HRP20200512T2 - Formulacije koje sadrže linaklotid za oralnu primjenu - Google Patents
Formulacije koje sadrže linaklotid za oralnu primjenu Download PDFInfo
- Publication number
- HRP20200512T2 HRP20200512T2 HRP20200512TT HRP20200512T HRP20200512T2 HR P20200512 T2 HRP20200512 T2 HR P20200512T2 HR P20200512T T HRP20200512T T HR P20200512TT HR P20200512 T HRP20200512 T HR P20200512T HR P20200512 T2 HRP20200512 T2 HR P20200512T2
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical preparation
- linaclotide
- constipation
- leucine
- preparation according
- Prior art date
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- KXGCNMMJRFDFNR-WDRJZQOASA-N linaclotide Chemical compound C([C@H](NC(=O)[C@@H]1CSSC[C@H]2C(=O)N[C@H]3CSSC[C@H](N)C(=O)N[C@H](C(N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=4C=CC(O)=CC=4)C(=O)N2)=O)CSSC[C@H](NC(=O)[C@H](C)NC(=O)[C@@H]2CCCN2C(=O)[C@H](CC(N)=O)NC3=O)C(=O)N[C@H](C(NCC(=O)N1)=O)[C@H](O)C)C(O)=O)C1=CC=C(O)C=C1 KXGCNMMJRFDFNR-WDRJZQOASA-N 0.000 title claims 22
- 229960000812 linaclotide Drugs 0.000 title claims 22
- 108010024409 linaclotide Proteins 0.000 title claims 22
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 43
- 206010010774 Constipation Diseases 0.000 claims 13
- ROHFNLRQFUQHCH-UHFFFAOYSA-N Leucine Natural products CC(C)CC(N)C(O)=O ROHFNLRQFUQHCH-UHFFFAOYSA-N 0.000 claims 12
- 208000002551 irritable bowel syndrome Diseases 0.000 claims 10
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- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical compound CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 claims 8
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- 239000008194 pharmaceutical composition Substances 0.000 claims 6
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- 125000001909 leucine group Chemical group [H]N(*)C(C(*)=O)C([H])([H])C(C([H])([H])[H])C([H])([H])[H] 0.000 claims 4
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- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 3
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- AYFVYJQAPQTCCC-GBXIJSLDSA-N L-threonine Chemical compound C[C@@H](O)[C@H](N)C(O)=O AYFVYJQAPQTCCC-GBXIJSLDSA-N 0.000 claims 1
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Classifications
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Claims (41)
1. Farmaceutski pripravak, naznačen time, da obuhvaća farmaceutski prihvatljiv nosač, linaklotid, kation koji je odabran od Mg2+, Ca2+, Zn2+, Mn2+, K+, Na+ ili Al3+, i jedan sterično zapriječen primarni amin, pri čemu je farmaceutski pripravak jedan čvrsti sastav za oralno primjenjivanje.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da se navedeni Mg2+, Ca2+, Zn2+, Mn2+, K+, Na+ ili Al3+, dobivaju kao magnezijev klorid, kalcijev klorid, kalcijev fosfat, kalcijev sulfat, cinkov acetat, manganov klorid, kalijev klorid, natrijev klorid ili aluminijev klorid.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da navedeni kation je Ca2+.
4. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da navedeni kation je Ca2+, i on je dobiven kao kalcijev klorid.
5. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da je sterično zapriječeni primarni amin jedna aminokiselina, polimerni amin, ili spoj sljedeće formule:
[image]
pri čemu su R1, R2 i R3 neovisno odabrani od sljedećih: H; -C(O)OH; C1-C6-alkil, opcionalno supstituiran s -CO2H, -CONH2, ili s 5-10-članim arilom ili heteroarilom; C1-C6-alkoksialkil; ili C1-C6-tioalkoksialkil, gdje bilo koja od alkilne ili arilne gornje skupine, može biti jednostruko ili višestruko supstituirana s halogenom ili -NH2, te uz uvjet da samo do dva od R1, R2 i R3, predstavljaju H.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da sterično zapriječeni primarni amin je histidin, fenilalanin, alanin, glutaminska kiselina, aspartna kiselina, glutamin, leucin, metionin, asparagin, tirozin, treonin, izoleucin, triptofan ili valin.
7. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da sterično zapriječeni primarni amin je leucin.
8. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak nadalje sadrži farmaceutski prihvatljivo klizno sredstvo, lubrikant ili aditiv koji djeluje i kao klizno sredstvo i kao lubrikant.
9. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak nadalje sadrži jedan ili više antioksidanata, farmaceutski prihvatljivo vezno sredstvo, ili farmaceutski prihvaljivo punilo.
10. Farmaceutski pripravak prema patentnom zahtjevu 9, naznačen time, da pripravak sadrži farmaceutski prihvatljivo vezno sredstvo koje je odabrano od sljedećih: polivinilni alkohol, polivinilpirolidon (povidon), škrob, maltodekstrin ili celulozni eter.
11. Farmaceutski pripravak prema patentnom zahtjevu 10, naznačen time, da farmaceutski prihvatljivo vezno sredstvo je celulozni eter koji je odabran od metilceluloze, etilceluloze, karboksimetilceluloze, hidroksietilceluloze, hidroksietilmetilceluloze, hidroksipropilceluloze i hidroksipropilmetilceluloze.
12. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 9 do 11, naznačen time, da pripravak sadrži farmaceutski prihvatljivo punilo i farmaceutski prihvatljivo punilo je celuloza, izomalt, manitol ili dibazični kalcijev fosfat.
13. Farmaceutski pripravak prema patentnom zahtjevu 12, naznačen time, da je celuloza odabrana od mikrofine celuloze i mikrokristalne celuloze.
14. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sterično zapriječen primarni amin je leucin i molarni omjer od leucina prema linaklotidu je najmanje 10:1.
15. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da kation je Ca2+, sterično zapriječen primarni amin je leucin i molarni omjer od Ca2+ prema leucinu je najmanje 1:1.
16. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sljedeći molarni omjer za kation: sterično zapriječen primarni amin: linaklotid, iznosi 40-100:20-50:1.
17. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da kation je Ca2+, sterično zapriječen primarni amin je leucin, a sljedeći molarni omjer za Ca2+: leucin: linaklotid, iznosi 60:30:1.
18. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da:
(i) produkt hidrolize ima sljedeću strukturu
[image]
koja sadrži manje od 2% po masi, kada se usporedi s masom linaklotida; ili
(ii) produkt oksidacije linaklotida koji ima molekularnu masu od 1542,8, sadrži manje od 2% po masi, kada se usporedi s masom linaklotida.
19. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak obuhvaća sljedeće:
linaklotid;
Ca2+;
leucin; i
hidroksipropilmetilcelulozu,
pri čemu je linaklotid prisutan u farmaceutskom sastavu s količinom između 100 μg i 600 μg, te sljedeći molarni omjer za Ca2+: leucin: linaklotid, iznosi između 5-100:5-50:1.
20. Farmaceutski pripravak prema patentnom zahtjevu 19, naznačen time, da je Ca2+ dobiven kao CaCl2.
21. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak obuhvaća obložena zrnca, a zrnca su obložena otopinom za oblaganje koja sadrži linaklotid.
22. Farmaceutski pripravak prema patentnom zahtjevu 21, naznačen time, da otopina za oblaganje obuhvaća sljedeće:
linaklotid;
Ca2+;
leucin; i
hidroksipropilmetilcelulozu,
pri čemu je linaklotid prisutan u farmaceutskom sastavu s količinom između 100 μg i 600 μg, te sljedeći molarni omjer za Ca2+: leucin: linaklotid, iznosi 5-100:5-50:1.
23. Farmaceutski pripravak prema patentnom zahtjevu 22, naznačen time, da zrnca sadrže mikrokristalnu celulozu.
24. Postupak proizvodnje farmaceutskog pripravka koji sadrži linaklotid ili njegovu sol, naznačen time, da postupak obuhvaća sljedeće:
(a) pripravljanje vodene otopine koja sadrži:
(i) linaklotid ili njegovu farmaceutski prihvatljivu sol;
(ii) kation koji je odabran od Mg2+, Ca2+, Zn2+, Mn2+, K+, Na+ ili Al3+, i jedan sterično zapriječen primarni amin;
i
(iii) prema potrebi, farmaceutski prihvatljivo vezno sredstvo; te
(b) nanošenje vodene otopine na farmaceutski prihvatljivo punilo u svrhu generiranja punila koje je obloženo linaklotidom.
25. Postupak prema patentnom zahtjevu 24, naznačen time, da se vodena otopina nanosi na punilo putem raspršivanja.
26. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 23, naznačen time, da je za uporabu u postupku liječenja pacijenta koji boluje od oštećenja crijevne peristaltike, sindroma iritabilnih crijeva, konstipacije, dispepsije, gastropareze, kronične crijevne pseudo-opstrukcije, Crohnove bolesti, ulcerativnog kolitisa, upalne bolesti crijeva, ili od bolova koji su povezani s konstipacijom.
27. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 26, naznačen time, da se kod sindroma iritabilnih crijeva radi o sindromu iritabilnih crijeva s prevladavajućom konstipacijom ili se radi o periodično promjenjivom sindromu iritabilnih crijeva.
28. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 27, naznačen time, da se kod navedenog sindroma iritabilnih crijeva radi o sindromu iritabilnih crijeva s prevladavajućom konstipacijom.
29. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 26, naznačen time, da navedena konstipacija je kronična konstipacija, idiopatska konstipacija, postoperativni ileus ili konstipacija uzrokovana uporabom opijata.
30. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 29, naznačen time, da navedena konstipacija je kronična konstipacija.
31. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži od 50 μg do 1 mg linaklotida.
32. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži 67,5 μg, 133 μg, 150 μg, 266 μg ili 300 μg linaklotida.
33. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži 266 μg linaklotida.
34. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži 133 μg linaklotida.
35. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 34, naznačen time, da se farmaceutski pripravak primjenjuje jednom dnevno ili dva puta dnevno.
36. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 35, naznačen time, da se farmaceutski pripravak primjenjuje jednom dnevno kao jedna ili dvije tablete ili kapsule.
37. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 36, naznačen time, da se farmaceutski pripravak primjenjuje na pacijentu u vremenskom periodu od najmanje četiri tjedna.
38. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 37, naznačen time, da liječenje s ovim pripravkom poboljšava barem jedan simptom koji je odabran od sljedećih: smanjenje abdominalnih bolova, povećanje broja potpuno spontanih crijevnih pokreta (CSBM – engl. complete spontaneous bowel movements) za vrijeme jednog tjedna, povećanje broja spontanih crijevnih pokreta (SBM – engl. spontaneous bowel movements) za vrijeme jednog tjedna, poboljšanje konzistencije stolice, smanjenje naprezanja, smanjenje abdominalne neugode, smanjenje nadimanja, ili smanjenje ozbiljnog simptomatskog stanja kod sindroma iritabilnih crijeva s konstipacijom (IBS-c – engl. irritable bowel syndrom with constipation).
39. Jedinični oblik za doziranje, naznačen time, da on sadržava farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 23.
40. Zabrtvljeni spremnik, naznačen time, da on obuhvaća veći broj jediničnih oblika za doziranje u skladu s patentnim zahtjevom 39.
41. Uporaba farmaceutskog pripravka prema bilo kojem od patentnih zahtjeva 1 do 23, naznačena time, da je za proizvodnju lijeka za liječenje pacijenta koji boluje od oštećenja crijevne peristaltike, sindroma iritabilnih crijeva, konstipacije, dispepsije, gastropareze, kronične crijevne pseudo-opstrukcije, Crohnove bolesti, ulcerativnog kolitisa, upalne bolesti crijeva ili od bolova koji su povezani s konstipacijom.
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PCT/US2009/004675 WO2010019266A2 (en) | 2008-08-15 | 2009-08-14 | Stable solid formulation of a gc-c receptor agonist polypeptide suitable for oral administration |
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