BR112016027580A8 - composição farmacêutica compreendendo ceritinib, processo para preparação de um comprimido que compreende o mesmo, e uso de grânulos consistindo de ceritinib e um ligante - Google Patents

composição farmacêutica compreendendo ceritinib, processo para preparação de um comprimido que compreende o mesmo, e uso de grânulos consistindo de ceritinib e um ligante

Info

Publication number
BR112016027580A8
BR112016027580A8 BR112016027580A BR112016027580A BR112016027580A8 BR 112016027580 A8 BR112016027580 A8 BR 112016027580A8 BR 112016027580 A BR112016027580 A BR 112016027580A BR 112016027580 A BR112016027580 A BR 112016027580A BR 112016027580 A8 BR112016027580 A8 BR 112016027580A8
Authority
BR
Brazil
Prior art keywords
ceritinib
binder
tablet
pharmaceutical composition
preparing
Prior art date
Application number
BR112016027580A
Other languages
English (en)
Other versions
BR112016027580A2 (pt
Inventor
Breulles Sebastien
Ensslin Simon
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=BR112016027580(A8) "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 BR112016027580A2 publication Critical patent/BR112016027580A2/pt
Publication of BR112016027580A8 publication Critical patent/BR112016027580A8/pt

Links

Classifications

    • 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
    • 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
    • A61K9/1652—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

formulação de ceritinib. a presente invenção se refere a uma nova composição farmacêutica compreendendo ceritinib. particularmente it é directed to o comprimido que é preparado por granulação a úmido, em que povidona é usado como um ligante. característica adicional da composição é que o fármaco e o ligante formam a fase interna, ao passo que todos os outros excipientes são adicionados em uma forma de pó como uma fase externa. deste modo, a aderência da composição é evitada e pode ser atingida suficiente dureza dos comprimidos.
BR112016027580A 2014-05-29 2015-05-27 composição farmacêutica compreendendo ceritinib, processo para preparação de um comprimido que compreende o mesmo, e uso de grânulos consistindo de ceritinib e um ligante BR112016027580A8 (pt)

Applications Claiming Priority (2)

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

Publications (2)

Publication Number Publication Date
BR112016027580A2 BR112016027580A2 (pt) 2017-08-15
BR112016027580A8 true BR112016027580A8 (pt) 2021-06-29

Family

ID=53298568

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016027580A BR112016027580A8 (pt) 2014-05-29 2015-05-27 composição farmacêutica compreendendo ceritinib, processo para preparação de um comprimido que compreende o mesmo, e uso de grânulos consistindo de ceritinib e um ligante

Country Status (27)

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

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
CL2016003047A1 (es) 2017-04-07
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
PE20170313A1 (es) 2017-04-18
HUE048950T2 (hu) 2020-09-28
EA036922B1 (ru) 2021-01-15
TW201613580A (en) 2016-04-16

Similar Documents

Publication Publication Date Title
MX2019005379A (es) Derivado de pirazolo-heteroarilo, metodo de preparacion y uso medico del mismo.
MY196909A (en) Boronic acid derivatives and therapeutic uses thereof
BR112017022604A2 (pt) composto, composição farmacêutica, uso de um composto e de uma combinação, e, combinação
BR112016015838A8 (pt) compostos heterocíclicos aromáticos, composição farmacêutica compreendendo os referidos compostos e produto de combinação
EP3263135A4 (en) Pharmaceutical composition for treating cancer comprising microrna as active ingredient
EP3210604A4 (en) Uses of duloxetine hcl medicament in preparing pharmaceutical composition for treatment of cancer
BR112017027414A2 (pt) Derivados hidroxiéster, processo para prepará- los e composições farmacêuticas os contendo
BR112017028318A2 (pt) compostos antibacterianos
EA201691988A1 (ru) Производные бороновой кислоты и их терапевтическое применение
MX2016016666A (es) Derivados de acido boronico y usos terapeuticos de los mismos.
CL2014002873A1 (es) Compuestos derivados de pirimidin-amina o triazin-amina, inhibidores de adn-pk; composicion farmaceutica; y su uso para el tratamiento del cancer.
BR112014010183B8 (pt) Composto, composição farmacêutica, produto, e, uso de um composto
BR112017007123A2 (pt) derivados de tetrahidroisoquinolina
BR112014029706A8 (pt) Composto, composição farmacêutica, e, uso de um composto
BR112016028845A2 (pt) composto, composição farmacêutica e uso de um composto
PH12016501462A1 (en) Neprilysin inhibitors
EP3297640A4 (en) Pharmaceutical co-crystal composition and use thereof
BR112018004065A2 (pt) Compostos heterocíclicos, composições farmacêuticas compreendendo os ditos compostos e usos terapêuticos dos mesmos
BR112016029013A2 (pt) aperfeiçoamento em composição nasal e método de utilização do mesmo
BR112017022158A2 (pt) compostos, composições farmacêuticas e uso de um composto
BR112017002852A2 (pt) compostos de azetidiniloxifenilpirrolidina
EP3285758A4 (en) Co-crystal composition and its pharmaceutical use
PH12018501709A1 (en) Naphthridinedione derivatives
HUP1500618A2 (en) Complexes of celecoxib and its salts and derivatives, process for the preparation thereof and pharmaceutical composition containing them
BR112017008867A2 (pt) inibidores de proteína quinases

Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B350 Update of information on the portal [chapter 15.35 patent gazette]
B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements