HRP20130173T1 - Farmaceutske formulacije ciklosporina - Google Patents

Farmaceutske formulacije ciklosporina Download PDF

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HRP20130173T1
HRP20130173T1 HRP20130173AT HRP20130173T HRP20130173T1 HR P20130173 T1 HRP20130173 T1 HR P20130173T1 HR P20130173A T HRP20130173A T HR P20130173AT HR P20130173 T HRP20130173 T HR P20130173T HR P20130173 T1 HRP20130173 T1 HR P20130173T1
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drug
formulation according
released
mini
hours
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HRP20130173AT
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Ivan Coulter
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Sigmoid Pharma Limited
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Claims (19)

1. Oralna formulacija ciklosporina koja se sastoji od mini-kapsula koje imaju jezgru koja se sastoji od ciklosporina u obliku solubilizirane tekućine, s tim da mini-kapsule imaju profil oslobađanja koji omogućava da se predsolubilizirani ciklosporin oslobađa barem u kolonu, za primjenu u: liječenju bolesti kolona, naročito upalnih ili ishemijom potaknutih bolesti, ishemičnih bolesti crijeva, nekrotizirajućeg enterokolitisa, celijakije ili proktitisa, ulceroznog kolitisa i/ili Crohnove bolesti liječenju ili prevenciji upalne bolesti crijeva, reakcija transplantata protiv primatelja i gastrointestinalne reakcije transplantata protiv primatelja i /ili iritabilnog kolona.
2. Formulacija prema zahtjevu 1, naznačena time da mini-kapsula može biti jednoslojna ili višeslojna.
3. Formulacija prema jednom od prethodnih zahtjeva, naznačena time da mini-kapsule imaju profil oslobađanja da bi mogle oslobađati predsolubilizirani ciklosporin u ileumu i/ili tankom crijevu.
4. Formulacija prema jednom od prethodnih zahtjeva, naznačena time da je ciklosporin tipa ciklosporin A, s tim da je ciklosporin opcionalno prisutan u jezgri u koncentraciji od 2,5 do 25% w/w, pretežito u koncentraciji od 2,5 do 10% w/w.
5. Formulacija prema jednom od prethodnih zahtjeva za primjenu u liječenju ulceroznog kolitisa ili Crohnove bolesti, koja ima profil rastvaranja kada se ispituje u uređaju U.S.P. tip II (lopatice) na 37°C i 50 rpm, u puferu pH 6.8 na sljedeći način: do 4 sata: oslobođeno manje od ili oko 20% lijeka; 6 sati: oslobođeno manje od ili oko 35% lijeka; 8 sati: oslobođeno manje od ili oko 50% lijeka; 12 sati: oslobođeno manje od ili oko 60% lijeka; 18 sati: oslobođeno manje od ili oko 75% lijeka; i 24 sata: oslobođeno od oko 25% do oko 100% lijeka.
6. Formulacija prema jednom od zahtjeva 1 do 4 za primjenu u liječenju gastrointestinalne reakcije transplantata protiv primatelja, koja ima profil rastvaranja kada se ispituje u uređaju U.S.P. tip II (lopatice) na 37°C i 50 rpm, u puferu pH 6.8 na sljedeći način: 1 sat: oslobođeno manje od ili oko 20% lijeka; 4 sata: oslobođeno manje od ili oko 35% lijeka; 6 sati: oslobođeno manje od ili oko 50% lijeka; 12 sati: oslobođeno manje od ili oko 60% lijeka; 16 sati: oslobođeno manje od ili oko 75% lijeka; i 24 sata: oslobođeno od oko 25% do oko 100% lijeka.
7. Formulacija prema jednom od prethodnih zahtjeva, naznačena time da se ovojnica mini-kapsule oblaže slojem s modificiranim oslobađanjem, s tim da se opcionalno koristi polimerni materijal za postizanje modificiranog oslobađanja, primjerice bilo koja kombinacija dostupnih akrilnih, metakrilnih polimera i polimera na bazi etilceluloze (kao što su Eudragit i Surelease®) kao i drugi polimeri s prirodnim polisaharidima.
8. Formulacija prema zahtjevu 7, naznačena time da je polimerni materijal metakrilat, etilceluloza ili mješavina metakrilata i etilceluloze.
9. Formulacija prema zahtjevu 7 ili 8, naznačena time da sloj sadrži agens za poticanje rastvaranja kojeg razgrađuju bakterije koje su uobičajeno prisutne u donjem gastrointestinalnom sustavu, primjerice naznačeno time da se agens za poticanje rastvaranja odabire iz jednoga ili više iz skupine pektina, amiloze i alginata ili njihovih derivata.
10. Formulacija prema zahtjevu 7, 8 ili 9, naznačena time da jezgra sadrži ciklosporin A, otapalo, solubilizirajući agens i emulgator.
11. Formulacija prema jednom od prethodnih zahtjeva, naznačena time da se mini-kapsule dobiju iskorištavanjem površinskog naprezanja različitih otopina u postupku u kojem se otopina jezgre i otopina ovojnice ištrcavaju kroz otvor ili mlaznicu s jednim ili više otvora, određenog promjera, a podložno određenim frekvencijama i gravitacijskom toku se oblikuju u oblik kugle i upadaju u protok zraka za hlađenje ili u otopinu za hlađenje ili stvrdnjavanje, a vanjska ovojnica se želira ili skrućuje.
12. Formulacija prema jednom od prethodnih zahtjeva, naznačena time da se sastoji od tvrde želatizirane kapsule, sadržaja za isipanje ili tableta koja sadrži mini-kapsule, s tim da opcionalno mini-kapsule također sadrže pomoćne tvari radi povećanja terapijskog potencijala ciklosporina u ileumu i kolonu, s tim da se opcionalno pomoćne tvari za povećanja terapijskog potencijala ciklosporina u ileumu i kolonu odabiru iz jednoga ili više iz skupine apsorpcijskih limitatora, surfaktanta, kosurfaktanta, suotapala, esencijalnih masti kao što su omega 3 masti, prirodni biljni ekstrakti kao što su nim, ionski izmjenjive smole, antioksidansi, polieteri, stabilizatori, konzervansi, konjugacijski povezivač za razgradnju bakterija kao što su azo spojevi, polisaharidi kao što su amiloza, guar guma, pektin, kitozan, inulin i ciklodekstrini.
13. Primjena ciklosporina u proizvodnji lijekova za primjenu u: liječenju ili prevenciji upalne bolesti crijeva, reakcija transplantata protiv primatelja i gastrointestinalne reakcije transplantata protiv primatelja i /ili iritabilnog kolona; i/ili u liječenju ulcroznog kolitisa i/ili Crohnove bolesti, s tim da se lijek proizvodi tako da ciklosporin, sam ili u kombinaciji, stavlja u mini-kapsule ili mini-kuglice koje ciljaju oslobađanje barem u kolonu.
14. Formulacija prema jednom od zahtjeva 1 do 12, naznačena time da se ciklosporin primjenjuje u kombinaciji s drugom terapeutski ili profilaktični aktivnom cjelinom, s tim da se drugi aktivni lijek opcionalno odabire među kalcineurinskim inhibitorima, npr. abetimus, deforolimus, everolimus, gusperimus, pimekrolimus, sirolimus, takrolimus, temsirolimus, glukokortikosteroidi; citostaticima npr. anakinra, azatioprin, eflunomid, metotreksat, mikofenolna kiselina, talidomid; antitijelima npr. anti-CD3 OKT3 usmjerena na receptore T stanica; sirolimus, interferonima, opioidima, TNF(-vezujućim proteinima, npr. infliksimab, etnercept. adalimumab, kukumin i katekinima; i mikofenolat mofetilne kiseline, s tim da se drugi aktivni lijek opcionalno odabire među određenim prirodnim ekstraktima, npr. ulje nima, aloe vera, tripala, ulje kurkume i druga esencijalna ulja, npr. EPA, DHA, spojena linolenska kiselina (CLA) i drugi derivati istih, biljni ekstrakti, npr. ekstrakti bobica, npr. borovnica, aki, rezorkinolni/fenolni lipidi, resveratrol, flavanoidi i derivati istih, samostalno ili u kombinaciji, proteini, terapeutski peptidi, cjepiva, antitijela ili dijelovi istih, te također da se drugi lijek opcionalno odabire iz jednog od navedenih ili kombinacije takrolimusa, sirolimusa, hidralazina, DMOG-a, inhibitora propil i/ili asparaginil hidroksilaze, EPA, DHA, prirodnih biljnih ekstrakata, prirodnih morskih ekstrakata ili drugih bioloških i aktivnih cjelina, npr. siRNA konstrukti.
15. Formulacija prema zahtjevu 14, naznačena time da se terapeutski ili profilaktički aktivna cjelina odabire između hidralazina, DMOG-a i drugih inhibitora propil i/ili asparaginil hidroksilaze.
16. Formulacija prema zahtjevu 14 ili 15, naznačena time da su ciklosporin i terapeutski ili profilaktički aktivna cjelina zajedno zatvoreni u mikro-kapsulama ili mikro-kuglicama.
17. Formulacija prema zahtjevu 14 u kojoj je drugi aktivni lijek imunološki modulirajuća cjelina, primjerice antigen, ajuvant, emulzija, ulje ili sitna molekula i koji se koristi kao cjepivo, modulator oralne tolerancije ili modulator alergena.
18. Oralna formulacija ciklosporina koja sadrži dozu ciklosporina i najmanje jednu farmaceutski prihvatljivu pomoćnu tvar i koja oslobađa ciklosporin u ileumu i/ili kolonu, za primjenu u liječenju upalnih bolesti crijeva kao npr. ulcerozni kolitis, Crohnova bolest ili gastrointestinalna reakcija transplantata protiv primatelja, s tim da je formulacija u obliku mini-kapsula s krutim, polukrutim ili tekućim punjenjem koje se sastoje od jednog sloja ili više slojeva, s tim da mini-kapsule imaju profil oslobađanja da se predsolubilizirani ciklosporin oslobađa u ileumu i/ili kolonu.
19. Formulacija prema zahtjevu 18 koja se koristi u liječenju i prevenciji gastrointestinalne reakcije transplantata protiv primatelja i osigurava značajno oslobađanje u cijelom gastrointestinalnom sustavu od tankog crijeva do kolona.
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