HUE026654T2 - Új gyógyszerészeti készítmény, amely tartalmaz 4-(4-(3-(4-klór-3-trifluormetil-fenil)-ureido)-3-fluor-fenoxi)-piridin-2-karbonsavat, hiperproliferatív rendellenességek kezelésére - Google Patents

Új gyógyszerészeti készítmény, amely tartalmaz 4-(4-(3-(4-klór-3-trifluormetil-fenil)-ureido)-3-fluor-fenoxi)-piridin-2-karbonsavat, hiperproliferatív rendellenességek kezelésére Download PDF

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HUE026654T2
HUE026654T2 HUE05792486A HUE05792486A HUE026654T2 HU E026654 T2 HUE026654 T2 HU E026654T2 HU E05792486 A HUE05792486 A HU E05792486A HU E05792486 A HUE05792486 A HU E05792486A HU E026654 T2 HUE026654 T2 HU E026654T2
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szilárd
rix
matrix
compound
cancer
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Jacques Dumas
Paul Ehrlich
Susanne Zuleger
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Bayer Healthcare Llc
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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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • 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
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    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
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    • 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
    • A61K9/146—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
    • A61K9/14—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
    • 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
    • A61K9/1617—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
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia

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  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Pyridine Compounds (AREA)
  • Emulsifying, Dispersing, Foam-Producing Or Wetting Agents (AREA)

Claims (9)

  1. ÙJ gyôgpÿe^s késxtîpêpys ÄslsnSä 4"(4-(3-(4~k?6Tvi'Pifliiöm5.et:0-feftil)--iu«klö>3~üiäür~fß»oxl)'' ïpîMispsssli Is^lésérfi Szabadakat igéoyp ontok
    1. Készítmény, amely legalább 4-|4.{3~(44#rks4ïiiStPnnéd}'-iioii|-ps^^ ksripssavHped! -apidok alapvetően sppffônAsn és gyégysxsréssstiSeg elfogadható mátrixot tartalmazd szilárd diszpetziói tartalmaz.
  2. 2. Âz 1. tgàsypiîxi síserlsű ké^faôty» alot a mátrix tartalmaz akStrsikezók alkotta psoptatböl vtlaszioh: 0ó|p3sírásp4ilsg slfeipdhatp fgÉImsft: polivkoi-pínüiidoö, v¾í^piπ'ôlkbîï/viïl:ö-~âee!:à; kopoilmor, pölmlkiÄrglkok poMmiiémgikcd, hiàpxsAiâ-'ÇSËuldÂ, kîte4%mpllp^l4tej ^dp^îgîliîlPsetil-cgHalé^ Mài®^p^îli«i«tü^ïulô^· Wtó«*9É1"ie&«J% ï)àîria«Î-katb(«iisîgilp^îplà^ eilmsipMx, pcdimemkrilätok, pídivinllPl&ohok poiimpilmcst% vi»ü--alköho{/yIai!4p^ip|p8*^:i.p!^a:oiMli gltptsídek, kmstiogami, karmgés, kitöÄ, Ä. imlldsxtnm
  3. 3. Az l. Igénypont szeriftti készítmény, ató § mátrix tartalmas a következők alkotta csoportból választott cukrot ds/vagy «akör^alköholt; Is^agy dklodoxtriat: szacharóz, laktős, ir&któs, oaaltós, raffrnő& $)ZsMi lakdk maaskj ípakit, «rktit, á^:^J^8ÍŐ%: Irmait, kodsn, msltodextrim ßmiklodesdn«, Mdroxipropib pmlklödfixirfe és spdiyfeaíÜ-dPp-ciklodsxkfák 4,. M'$. igésypôapSKSïârtikèsÂiteényj aixd alköíp esojprtbdl választott gyŐgysxerésZfitlleg Mdroxlproplbeellalőz, hiÉxpípdpil-patífe cellulóz és ppiifidlémglllml. 5. & 2. igénypont szerinti kásxilméríyy ahol a mátrix tarmimaz pöilkipiipktplldpa. 6. A 2. igénypont szerinti készítmény, ahol & mánix tartsM&ä kidroxipropgmellpi&t
  4. 7. Készítmény, amely legalább 4* {4-f3<4*kl<^-3ddff«ometü'feajl}-mei<k|^fiat|!|N*ö5d}«phi<üft-2«> karböss&amp;ymr«di--smkiöi, szolvétjaít, htdrátj&amp;ft, gyégyszerészetUeg elfogadható sait vagy fikék kombinációit és gyógyszarésaetílfig fii fogadhat 6 mátrixot tartalmazó szilárd diszpesziót tartalmaz, ahol mátrix tartalmaz a következők alkotta csoportból választott iyógy$mrt:saesileg elfogadható polimert: polivimi-pirrohdon. virul-pitTolidon/vitsíl-acstái ; kopölím*m, pol laikiiért-gMköl, peliKrilén-gítköl, hidt οχ lalkü-celhílóz, h Idtoxiptopil -csikóik, hldroxialklhmedlmallukk, hidrPxipreíiS>«r«^Ní«^«tó2. karboxImedkxîilriièSjpâtrmot-karboximedk esilalSa,: etioadkbk, poiimeî&amp;krilâtok, psrtMtiitPikoiiol, j^lMail-acetâî, vsrsl KsíksöíissIíVíxtil^c.éSÉtfkoyí«! mxöí', poHpikokáált glseoridfik, x&amp;taákpnm kanagén, khozám kitin, poiklsatrm, dmirist, fesïdésytêJs Éshérjék, S. KészSknény, stooly legalább 4..{4d3'{4^i^-3“bifl«otmetjl-fenil}'ts«i||dip|^flüi3iÎèKôâ8}-piri<^»>t.“ karhöpsay-tootikaispldpt, moiväi|ibt> hídrátjak, gyógysserészetileg elfogadható sóit Vágy ezek kombinációit és gyógysafirészstllfig élfdgpdható isitrixoi tartalmazó szilái diszperztől tartalmaz, sliól piátrix taitsiksaz a kövfidípzők alköim esopodhdl vsilasaíea etskrot és/vagy- s.pskoi'-slkokoh es/vagy ükiddaxtdst; má&amp;imréz^ Jákt&amp;z, feiktsá,mákóz, raüaóz, mmaiéz, morttáK,malin, mallpésxirto,. |ri 9. A 7. igénypont szedni készítmény, ahol a mátrix mémî «gy, s következők alkotta mapori bói választott gyógyszerészéitől; éliogadható polimert; polMml-pimtHdon, hsdroxiproptl OeUulóz, Indroxípmpik mstil-eeíMőz és poíietüén-giikol. Ili 7. igé«yporsl::à^ôCMs^!œéftÿvstel:àÂt»iirta]maxpoUvk«ipin®|dçpt Ily A 7. Igénypont szbfei készítmény »hol &amp; mátrix tartalmaz hiánjxi'propll-célkdóxí.
  5. 12. Az előző Igéttypentok bármelyike szerinti fcéariönésvy, mi mába alkalmazásra szánt gyógyszerészeti készítmény.
  6. 13. Az előzd igénypontok bármelyike .szerimi készítmény,, mai tabletta formájában lévő gyógyszerészeti készítmény.
  7. 14. Az előző igénypontok bármelyike szerinti készítmény, ami kapszula formájában lévő gyégys.íetészt'ííkészitméfíy.
  8. 15. Az mézé igénypontók bánselyik« s;æ£&amp;ÉbÉ®Éi|y, and por vágy grannléintn forifopban lévő jfyőgyszerészeír készítmény. 16 Eiísrő. %>{4 p^44riór«3-tnü»otmetörfemi ‘ meitfevI^flaÂ^xîl-piridîô^ÎÈÂ^â^ÈBlÉ’^ÉÉà: szilárd diszperziójának előállítására alapvétőét) amorf formában, amely tartalmaz egy, a következők alkotta csoportból választott módszert: foziós/őntiedék . technológia, meleg őmledék (kot melt) eximáálás, oldószer feepártas, fagyasztva szárítás, porlasztva szárítás, porok vagy granblátömak rétegzése, együttes lecsapás, sznperkrítlkys folyadék technológia és elektrosztatikus azál.képzés, 17. A» 145. igénypontok bármelyike szerinti gj^|ysz®Rfes^:tóxiteény tópétpri^átotiv rendellenességek kezelésében történő alkalmazásra emlősöknél, ideértve az embert, vagy egyetlen azsíMgt vagy más terápiákkal kombinálva,
  9. 18.. Ág 1* í 5. igénypontok bármelyike szerinri gyógyszerészei készítmény tik kezelésébe! príáttő lá^ma^m'iióiNóteélriái^ye az embert, vagy egyeben szerként vagy más terápiákkal komlpáívst. 19. áiilS. igénylőtök bármelyike szermi gyógyszerészei készítmény rák kezelésében törtéai IMmazásrs karip bstegyfo kombinálva egy eietpgikssg tenáptával.
HUE05792486A 2004-08-27 2005-08-29 Új gyógyszerészeti készítmény, amely tartalmaz 4-(4-(3-(4-klór-3-trifluormetil-fenil)-ureido)-3-fluor-fenoxi)-piridin-2-karbonsavat, hiperproliferatív rendellenességek kezelésére HUE026654T2 (hu)

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HUE05792486A HUE026654T2 (hu) 2004-08-27 2005-08-29 Új gyógyszerészeti készítmény, amely tartalmaz 4-(4-(3-(4-klór-3-trifluormetil-fenil)-ureido)-3-fluor-fenoxi)-piridin-2-karbonsavat, hiperproliferatív rendellenességek kezelésére
HUS1700047C HUS1700047I1 (hu) 2004-08-27 2017-11-21 Új gyógyszerészeti készítmény, amely tartalmaz 4-(4-(3-(4-klór-3-trifluormetil-fenil)-ureido)-3-fluor-fenoxi)-piridin-2-karbonsavat, hiperproliferatív rendellenességek kezelésére

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HUS1700047C HUS1700047I1 (hu) 2004-08-27 2017-11-21 Új gyógyszerészeti készítmény, amely tartalmaz 4-(4-(3-(4-klór-3-trifluormetil-fenil)-ureido)-3-fluor-fenoxi)-piridin-2-karbonsavat, hiperproliferatív rendellenességek kezelésére

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EP (2) EP1793824B1 (hu)
JP (1) JP5017115B2 (hu)
KR (1) KR101336737B1 (hu)
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AR (1) AR050616A1 (hu)
AU (1) AU2005279996A1 (hu)
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HR (1) HRP20160156T1 (hu)
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