CR20130649A - Liberación modificada de 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]-amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluoro-metil)-fenil]-benzamida solubilizada utilizando ácidos orgánicos - Google Patents

Liberación modificada de 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]-amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluoro-metil)-fenil]-benzamida solubilizada utilizando ácidos orgánicos

Info

Publication number
CR20130649A
CR20130649A CR20130649A CR20130649A CR20130649A CR 20130649 A CR20130649 A CR 20130649A CR 20130649 A CR20130649 A CR 20130649A CR 20130649 A CR20130649 A CR 20130649A CR 20130649 A CR20130649 A CR 20130649A
Authority
CR
Costa Rica
Prior art keywords
methyl
organic acids
banzamide
metil
penyl
Prior art date
Application number
CR20130649A
Other languages
English (en)
Inventor
Shoufeng Li
Saran Kumar
Nikhil Javant Kavimandan
Enxian Lu
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=46317545&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CR20130649(A) "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 CR20130649A publication Critical patent/CR20130649A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/14—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing three or more hetero rings
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/20—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P35/02—Antineoplastic agents specific for leukemia

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

Se inventaron composiciones farmacéuticas solubles denilotinib, o de una sal farmacéuticamente aceptable del mismo,utilizando uno o más ácidos orgánicos que funcionan como un agente solubilizante, que aumentan la biodisponibilidad del nilotinib, y que suprimen el efecto del alimento asociado con ciertas composiciones de nilotinib.
CR20130649A 2011-06-14 2013-12-12 Liberación modificada de 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]-amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluoro-metil)-fenil]-benzamida solubilizada utilizando ácidos orgánicos CR20130649A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161496913P 2011-06-14 2011-06-14
US201161541306P 2011-09-30 2011-09-30

Publications (1)

Publication Number Publication Date
CR20130649A true CR20130649A (es) 2014-02-04

Family

ID=46317545

Family Applications (1)

Application Number Title Priority Date Filing Date
CR20130649A CR20130649A (es) 2011-06-14 2013-12-12 Liberación modificada de 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]-amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluoro-metil)-fenil]-benzamida solubilizada utilizando ácidos orgánicos

Country Status (20)

Country Link
US (1) US20150273070A1 (es)
EP (1) EP2721024A1 (es)
JP (1) JP2014517040A (es)
KR (1) KR20140036225A (es)
CN (1) CN103608342A (es)
AP (1) AP2013007233A0 (es)
AR (1) AR086913A1 (es)
BR (1) BR112013032122A2 (es)
CA (1) CA2838741A1 (es)
CL (1) CL2013003576A1 (es)
CO (1) CO6801777A2 (es)
CR (1) CR20130649A (es)
EA (1) EA201490014A1 (es)
GT (1) GT201300309A (es)
IL (1) IL229395A0 (es)
MX (1) MX2013014788A (es)
PE (1) PE20141318A1 (es)
SG (1) SG194756A1 (es)
TW (1) TW201311246A (es)
WO (1) WO2012174082A1 (es)

Families Citing this family (22)

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Publication number Priority date Publication date Assignee Title
EP2742940B1 (en) 2012-12-13 2017-07-26 IP Gesellschaft für Management mbH Fumarate salt of (R)-3-(6-(4-methylphenyl)-pyridin-3-yloxy)-l-aza-bicyclo-[2.2.2]octane for adminstration once daily, twice daily or thrice daily
KR101633292B1 (ko) * 2014-02-25 2016-06-24 동아에스티 주식회사 용법이 개선된 엔테카비어를 함유하는 약학적 조성물
WO2015130083A1 (ko) * 2014-02-25 2015-09-03 동아에스티 주식회사 용법이 개선된 엔테카비어를 함유하는 약학적 조성물
MX2017004770A (es) 2014-10-16 2017-07-26 Apotex Inc Formas solidas del clorhidrato de nilotinib.
WO2017158625A1 (en) 2016-03-17 2017-09-21 Sun Pharmaceutical Industries Ltd. Pharmaceutical composition of nilotinib
FI3436461T3 (fi) 2016-03-28 2024-01-16 Incyte Corp Pyrrolotriatsiiniyhdisteitä tam-inhibiittoreina
US10449195B2 (en) 2016-03-29 2019-10-22 Shenzhen Pharmacin Co., Ltd. Pharmaceutical formulation of palbociclib and a preparation method thereof
WO2019018570A1 (en) * 2017-07-19 2019-01-24 Ignyta, Inc. PHARMACEUTICAL COMPOSITIONS CONTAINING ENTRECTINIB
CZ2017821A3 (cs) 2017-12-20 2019-07-03 Zentiva, K.S. Léková forma obsahující krystalický nilotinib
TWI770624B (zh) 2018-06-15 2022-07-11 漢達生技醫藥股份有限公司 尼洛替尼十二烷基硫酸鹽在製備用於治療慢性骨髓性白血病之劑型的用途
US11241438B2 (en) 2018-06-29 2022-02-08 Incyte Corporation Formulations of an AXL/MER inhibitor
WO2020101597A2 (en) * 2018-08-27 2020-05-22 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Capsule compositions comprising tyrosine-kinase inhibitors
CN113573712A (zh) * 2019-02-18 2021-10-29 斯莱班克制药有限责任公司 尼洛替尼的药物组合物
JP7378279B2 (ja) * 2019-11-18 2023-11-13 日本化薬株式会社 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
AU2021212258A1 (en) 2020-01-31 2022-09-29 Nanocopoeia, Llc Amorphous nilotinib microparticles and uses thereof
EP4142699A1 (en) * 2020-04-30 2023-03-08 Nanocopoeia LLC Orally disintegrating tablet comprising amorphous solid dispersion of nilotinib
JP7489849B2 (ja) 2020-07-20 2024-05-24 日本化薬株式会社 ニロチニブ錠剤
EP4185273A1 (en) * 2020-07-24 2023-05-31 Lonza Bend Inc. Spray drying of supersaturated solutions of api with acetic acid
CN114306245A (zh) 2020-09-29 2022-04-12 深圳市药欣生物科技有限公司 无定形固体分散体的药物组合物及其制备方法
CA3193829A1 (en) * 2020-09-29 2022-04-07 Shenzhen Pharmacin Co., Ltd. Pharmaceutical compositions
MX2023015480A (es) 2021-06-19 2024-01-19 Helm Ag Composicion granulada que comprende nilotinib.
EP4122452A1 (en) * 2021-07-23 2023-01-25 KRKA, d.d., Novo mesto Pharmaceutical composition comprising nilotinib and method of manufacturing the same

Family Cites Families (14)

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Publication number Priority date Publication date Assignee Title
ATE424815T1 (de) * 2001-12-03 2009-03-15 Dor Biopharma Inc Stabilisierte umkehr-mizellen-zusammensetzungen und ihre verwendung
SA06270147B1 (ar) * 2005-06-09 2009-12-22 نوفارتيس ايه جي عملية لتخليق 5-(مثيل–1h–إيميدازول–1-يل )–3-(ثلاثي فلـورو مثيل)–بنزامـين
ES2356257T3 (es) * 2005-06-09 2011-04-06 Novartis Ag Proceso para la síntesis del 5-(metil-1h-imidazol-1-il)-3-(trifluorometil)-bencenoamina.
CN101228151B (zh) * 2005-07-20 2013-01-09 诺瓦提斯公司 4-甲基-n-[3-(4-甲基-咪唑-1-基)-5-三氟甲基-苯基]-3-(4-吡啶-3-基-嘧啶-2-基氨基)-苯甲酰胺的盐
GT200600316A (es) 2005-07-20 2007-04-02 Sales de 4-metilo-n-(3-(4-metilo-imidazol-1-ilo)-5-trifluorometilo-fenilo)-3-(4-piridina-3-ilo-pirimidina-2-iloamino)- benzamida.
CN101228150B (zh) * 2005-07-20 2014-10-15 诺华股份有限公司 4-甲基-n-[3-(4-甲基-咪唑-1-基)-5-三氟甲基-苯基]-3-(4-吡啶-3-基-嘧啶-2-基氨基)-苯甲酰胺的晶形
GT200600315A (es) * 2005-07-20 2007-03-19 Formas cristalinas de 4-metilo-n-[3-(4-metilo-imidazol-1-ilo)-5-trifluorometilo-fenilo]-3-(4-pyridina-3-ilo-pirimidina-2-iloamino)-benzamida
CN104721168A (zh) * 2006-08-25 2015-06-24 贝林格尔·英格海姆国际有限公司 控制释放***及其制造方法
EP1923053A1 (en) * 2006-09-27 2008-05-21 Novartis AG Pharmaceutical compositions comprising nilotinib or its salt
CA2667720A1 (en) * 2006-11-09 2008-05-15 Abbott Gmbh & Co. Kg. Pharmaceutical dosage form for oral administration of tyrosine kinase inhibitor
GB0716591D0 (en) * 2007-08-24 2007-10-03 Vereniging Het Nl Kanker I Composition
US20100016590A1 (en) * 2008-07-17 2010-01-21 Teva Pharmaceutical Industries Ltd. Nilotinib intermediates and preparation thereof
PL2262793T3 (pl) * 2008-11-05 2013-01-31 Teva Pharma Formy krystaliczne nilotynibu HCL
EP2571863B1 (en) * 2010-06-21 2015-09-23 Teva Pharmaceutical Industries Ltd. Nilotinib salts and crystalline forms thereof

Also Published As

Publication number Publication date
WO2012174082A1 (en) 2012-12-20
CN103608342A (zh) 2014-02-26
EP2721024A1 (en) 2014-04-23
TW201311246A (zh) 2013-03-16
KR20140036225A (ko) 2014-03-25
JP2014517040A (ja) 2014-07-17
EA201490014A1 (ru) 2014-04-30
MX2013014788A (es) 2014-07-28
IL229395A0 (en) 2014-01-30
GT201300309A (es) 2015-02-19
CA2838741A1 (en) 2012-12-20
CL2013003576A1 (es) 2014-07-11
SG194756A1 (en) 2013-12-30
CO6801777A2 (es) 2013-11-29
PE20141318A1 (es) 2014-10-13
US20150273070A1 (en) 2015-10-01
AP2013007233A0 (en) 2013-11-30
BR112013032122A2 (pt) 2016-12-13
AR086913A1 (es) 2014-01-29

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