HUE028832T2 - Hialuronidáz és immunglobulin stabil ko-formulációja, valamint ennek elõállítási eljárása - Google Patents

Hialuronidáz és immunglobulin stabil ko-formulációja, valamint ennek elõállítási eljárása Download PDF

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HUE028832T2
HUE028832T2 HUE10760140A HUE10760140A HUE028832T2 HU E028832 T2 HUE028832 T2 HU E028832T2 HU E10760140 A HUE10760140 A HU E10760140A HU E10760140 A HUE10760140 A HU E10760140A HU E028832 T2 HUE028832 T2 HU E028832T2
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stable
hyaluronidase
administration
protein
formulations
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HUE10760140A
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Wolfgang Teschner
Sonja Svatos
Leopold Bruckschwaiger
Alfred Weber
Hans-Peter Schwarz
Laura Lei
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Baxalta Inc
Baxalta GmbH
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Claims (17)

  1. és iÄstogloWt«: stabil k>foÂÉâ©li^, ennék eloillbhi eljárás# SZABADALMI eÉMYPöUTÖK 1 * Sznbkotin beadáshoz Mrntóázott stabil készteély, äföÄ'te:. á stabil klsdbneny egy tóyeknny kn-fertmiiaeio; âèiWiSÂf $ü*-jia;4 és S Mzőtt 'van* iôkiazlve; es n készibnéby· s kővetkező komponenseket tarmbnnzza: lltïtpyjîlbfeilm (ICL leplább 10 v% koneenitáslöban; «P pl#at0 iialmwObz leplâbb 50 L/rnl koncentrációban, és olyan mennyiségben van jelen, amely lebélÔyé teszi a lépltmény szalÉÂ beadását egyetlen injefceiős pontban, p lmnlagglelmlib lÄawms: mf&ziás sebességével azonos,. vagy nagyobb infaziôs sebességgel; es çgy altMilmÄay só legalább 0,05 M koneentóeiőban, ahol & IptótóÉlDÓ egészen 32 e€~Ig tóbl, legalább 0 hónapig,
  2. 2. Stabil imszlímény szubkután beídásboabsmműésva,, átok a stabil készllntóy egy folyékony ko-ibmmMció; a kétólPÉty jÄja 4 és 5 közOtt van, Inklnzíve; m akétóitplny a kővetkező koni|Kpeoseket íanalmazza: Ií»mtgIobgfe legalább 10 vbl^lmKtettóei^a»; oav oÄato bíöiuroniááz leaálbb 50 B/rol konc^nttielőlm, és legalább 100 fE/gj fß aránkban van jelen, és egy glkilüm-klodd só tegaIát>&%0SM konoimttÉáSta«, ahol a ko^nsmuláeié egészen 32 AMgtóbiL legalább # hónapig,
  3. 3. -M í, vagy 2, Igénypont, szerinti stabil íolyékony koAnttóííÉnó, amely tartalmaz meg égy aminosav stábülzálószert Is, legalább 0,1 M ntgMyisIgbeit, ahol m aroloosav stabilizálószert előnyösen a kővetkező esopoAből válasziratok Id: altón, hlstótáp arginin, Iízm, ónéin, itóenem, valin, mebntna, gllein és prolin, még előnyösebben az aminneav stabilizálószer glieio vagy proin,
  4. 4. Az 1 -3 igénypontok bármelyike szertni stabil, Myékony kodbrraidádó, ahol az ató~ nosav stabilizlloszer mennyisége legalább 0,1 M, 0,10 M, 0,2 M, 0,25 M,.0,3 M, 0,35 M, %#M* 0,45 M, 0,5 M, 0,6 M, 0,7 M vagy 0,75 M, az aminosav slabillzálészer mennyisép előnyösebben 0,25 M.
  5. 5, Az I “4. igfeygeeíok bánnetyike szerinti stabil Mvékony ko-formuláció, .ahol az IG 10 v%v II v%, $2 v%s: 13 v%,: 14 v%, 15 v%, 16 v%, 17 IS v%,19 vSé* ;20 v%, 21. v%, 22 v% vagy több* m ICI előnyöset* It 4% és: 20 'v% között va«,
  6. 6, Az 1-1. igé«>post«É: bárBtelyiie sajtói stabil felyéköay fcö-Mmndáeié, ahol m lö h^^:pímm£két származik, előnyösen ahol m 10-t a tanán plazmáié! egy alkoholos fmkeioBÉást tastnlniazó tisztítási: eljárással tisztitek, el&tylsebben ahol az KH m ollbM mMszetek közül bà&mt lylkkhitis^ttjok tombbr pollstiléagllíölos (FEG1 kiesapás, lenesem!# tomialppliia, enzimes hasítás, diaszÉrés vagy nteaszirés. 7λ· As 1 g$, igénypontok bfenefyfe sasetta staMk üly#miy Im-ümaslieü, ahol az IPA egy vMtsesöldmníé lépésttek vetjük alá, amelyet a kêv&ifcmfâk közöl vitaszfediÄ Mr ialebálás pllNi-,0 étűken fmpzánnei vagy anélkül, ol#sasr ôetergens kezelés es aaptszüta. I, Âz h% igénypontok bármelyike szénné stabil, Eüyéfeoay ko-ünnniacló, ahol m IG tartalmaz !gG-t, IgA-t és IgM-ei ahol az. ICI elényösea több inlet 0599 IgG-t tartalmaz. & Az I -8. igénypontok hániolylko szeműi stabil, Mlyűknny kö-üzmüáeiö, ahol m alká- {ífém-kloöd lehet KO vagy NaClI, ahol m alkÄÄ-hüfkl so GörfÖsen Ä| is azKaCI psflsi* ge 0.025 Ki 0,03 Μ, 0,04 Μ 0,05 Μ, 0,00 Μ, 0,09 Μ, 0,1 Μ, 0J 5 Μ, 0,2 Κ4, vagy 13,25 Μ, az NaCI mennyisége előnyösebben 0,15 Μ, ΙΟ. Μ 1-0. igénypûiok Mrmstylke szériát stabil, ülyiknny knÄmMlelö, jW az old-ható liialuroTíkláz a EH2Û, vagy annak csonkított foratáfa, ahol a EH2Û előnyösen Miét jak, szarvas-ntarlm, mj$ ptti htmtáa 1¾¾ a 10120 még efönyösebien egy estaOtoít fennan KÉ20, ás a s^oráltoít tanán fIÍ2Ö-aí azok Mzti a ftapepidek közöl válnszt|nk ki, amelyeknek az amioosáv szekvenciáéiba 4-M Máma szakvetóa^vááato mntatful be». Illetve ezek alléi- vagy egyéb variánsai közül. II. Az 140. Igénypontéi bármelyik®: szerinti stabil, íolyékooy ko-i««nÍáeM, ahol az oldható hl doromdáz jelölése rHnPH20,
  7. 12. Az 141, igénypontok bárrMÉyile áMdöh stóbíl, folyékony ko~lbr«BÍ&amp;íó, abof m <4dhaíé tbalorooMÄ koneemzÉeiága 50 E/räi, 100 IAbI, 200 B/mí 300 IííbL 400 Honi S0Ö 1/ mi vagy tSi, ahol M oldható blahrronídáz kooeewfcÍó|a eiényösen 250 IHni és 350 lAnl kizöít vao.
  8. 13. Az 142, igénypontok bámaelyike szeAnti síakii Wy'êmàf kb-âlffîiülâëldj almi az olÉhain iMoronidiz aranya 100 B/g 10,150 E/g lö, 200 1% IS, 250 ©g KI, 300 izg Kj, 400 E/g KI, 500 E/g IG, 600 E/g Ki 700 E/g KI, 800 E/g IG, 900 E/g Ki 1000 E/g IG, 1200 E/g Ki, 1500 E/g Ki IÍ00 E/g KI, 2000 E/g IG, 3000 E/g Ki 4000 E/g !G vagy 5000 E/g IG, az aldteé Malitaanim; atánya ielinydsen 250 E/g IG, 100 E/g IG, 1000 li/g IG,: laÖO Is/g IG vagy a000 L«g IG. ! 4. Az 14,1, Igénypontok; bánneMfce szerinti stabil, ánmlynék a pH^skoseetilrált formában 4,4 és 4$ közölt van,
  9. 15, Az l-:M< igényponfok bármelyike szerinti stabil folyékony ko-íbníredáelé, ahol a ko-fomtulieto többszörös dózis beadására, vagy egyszeres dózis beadásán* aikatrmiisn
  10. 16, Az 1 -1 $. igéiryimnfok bármelyike szerion, stabil folyékony lo-formoMÄ ahol m. Î# egySKeres dózis beadására alkalmas nmtmyiségben. vm jelen, egy Ilivel leülttel! 'betegség vagy állgpot kezelésére, ahol m 10 mennyisége előnyösen alkalmas napi* lfoti,: kéfoetl,: 2-3 hetenkénti 3-4 heienkéni vagy havi egyszeres beadásra, egy IG-vel kezelhető betegség:vágy lllapöt kezelésére,
  11. 17, Az; Ι-Ί6, igénypontok bánpelyike szériái stabil, folyékony ko-fortnoláeló, ahol m Í3 foémryisége a Imfomadációban lényegében Ugyanaz, tórát az egyszeres dözia beadására alkjÉmas mennyiség, fea mtrayénásan aájnk be egÿ IG-vél kezeibe# belsőség vagy állapot kezelésére.
  12. 18, Az 1 -17, igénypontok: bámMyíké szerinti tÉÉsil folyékony fe-fozmMÍádá, ahol a ko-fómadáélő egyetlen dózis beadására: alkálmas, és az JG mennyisége legalább 1 gramm (gh 2 g, 3 g, 4 g, 5 g, lÖ:g,20:g, 30 g, 40 g, Si gi Ő0 g, 70 gv 80 g, 00 g, 100 g vagy 200 g vagy 1-20(¾ Í-I0O g, 10400 g, $-50 g, ő-50 g vagy 5-100 g. ! 9, Az l-lt, igénypódfok Mmmlyike szedni stabil, folyékony ko-formnlMá.; ahol a ko- foroiuláelő egyetlen dózis beadására alkáímas, és a fnalmnnliiz mennyisége legalább 500 igpég, 1000 Bgység, 2000 Egység* 3000 Egység, 10,000 Egység*· 30,0# I^slg*· 40*#Ö Egység, 50,000 Egység* 60*000 Egység* 701100 Egység, 80,000 Egység, 9Í|000: Egység, 10O*ffi0 Egység vagy több,
  13. 20, Az t4f, tgéoypnlol bármelyike szerinti, stabi, folyékony kö-formoIMó, amely 28 °€om 6 hónapig, 7 hónapig, B hónapig* 0 bőnapig, 10 hónapig* 11 hónapig, 12 hónapig, vagy tovább stabil
  14. 21, Az 1-20, igénypontok bármelyike szerinti stabil folyékony ko^fommláéló:, amely emellett 0-10 'ö(3 közöd 6 hónapig,: í évig, 2 évig, vagy tovább stabil
  15. 22, Készlet, amely az 1-2L Igénypontok Mrmetyike szerinti stabil folyékony ho-fonnaláelöi lwtalm:azza, valamint adott esetben tartalmaz használati ntasltást is,
  16. 23, Tartéedány,: amely az 1-21. igénypontok bármelyike szerinti stabil, folyékony ko-íbrmuláelőt tartalmazza,: ahol. a t&amp;rtóedény előnyösen egy esd, egy palack, egy f óla vagy egy fées* kendő. 24, A. 23. igénypont szerinti tarfoeéfoy, amely tarfolpazmég egy itplolóslit: Is, 25, A 23. vagy 24, igénypont szerinti tartóedéni* amelyben a stabil* folyékony ko* ibmmláeioí egyszeri dózis beadására vagy több dózis beadására biztosiunk,
  17. 26, Egy készlet, amely a 23-25, igénypontok bármelyike szerkói tariőedényt tartalmazza, valamint tanaimat egy eszközt a Mszitmény iníímdáiátására. 2?.. Az1 -21.. Igépypootbk báemely&amp;e sæéÂi stabil, Iblyékesy ke-lemmládó alkalmazásé egy lîl-Veî kezelhető betegség; vagy állapot kezelésébe alkalmas gyógyszer kis^elésête, aboi ml®-vei kezelhető betegséget vagy âli^)otôt a Mve&amp;ez§ esepottbél választóink: kî: pâmer immimdelet» enela betegségek, szekunder imMndeíMetóa betegségek, gyulladásos betegségek, autöbona® betegségek és akut íerídzések. 2§. Az 1-2L igénypoatek bármelyike szét» iü, Myékoiay .kortomtílM# Zkabnazisa egy W*ml kezelhető betegség vagy állapot kepéére, ahol m Ká-vel kezelbeib beteggel vagy állá» point a következe esoportbOi Mlaszthaiok II: primer Imrnuadeieleneia betegségek, mäsmä&amp;t :MtótpMéíeasím.feélÉ^gdk,: gyulladásos betegségek, auioimtmim betegségek és álét fertőzéséit
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