IL283276B2 - Compositions comprising 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid and n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and uses thereof - Google Patents

Compositions comprising 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid and n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and uses thereof

Info

Publication number
IL283276B2
IL283276B2 IL283276A IL28327621A IL283276B2 IL 283276 B2 IL283276 B2 IL 283276B2 IL 283276 A IL283276 A IL 283276A IL 28327621 A IL28327621 A IL 28327621A IL 283276 B2 IL283276 B2 IL 283276B2
Authority
IL
Israel
Prior art keywords
compound
pharmaceutical composition
substantially amorphous
tablet
patient
Prior art date
Application number
IL283276A
Other languages
English (en)
Hebrew (he)
Other versions
IL283276B1 (en
IL283276A (en
Original Assignee
Vertex Pharma
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=50628072&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=IL283276(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Vertex Pharma filed Critical Vertex Pharma
Publication of IL283276A publication Critical patent/IL283276A/en
Publication of IL283276B1 publication Critical patent/IL283276B1/en
Publication of IL283276B2 publication Critical patent/IL283276B2/en

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    • 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/443—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • 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
    • 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
    • A61K9/2072—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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Obesity (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
IL283276A 2012-11-02 2013-11-01 Compositions comprising 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid and n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and uses thereof IL283276B2 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201261721622P 2012-11-02 2012-11-02
US201261728328P 2012-11-20 2012-11-20
US201361770668P 2013-02-28 2013-02-28
US201361824005P 2013-05-16 2013-05-16
US201361840668P 2013-06-28 2013-06-28
PCT/US2013/067952 WO2014071122A1 (en) 2012-11-02 2013-11-01 Pharmaceutical compositions for the treatment of cftr mediated diseases

Publications (3)

Publication Number Publication Date
IL283276A IL283276A (en) 2021-07-29
IL283276B1 IL283276B1 (en) 2024-01-01
IL283276B2 true IL283276B2 (en) 2024-05-01

Family

ID=50628072

Family Applications (2)

Application Number Title Priority Date Filing Date
IL283276A IL283276B2 (en) 2012-11-02 2013-11-01 Compositions comprising 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid and n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and uses thereof
IL238551A IL238551B (en) 2012-11-02 2015-04-30 Preparations containing 3-(6-(1-(2,2-difluorobenzo[1,3][d]dioxol-5-yl)cycloproponecarboxamide)-3-methylpyridin-2-yl)benzoic acid and n-(5-hydroxy- 2,4-di-tert-butyl-phenyl)-4-oxo-h1-quinoline-3-carboxamide and their uses

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL238551A IL238551B (en) 2012-11-02 2015-04-30 Preparations containing 3-(6-(1-(2,2-difluorobenzo[1,3][d]dioxol-5-yl)cycloproponecarboxamide)-3-methylpyridin-2-yl)benzoic acid and n-(5-hydroxy- 2,4-di-tert-butyl-phenyl)-4-oxo-h1-quinoline-3-carboxamide and their uses

Country Status (30)

Country Link
US (4) US20140163068A1 (cg-RX-API-DMAC7.html)
EP (3) EP4556008A3 (cg-RX-API-DMAC7.html)
JP (4) JP6302923B2 (cg-RX-API-DMAC7.html)
KR (1) KR102396897B1 (cg-RX-API-DMAC7.html)
CN (2) CN111671751A (cg-RX-API-DMAC7.html)
AR (1) AR093340A1 (cg-RX-API-DMAC7.html)
AU (4) AU2013337730B2 (cg-RX-API-DMAC7.html)
BR (1) BR112015009913B1 (cg-RX-API-DMAC7.html)
CA (1) CA2890106C (cg-RX-API-DMAC7.html)
CL (1) CL2015001148A1 (cg-RX-API-DMAC7.html)
CY (1) CY1121070T1 (cg-RX-API-DMAC7.html)
DK (2) DK2914248T4 (cg-RX-API-DMAC7.html)
ES (2) ES2694290T5 (cg-RX-API-DMAC7.html)
FI (2) FI3470063T3 (cg-RX-API-DMAC7.html)
HR (2) HRP20181740T4 (cg-RX-API-DMAC7.html)
HU (2) HUE070382T2 (cg-RX-API-DMAC7.html)
IL (2) IL283276B2 (cg-RX-API-DMAC7.html)
LT (2) LT3470063T (cg-RX-API-DMAC7.html)
MX (2) MX368353B (cg-RX-API-DMAC7.html)
NZ (2) NZ708474A (cg-RX-API-DMAC7.html)
PL (2) PL2914248T5 (cg-RX-API-DMAC7.html)
PT (2) PT2914248T (cg-RX-API-DMAC7.html)
RS (2) RS57831B2 (cg-RX-API-DMAC7.html)
SG (3) SG10201913581UA (cg-RX-API-DMAC7.html)
SI (2) SI2914248T2 (cg-RX-API-DMAC7.html)
SM (2) SMT202500078T1 (cg-RX-API-DMAC7.html)
TR (1) TR201815218T4 (cg-RX-API-DMAC7.html)
TW (2) TW201422253A (cg-RX-API-DMAC7.html)
UA (2) UA117464C2 (cg-RX-API-DMAC7.html)
WO (1) WO2014071122A1 (cg-RX-API-DMAC7.html)

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CN101910156B (zh) 2007-12-07 2013-12-04 沃泰克斯药物股份有限公司 3-(6-(1-(2,2-二氟苯并[d][1,3]间二氧杂环戊烯-5-基)环丙烷甲酰氨基)-3-甲基吡啶-2-基)苯甲酸的固体形式
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AR081760A1 (es) 2010-04-07 2012-10-17 Vertex Pharma Una composicion farmaceutica para administracion oral que comprende acido 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-il)ciclopropancarboxamido)-3-metilpiridin-2-il)benzoico, un metodo para producir la misma, una tableta y una forma unitaria de dosificacion oral que la comprende y el uso de la misma para la fabricacion de un medicamento
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HUE047354T2 (hu) 2011-05-18 2020-04-28 Vertex Pharmaceuticals Europe Ltd Ivacaftor deuterizált származékai
EP2776427B1 (en) 2011-11-08 2017-02-01 Vertex Pharmaceuticals Incorporated Modulators of atp-binding cassette transporters
ES2982694T3 (es) 2012-01-06 2024-10-17 H Lundbeck As Compuestos de carbamato para su uso en tratamiento
CA2865519C (en) 2012-02-27 2018-01-02 Vertex Pharmaceuticals Incorporated Pharmaceutical compositions comprising a solid dispersion of n-[2,4-bis(1,1-dimethylethyl0-5-hydroxyphenyl-1]-1,4-dihydro-4-oxoquinolone-3-carboxamide for treating cystic fibrosis
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DK2914248T4 (da) * 2012-11-02 2024-01-02 Vertex Pharma Farmaceutiske sammensætninger til behandlingen af cftr medierede sygdomme
US9303918B2 (en) * 2013-03-15 2016-04-05 Monosol Rx, Llc Process for drying a wet film with control of loss on drying
WO2014176553A1 (en) * 2013-04-26 2014-10-30 Vertex Pharmaceuticals Incorporated Correctors acting through msd1 of cftr protein
RU2016122882A (ru) * 2013-11-12 2017-12-19 Вертекс Фармасьютикалз Инкорпорейтед Способ получения фармацевтических композиций для лечения опосредованных cftr заболеваний
MX387720B (es) 2014-04-15 2025-03-12 Vertex Pharma Composiciones farmacéuticas para el tratamiento de enfermedades mediadas por el regulador de conductancia de transmembrana de fibrosis quística.
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MX381732B (es) 2014-11-18 2025-03-13 Vertex Pharma Proceso para efectuar la prueba de alto rendimiento de la cromatografia liquida de alta resolucion.
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