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AR122475A2 - Dispersiones sólidas extruidas por fusión que contienen un agente inductor de apoptosis - Google Patents

Dispersiones sólidas extruidas por fusión que contienen un agente inductor de apoptosis

Info

Publication number
AR122475A2
AR122475A2 ARP210101264A ARP210101264A AR122475A2 AR 122475 A2 AR122475 A2 AR 122475A2 AR P210101264 A ARP210101264 A AR P210101264A AR P210101264 A ARP210101264 A AR P210101264A AR 122475 A2 AR122475 A2 AR 122475A2
Authority
AR
Argentina
Prior art keywords
pharmaceutically acceptable
compound
solid dispersion
solid
crystalline form
Prior art date
Application number
ARP210101264A
Other languages
English (en)
Inventor
David J Lindley
Yeshwant D Sanzgiri
Ping Tong
Esther Birtalan
Peter Hoelig
Original Assignee
Abbvie Ireland Unlimited Co
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=44903438&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR122475(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Abbvie Ireland Unlimited Co filed Critical Abbvie Ireland Unlimited Co
Publication of AR122475A2 publication Critical patent/AR122475A2/es

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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/541—Non-condensed thiazines 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
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
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    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
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    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
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    • 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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • 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
    • A61K9/14—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
    • A61K9/1682—Processes
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/2095—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
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    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
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    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
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    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
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  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Transplantation (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Una dispersión sólida pro-apoptótica que comprende, en una forma esencialmente no cristalina, un compuesto inhibidor de familia de proteínas Bcl-2 de la fórmula (1), definido en la presente, disperso en una matriz sólida que comprende (a) un vehículo polimérico soluble en agua farmacéuticamente aceptable y (b) un agente tensioactivo farmacéuticamente aceptable. Un proceso para preparar dicha dispersión sólida que comprende someter a una temperatura elevada el compuesto de la fórmula (1), el vehículo polimérico soluble en agua y el agente tensioactivo, para proveer una mezcla semisólida extruible; extrudir la mezcla semisólida; y enfriar el extrudado resultante para proveer una matriz sólida que comprende el vehículo polimérico y el agente tensioactivo y en el cual está disperso el compuesto en una forma esencialmente no cristalina. La dispersión sólida es apropiada para una administración por vía oral a un sujeto que la necesita para tratar una enfermedad caracterizada por la sobreexpresión de una o más proteínas antiapoptóticas de la familia Bcl-2, por ejemplo cáncer o una enfermedad inmune o autoinmune. Reivindicación 1: Una composición farmacéutica apropiada para la inducción de apoptosis caracterizada porque comprende una dispersión sólida que comprende: un compuesto 4-(4-{[2-(4-clorofenil)-4,4-dimetilciclohex-1-en-1-il]metil}piperazin-1-il)-N-({3-nitro-4-[(tetrahidro-2H-piran-4-ilmetil)amino]fenil}sulfonil)-2-(1H-pirrolo[2,3-b]piridin-5-iloxi)benzamida o una sal farmacéuticamente aceptable del mismo presente en una cantidad de entre 5% y 40% en peso. por lo menos un vehículo polimérico soluble en agua farmacéuticamente aceptable presente en una cantidad de entre 40% y 85% en peso, donde el por lo menos un vehículo polimérico soluble en agua farmacéuticamente aceptable se selecciona entre el grupo que consiste en povidonas, copovidonas, HPMC, copolímeros injertados de polietilenglicol / polivinilcaprolactama / acetato de polivinilo y mezclas de los mismos; y por lo menos un tensioactivo farmacéuticamente aceptable presente en una cantidad de entre 5% y 20% en peso, donde el por lo menos un tensioactivo farmacéuticamente aceptable se selecciona entre el grupo que consiste en glicéridos de polioxietileno, monoésteres de ácidos grasos y sorbitán, polisorbatos, succinato de a-tocoferol y polietilenglicol (TPGS) y mezclas de los mismos; donde la dispersión sólida comprende menos del 5% del compuesto o una sal farmacéuticamente aceptable del mismo en forma cristalina, como se observa en el análisis de difracción de rayos X.
ARP210101264A 2010-10-29 2021-05-10 Dispersiones sólidas extruidas por fusión que contienen un agente inductor de apoptosis AR122475A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US40852710P 2010-10-29 2010-10-29

Publications (1)

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AR122475A2 true AR122475A2 (es) 2022-09-14

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ID=44903438

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP110104026A AR083656A1 (es) 2010-10-29 2011-10-28 Dispersiones solidas extruidas por fusion que contienen un agente inductor de apoptosis, proceso para preparar, metodo de tratamiento
ARP210101264A AR122475A2 (es) 2010-10-29 2021-05-10 Dispersiones sólidas extruidas por fusión que contienen un agente inductor de apoptosis

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US (2) US20120108590A1 (es)
EP (3) EP3219308A1 (es)
JP (2) JP5902187B2 (es)
KR (2) KR101836820B1 (es)
CN (2) CN108175749B (es)
AR (2) AR083656A1 (es)
AU (1) AU2011361704B2 (es)
BR (1) BR112013010524A8 (es)
CA (1) CA2813985C (es)
CL (1) CL2013001120A1 (es)
CO (1) CO6781472A2 (es)
CR (2) CR20180289A (es)
CY (1) CY1119993T1 (es)
DK (1) DK2613769T3 (es)
DO (2) DOP2013000092A (es)
EC (2) ECSP13012647A (es)
ES (1) ES2647583T3 (es)
GT (1) GT201300102A (es)
HK (1) HK1243761A1 (es)
HR (1) HRP20171884T1 (es)
HU (1) HUE035169T2 (es)
IL (2) IL226215A (es)
LT (1) LT2613769T (es)
ME (1) ME02942B (es)
MX (2) MX362113B (es)
MY (1) MY189224A (es)
NO (1) NO2613769T3 (es)
NZ (1) NZ608907A (es)
PE (2) PE20171242A1 (es)
PH (1) PH12013500686A1 (es)
PL (1) PL2613769T3 (es)
PT (1) PT2613769T (es)
RS (1) RS56718B1 (es)
RU (2) RU2577859C2 (es)
SG (2) SG189477A1 (es)
SI (1) SI2613769T1 (es)
TW (2) TWI535699B (es)
UA (1) UA113500C2 (es)
UY (3) UY39192A (es)
WO (1) WO2012121758A1 (es)
ZA (2) ZA201302669B (es)

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IL251877A0 (en) 2017-06-29
BR112013010524A8 (pt) 2018-02-06
ES2647583T3 (es) 2017-12-22
WO2012121758A1 (en) 2012-09-13
MX2013004843A (es) 2013-10-01
PL2613769T3 (pl) 2018-04-30
CL2013001120A1 (es) 2013-10-04
CN103282025A (zh) 2013-09-04
DOP2017000003A (es) 2017-04-16
ME02942B (me) 2018-04-20
ZA201401440B (en) 2015-06-24
SG2014015077A (en) 2014-04-28
CN103282025B (zh) 2018-01-02
PE20171242A1 (es) 2017-08-24
EP3219308A1 (en) 2017-09-20
AU2011361704A1 (en) 2013-05-02
CN108175749A (zh) 2018-06-19
EP2613769B1 (en) 2017-09-27
MX362113B (es) 2019-01-07
NZ608907A (en) 2015-05-29

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