A1 (ru) 2017-04-28
AU2018203007A1 (en) 2018-05-17
PL3148513T3 (pl) 2020-08-24
AR100625A1 (es) 2016-10-19
EA036922B1 (ru) 2021-01-15
AU2019232937B2 (en) 2020-10-15
KR20170008239A (ko) 2017-01-23
BR112016027580A2 (pt) 2017-08-15
MX2016015736A (es) 2017-03-16
AU2015265470A1 (en) 2016-11-24
US20190022095A1 (en) 2019-01-24
SI3148513T1 (sl) 2020-07-31
ES2792574T3 (es) 2020-11-11
US12357630B2 (en) 2025-07-15
UY36140A (es) 2016-01-08
SG11201609208UA (en) 2016-12-29
JP7084955B2 (ja) 2022-06-15
PH12016502272A1 (en) 2017-02-06
US20170112834A1 (en) 2017-04-27
CN106456640A (zh) 2017-02-22
TN2016000484A1 (en) 2018-04-04
CA2948291A1 (en) 2015-12-03
IL248835A0 (en) 2017-01-31
EP3148513B1 (en) 2020-02-26
TWI721946B (zh) 2021-03-21
AU2019232937A1 (en) 2019-10-10

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