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AR083656A1 - Dispersiones solidas extruidas por fusion que contienen un agente inductor de apoptosis, proceso para preparar, metodo de tratamiento - Google Patents

Dispersiones solidas extruidas por fusion que contienen un agente inductor de apoptosis, proceso para preparar, metodo de tratamiento

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Publication number
AR083656A1
AR083656A1 ARP110104026A ARP110104026A AR083656A1 AR 083656 A1 AR083656 A1 AR 083656A1 AR P110104026 A ARP110104026 A AR P110104026A AR P110104026 A ARP110104026 A AR P110104026A AR 083656 A1 AR083656 A1 AR 083656A1
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AR
Argentina
Prior art keywords
independently
groups
halo
amino
heterocyclic ring
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Application number
ARP110104026A
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English (en)
Inventor
David J Lindley
Yeshwant D Sanzgiri
Ping Tong
Esther Birtalan
Peter Hoelig
Original Assignee
Abbott Lab
Abbott Gmbh & Co Kg
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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=AR083656(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Abbott Lab, Abbott Gmbh & Co Kg filed Critical Abbott Lab
Publication of AR083656A1 publication Critical patent/AR083656A1/es

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    • A—HUMAN NECESSITIES
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    • 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
    • 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
    • A61K31/535—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
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    • 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
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    • 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
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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    • 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
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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    • 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
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Abstract

Reivindicación 1: Una dispersión sólida caracterizada porque comprende, en forma esencialmente no cristalina, un compuesto de fórmula (1) donde: R0 es halo; R1 y R2 son H o son en forma independiente metilo o metoxi; R3 y R4 son en forma independiente metilo o metoxi si R1 y R2 son H, o son H si R1 y R2 son en forma independiente metilo o metoxi; A1 y A2 son en forma independiente entre sí CH o N; R5 es alquilo C1-4 o haloalquilo, alquilsulfonilo C1-4 o haloalquilsulfonilo, halo, nitro o ciano; X es -O- o -NH-; Y es -(CH2)n- donde n es 0, 1, 2 ó 3; y R6 es un anillo carbocíclico o heterocíclico de entre 3 y 7 miembros no sustituido o sustituido como se define en la presente, o es NR7R8 donde, si R6 es NR7R8, R7 y R8 son en forma independiente entre sí H o grupos R9-(CH2)m-, donde no más que uno de R7 y R8 es H, donde cada R9 es en forma independiente un anillo carbocíclico o heterocíclico de entre 3 y 7 miembros, opcionalmente sustituido con no más que dos grupos Z1 como se define más adelante, y cada m es en forma independiente 0 ó 1; y donde, si R6 es un anillo carbocíclico o heterocíclico sustituido, los sustituyentes sobre el mismo son no más que dos grupos Z1 y/o no más que un grupo Z2, donde los grupos Z1 se seleccionan en forma independiente entre (a) alquilo C1-4, alquenilo C2-4, alcoxi C1-4, alquiltio C1-4, alquilamino C1-4, alquilsulfonilo C1-4, alquilsulfonilamino C1-4, alquilcarbonilo C1-4, alquilcarbonilamino C1-4 y alquilcarboxi C1-4, cada uno opcionalmente sustituido con uno o más sustituyentes seleccionados en forma independiente entre halo, hidroxi, alcoxi C1-4, amino, alquilamino C1-4, di-(alquil C1-4)amino y ciano, grupos (b) halo, (e) hidroxi, (f) amino y (g) oxo, y Z2 es (i) otro anillo carbocíclico o heterocíclico de entre 3 y 6 miembros, opcionalmente sustituido con no más que dos grupos Z1 como se define precedentemente, o (ii) NR7R8 donde R7 y R8 son como se definen precedentemente; o una sal aceptable farmacéuticamente del mismo; dispersado en una matriz sólida que comprende (a) al menos un vehículo polimérico soluble en agua farmacéuticamente aceptable y (b) al menos un surfactante farmacéuticamente aceptable.Reivindicación 10: La dispersión sólida de la reivindicación 9, caracterizada porque el compuesto es 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. Reivindicación 15: La dispersión sólida de la reivindicación 14, caracterizada porque, en el compuesto de fórmula (1), dicho anillo saturado se selecciona entre el grupo que consiste en los anillos ciclopropilo, ciclobutilo, ciclopentilo, ciclohexilo, azetidinilo, oxetanilo, tietanilo, pirrolidinilo, imazolidinilo, pirazolidinilo, tetrahidrofuranilo, oxazolidinilo, isoxazolidinilo, tiophanilo, tiazolidinilo, isotiazolidinilo, piperidinilo, piperazinilo, tetrahidropiranilo, 1,4-dioxanilo, morfolinilo y tetrahidrotiopiranilo. Reivindicación 32: Un proceso para preparar una dispersión sólida, caracterizado porque comprende: (a) someter a temperatura elevada (i) un ingrediente farmacéuticamente activo (API) que comprende un compuesto de fórmula (1) donde: R0 es halo; R1 y R2 son H o son en forma independiente metilo o metoxi; R3 y R4 son en forma independiente metilo o metoxi si R1 y R2 son H, o son H si R1 y R2 son en forma independiente metilo o metoxi; A1 y A2 son en forma independiente entre sí CH o N; R5 es alquilo C1-4 o haloalquilo, alquilsulfonilo C1-4 o haloalquilsulfonilo, halo, nitro o ciano; X es -O- o -NH-; Y es -(CH2)n- donde n es 0, 1, 2 ó 3; y R6 es un anillo carbocíclico o heterocíclico de entre 3 y 7 miembros no sustituido o sustituido como se define en la presente, o es NR7R8 donde, si R6 es NR7R8, R7 y R8 son en forma independiente entre sí H o grupos R9-(CH2)m-, donde no más que uno de R7 y R8 es H, donde cada R9 es en forma independiente un anillo carbocíclico o heterocíclico de entre 3 y 7 miembros, opcionalmente sustituido con no más que dos grupos Z1 como se define más adelante, y cada m es en forma independiente 0 ó 1; y donde, si R6 es un anillo carbocíclico o heterocíclico sustituido, los sustituyentes sobre el mismo son no más que dos grupos Z1 y/o no más que un grupo Z2, donde los grupos Z1 se seleccionan en forma independiente entre (a) alquilo C1-4, alquenilo C2-4, alcoxi C1-4, alquiltio C1-4, alquilamino C1-4, alquilsulfonilo C1-4, alquilsulfonilamino C1-4, alquilcarbonilo C1-4, alquilcarbonilamino C1-4 y alquilcarboxi C1-4, cada uno opcionalmente sustituido con uno o más sustituyentes seleccionados en forma independiente entre halo, hidroxi, alcoxi C1-4, amino, alquilamino C1-4, di-(alquil C1-4)amino y ciano, grupos (b) halo, (e) hidroxi, (f) amino y (g) oxo, y Z2 es (i) otro anillo carbocíclico o heterocíclico de entre 3 y 6 miembros, opcionalmente sustituido con no más que dos grupos Z1 como se define precedentemente, o (ii) NR7R8 donde R7 y R8 son como se definen precedentemente; o una sal aceptable farmacéuticamente del mismo, (ii) un vehículo polimérico soluble en agua farmacéuticamente aceptable y (iii) un surfactante farmacéuticamente aceptable para dar una mezcla semisólida extruíble; (b) extruir la mezcla semi-sólida; y (c) enfriar el extrudato resultante para dar una matriz sólida que comprende el vehículo polimérico y el surfactante y que tiene el compuesto o sal del mismo dispersado en forma esencialmente no cristalina sobre el mismo. Reivindicación 42: El proceso de la reivindicación 41, caracterizado porque el API es 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.
ARP110104026A 2010-10-29 2011-10-28 Dispersiones solidas extruidas por fusion que contienen un agente inductor de apoptosis, proceso para preparar, metodo de tratamiento AR083656A1 (es)

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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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