CA3211395A1 - Compositions de forme iv essentiellement pure de n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide et leurs utilisations - Google Patents

Compositions de forme iv essentiellement pure de n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide et leurs utilisations Download PDF

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Publication number
CA3211395A1
CA3211395A1 CA3211395A CA3211395A CA3211395A1 CA 3211395 A1 CA3211395 A1 CA 3211395A1 CA 3211395 A CA3211395 A CA 3211395A CA 3211395 A CA3211395 A CA 3211395A CA 3211395 A1 CA3211395 A1 CA 3211395A1
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Prior art keywords
benzamide
fluoro
dihydroxypropoxy
difluoro
phenylamino
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Pending
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CA3211395A
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English (en)
Inventor
Erwin IRDAM
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Warner Lambert Co LLC
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Warner Lambert Co LLC
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Publication of CA3211395A1 publication Critical patent/CA3211395A1/fr
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C259/00Compounds containing carboxyl groups, an oxygen atom of a carboxyl group being replaced by a nitrogen atom, this nitrogen atom being further bound to an oxygen atom and not being part of nitro or nitroso groups
    • C07C259/04Compounds containing carboxyl groups, an oxygen atom of a carboxyl group being replaced by a nitrogen atom, this nitrogen atom being further bound to an oxygen atom and not being part of nitro or nitroso groups without replacement of the other oxygen atom of the carboxyl group, e.g. hydroxamic acids
    • C07C259/10Compounds containing carboxyl groups, an oxygen atom of a carboxyl group being replaced by a nitrogen atom, this nitrogen atom being further bound to an oxygen atom and not being part of nitro or nitroso groups without replacement of the other oxygen atom of the carboxyl group, e.g. hydroxamic acids having carbon atoms of hydroxamic groups bound to carbon atoms of six-membered aromatic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/166Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
    • 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
    • A61K47/30Macromolecular 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
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente divulgation concerne : a) une composition cristalline de forme IV essentiellement pure de N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophénylamino)-benzamide ; b) des compositions pharmaceutiques comprenant la composition cristalline de forme IV essentiellement pure de N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophénylamino)-benzamide, et, éventuellement, un excipient pharmaceutiquement acceptable ; et c) des méthodes de traitement d'une tumeur, d'un cancer ou d'un trouble de type RASopathie par l'administration de la composition cristalline de forme IV essentiellement pure de N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophénylamino)-benzamide à un sujet qui en a besoin.
CA3211395A 2021-02-17 2021-02-17 Compositions de forme iv essentiellement pure de n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide et leurs utilisations Pending CA3211395A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2021/018378 WO2022177556A1 (fr) 2021-02-17 2021-02-17 Compositions de forme iv essentiellement pure de n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophénylamino)-benzamide et leurs utilisations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3304466A Division CA3304466A1 (en) 2021-02-17 Compositions of essentially pure form iv of n-((r)-2,3- dihydroxypropoxy)-3,4-difluoro-2- (2-fluoro-4-iodophenylamino)- benzamide and uses thereof

Publications (1)

Publication Number Publication Date
CA3211395A1 true CA3211395A1 (fr) 2022-08-25

Family

ID=74860567

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3211395A Pending CA3211395A1 (fr) 2021-02-17 2021-02-17 Compositions de forme iv essentiellement pure de n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide et leurs utilisations

Country Status (11)

Country Link
EP (1) EP4294789A1 (fr)
JP (1) JP2024507822A (fr)
KR (1) KR20230148177A (fr)
CN (1) CN117500781A (fr)
AR (1) AR124907A1 (fr)
AU (1) AU2021428932A1 (fr)
CA (1) CA3211395A1 (fr)
IL (1) IL304974A (fr)
MX (1) MX2023009555A (fr)
TW (1) TW202245746A (fr)
WO (1) WO2022177556A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024507213A (ja) * 2021-02-17 2024-02-16 スプリングワークス、セラピューティクス、インコーポレイテッド N-((r)-2,3-ジヒドロキシプロポキシ)-3,4-ジフルオロ-2-(2-フルオロ-4-ヨード-フェニルアミノ)-ベンズアミドの分散性製剤及びその使用
US20250282715A1 (en) 2022-05-17 2025-09-11 Assia Chemical Industries Ltd. Solid state forms of mirdametinib and process for preparation thereof

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002006213A2 (fr) 2000-07-19 2002-01-24 Warner-Lambert Company Esters oxygenes d'acides 4-iodophenylamino benzhydroxamiques
MXPA05003431A (es) * 2002-11-15 2005-07-05 Warner Lambert Co Quimioterapia de combinacion.
BRPI0415710A (pt) * 2003-10-21 2006-12-19 Warner Lambert Co formas polimórficas de n-[(r)-2,3-dihidróxi-propóxi]-3,4-diflúor-2-(2-flúor-4-io dofenilamino)-benzamida
WO2006134469A1 (fr) * 2005-06-14 2006-12-21 Warner-Lambert Company Llc Procedes de preparation d'un inhibiteur de mek
WO2007042885A2 (fr) * 2005-10-07 2007-04-19 Pfizer Products Inc. Combinaison therapeutique

Also Published As

Publication number Publication date
AU2021428932A1 (en) 2023-09-21
EP4294789A1 (fr) 2023-12-27
TW202245746A (zh) 2022-12-01
WO2022177556A1 (fr) 2022-08-25
MX2023009555A (es) 2023-11-10
CN117500781A (zh) 2024-02-02
IL304974A (en) 2023-10-01
JP2024507822A (ja) 2024-02-21
AR124907A1 (es) 2023-05-17
KR20230148177A (ko) 2023-10-24

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