HRP20240033T1 - Formulacija koja sadrži inhibitor mek - Google Patents

Formulacija koja sadrži inhibitor mek Download PDF

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Publication number
HRP20240033T1
HRP20240033T1 HRP20240033TT HRP20240033T HRP20240033T1 HR P20240033 T1 HRP20240033 T1 HR P20240033T1 HR P20240033T T HRP20240033T T HR P20240033TT HR P20240033 T HRP20240033 T HR P20240033T HR P20240033 T1 HRP20240033 T1 HR P20240033T1
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Croatia
Prior art keywords
pharmaceutical preparation
preparation
weight
cancer
hydroxyethyloxy
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HRP20240033TT
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English (en)
Inventor
Christoph Max Krell
Marian Misun
Daniel Andreas Niederer
Werner Heinz Pachinger
Marie-Christine Wolf
Daniel Zimmermann
Weidong Liu
Peter J. Stengel
Paul Nichols
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Array Biopharma, Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50488781&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20240033(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Array Biopharma, Inc. filed Critical Array Biopharma, Inc.
Publication of HRP20240033T1 publication Critical patent/HRP20240033T1/hr

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D235/00Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings
    • C07D235/02Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings condensed with carbocyclic rings or ring systems
    • C07D235/04Benzimidazoles; Hydrogenated benzimidazoles
    • C07D235/06Benzimidazoles; Hydrogenated benzimidazoles with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached in position 2
    • C07D235/08Radicals containing only hydrogen and carbon atoms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41841,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D235/00Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings
    • C07D235/02Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings condensed with carbocyclic rings or ring systems
    • C07D235/04Benzimidazoles; Hydrogenated benzimidazoles
    • C07D235/06Benzimidazoles; Hydrogenated benzimidazoles with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached in position 2
    • CCHEMISTRY; METALLURGY
    • C30CRYSTAL GROWTH
    • C30BSINGLE-CRYSTAL GROWTH; UNIDIRECTIONAL SOLIDIFICATION OF EUTECTIC MATERIAL OR UNIDIRECTIONAL DEMIXING OF EUTECTOID MATERIAL; REFINING BY ZONE-MELTING OF MATERIAL; PRODUCTION OF A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; SINGLE CRYSTALS OR HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; AFTER-TREATMENT OF SINGLE CRYSTALS OR A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; APPARATUS THEREFOR
    • C30B29/00Single crystals or homogeneous polycrystalline material with defined structure characterised by the material or by their shape
    • C30B29/54Organic compounds
    • CCHEMISTRY; METALLURGY
    • C30CRYSTAL GROWTH
    • C30BSINGLE-CRYSTAL GROWTH; UNIDIRECTIONAL SOLIDIFICATION OF EUTECTIC MATERIAL OR UNIDIRECTIONAL DEMIXING OF EUTECTOID MATERIAL; REFINING BY ZONE-MELTING OF MATERIAL; PRODUCTION OF A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; SINGLE CRYSTALS OR HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; AFTER-TREATMENT OF SINGLE CRYSTALS OR A HOMOGENEOUS POLYCRYSTALLINE MATERIAL WITH DEFINED STRUCTURE; APPARATUS THEREFOR
    • C30B7/00Single-crystal growth from solutions using solvents which are liquid at normal temperature, e.g. aqueous solutions
    • C30B7/08Single-crystal growth from solutions using solvents which are liquid at normal temperature, e.g. aqueous solutions by cooling of the solution
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Inorganic Chemistry (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Metallurgy (AREA)
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  • Crystallography & Structural Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Claims (13)

1. Farmaceutski pripravak, naznačen time što sadrži: – 5-10% kristaliziranog (2-hidroksietiloksi)amida 6-(4-brom-2-fluorfenilamino)-7-fluor-3-metil-3H-benzimidazol-5-karboksilne kiseline, – 50-60%, po mogućnosti 55-56%, monohidrata laktoze, te – 20-40%, po mogućnosti 30-36%, mikrokristalne celuloze, prema težini pripravka.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što dodatno sadrži: – 1,5-2,5% umreženog karboksimetilceluloza-natrija, – 0,5-0,9% magnezijevog stearata, te – 0,1-1% koloidnog silicijevog dioksida/koloidnog bezvodnog silicijevog dioksida, prema težini pripravka.
3. Farmaceutski pripravak u skladu s patentnim zahtjevom 2, naznačen time što sadrži: – 5-10% kristaliziranog (2-hidroksietiloksi)amida 6-(4-brom-2-fluorfenilamino)-7-fluor-3-metil-3H-benzimidazol-5-karboksilne kiseline, – 50-60% monohidrata laktoze, – 20-40% mikrokristalne celuloze, – 2% umreženog karboksimetilceluloza-natrija, – 0,75% magnezijevog stearata, te – 0,25% koloidnog silicijevog dioksida/koloidnog bezvodnog silicijevog dioksida, prema težini pripravka.
4. Farmaceutski pripravak u skladu s patentnim zahtjevom 3, naznačen time što sadrži: – 5-10% kristaliziranog (2-hidroksietiloksi)amida 6-(4-brom-2-fluorfenilamino)-7-fluor-3-metil-3H-benzimidazol-5-karboksilne kiseline, prema težini pripravka, – 55-56% monohidrata laktoze, prema težini pripravka, – 30-36% mikrokristalne celuloze, prema težini pripravka, – 2% umreženog karboksimetilceluloza-natrija, prema težini pripravka, – 0,75% magnezijevog stearata, prema težini pripravka, te – 0,25% koloidnog silicijevog dioksida/koloidnog bezvodnog silicijevog dioksida, prema težini pripravka.
5. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što sadrži 45 mg kristaliziranog (2-hidroksietiloksi)amida 6-(4-brom-2-fluorfenilamino)-7-fluor-3-metil-3H-benzimidazol-5-karboksilne kiseline.
6. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-5, naznačen time što je farmaceutski pripravak u obliku pogodnom za oralnu primjenu u obliku jedinice doziranja.
7. Farmaceutski pripravak u skladu s patentnim zahtjevom 6, naznačen time što je farmaceutski pripravak u obliku tablete.
8. Farmaceutski pripravak u skladu s patentnim zahtjevom 7, naznačen time što je tableta obložena tableta.
9. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što je namijenjen upotrebi u liječenju proliferativne bolesti kod subjekta, gdje je proliferativna bolest po mogućnosti rak, po mogućnosti rak kojeg se bira između čvrstog tumora ili primarnog limfoma CNS.
10. Farmaceutski pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 9, naznačen time što je proliferativna bolest rak kojeg se bira između melanoma, raka gušterače, raka jajnika, raka jajovoda, raka peritoneuma, raka žučovoda, raka debelog crijeva ili raka rektuma.
11. Farmaceutski pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 10, naznačen time što je proliferativna bolest melanom.
12. Farmaceutski pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 10, naznačen time što je proliferativna bolest rak debelog crijeva.
13. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačen time što sadrži: – 6,25% kristaliziranog (2-hidroksietiloksi)amida 6-(4-brom-2-fluorfenilamino)-7-fluor-3-metil-3H-benzimidazol-5-karboksilne kiseline, – 55,63% monohidrata laktoze, – 35,13% mikrokristalne celuloze, – 2,00% umreženog karboksimetilceluloza-natrija, – 0,75% magnezijevog stearata, te – 0,25% of koloidni silicijev dioksid/koloidni bezvodni silicijev dioksid, prema težini pripravka; i gdje farmaceutski pripravak može sadržavati oblogu od filma.
HRP20240033TT 2012-10-19 2013-10-18 Formulacija koja sadrži inhibitor mek HRP20240033T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261716169P 2012-10-19 2012-10-19
EP19211405.6A EP3702351B1 (en) 2012-10-19 2013-10-18 Formulation comprising a mek inhibitor

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HRP20240033T1 true HRP20240033T1 (hr) 2024-03-29

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US (7) US9238627B2 (hr)
EP (3) EP4306171A3 (hr)
JP (3) JP6385939B2 (hr)
CN (3) CN104870427B (hr)
AR (1) AR099630A1 (hr)
BR (1) BR112015008623B1 (hr)
CA (2) CA2888474C (hr)
CY (1) CY1122670T1 (hr)
DK (2) DK3702351T3 (hr)
ES (1) ES2772498T3 (hr)
FI (1) FI3702351T3 (hr)
HK (1) HK1214254A1 (hr)
HR (1) HRP20240033T1 (hr)
HU (1) HUE047708T2 (hr)
JO (1) JOP20130304B1 (hr)
LT (1) LT3702351T (hr)
PL (2) PL3702351T3 (hr)
PT (2) PT2909182T (hr)
RS (1) RS65117B1 (hr)
RU (2) RU2018127873A (hr)
SI (2) SI3702351T1 (hr)
TW (1) TWI650316B (hr)
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RU2018127873A (ru) 2019-03-14
US10398683B2 (en) 2019-09-03
BR112015008623A2 (pt) 2017-07-04
EP3702351B1 (en) 2023-11-22
ES2772498T3 (es) 2020-07-07
RU2669391C2 (ru) 2018-10-11
DK3702351T3 (da) 2024-01-29
AR099630A1 (es) 2016-08-10
PT2909182T (pt) 2020-03-02
JP2018135399A (ja) 2018-08-30
WO2014063024A1 (en) 2014-04-24
EP2909182A4 (en) 2016-07-06
US20160168104A1 (en) 2016-06-16
US20160168103A1 (en) 2016-06-16
CA2888474C (en) 2021-03-02
JP2016503391A (ja) 2016-02-04
TWI650316B (zh) 2019-02-11
HK1214254A1 (zh) 2016-07-22
EP2909182B1 (en) 2019-12-04
US9598376B2 (en) 2017-03-21
US9382212B1 (en) 2016-07-05
US20140128442A1 (en) 2014-05-08
DK2909182T3 (da) 2020-02-17
EP4306171A2 (en) 2024-01-17
BR112015008623B1 (pt) 2022-10-25
EP4306171A3 (en) 2024-04-03
TW201427956A (zh) 2014-07-16
PT3702351T (pt) 2024-01-17
US9562016B2 (en) 2017-02-07
US20180296533A1 (en) 2018-10-18
CA3079071C (en) 2022-06-07
CN109336824A (zh) 2019-02-15
JOP20130304B1 (ar) 2021-08-17
US9980944B2 (en) 2018-05-29
US20200171002A1 (en) 2020-06-04
CN109336824B (zh) 2022-11-11
CA3079071A1 (en) 2014-04-24
US20170231963A1 (en) 2017-08-17
CY1122670T1 (el) 2021-03-12
SI2909182T1 (sl) 2020-03-31
EP2909182A1 (en) 2015-08-26
CA2888474A1 (en) 2014-04-24
FI3702351T3 (fi) 2024-01-24
RS65117B1 (sr) 2024-02-29
US9238627B2 (en) 2016-01-19
JP2019194272A (ja) 2019-11-07
CN109456272A (zh) 2019-03-12
JP6385939B2 (ja) 2018-09-05
CN104870427B (zh) 2018-10-23
PL2909182T3 (pl) 2020-06-01
PL3702351T3 (pl) 2024-04-02
SI3702351T1 (sl) 2024-03-29
EP3702351A1 (en) 2020-09-02
RU2015118572A (ru) 2016-12-20
US10729678B2 (en) 2020-08-04
US20160168102A1 (en) 2016-06-16
JP6737838B2 (ja) 2020-08-12
LT3702351T (lt) 2024-01-10
CN104870427A (zh) 2015-08-26
HUE047708T2 (hu) 2020-05-28

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