DK2790699T3 - Farmaceutisk sammensætning med forbedret biotilgængelighed for hydrofob forbindelse med højt smeltepunkt - Google Patents

Farmaceutisk sammensætning med forbedret biotilgængelighed for hydrofob forbindelse med højt smeltepunkt Download PDF

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Publication number
DK2790699T3
DK2790699T3 DK12801538.5T DK12801538T DK2790699T3 DK 2790699 T3 DK2790699 T3 DK 2790699T3 DK 12801538 T DK12801538 T DK 12801538T DK 2790699 T3 DK2790699 T3 DK 2790699T3
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compound
composition
solid dispersion
polymer
copovidone
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DK12801538.5T
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English (en)
Inventor
Antonio A Albano
Dipen Desai
James Dinunzio
Zenaida Go
Raman Mahadevan Iyer
Harpreet K Sandhu
Navnit Hargovindas Shah
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Hoffmann La Roche
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    • 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
    • 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
    • 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
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/141—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
    • A61K9/143—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 inorganic 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
    • A61K9/141—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
    • 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
    • A61K9/2022—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (21)

1. Farmaceutisk sammensætning omfattende en faststof dispersion, der omfatter en polymer, som er polyvinylpyrrolidon (PVP) eller copovidon, en forbindelse ifølge formlen (I),
(I), eller en forbindelse ifølge formlen (II),
(II), og eventuelt et overfladeaktivt middel og/eller hydroxypropylmethylcellulose-acetatsuccinat.
2. Sammensætning ifølge krav 1, hvor forbindelsen er molekylært dispergeret i polymeren.
3. Sammensætning ifølge krav 1 eller 2, hvor faststof dispersionen er et faststof molekylært kompleks af forbindelsen og polymeren.
4. Sammensætning ifølge krav 3, hvor forbindelsen er immobiliseret i en matrix, der er dannet af polymeren.
5. Sammensætning ifølge et hvilket som helst af kravene 1 til 4, hvor polymeren er copovidon.
6. Sammensætning ifølge et hvilket som helst af kravene 1 til 5, hvor forbindelsen er til stede i en mængde på fra ca. 1 vægtprocent til ca. 50 vægtprocent af faststof dispersionen.
7. Sammensætning ifølge et hvilket som helst af kravene 1 til 6, hvor polymeren er til stede i en mængde på fra ca. 50 vægtprocent til ca. 98,8 vægtprocent af faststof dispersionen.
8. Sammensætning ifølge et hvilket som helst af kravene 1 til 7, hvor faststof dispersionen er fremstillet ved anvendelse af en hot melt-ekstruderingsproces.
9. Sammensætning ifølge et hvilket som helst af kravene 1 til 8, der endvidere omfatter et strømningsfremmende middel.
10. Sammensætning ifølge krav 9, hvor det strømningsfremmende middel er kolloid silikone.
11. Sammensætning ifølge krav 9 eller 10, hvor det strømningsfremmende middel er til stede i en mængde på op til ca. 5 vægtprocent af sammensætningen.
12. Sammensætning ifølge et hvilket som helst af kravene 1 til 11, hvor polymeren er copovidon og faststof dispersionen omfatter et overfladeaktivt middel.
13. Sammensætning ifølge krav 12, hvor det overfladeaktive middel er valgt fra gruppen bestående af natriumlaurylsulfat (SLS), glycerolmonostearat, dioctylnatriumsuccinat (DOSS) og blandinger deraf.
14. Sammensætning ifølge krav 12 eller 13, hvor det overfladeaktive middel er dioctylnatriumsuccinat.
15. Sammensætning ifølge et hvilket som helst af kravene 12 til 14, hvor det overfladeaktive middel er til stede i en mængde på op til ca. 10 vægtprocent af faststof dispersionen.
16. Sammensætning ifølge et hvilket som helst af kravene 1 til 15, hvor forbindelsen er en forbindelse med formlen (I).
17. Sammensætning ifølge et hvilket som helst af kravene 1 til 15, hvor forbindelsen er en forbindelse med formlen (II).
18. Sammensætning ifølge et hvilket som helst af kravene 1 til 11, hvor forbindelsen er en forbindelse med formlen (II), og polymeren er copovidon, og faststof dispersionen omfatter hydroxypropylmethylcellulose-acetatsuccinat.
19. Sammensætning ifølge krav 18, hvor copovidon og hydroxypropylmethylcellulose-acetatsuccinat er til stede i faststof dispersionen i et forhold på fra henholdsvis ca. 15:85 til ca. 40:60.
20. Sammensætning ifølge et hvilket som helst af kravene 1 til 19 til anvendelse som medikament.
21. Sammensætning ifølge et hvilket som helst af kravene 1 til 19 til anvendelse som medikament til behandling af cancer, navnlig melanom.
DK12801538.5T 2011-12-13 2012-12-10 Farmaceutisk sammensætning med forbedret biotilgængelighed for hydrofob forbindelse med højt smeltepunkt DK2790699T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161569863P 2011-12-13 2011-12-13
PCT/EP2012/074884 WO2013087546A1 (en) 2011-12-13 2012-12-10 Pharmaceutical composition with improved bioavailability for high melting hydrophobic compound

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DK2790699T3 true DK2790699T3 (da) 2017-06-19

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US (3) US20130172375A1 (da)
EP (1) EP2790699B2 (da)
JP (1) JP5936705B2 (da)
KR (1) KR101637793B1 (da)
CN (1) CN103998037B (da)
BR (1) BR112014010290B8 (da)
CA (1) CA2850706C (da)
DK (1) DK2790699T3 (da)
ES (1) ES2627531T5 (da)
HU (1) HUE034548T2 (da)
MX (1) MX348654B (da)
PL (1) PL2790699T5 (da)
RU (1) RU2014127142A (da)
SI (1) SI2790699T1 (da)
WO (1) WO2013087546A1 (da)

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PE20121327A1 (es) 2009-11-06 2012-10-18 Plexxikon Inc Compuestos y metodos para la modulacion de cinasas, e indicaciones para ello
PL2672967T3 (pl) 2011-02-07 2019-04-30 Plexxikon Inc Związki i sposoby modulacji kinaz i wskazania ku temu
TWI558702B (zh) 2011-02-21 2016-11-21 普雷辛肯公司 醫藥活性物質的固態形式
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EP2815749A1 (en) 2013-06-20 2014-12-24 IP Gesellschaft für Management mbH Solid form of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione having specified X-ray diffraction pattern
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CZ2015250A3 (cs) 2015-04-14 2016-10-26 Zentiva, K.S. Amorfní formy vemurafenibu
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SI3644970T1 (sl) * 2017-06-30 2022-05-31 Acrotech Biopharma Llc Nove oralne formulacije belinostata
TWI833710B (zh) * 2017-10-06 2024-03-01 香港商慧源香港創新有限公司 高單位含量口服型紫杉烷組合物及方法
JPWO2021006267A1 (da) * 2019-07-08 2021-01-14

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RU2014127142A (ru) 2016-02-10
BR112014010290B1 (pt) 2022-11-01
MX2014006693A (es) 2014-07-14
US20200330600A1 (en) 2020-10-22
US20180369388A1 (en) 2018-12-27
MX348654B (es) 2017-06-21
CA2850706A1 (en) 2013-06-20
HUE034548T2 (en) 2018-02-28
US20130172375A1 (en) 2013-07-04
PL2790699T5 (pl) 2020-06-29
KR20140096124A (ko) 2014-08-04
PL2790699T3 (pl) 2017-08-31
KR101637793B1 (ko) 2016-07-07
JP2015500306A (ja) 2015-01-05
JP5936705B2 (ja) 2016-06-22
EP2790699A1 (en) 2014-10-22
WO2013087546A1 (en) 2013-06-20
BR112014010290A2 (pt) 2017-05-02
CN103998037B (zh) 2018-02-16
BR112014010290B8 (pt) 2022-11-29
EP2790699B2 (en) 2020-01-01
CA2850706C (en) 2020-05-12
ES2627531T3 (es) 2017-07-28
SI2790699T1 (sl) 2017-06-30
ES2627531T5 (es) 2020-07-23
EP2790699B1 (en) 2017-04-05
CN103998037A (zh) 2014-08-20

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