CN106456640B - 色瑞替尼制剂 - Google Patents

色瑞替尼制剂 Download PDF

Info

Publication number
CN106456640B
CN106456640B CN201580028582.7A CN201580028582A CN106456640B CN 106456640 B CN106456640 B CN 106456640B CN 201580028582 A CN201580028582 A CN 201580028582A CN 106456640 B CN106456640 B CN 106456640B
Authority
CN
China
Prior art keywords
ceritinib
tablet
pharmaceutical composition
weight
binder
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.)
Active
Application number
CN201580028582.7A
Other languages
English (en)
Chinese (zh)
Other versions
CN106456640A (zh
Inventor
S·布鲁勒斯
S·恩斯林
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis AG
Original Assignee
Novartis AG
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
Family has litigation
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=CN106456640(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis AG filed Critical Novartis AG
Publication of CN106456640A publication Critical patent/CN106456640A/zh
Application granted granted Critical
Publication of CN106456640B publication Critical patent/CN106456640B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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)
CN201580028582.7A 2014-05-29 2015-05-27 色瑞替尼制剂 Active CN106456640B (zh)

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

Publications (2)

Publication Number Publication Date
CN106456640A CN106456640A (zh) 2017-02-22
CN106456640B true CN106456640B (zh) 2021-05-14

Family

ID=53298568

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201580028582.7A Active CN106456640B (zh) 2014-05-29 2015-05-27 色瑞替尼制剂

Country Status (27)

Country Link
US (4) US20170112834A1 (cg-RX-API-DMAC10.html)
EP (1) EP3148513B1 (cg-RX-API-DMAC10.html)
JP (3) JP6679578B2 (cg-RX-API-DMAC10.html)
KR (1) KR20170008239A (cg-RX-API-DMAC10.html)
CN (1) CN106456640B (cg-RX-API-DMAC10.html)
AR (1) AR100625A1 (cg-RX-API-DMAC10.html)
AU (3) AU2015265470A1 (cg-RX-API-DMAC10.html)
BR (1) BR112016027580A8 (cg-RX-API-DMAC10.html)
CA (1) CA2948291A1 (cg-RX-API-DMAC10.html)
CL (1) CL2016003047A1 (cg-RX-API-DMAC10.html)
DK (1) DK3148513T3 (cg-RX-API-DMAC10.html)
EA (1) EA036922B1 (cg-RX-API-DMAC10.html)
EC (1) ECSP16096826A (cg-RX-API-DMAC10.html)
ES (1) ES2792574T3 (cg-RX-API-DMAC10.html)
HU (1) HUE048950T2 (cg-RX-API-DMAC10.html)
IL (1) IL248835B (cg-RX-API-DMAC10.html)
MX (1) MX373624B (cg-RX-API-DMAC10.html)
PE (1) PE20170313A1 (cg-RX-API-DMAC10.html)
PH (1) PH12016502272A1 (cg-RX-API-DMAC10.html)
PL (1) PL3148513T3 (cg-RX-API-DMAC10.html)
PT (1) PT3148513T (cg-RX-API-DMAC10.html)
SG (1) SG11201609208UA (cg-RX-API-DMAC10.html)
SI (1) SI3148513T1 (cg-RX-API-DMAC10.html)
TN (1) TN2016000484A1 (cg-RX-API-DMAC10.html)
TW (1) TWI721946B (cg-RX-API-DMAC10.html)
UY (1) UY36140A (cg-RX-API-DMAC10.html)
WO (1) WO2015181739A1 (cg-RX-API-DMAC10.html)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI721946B (zh) 2014-05-29 2021-03-21 瑞士商諾華公司 色瑞替尼調配物
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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008073687A2 (en) * 2006-12-08 2008-06-19 Irm Llc Compounds and compositions as protein kinase inhibitors

Family Cites Families (12)

* 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
TW200803850A (en) * 2006-03-06 2008-01-16 Wyeth Corp Tablet formulations and processes
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
EA019941B1 (ru) * 2006-12-08 2014-07-30 АйАрЭм ЭлЭлСи Соединения и композиции в качестве ингибиторов протеинкиназы
EP2090297A1 (en) 2008-02-13 2009-08-19 Boehringer Ingelheim International GmbH Formulations of flibanserin
ES2377869T3 (es) 2008-09-04 2012-04-02 Cargill, Incorporated Fabricación de comprimidos de eritritol
JO3635B1 (ar) 2009-05-18 2020-08-27 Millennium Pharm Inc مركبات صيدلانية صلبة وطرق لانتاجها
CN102480998B (zh) 2009-08-18 2016-05-25 卡吉尔公司 赤藓醇和异麦芽酮糖醇的压片
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
CN103200828A (zh) 2010-09-07 2013-07-10 卡吉尔公司 固体化糖醇混合物
TWI721946B (zh) 2014-05-29 2021-03-21 瑞士商諾華公司 色瑞替尼調配物

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008073687A2 (en) * 2006-12-08 2008-06-19 Irm Llc Compounds and compositions as protein kinase inhibitors

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Thomas H. Marsilje et al..Synthesis, Structure−Activity Relationships, and in Vivo Efficacy of the Novel Potent and Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor (LDK378) Currently in Phase 1 and Phase 2 Clinical Trials.《Journal of Medicinal Chemistry》.2013,第56卷5675-5690. *

Also Published As

Publication number Publication date
PH12016502272A1 (en) 2017-02-06
AU2019232937B2 (en) 2020-10-15
US20200009141A1 (en) 2020-01-09
US20210154194A1 (en) 2021-05-27
KR20170008239A (ko) 2017-01-23
MX2016015736A (es) 2017-03-16
MX373624B (es) 2020-05-22
BR112016027580A2 (pt) 2017-08-15
JP6679578B2 (ja) 2020-04-15
EA036922B1 (ru) 2021-01-15
IL248835A0 (en) 2017-01-31
EP3148513A1 (en) 2017-04-05
PL3148513T3 (pl) 2020-08-24
AU2019232937A1 (en) 2019-10-10
US11000523B2 (en) 2021-05-11
EA201692310A1 (ru) 2017-04-28
SI3148513T1 (sl) 2020-07-31
WO2015181739A1 (en) 2015-12-03
PT3148513T (pt) 2020-05-27
PE20170313A1 (es) 2017-04-18
JP2020114834A (ja) 2020-07-30
AU2018203007A1 (en) 2018-05-17
JP7084955B2 (ja) 2022-06-15
TN2016000484A1 (en) 2018-04-04
US12357630B2 (en) 2025-07-15
UY36140A (es) 2016-01-08
HUE048950T2 (hu) 2020-09-28
EP3148513B1 (en) 2020-02-26
IL248835B (en) 2020-05-31
DK3148513T3 (da) 2020-05-25
CA2948291A1 (en) 2015-12-03
SG11201609208UA (en) 2016-12-29
ECSP16096826A (es) 2018-04-30
CL2016003047A1 (es) 2017-04-07
TWI721946B (zh) 2021-03-21
BR112016027580A8 (pt) 2021-06-29
US20190022095A1 (en) 2019-01-24
TW201613580A (en) 2016-04-16
CN106456640A (zh) 2017-02-22
AU2018203007B2 (en) 2019-07-18
JP2017520619A (ja) 2017-07-27
JP2022078236A (ja) 2022-05-24
AR100625A1 (es) 2016-10-19
US20170112834A1 (en) 2017-04-27
AU2015265470A1 (en) 2016-11-24
ES2792574T3 (es) 2020-11-11

Similar Documents

Publication Publication Date Title
US12357630B2 (en) Ceritinib formulation
JP2008509192A (ja) プラミペキソール又はその医薬品として許容される塩を含む放出が延長された錠剤調合物、その製造方法及びその使用
NO341027B1 (no) Tablett med høyt medikamentinnhold og fremgangsmåte for fremstilling derav
KR101977785B1 (ko) 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제 및 그 제조방법
EP3411018A1 (en) Galenic formulations of organic compounds
CN108174596A (zh) 包含8-[(3r)-3-氨基-1-哌啶基]-7-(2-丁炔-1-基)-3,7-二氢-3-甲基-1-[4-甲基-2-喹唑啉基)甲基]-1h-嘌呤-2,6-二酮或其药学上可接受的盐的药物组合物
TWI436760B (zh) 阿利克侖之蓋崙(galenical)調配物
RU2613192C1 (ru) Таблетки клозапина с пролонгированным высвобождением
JP7378279B2 (ja) ニロチニブを有効成分とする医薬錠剤及びその製造方法
WO2006123213A1 (en) Modified release formulations of gliclazide
US20160022661A1 (en) Dosage Form Comprising Crizotinib
KR20120134545A (ko) 안정성 및 함량 균일성이 개선된 속방성 약학 조성물의 제조방법
CN110227067B (zh) 一种盐酸普拉克索缓释片及其制备方法
HK1229715B (en) Ceritinib formulation
HK1229715A1 (en) Ceritinib formulation
CN108236609B (zh) 一种gpr40激动剂药物组合物及其制备方法
JP7308022B2 (ja) 速溶性薬物の苦味が抑制された口腔内崩壊錠
JP6858873B2 (ja) セレコキシブを含む錠剤
TW202339723A (zh) 一種固體藥物組合物
EP2749271A1 (en) Optimized manufacturing method and pharmaceutical formulation of imatinib
EA041427B1 (ru) Фармацевтические лекарственные формы

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant