BR112013032122A2 - liberação modificada de 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluorometil)fenil] benzamida solubilizada usando ácidos orgânicos - Google Patents

liberação modificada de 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluorometil)fenil] benzamida solubilizada usando ácidos orgânicos

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Publication number
BR112013032122A2
BR112013032122A2 BR112013032122A BR112013032122A BR112013032122A2 BR 112013032122 A2 BR112013032122 A2 BR 112013032122A2 BR 112013032122 A BR112013032122 A BR 112013032122A BR 112013032122 A BR112013032122 A BR 112013032122A BR 112013032122 A2 BR112013032122 A2 BR 112013032122A2
Authority
BR
Brazil
Prior art keywords
methyl
organic acids
imidazol
pyridinyl
pyrimidinyl
Prior art date
Application number
BR112013032122A
Other languages
English (en)
Inventor
Enxian Lu
Nikhil Javant Kavimandan
Saran Kumar
Shoufeng Li
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=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112013032122(A2) "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 BR112013032122A2 publication Critical patent/BR112013032122A2/pt

Links

Classifications

    • 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
    • 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
    • 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

Abstract

resumo patente de invenção: "liberação modificada de 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluorometil)fenil] benzamida solubilizada usando ácidos orgânicos". a presente invenção refere-se a composições farmacêuticas solúveis de nilotinib amorfo ou de um sal farmaceuticamente aceitável do mesmo com a utilização de um ou mais ácidos orgânicos que funcionam como agente de solubilização, aumentando a bio-disponibilidade do nilotinib e suprimindo o efeito de alimento associado com determinadas composições de nilotinib. as composições farmacêuticas estão em formas de dosagem oral sólidas, incluindo cápsulas e comprimidos. 20018477v1
BR112013032122A 2011-06-14 2012-06-13 liberação modificada de 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluorometil)fenil] benzamida solubilizada usando ácidos orgânicos BR112013032122A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161496913P 2011-06-14 2011-06-14
US201161541306P 2011-09-30 2011-09-30
PCT/US2012/042205 WO2012174082A1 (en) 2011-06-14 2012-06-13 Modified release of 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-n-5-(4-methyl-1h-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide solubilized using organic acids

Publications (1)

Publication Number Publication Date
BR112013032122A2 true BR112013032122A2 (pt) 2016-12-13

Family

ID=46317545

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013032122A BR112013032122A2 (pt) 2011-06-14 2012-06-13 liberação modificada de 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluorometil)fenil] benzamida solubilizada usando ácidos orgânicos

Country Status (20)

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

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EP3251673A1 (en) 2012-12-13 2017-12-06 IP Gesellschaft für Management mbH Combination therapy comprising a cdk4/6 inhibitor and a pi3k inhibitor for use in the treatment of cancer
WO2015130083A1 (ko) * 2014-02-25 2015-09-03 동아에스티 주식회사 용법이 개선된 엔테카비어를 함유하는 약학적 조성물
KR101633292B1 (ko) * 2014-02-25 2016-06-24 동아에스티 주식회사 용법이 개선된 엔테카비어를 함유하는 약학적 조성물
AU2015333530A1 (en) 2014-10-16 2017-04-27 Apotex Inc. Solid forms of nilotinib hydrochloride
EP3429589B1 (en) 2016-03-17 2022-12-14 Sun Pharmaceutical Industries Ltd Pharmaceutical composition of nilotinib
SG11201808582RA (en) 2016-03-28 2018-10-30 Incyte Corp Pyrrolotriazine compounds as tam inhibitors
US10449195B2 (en) 2016-03-29 2019-10-22 Shenzhen Pharmacin Co., Ltd. Pharmaceutical formulation of palbociclib and a preparation method thereof
EP3654952A1 (en) * 2017-07-19 2020-05-27 Ignyta, Inc. Pharmaceutical compositions comprising entrectinib
CZ2017821A3 (cs) 2017-12-20 2019-07-03 Zentiva, K.S. Léková forma obsahující krystalický nilotinib
EP3806858A4 (en) * 2018-06-15 2022-03-09 Handa Pharmaceuticals, Inc. SALTS OF KINASE INHIBITORS AND ASSOCIATED COMPOSITIONS
EP3813800A1 (en) * 2018-06-29 2021-05-05 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
EP3914252A4 (en) * 2019-02-18 2022-03-30 Slayback Pharma LLC PHARMACEUTICAL COMPOSITION OF NILOTINIB
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
EP4185273A1 (en) * 2020-07-24 2023-05-31 Lonza Bend Inc. Spray drying of supersaturated solutions of api with acetic acid
WO2022068876A1 (en) * 2020-09-29 2022-04-07 Shenzhen Pharmacin Co., Ltd. Pharmaceutical compositions
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
CA3224750A1 (en) 2021-06-19 2022-12-22 Helm Ag Granulate composition comprising nilotinib
EP4122452A1 (en) * 2021-07-23 2023-01-25 KRKA, d.d., Novo mesto Pharmaceutical composition comprising nilotinib and method of manufacturing the same

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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
CN101184748B (zh) * 2005-06-09 2011-09-28 诺瓦提斯公司 合成5-(甲基-1h-咪唑-1-基)-3-(三氟甲基)苯胺的方法
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
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Also Published As

Publication number Publication date
CA2838741A1 (en) 2012-12-20
KR20140036225A (ko) 2014-03-25
CN103608342A (zh) 2014-02-26
SG194756A1 (en) 2013-12-30
AR086913A1 (es) 2014-01-29
IL229395A0 (en) 2014-01-30
CR20130649A (es) 2014-02-04
EA201490014A1 (ru) 2014-04-30
EP2721024A1 (en) 2014-04-23
PE20141318A1 (es) 2014-10-13
WO2012174082A1 (en) 2012-12-20
AP2013007233A0 (en) 2013-11-30
GT201300309A (es) 2015-02-19
US20150273070A1 (en) 2015-10-01
JP2014517040A (ja) 2014-07-17
CO6801777A2 (es) 2013-11-29
CL2013003576A1 (es) 2014-07-11
MX2013014788A (es) 2014-07-28
TW201311246A (zh) 2013-03-16

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