HRP20171939T1 - Formulacija protutijela i režimi terapije - Google Patents

Formulacija protutijela i režimi terapije Download PDF

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HRP20171939T1
HRP20171939T1 HRP20171939TT HRP20171939T HRP20171939T1 HR P20171939 T1 HRP20171939 T1 HR P20171939T1 HR P20171939T T HRP20171939T T HR P20171939TT HR P20171939 T HRP20171939 T HR P20171939T HR P20171939 T1 HRP20171939 T1 HR P20171939T1
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antibody
seq
heavy chain
light chain
sequence
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HRP20171939TT
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Dingjiang Liu
Holly Zhuohong Huang
David Andrew Martin
Christopher Boyd Russell
David H. Salinger
Scott Walter Baumgartner
Christopher J. Endres
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Kirin-Amgen, Inc.
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Application filed by Kirin-Amgen, Inc. filed Critical Kirin-Amgen, Inc.
Publication of HRP20171939T1 publication Critical patent/HRP20171939T1/hr

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Claims (17)

1. Farmaceutska formulacija, koja sadrži vodenu otopinu pufera glutaminske kiseline i protutijela koje sadrži sekvencu varijabilne domene teškog lanca koja obuhvaća SEQ ID NO:3 i sekvencu varijabilne domene lakog lanca koja obuhvaća SEQ ID NO:4, naznačena time da se navedeno protutijelo specifično veže na ljudski receptor A za IL-17, te što: a) navedena formulacija sadrži glutaminsku kiselinu u koncentraciji od 5-30 mM ± 0,2 mM; b) navedena formulacija ima pH 4,5-5,2 ± 0,2; c) navedena formulacija dalje sadrži 2-4% prolin (mas/v) i 0,005-0,02% (mas/v) polisorbat 20; d) navedeno protutijelo ima koncentraciju od 100 do 150 mg/ml.
2. Farmaceutska formulacija prema zahtjevu 1, naznačena time da protutijelo sadrži sekvencu teškog lanca koja obuhvaća SEQ ID NO:1 i sekvencu lakog lanca koja obuhvaća SEQ ID NO:2, ili alternativno, sekvencu teškog lanca koja obuhvaća SEQ ID NO:12 i sekvencu lakog lanca koja obuhvaća sekvencu SEQ ID NO:2.
3. Farmaceutska formulacija prema zahtjevu 1 ili zahtjevu 2, naznačena time da nadalje ima osmolarnost od 250 do 400 mOsm/L.
4. Farmaceutski kontejner, koji obuhvaća posudu i farmaceutsku formulaciju prema bilo kojem od zahtjeva 1 do 3, naznačena time da je navedena posuda bočica, boca, prethodno napunjena injekcija, ili prethodno napunjena autoinjektorska injekcija.
5. Komplet, naznačen time da sadrži jedan ili više farmaceutskih spremnika prema zahtjevu 4 i upute u vezi s njihovom upotrebom.
6. Farmaceutska formulacija prema bilo kojem od zahtjeva 1-3 naznačena time da je za upotrebu u postupku liječenja psorijaze kod humanog pacijenta, pri čemu je protutijelo u dozi od 70, 140, 210 ili 280 mg.
7. Farmaceutska formulacija za upotrebu prema zahtjevu 6, naznačena time da se navedenom pacijentu daje doza od 70 do 280 mg navedenog protutijela svakog tjedna, svaka dva tjedna i/ili svakog mjeseca.
8. Farmaceutska formulacija za upotrebu prema zahtjevu 7, naznačena time da se doza od 140 mg navedenog protutijela daje pacijentima koji imaju tjelesnu masu koja je manja od ili približno jednaka 100 kg, te da se doza od 210 mg navedenog protutijela daje pacijentima koji imaju tjelesnu masu koja je veća od 100 kg.
9. Farmaceutska formulacija za upotrebu prema bilo kojem od zahtjeva 6 do 8, naznačena time da se psorijaza bira iz skupine koja sadrži: a) psorijazu koja dovodi do stvaranja plaka; b) umjerenu psorijazu do psorijaze s ozbiljnim simptomima koja dovodi do stvaranja plaka; c) kroničnu umjerenu psorijazu do psorijaze s ozbiljnim simptomima koja dovodi do stvaranja plaka i navedeni pacijenti su kandidati za sistemsku terapiju ili fototerapiju; i d) kroničnu umjerenu psorijazu do psorijaze s ozbiljnim simptomima koja dovodi do stvaranja plaka i što navedeni pacijenti ne reagiraju na, imaju kontraindikaciju prema, ili su netolerantni na druge sistemske terapije uključujući ciklosporin, metotreksat, i psoralen plus fototerapiju ultraljubičastim-A zračenjem.
10. Farmaceutska formulacija za upotrebu prema bilo kojem od zahtjeva 6 do 9, naznačena time da navedena farmaceutska formulacija sadrži oko 140 mg/ml navedenog protutijela, koje je formulirano s 10 ± 0,2 mM glutaminskom kiselinom, 3 ± 0,2% (mas/v) L-prolinom, 0,01 ± 0,002% (mas/v) polisorbatom 20, pH 4,8 ± 0,2.
11. Farmaceutska formulacija za upotrebu prema bilo kojem od zahtjeva 6-10, naznačena time da se navedena farmaceutska formulacija daje subkutano, intradermalno, intramuskularno, i/ili intravenozno.
12. Farmaceutski pripravak koji sadrži protutijelo od oko 100-150 mg/ml, koje je formulirano s: i) glutaminskom kiselinom u koncentraciji od 10 mM; ii) pH od 4,8 ± 0,2; iii) 3% prolinom (mas/v) i 0,01% (mas/v) polisorbatom 20; pri čemu se navedeno protutijelo bira iz skupine koja sadrži: a) protutijelo koje sadrži sekvencu varijabilne domene teškog lanca koja sadrži SEQ ID NO:3 i sekvencu varijabilne domene lakog lanca koja sadrži SEQ ID NO:4, pri čemu se navedeno protutijelo specifično veže za ljudski receptor A za IL-17; i b) protutijelo koje sadrži sekvencu teškog lanca koja sadrži SEQ ID NO:1 i sekvencu lakog lanca koji sadrži SEQ ID NO:2, ili alternativno, sekvencu teškog lanca koja sadrži SEQ ID NO:12 i sekvencu lakog lanca koja sadrži SEQ ID NO:2, za upotrebu u postupku liječenja psorijaznog artritisa kod humanog pacijenta, pri čemu je protutijelo u dozi od 70, 140, 210 ili 280 mg.
13. Farmaceutski pripravak koji sadrži protutijelo od oko 100-150 mg/ml, koje je formulirano s: i) glutaminskom kiselinom u koncentraciji od 10 mM; ii) pH od 4,8 ± 0,2; iii) 3% prolinom (mas/v) i 0,01% (mas/v) polisorbatom 20; pri čemu se navedeno protutijelo bira iz skupine koja sadrži: a) protutijelo koje sadrži sekvencu varijabilne domene teškog lanca koja sadrži SEQ ID NO:3 i sekvencu varijabilne domene lakog lanca koja sadrži SEQ ID NO:4, pri čemu se navedeno protutijelo specifično veže za ljudski receptor A za IL-17; i b) protutijelo koje sadrži sekvencu teškog lanca koja sadrži SEQ ID NO: 1 i sekvencu lakog lanca koji sadrži SEQ ID NO:2, ili alternativno, sekvencu teškog lanca koja sadrži SEQ ID NO:12 i sekvencu lakog lanca koja sadrži SEQ ID NO:2, za upotrebu u postupku liječenja astme kod humanog pacijenta, što je navedeno protutijelo u dozi od 70, 140, 210 ili 280 mg.
14. Farmaceutski pripravak koji sadrži protutijelo od oko 100-150 mg/ml, koje je formulirano s: i) glutaminskom kiselinom u koncentraciji od 10 mM; ii) pH od 4,8 ± 0,2; iii) 3% prolinom (mas/v) i 0,01% (mas/v) polisorbatom 20; pri čemu se navedeno protutijelo bira iz skupine koja sadrži: a) protutijelo koje sadrži sekvencu varijabilne domene teškog lanca koja sadrži SEQ ID NO:3 i sekvencu varijabilne domene lakog lanca koja sadrži SEQ ID NO:4, pri čemu se navedeno protutijelo specifično veže za ljudski receptor A za IL-17; i b) protutijelo koje sadrži sekvencu teškog lanca koja sadrži SEQ ID NO: 1 i sekvencu lakog lanca koji sadrži SEQ ID NO:2, ili alternativno, sekvencu teškog lanca koja sadrži SEQ ID NO:12 i sekvencu lakog lanca koja sadrži SEQ ID NO:2, za upotrebu u postupku liječenja ankilozirajućeg spondilitisa kod humanog pacijenta, što je navedeno protutijelo u dozi od 70, 140, 210 ili 280 mg.
15. Farmaceutski pripravak koji sadrži protutijelo od oko 100-150 mg/ml, koje je formulirano s: i) glutaminskom kiselinom u koncentraciji od 10 mM; ii) pH od 4,8 ± 0,2; iii) 3% prolinom (mas/v) i 0,01% (mas/v) polisorbatom 20; pri čemu se navedeno protutijelo bira iz skupine koja sadrži: a) protutijelo koje sadrži sekvencu varijabilne domene teškog lanca koja sadrži SEQ ID NO:3 i sekvencu varijabilne domene lakog lanca koja sadrži SEQ ID NO:4, pri čemu se navedeno protutijelo specifično veže za ljudski receptor A za IL-17; i b) protutijelo koje sadrži sekvencu teškog lanca koja sadrži SEQ ID NO: 1 i sekvencu lakog lanca koji sadrži SEQ ID NO:2, ili alternativno, sekvencu teškog lanca koja sadrži SEQ ID NO:12 i sekvencu lakog lanca koja sadrži SEQ ID NO:2, za upotrebu u postupku liječenja multiple skleroze kod humanog pacijenta, što je navedeno protutijelo u dozi od 70, 140, 210 ili 280 mg.
16. Formulacija za upotrebu prema bilo kojem od zahtjeva 12 do 15, naznačena time da navedena farmaceutska formulacija nadalje sadrži oko 140 mg/ml navedenog protutijela i što navedeni lijek ima viskoznost od 5 do 7 cP na 25 stupnjeva C.
17. Formulacija za upotrebu prema bilo kojem od zahtjeva 12 do 16, naznačena time da se farmaceutska formulacija daje subkutano, intradermalno, intramuskularno, i/ili intravenozno.
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