HUE029532T2 - Hatóanyagok légúti beadása - Google Patents
Hatóanyagok légúti beadása Download PDFInfo
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- HUE029532T2 HUE029532T2 HUE10727553A HUE10727553A HUE029532T2 HU E029532 T2 HUE029532 T2 HU E029532T2 HU E10727553 A HUE10727553 A HU E10727553A HU E10727553 A HUE10727553 A HU E10727553A HU E029532 T2 HUE029532 T2 HU E029532T2
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Claims (11)
- Sisfeaőslmi igét'ypentok !. Adagoló InhaiálókésziUékbőf beadható gyógyszerkészítmény, s.m«Jy fertl&maz egy szaszpenziős közegei, amely tartalmaz egy gydgysasarêaasîlfeg^llôpdhatô bajtógázt; ihaióanyag részecskék kél vagy több eltérő fajtáját, ahol a tananyag részecskék két vagy több éltófö iél· iájának: iiaísáegylke eltérő hatóanyagot tartalmaz. ahoi a hatóanyag részecskék első fajtája giikopirrolát és ennek btefüyaa gy%ys;;sfésîæîileg elfogadható sói, észterei, enantktmerei, ermttiomawnek keverékei vagy szol vígj ai .közöl kiválasztod; hatóanyagot tartal maz, a hatóanyag részecskék egy másodtk £$$}* formet«*»! és enaefe bázmbyim gyögyszeiészetjlég .elfogadható sói, -észtere*, enam loméra, enanboresreisek keverékei vagy szolvátjaj közűi klvsiäszäöl* hatóanyagot ü;r-ialmsz-és :feeMegi^etö- mmzpépdáiő téweesÂ-«gy %'agyiöhb-fajtáját,, ebei a batbasyag fészèôsbefe két vagy több eltérő fajtája és a szuszpendáló részecskék egy vagy több fajtája a szoszpeaziós közegben egyölt eUmlyezkeáve ko-szuszpenziól alkotni ahol a SKöszgasdáié részecskék legalább egy hsjiSja perforál!: mikroszkópok# tartalmaz, amely perié·· rák mikrosz-erkezesek DSKRi (Ifk-alisatesttbstt-glicero'-c -feszfofcoUoij # kateiosn-kioridôi tártslmásmák. 2. À* h ïgéîîypôat. szedőit gyógysmíMszlfmésty, amely hatóanyag részecskék legalább héron-, eltétô f&j-tájál tartalmazza, ahoi a hatóanyag. témmékék legalább három fajtának mindegyike eltérő hatóanyagot tanai·· tesz, és a hatóanyag részecskék egy harmadik fajtája tartalmaz egy hatóanyagot beklomctazon, budeszothd. eikieköttidi fluhtlplld* ílniikazzm. medl-predöizoioru mometazon, predtstzosv és amakinoion, valamin! ezek bárpmlvjkénók gyögyszerészetiieg elfogadható sók észterei vagy szohastlaí közöl kivaisztya. 5, A 2. igénypont szerinti gybgyszörkésztmény, ahol áhatóanyag részecskék harmadik fajtája tartalmai egy hatóanyagot íhaikazon és budeszonld közöl kiválasztva.
- 4. Az előző Igénypontok bármelyike szerinti gyêgywr&észimïdnys.8hol.a'.hatéai^agÂ^bi$M.lk^gai#b 50 tédbgnrKv ânak optika; átmérője 5 μη; vagy kisebb,
- 5. Az 1. igénypont szerinti gyógyszerkészítmény, amelylsen a peeibrák mlkrbszerkezeíek porlasztást* szántási cparas alkalmazásával vannak előállítvtt,
- 6. Az S. igénypont szerinti gyógyszerkészítmény, amelyben a perforált mikíoszerkezotek fterűüorokfil-bromid, DSPC (1.2-diszterod-smghcerö' •S-foszfokolm) és kalcíum-klortd vízben készült, porlasztva szárított emulzióját tartalmazzák. ?.. Az I . igénypont szerinti gyógyszerkészítmény, ahöitt':M««|3#Äö á"§fd^ét*8ié'á%ÖI#g 1 mgónl és 15 mgíml közötti, 3 ssgöni é? lö mg/snl közötti 3 mg/ntj és k mgösl közötti, viälstölfät é RisZtnl koncentrációk közöl kiválasztott koncentrációban tartalmazza. S- Az \ igénypont szmnti gy<\gyszerkészftméuy, ahol a sznszpendáió részecskéit legalább egy fajián&k mindegyike Η) pm és 500 ore közötti, S pírt és 730 am közöd! vagy I ptn és .> por közötti MMAD közül kiválasztott MM AIM rental;,
- 9, As b igénypont szerkói gybgysaeÉlSSbiôébÿ, areslyhéü a; s&pssqsendáfó· részecskék -legalább égy fáj» tánsk mmffegyils; 0,5 gm és l| pm kóKütb IsÁopt ytorretl középes optikai 'MmétS^Ű. Kk Az L Igénypont szedrei gyógyszerkészítmény, amelyben. δ' héjiógát 'MFA- hűtőgáz, FF€ hsjtégàzés «•sok kombinációi közül kiválasztott .hajtógázt 'tartalmaz, és: -amelyben a szoszpeoziés közeg további alkotórészüktől lényegében mentes I I, Az I. Igénypont szét Inti gyógyszerkészítmény, amelyben « szosxpendalő részecskék teljes tömege meghaladja os eltérd fajtáj ö Hatóanyag tészeeskék teljes tömegét, és a szttszpeadalá tésseeskek teljes tömegének a hatóanyag részecskék teljes tömegétxe vonatkoztatott aránya 10 és 200 közötti, ói) és 200 közötti S S és 60 kősóm és SS és 170 közötti arányok közül van kiválasztva
- 12, Ax 1, igénypont szerinti gyógyszerkészítmény, &ta«jyben a legalább egy fajta szuszpendáló részecske telje» tömegének a legalább egy fajta hatóanyag részecske teljes tömegére vonatkozatott aránya S feletti és legfeljebb L5, legfeljebb 5, legföljebb 10, legföljebb 1.5, legfeljebb 17, legfeljebb 20, legfeljebb 30, legfeljebb 40. legfeljebb 50, legfeljebb 60, legfeljebb 75, legfeljebb 100, legfeljebb 150 és legfeljebb 200 arányok közöl van kív&lasziva, 13. A:» 1- Igénypont szerinti gyógyszerkészítmény, amelyben a áznszpentlalo részecskék a hatóanyag részecskékkel együtt elhelyezkedve maradnak még akkor is, ha azok legalább I g, legalább íö-g, leplább S0 g és legalább Uíö g gyorsulás értékek közül kiválasztott gyorsulás« eentófagálással 'megnövelt' felhajtóerőknek vannak kitéve, H. Az I, igénypont szerinti gyógyszerkészítmény. »mélyben a hajlógáz HFA haj tógáz; a hatóanyag téazecskék első fajtája gíikophroiátoi laxlalmaz, beleértve ennek bármi íven gyógyszerészeti-leg elfogadható sóit, észtereit, enantíomereit, enantiomereinek keverékeit vagy szoivátjait, szuszpenzlós közegben szavzpendálva az adagoló inhalálókészülék egyszeri működtetésével beadott' legfeljebb §0 pg gjikopirmiát dózis biztosításához elegendő koncentrációban; a hatóanyag részecskék második fajtája formotetolt tartalmaz, beleértve ennek Mnsílyen gyógyszerésze-tüeg elfogadható sóit, észtereit, eoantiomerai, enantiomexeinek keverékeit vagy szoivátjaik sznszpenziós közegben szuszpendáiva az adagoló inhalálókészülék egyszeri tsöködtetésévei beadott 3 pg és 10 pg közötti formol ért) 1 dozss biztosításához elegendő koncentrációban; és a nagyszámú belélegexheto szánsz szetsesös sztsszpetKlálö sészeeske ij g.m és iö pm között! térfogat szerimi közepes optikai átmérőjű perforált mitoszsrkóxeteket tarütlmsop és ahol a hatóanyag részecskék első és .második fejtája a sxmszpenzjós közegben pagyszámó szhsgpéridSlb zésxcekkevel együtt elhelyezkedve ko--szó -síper! siót köpsz.5. Ak L ígétsyposíl szerint! ^6&SMrkê$3â$®$Xï%\ .apteiÿbph 3 hojtógáz HFA hajtógáz; 3 hatóanyag részecskék első fajtája glikopirrolátot tartalmaz,. befeérive ennek bármily«» gyógyszerészed' kg elfogadható sóig észtereit, eoantiomenrit, enantiomeremsk keverékei: vagy szolvátjsh, aha! &: hatóanyag részecskék alsó fajtájának legalább 90% iérfogat%·» 7 μη* vagy ennél kisebb optikai átmérőjű, amely s szász-penztós közegben az adagoló inhalálókészülék egyszeri működtetésével beadod legfeljebb 80 pg'.glikoptxKÄ dózis biztosításához elegendő koncentrációban van szuszpendálva; s hatóanyag részecskék második lajtája formoteroit tartalmaz, beleértve ennek bármi lyet* gyógyszerésze-tiieg elfogadható són, észteren, enastiomeroit, enaatíomereinek keverékeit vagy »zoiv&tjait, estély a szuszpeh-ziós közegben m adagoló inhalálókészülék egyszeri -működtetésével beadott 2 pg és 10 ag közötti fermorerol dózis biztosításához elegendő koncentrációban van sznszpsndálya; tartalmazza továbbá hatóanyag részecskék harmadik ihjtáját, -amely egy koriikosrisroidol ferialmaz heklomctazorp fesdsszonkl, crklezonki, flnnizöüd: ilttílkazon, metíi-prodaizíolon, .mometata, : prédáikon és írimakinolött közül kiválasztva, beleértve ezek Mrm'ilysn gyógyszeaészetíieg aiiogsáható soit, észtereit, ennruiomercii, ertantiomefeinek keverékeit vagy szolváljalp és ahol a nagyszámú beiélegezhetö száraz szemcsés sznszpenöálö részecske 1,5 po és iö gnt közötti tériö' gat szerinti közepes optikai átmérőjű périmai? ndkroszerkeaeteket i&ri&imaz, és álról a hatóanyag részecskék alsói második és harmadik fajtája a sznszpenziós közegben a îïag^ysMîmr sztïszpeîïdàkkrèszeeskévebegy-Ôtt síbe-lyöákSílve ko-szttszpéMiót képeik 16, A 14, vagy 15, igénypont szennü gyógyszetkésjdtmény. ahol a szuszpenzáós közeg a bríélegezhete asgysz&mü száras, szemcsés sznszpendáló részecskét 1 ntg/ml és 15 mg/mi közötti, 3 mg/ml és 10 mg.·ml közötti, 5 mg/mi és Ö mg/ml közötti és 6 mg/mi koncentrációk közül kiválaszort koncentrációban tartalmazza. I?, .Az előző igénypontok bármelyike szerinti gyógyszerkészítmény* amelyben a glköpirrölé? gyógyszerészetiisg elfogadható sója Pmorld. klórid, brontid, jodrd, oitrát, szálfát, foszfát, formMí, acetóí, tritluoraccfát, propionát. butirát, laktál, cltrát, tartat ál, malát, máleát, sznkcináí, benzoát, p-kJórhOKZöóí,. ddenilacetar vagy trifenilacetát, ö-indroxihenzoát. p-hidrosibenzoá·. irinőroxinaftalin-S-karboxílát, 3-hiározt" tíalP'Ji!t-24;arboxíIát, meiánszuikmáí és beozolszuiionát közül van kiválasztva. 1:1 Â 17. igénypont szerinti gyógyszerkészítmény, amelyben a gükopiíToiál gyógyszerészeti lég élfögadhaíó sója J-lfeiklopenttMtidroxifenifecsfibojdj-kl-dlmettfpirroiidttitutn'hromid.
- 19, Az elűzd igénypontok hámteiyike skérintf gy:ó#á:^étlté:Sk.iiKdéhyí áaielybén a Tdrmowoi gyógyszsrik szetlleg -elfogadható sója hidmklertd, hltehrottíid, kóösav, foszforsav* ibmámav, inaleiBSsv, ecefsav, tejsav, eiszomsav, borkösav, aszkorbins&v, horostyánkőssv, glotársav, giüktsrssáv, trikarbáilüs&v, edemsav, heirzoessv, S>meiokthenæossa:y,. mlleilsav, o~ és prhtáoxtbeoxoesav, p-któriamzoesav, melánsztriiodsav, gdphmi'· szoimnssv és S-ltid?*»·'i-2 -nafi ahokarbonsav- sók: közül van kiválasztva. .20. A 12. %é»ypöhi mrfetti gyógysKerkészitesny, amelyben a fomiókkóí éiíógááha- tó sója fb?möts.róí-ímrtarát,
- 21, Az éiózó igénypontok bármelyike szerint! gyógyszeíkészmrmny, mnslÿben legalább egy hatóanyag kristályos vagy lényegében kristályos formában vontaién.
- 22. Az előző igénypontok'bármelyike sïerlptl .gyégyMerkiSÂtény5. «meîybso az Ssszas hatóanyag kristályos vagy lényegében kristályos formában vas jelem22, Adagoló immlálóksszStléh,: amely agy, az 1Α2, tgépypsmtok bármelyikében meghatározók kásáit" fnényf tárirbmaz, amely ádágóló stíhaláiekésaSlákból as MPI lémdtdmz ksMlMse · folyamán a :szoszpenziő3 Ibrirmi» beadott dózis egyenletessége {-'ODÚ") a hatóanyagra vonatkozóan mindvégig a kivetkezők Maüi kiválasztód:: ±W% 00U vagy jöbb, a- 2S% DBIJ vagy jobb ás A 20¾¾ BDtl vagyjobb.
- 24. Az 1-22¾ iglhypóólók bármelyikében móglístarözótt gyógysanrkésztoáétty orvosságban tdrfenS·'alkalmazásra. 22, A® I -22, Igénypontok Mmmiyikébea snegbstámzoti pógysaafkészltméky poimonáris betegség vagy rehdeUePósség kezelésében tötténŐ alkalmazásra. 2b, A 23. Igénypont szerimi gyógysKerkásgltmény a megadod alkstkaazástvs, ahol a pidsnonáris betegség vágy rendellenesség asztma, COfP, krötrikns bórghumt, emrizéms, Mrg&águlst, allergiás onpyáikshártys-"gyulladás, arcüreggyulladás.,· tiidbérszüktsiéí, gyóilalás, öllergláfe, 'légzészavar, lépési elégtelenség tânetçaôpoît, pulmonám mpórizMió, éisztás bbrózlsszl kapcsolatos lüdógyaüsdás és· cisztás iiferózlssas kapcsolatos puimonám elzáródé legalább egyiké közül van kiválasztva. 27. A 25. igénypont sZérlnil.gyógysprMSKíppény á megadott alkzhpálgásra, ahol a betegség vagy rendellenesség CÖFÍ3. 28:. A 14-16. Igénypontok bármelyike szerinti gyógyszerkószltnfeny, amelyben a Isübanyag részecskék első fajtája a szuszpenziós közegben tus adagoló inhalálókészülék egyszeri mőköritelssével. beadott legfeljebb 40 gg glikop.irrolát dózis blztoshisáitoz élegendó könceMmcióben vart szpzpémlálva, 22. A 14-IJ; Igónypomok bármelyiké: szerinti gyrigyszerifeszittnény, amelyben a hatóanyag részecskék elad íájtáta a sznszpenztós közegbei) az adagoló imiálálókészbiék egyszeri működtetésével beadod legfeljebb 21) pg gllkopirrolál dózis blztöskásálfez eiegendó kooeemmelóban ven szuszpendáiva.
- 30, A f4-16., igásyp<gitök lÄMiylks msrißü -^ág^mvkés^tméay^ smelybsîï a hatóanyag rôsæîckkék els§ fájbya .s s:ÄiiSK|>@»aiös köaagbaa aa adagoló iödalálókdagklófc sgysaeri m$k66isíéséve3 besdotí fcg&ljebb î8 μg^gllköpù'miáí.iáô2ls·bi¾teMA1¾··β3δ^«i!fö,kon¢s6ö6^iéb¾5 vm $rmnzpmiMv®< 31, Λ 3:0'30. :%6aypa*öfc' fetagiyitee «gesaftt! fyó^ysKerk0Síal0Hí5«>·:, aóíeiybsn a i)aiéa«yag aJkKacsklk második IbJ iája a sæus^msæiôs- :ktegbsæ as adagoló ihbaÍálófcéSK4í!#k,^ys^jii: «)6kddfêës6M: feeÄft I gg ss 3: og kögótb Isaanoísíö! ddais bisiöslídsfeg alsgsndd kosesR&ádÖká» vas szosspendófea. 33, A 30-30:: igdnyposíok feármsdylks sssa-ind gyógysgoíidssiOodpy ( ardelylxói a halódgyag tdpaeskák második by iája á sm&^mmés fcbaagib«!« as adagold i»bs#:16Msgö}ft· ggy^mrj W§kö<áte«^v6!, Okádok kgísk jobb 5 pgioOMterobdogis Idziokbásáims elsgándó konesoddambyo van aagsapopdálvii
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HUE10721258A HUE031283T2 (hu) | 2009-05-29 | 2010-05-28 | Nyújtott hatású muszkarin antagonisták és nyújtott hatású béta 2 adrenerg receptor agonisták pulmonáris beadására alkalmas készítmények és ezekkel kapcsolatos eljárások és rendszerek |
HUE16164844A HUE047803T2 (hu) | 2009-05-29 | 2010-05-28 | Két vagy több hatóanyag légúti beadására alkalmas készítmények, eljárások és rendszerek |
HUE16164849A HUE047823T2 (hu) | 2009-05-29 | 2010-05-28 | Hatóanyagok belégzéssel történõ beadására alkalmas készítmények és ezzel kapcsolatos eljárások és rendszerek |
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