CL2016003047A1 - Composición farmacéutica que comprende al menos 150 mg y hasta 700 mg de ceritinib y más del 40% y hasta 70% por peso de ceritinib con base al peso de la composición que comprende gránulos de ceritinib y un aglutinante; tableta; proceso de preparación de una tableta; y uso de la composición farmacéutica y de la tableta. - Google Patents

Composición farmacéutica que comprende al menos 150 mg y hasta 700 mg de ceritinib y más del 40% y hasta 70% por peso de ceritinib con base al peso de la composición que comprende gránulos de ceritinib y un aglutinante; tableta; proceso de preparación de una tableta; y uso de la composición farmacéutica y de la tableta.

Info

Publication number
CL2016003047A1
CL2016003047A1 CL2016003047A CL2016003047A CL2016003047A1 CL 2016003047 A1 CL2016003047 A1 CL 2016003047A1 CL 2016003047 A CL2016003047 A CL 2016003047A CL 2016003047 A CL2016003047 A CL 2016003047A CL 2016003047 A1 CL2016003047 A1 CL 2016003047A1
Authority
CL
Chile
Prior art keywords
ceritinib
tablet
pharmaceutical composition
weight
granules
Prior art date
Application number
CL2016003047A
Other languages
English (en)
Inventor
Sebastien Breulles
Simon Ensslin
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=CL2016003047(A1) "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 CL2016003047A1 publication Critical patent/CL2016003047A1/es

Links

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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cephalosporin Compounds (AREA)

Abstract

El problema técnico a resolver parece ser la necesidad de proporcionar una composición farmacéutica con una alta carga de Ceritinib, solucionando el problema de tendencia a la adhesión/incrustación que posee el Ceritinib. Como solución se propone una composición farmacéutica que comprende al menos 150 mg y hasta 750 mg de Ceritinib y más de un 40% y hasta un 70% por peso de Ceritinib en base al peso total de la composición farmacéutica que comprende gránulos que consisten esencialmente de Ceritinib y un aglutinante y los gránulos son obtenibles mediante granulación húmeda. Además se divulga una tableta, un proceso de preparación de una tableta y el uso de una composición farmacéutica o de una tableta.
CL2016003047A 2014-05-29 2016-11-28 Composición farmacéutica que comprende al menos 150 mg y hasta 700 mg de ceritinib y más del 40% y hasta 70% por peso de ceritinib con base al peso de la composición que comprende gránulos de ceritinib y un aglutinante; tableta; proceso de preparación de una tableta; y uso de la composición farmacéutica y de la tableta. CL2016003047A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201462004359P 2014-05-29 2014-05-29

Publications (1)

Publication Number Publication Date
CL2016003047A1 true CL2016003047A1 (es) 2017-04-07

Family

ID=53298568

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2016003047A CL2016003047A1 (es) 2014-05-29 2016-11-28 Composición farmacéutica que comprende al menos 150 mg y hasta 700 mg de ceritinib y más del 40% y hasta 70% por peso de ceritinib con base al peso de la composición que comprende gránulos de ceritinib y un aglutinante; tableta; proceso de preparación de una tableta; y uso de la composición farmacéutica y de la tableta.

Country Status (27)

Country Link
US (4) US20170112834A1 (es)
EP (1) EP3148513B1 (es)
JP (3) JP6679578B2 (es)
KR (1) KR20170008239A (es)
CN (1) CN106456640B (es)
AR (1) AR100625A1 (es)
AU (3) AU2015265470A1 (es)
BR (1) BR112016027580A8 (es)
CA (1) CA2948291A1 (es)
CL (1) CL2016003047A1 (es)
DK (1) DK3148513T3 (es)
EA (1) EA036922B1 (es)
EC (1) ECSP16096826A (es)
ES (1) ES2792574T3 (es)
HU (1) HUE048950T2 (es)
IL (1) IL248835B (es)
MX (1) MX2016015736A (es)
PE (1) PE20170313A1 (es)
PH (1) PH12016502272A1 (es)
PL (1) PL3148513T3 (es)
PT (1) PT3148513T (es)
SG (1) SG11201609208UA (es)
SI (1) SI3148513T1 (es)
TN (1) TN2016000484A1 (es)
TW (1) TWI721946B (es)
UY (1) UY36140A (es)
WO (1) WO2015181739A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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 (5)

* 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
UA100846C2 (uk) * 2006-12-08 2013-02-11 Айерем Елелсі Сполуки та композиція як інгібітори протеїнкінази
KR101149295B1 (ko) * 2006-12-08 2012-07-05 아이알엠 엘엘씨 단백질 키나제 억제제로서의 화합물
EP2090297A1 (en) 2008-02-13 2009-08-19 Boehringer Ingelheim International GmbH Formulations of flibanserin
EP2568971B1 (en) * 2010-05-11 2020-10-14 Mitsubishi Tanabe Pharma Corporation Canagliflozin containing tablets

Also Published As

Publication number Publication date
US20170112834A1 (en) 2017-04-27
SG11201609208UA (en) 2016-12-29
AU2019232937B2 (en) 2020-10-15
JP7084955B2 (ja) 2022-06-15
US11000523B2 (en) 2021-05-11
EA201692310A1 (ru) 2017-04-28
MX2016015736A (es) 2017-03-16
AU2018203007A1 (en) 2018-05-17
JP6679578B2 (ja) 2020-04-15
AU2019232937A1 (en) 2019-10-10
CN106456640A (zh) 2017-02-22
WO2015181739A1 (en) 2015-12-03
DK3148513T3 (da) 2020-05-25
AU2015265470A1 (en) 2016-11-24
ECSP16096826A (es) 2018-04-30
IL248835A0 (en) 2017-01-31
CA2948291A1 (en) 2015-12-03
UY36140A (es) 2016-01-08
TWI721946B (zh) 2021-03-21
US20210154194A1 (en) 2021-05-27
BR112016027580A2 (pt) 2017-08-15
AU2018203007B2 (en) 2019-07-18
CN106456640B (zh) 2021-05-14
PL3148513T3 (pl) 2020-08-24
US20200009141A1 (en) 2020-01-09
JP2020114834A (ja) 2020-07-30
ES2792574T3 (es) 2020-11-11
EP3148513A1 (en) 2017-04-05
JP2017520619A (ja) 2017-07-27
PH12016502272A1 (en) 2017-02-06
KR20170008239A (ko) 2017-01-23
US20190022095A1 (en) 2019-01-24
AR100625A1 (es) 2016-10-19
TN2016000484A1 (en) 2018-04-04
EP3148513B1 (en) 2020-02-26
SI3148513T1 (sl) 2020-07-31
PT3148513T (pt) 2020-05-27
IL248835B (en) 2020-05-31
JP2022078236A (ja) 2022-05-24
BR112016027580A8 (pt) 2021-06-29
PE20170313A1 (es) 2017-04-18
HUE048950T2 (hu) 2020-09-28
EA036922B1 (ru) 2021-01-15
TW201613580A (en) 2016-04-16

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