HRP20161742T1 - Soli i polimorfi od 8-fluoro-2-{4-[(metilamino)metil]fenil}-1,3,4,5-tetrahidro-6h-azepino[5,4,3-cd]indol-6-ona - Google Patents

Soli i polimorfi od 8-fluoro-2-{4-[(metilamino)metil]fenil}-1,3,4,5-tetrahidro-6h-azepino[5,4,3-cd]indol-6-ona Download PDF

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HRP20161742T1
HRP20161742T1 HRP20161742TT HRP20161742T HRP20161742T1 HR P20161742 T1 HRP20161742 T1 HR P20161742T1 HR P20161742T T HRP20161742T T HR P20161742TT HR P20161742 T HRP20161742 T HR P20161742T HR P20161742 T1 HRP20161742 T1 HR P20161742T1
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salt
salt according
group
camsylate
ppm
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HRP20161742TT
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Patricia Ann Basford
Anthony Michael Campeta
Adam Gillmore
Matthew Cameron Jones
Eleftherios Kougoulos
Suman Luthra
Robert Walton
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Pfizer Inc.
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Publication of HRP20161742T1 publication Critical patent/HRP20161742T1/hr
Publication of HRP20161742T4 publication Critical patent/HRP20161742T4/hr

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Claims (27)

1. Kamsilat-sol, naznačena time, da je od 8-fluoro-2-{4-[(metilamino)metil]fenil}-1,3,4,5-tetrahidro-6H-azepino[5,4,3-cd]indol-6-ona.
2. Sol prema zahtjevu 1, naznačena time, da sol je kristalna.
3. Sol prema zahtjevu 1, naznačena time, da je to kristalna bezvodna sol.
4. Sol prema bilo kojem od zahtjeva 1 do 3, naznačena time, da kamsilat je S-kamsilat.
5. Sol prema bilo kojem od zahtjeva 1 do 3, naznačena time, da kamsilat je R-kamsilat.
6. Sol prema bilo kojem od zahtjeva 1 do 5, naznačena time, da sol ima uzorak difrakcije praha X-zraka koji sadrži jednu ili više ili tri ili više ili tri vršne vrijednosti s difrakcijskim kutevima (2θ) odabranima iz skupine koja se sastoji od 12,2 ± 0,2, 14,8 ± 0,2 i 22,4 ± 0,2, pri čemu se navedeni uzorak rendgenske difrakcije praha dobiva uporabom bakar-K-α1-X-zraka valne duljine od 1,5406 Angstroma.
7. Sol prema bilo kojem od zahtjeva 1 do 6, naznačena time, da sol ima kruto stanje NMR spektra koje sadrži jedan ili više 13C-kemijskih pomaka odabranih iz skupine koja se sastoji od 213,4 ± 0,2, 171,8 ± 0,2 i 17,3 ± 0,2 ppm.
8. Sol prema bilo kojem od zahtjeva 1 do 7, naznačena time, da sol ima kruto stanje NMR spektra koje sadrži jedan ili više 19F-kemijskih pomaka odabranih iz skupine koja se sastoji od -118,9 ± 0,2 i -119,7 ppm ± 0,2.
9. Sol prema bilo kojem od zahtjeva 1 do 8, naznačena time, da sol ima uzorak difrakcije praha X-zraka koji sadrži jednu ili više ili tri ili više ili tri vršne vrijednosti s difrakcijskim kutevima (2θ) odabranima iz skupine koja se sastoji od 12,2 ± 0,2, 14,8 ± 0,2 i 22,4 ± 0,2, koji se dobiva uporabom bakar-K-α1-X-zraka valne duljine od 1,5406 Angstroma; gdje kruto stanje NMR spektra sadrži jedan ili više ili dva ili više ili tri 13C-kemijska pomaka odabrana iz skupine koja se sastoji od 213,4 ± 0,2, 171,8 ± 0,2 i 17,3 ± 0,2 ppm; i kruto stanje NMR spektra sadrži jedan ili više ili dva 19F-kemijska pomaka odabrana iz skupine koja se sastoji od -118,9 ± 0,2 i -119,7 ppm ± 0,2.
10. Sol prema bilo kojem od zahtjeva 1 do 9, naznačena time, da sol je bitno čisti polimorf od polimorfa S-kamsilat-oblik A.
11. Sol prema bilo kojem od zahtjeva 1 do 3, naznačena time, da sol je bitno čisti polimorf od polimorfa S-kamsilat-oblik B ili je bitno čisti polimorf od polimorfa S-kamsilat-oblik C.
12. Maleat-sol, naznačena time, da je od 8-fluoro-2-{4-[(metilamino)metil]fenil}-1,3,4,5-tetrahidro-6H-azepino[5,4,3-cd]indol-6-ona.
13. Sol prema zahtjevu 12, naznačena time, da sol je kristalna.
14. Sol prema zahtjevu 12, naznačena time, da sol je kristalna bezvodna sol.
15. Sol prema bilo kojem od zahtjeva 12 do 14, naznačena time, da sol ima uzorak difrakcije praha X-zraka koji sadrži vršne vrijednosti s difrakcijskim kutevima (2θ) od 6,0 ± 0,2, 20,3 ± 0,2 i 21,7 ± 0,2, pri čemu se navedeni uzorak rendgenske difrakcije praha dobiva uporabom bakar-K-α1-X-zraka valne duljine od 1,5406 Angstroma.
16. Sol prema bilo kojem od zahtjeva 12 do 15, naznačena time, da sol je bitno čisti polimorf od polimorfa maleat-oblik A.
17. Sol prema bilo kojem od zahtjeva 12 do 14, naznačena time, da sol ima uzorak difrakcije praha X-zraka koji sadrži vršne vrijednosti s difrakcijskim kutevima (2θ) od 7,5 ± 0,2, 11,3 ± 0,2 i 24,3 ± 0,2, pri čemu se navedeni uzorak rendgenske difrakcije praha dobiva uporabom bakar-K-α1-X-zraka valne duljine od 1,5406 Angstroma.
18. Sol prema bilo kojem od zahtjeva 12 do 14 i 17, naznačena time, da sol ima kruto stanje NMR spektra koje sadrži jedan ili više 13C-kemijskih pomaka odabranih iz skupine koja se sastoji od 171,3 ± 0,2, 112,4 ± 0,2 i 43,8 ± 0,2 ppm.
19. Sol prema bilo kojem od zahtjeva 12 do 14 i 17 do 18, naznačena time, da sol ima kruto stanje NMR spektra koje sadrži 19F-kemijski pomak na -123,1 ppm ± 0,2.
20. Sol prema bilo kojem od zahtjeva 12 do 14 i 17 do 19, naznačena time, da sol ima uzorak difrakcije praha X-zraka koji sadrži jednu ili više ili dvije ili više ili tri vršne vrijednosti s difrakcijskim kutevima (2θ) odabranima iz skupine koja se sastoji od 7,5 ± 0,2, 11,3 ± 0,2 i 24,3 ± 0,2, koji se dobiva uporabom bakar-K-α1-X-zraka valne duljine od 1,5406 Angstroma; gdje kruto stanje NMR spektra sadrži jedan ili više ili dva ili više ili tri 13C-kemijska pomaka odabrana iz skupine koja se sastoji od 171,3 ± 0,2, 112,4 ± 0,2 i 43,8 ± 0,2 ppm; i kruto stanje NMR spektra sadrži 19F-kemijski pomak na -123,1 ± 0,2 ppm.
21. Sol prema bilo kojem od zahtjeva 12 do 14 i 17 do 20, naznačena time, da sol je bitno čisti polimorf od polimorfa maleat-oblik B.
22. Farmaceutski sastav, naznačen time, da obuhvaća sol prema bilo kojem od zahtjeva 1 do 21.
23. Sol prema bilo kojem od zahtjeva 1 do 21, i farmaceutski sastav prema zahtjevu 22, naznačen/a time, da se upotrebljava u postupku liječenja bolesnih stanja kod sisavaca koja su posredovana putem djelovanja poli(ADP-riboza)-polimeraza, pri čemu postupak obuhvaća primjenu terapeutski učinkovite količine navedene soli ili navedenog farmaceutskog sastava, na sisavcu kojemu je to potrebno.
24. Sol prema bilo kojem od zahtjeva 1 do 21, i farmaceutski sastav prema zahtjevu 22, naznačen/a time, da se upotrebljava u postupku liječenja raka kod sisavaca, pri čemu postupak obuhvaća primjenu terapeutski učinkovite količine navedene soli ili navedenog farmaceutskog sastava, na sisavcu kojemu je to potrebno.
25. Uporaba soli prema bilo kojem od zahtjeva 1 do 21, naznačena time, da je za proizvodnju lijeka za liječenje raka.
26. Postupak, naznačen time, da se koristi za proizvodnju soli prema bilo kojem od zahtjeva 1 do 21.
27. Postupak prema zahtjevu 26, naznačen time, da sol je polimorfna sol i bitno je oslobođena od ostalih polimorfnih oblika od 8-fluoro-2-{4-[(metilamino)metil]fenil}-1,3,4,5-tetrahidro-6H-azepino[5,4,3-cd]indol-6-ona.
HRP20161742TT 2010-02-12 2011-02-10 Soli i polimorfi od 8-fluoro-2-{4-[(metilamino)metil]fenil}-1,3,4,5-tetrahidro-6h-azepino[5,4,3-cd]indol-6-ona HRP20161742T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US30427710P 2010-02-12 2010-02-12
EP11708094.5A EP2534153B2 (en) 2010-02-12 2011-02-10 Salts and polymorphs of 8-fluoro-2-{4-[(methylamino}methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one
PCT/IB2011/050571 WO2011098971A1 (en) 2010-02-12 2011-02-10 Salts and polymorphs of 8-fluoro-2-{4-[(methylamino}methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one

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HRP20161742T1 true HRP20161742T1 (hr) 2017-02-24
HRP20161742T4 HRP20161742T4 (hr) 2024-07-05

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HRP20161742TT HRP20161742T4 (hr) 2010-02-12 2011-02-10 Soli i polimorfi od 8-fluoro-2-{4-[(metilamino)metil]fenil}-1,3,4,5-tetrahidro-6h-azepino[5,4,3-cd]indol-6-ona
HRP20191944TT HRP20191944T1 (hr) 2010-02-12 2019-10-25 Soli i polimorfi od 8-fluoro-2-{4-[(metilamino)metil]fenil}-1,3,4,5-tetrahidro-6h-azepino[5,4,3-cd]indol-6-ona

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CY1122218T1 (el) 2020-11-25

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