HUE030158T2 - Glükopiranozil-csoporttal szubsztituált benzolszármazékot tartalmazó gyógyászati készítmény - Google Patents

Glükopiranozil-csoporttal szubsztituált benzolszármazékot tartalmazó gyógyászati készítmény Download PDF

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HUE030158T2
HUE030158T2 HUE08787264A HUE08787264A HUE030158T2 HU E030158 T2 HUE030158 T2 HU E030158T2 HU E08787264 A HUE08787264 A HU E08787264A HU E08787264 A HUE08787264 A HU E08787264A HU E030158 T2 HUE030158 T2 HU E030158T2
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pharmaceutical composition
dpp
inhibitor
glucose
glucopyranosyl
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HUE08787264A
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Klaus Dugi
Michael Mark
Leo Thomas
Frank Himmelsbach
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Boehringer Ingelheim Int
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    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
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    • 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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
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    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
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Claims (6)

  1. Glüköpiras*«#i!»i\«.oporttal szniwmnmlí heaz o tsz ár?ív^^ekot tartalmazó gyógyászati készítmény
    1, GyógyászaU készítmény, amely az Gkk'>r-4-(p-D-gItík.opifanoZ“l“íl}'"2~l4*({S)-4ítrahidrofuran-341~oxi t-henzi 1Mnmzd elitevfiásó, glükopiranozil-csoporftal szuhszti-\XVMé benzolszármazékot 1 -|{4-meUbktnazGll»||4i)-i»odUAi-mettt-?-<2-hutin- 1 -11)--8^3- (I^annmj-píperiiiínG-ítyxantm ehsgvezéső PfpvIV-mhtMtprml vagy aapil győgyár szatiiag elfogadható sójával együtt tartalmazza.
  2. 2. Az 1 . igénypont szerinti gyógyászati készítmény, azzal jellemezve, hogy alkalmas a glükoplnmozü-osopürttal szubsztitnált benzolszármazék és a DFF-IY-lpMfeltor kombinálj egytdajd vagy egymást követő alkalmazáséra, X Az elérő igénypontok egyike szerinti gyógyászati ké.vzüméoY, azzal jellemezve* bogy a glUkopiranozif-csoporttól sztfoaztifollt benzélsAínazék és a OFF-I¥-inMligtf egyetlen dózisainkban van lelete
  3. 4. Az előző Igénypontok egyike szerinti gyógyászati készítmény, azzal jellemezve, hogy a gfokopirattoxil-esoporttal szttbsztua|t|é^^ólP.^FI^l .<$1 I IMP^I^^IiFÍFt:tpr: külőn-kíüün dózisainkban van jelen,
  4. 5, Az előző igénypontok egyike szerinti gyógyászati készítmény, azzal jellemezve, bogs 5 ¥ m„ méta 'isegts. glukopttanorP-v vg > í ti < t\ fom ol- , tM\'*ot őartalmaz* ó, Az 5, Igénypont szerinti gyógyászati készítmény* amely $ mg, lü mg, lő mg, 211 mg, 2$ mg vagy 50 mg mennyiségé, glükoptranozii-csoporttal szubszdtuáli benzol-azat mázokot uatafo-az % Az előző igén} pontok egyike szerinti gyógyászati készítmény, amely 0,S-1Ö mg mennyiségű DPP-IV ·inhibitort tartalmaz. S. A ?. igénypont szerinti gyógyászati 2,5 mg vagy 5 mg mennyiségű DPlMVbnbibUort tartalmaz, H M U 2., 3. vagy 4. igéa>*l· szerinti lyolpáiiaikiszimtény, amely 5-50 mg mennyiségik gItlkopua»ozíl-CM|Kí#al sm^É^iksált és 0,5-iö mg :Í3FI^I¥4|jl)|bi(ort tartalmaz.
  5. 10. Az előző iaérnpuTüok bármelyike szerinti gyógyászati készítmény, azzal jel-lemezve, hogy a gyógyászati készítmény óráim adagoláshoz alkalmas szilárd alakban von formuláivá, Π. Az 1 -1Ö. igénypontok: egyike sprfnti gyógyászati készítmény a következőkre jförténő alkalmazásra. * 3 kővetkezőkből álló csoportból kiválasztott anyagesere-rerdelienesség megélő-mse, kodem tőse ke <. 0-, - elmdvf adá\mvd ,^se i\5 Aon t'pirm oakorhetegseg, 2-es típusú cukorbetegség, csökkent ghlkőzmleranda, emel keddit éhomi véretikőrszlní, hipergtikémia, étkezés után* hlpergiikémla. túlsúly* dliizás #· mátitmlllöi' MlMlfÉípá; vagy - vércukorszím-szabályozás javítása és/vagy az éhomi plena^gltlké^zinteaz étkezős utam plaznm deké/sznaéa sags a üb\le glikoztlált hetnogiobin agatticnck esők-kerítése, vagy - csökkent glükóztól «randa, érnelkédett éhem! vli^ ésA agy anyagcsere-szindrőmá állapotából 2-es típusú cukorbetegség állapotába történő előrehaladás megelőzése, láátl%P késleltetése vagy visszaÉrrtlItásayyngy - a eokorhetegseg komplikációiból túgymuü a szörkeMlyog, a mikro- és; makro-vaszkuláris betegségek, mint például a nephropathia, retínopaihía, «európaiból, szövet-iseh-K?ttia. arteriosclerosis, szivizosniniarktus, stroke és perifériás arteries elzáródásom beiegség) álléíésoportbói :kAI!:ásziöttsál|á|mt;: vágy readfölleneasé|rtúegelőzése, kéaldté-tése, kezelése vagy előrehaladásának lassítása; vagy - iesisúiyesökkentés vagy testsúlynövekidés megelőzése vagy testsűiyesökkentés elősegítése; vagy - a hasnyálmirigy béta-sejtjei degenerációjának és/vagy a hasnyálmirigy béta-sejtjei működőképessége csökkenésének megdoeése. lassítása, késleltetése vagy kezdése és/vagy iá: basnyálmMgy feétaAéjitjei mfk^||pp|ÍPtiek javllüa és/vagy hearts állítass és vagy a «..sniatmingy maköA'keres nizuiin-szckiccmjának helyreállítását; vágy - a máj zsír rendellenes telhaimoződásával összefüggő betegségek vagy állapotok méplözéséziasiiítása, késidteiÉsö vagy kezdése; vágy ·.*· az :fa£ül inérzékenység fenntartása és/vagy javítása es/vagy f hlgerisstliiéföiá Cs \.no> mzulntrezisztetavt sa oVwtagy megelőzése', egy, a fenti beavatkozási ok lm rásKorutó pádeosben, 12, A 11, igértypont szerinti gyógyászait készítmény vércukorá^jny-mibályosás jr^ Vitására történő a *<ιΙ*"*ία>«',e- upuvn cxáorknegsőgK-u' vm * do lucartrtekfem. \' A 1 1, vagy 12, igény posst szermű gyógyászati kdvnntény az igényelt alkat* utazásra, azzal jellemezve, hogy a glükopiranozH-csopomai saubsztintált benzolszármazékot a DPP-IY-inhibitorral kombinálva vagy azzal feh állva adagoljuk, li. A ll,, O '<i«' Π geovoztíiXi ϊ ipog'tst-au kee/itjve*'N igenyelt oJka. mazásra, ahol a páciens a kivetkező csoportból kiválasztott egy xagy több állapottal diagnosztizált egyén: túlsúly, elhízás, zsigeri tipusü. elhízMMhasi tipusó elhízás. tő \ U.< 12 sags 13 tgen>pont s/enoíi gyogv^som készítmény ,v m\tneh alLA mazásra, ahol a páciens olyan szentély, akire a kivetkező állapotok közül egy, kettő vagy több jellemző: |a) 110 mg/dl-nd nagplbbgklzáíebbrik 121 mg/di-nÉI: n^ólií#ömi'vi^|j^fe vagy szérum gíükóz-koneentráció; {b) H0 rng/dí vagy nagyobb étkezés utéMplazma glOkóz-koncenirácíő; (c) 6,5 % vagy nagyobb, közelebbről, 8,0 % vagy nagyobb HbA lekérték, lü, Λ U,> 12 vagy 13 igénypont szerinti gyógyászati. készmnéns uz igényelt aikab raazásra, ahol a páciens olyan személy, akire a következő állapotok- közül egy, kettő vagy több jellemző: (a? elhízás, zsigeri típusú elhízás és/vagv hasi típusú elhízás, (b) 150 mg/dl vagy nagyobb vér trigíkerid-szmt, (e) nőknél 40 mg/dl-né! kisebb, férfiaknál 50 mgúll-nél kisebb vér HDL-koleszzerinszim, (d) 130 Hgrnm vagy nagyobb szbztolés vérnyomás 85 Hgmm vagy nagyobb diasz*. Oils vérnyomás, (e) 1 lOmg-'dl vagy nagyobbéhoroi vérglükózsaánt. I?. A 11,, 12. vagy lő. igénypont szerinti gyógyászati készítmény az igenyelt alkalmazásra, ahol a páciens olyan személy, akinél a otetformimtal vegzou monorerápia el- Itn|aval3í ésAPgy aÉ! a u apu*\ 4o w^u' *<e»fny»c«&amp;é>· »r *tat> IS, A 11., 12. vagy 13, Igénypont szermii gyógyászati készítmény az igényelt alkal* mazásra, ahol a páciens olyan személy, akiben a vércukotsztat-szafeályozás egy SGLT2-mhiixUomé. közckbbröL az 1. igénypont szerinti, gíükopiraaoztl<soporual szubszíitnált benzolszármazékkal végzett muatnerápta ellenére elégtelen.
  6. 19. A Π,, 12, \ap> 13. igénypont szeműt gségsavout Keá/itmém a - tgemeíi elkel' mazasra. ahol a páciens olyan személy, akiben a véreuk>.írsz!nkszabályoáns égy OltSr I V-inbibitorrak közelebbről, az 1. igénypont szerinti Dl^-IY-ínhibitorral végzett mono-terápia ellenére elégtelen.
HUE08787264A 2007-08-16 2008-08-15 Glükopiranozil-csoporttal szubsztituált benzolszármazékot tartalmazó gyógyászati készítmény HUE030158T2 (hu)

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