HRP20211244T1 - Farmaceutske kompozicije koje sadrže n-(3,5-dimetoksifenil)-n'-(1-metiletil)-n-[3-(1-metil-1h-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamin - Google Patents

Farmaceutske kompozicije koje sadrže n-(3,5-dimetoksifenil)-n'-(1-metiletil)-n-[3-(1-metil-1h-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamin Download PDF

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HRP20211244T1
HRP20211244T1 HRP20211244TT HRP20211244T HRP20211244T1 HR P20211244 T1 HRP20211244 T1 HR P20211244T1 HR P20211244T T HRP20211244T T HR P20211244TT HR P20211244 T HRP20211244 T HR P20211244T HR P20211244 T1 HRP20211244 T1 HR P20211244T1
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cancer
pharmaceutical composition
treatment
composition according
methylethyl
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HRP20211244TT
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Diego Fernando Domenico BROGGINI
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Astex Therapeutics Limited
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/498—Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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    • A—HUMAN NECESSITIES
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    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
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    • C09K15/00—Anti-oxidant compositions; Compositions inhibiting chemical change
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Claims (32)

1. Uporaba meglumina u farmaceutskoj kompoziciji kako bi se povećala kemijska stabilnost N-(3,5-dimetoksifenil)-N'-(1-metiletil)-N-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamina, njegove farmaceutski prihvatljive soli ili njegovog solvata, sadržanog u navedenoj kompoziciji.
2. Uporaba meglumina u farmaceutskoj kompoziciji kako bi se prevenirala, odložila, usporila ili umanjila transformacija N-(3,5-dimetoksifenil)-N'-(1-metiletil)-N-[3-(1-metil-1H)-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamina, njegove farmaceutski prihvatljive soli ili njegovog solvata, sadržanog u kompoziciji, u 6,8-dimetoksi-4-(1-metiletil)-1-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]-2,3,4,5-tetrahidro-1H-1,4-benzodiazepin, njegovu farmaceutski prihvatljivu sol ili njegov solvat.
3. Uporaba u skladu sa patentnim zahtjevom 1 ili 2, naznačeno time što je farmaceutska kompozicija tableta ili kapsula.
4. Uporaba u skladu sa bilo kojim od patentnih zahtjeva 1 do 3, naznačeno time što farmaceutska kompozicija sadrži N-(3,5-dimetoksifenil)-N'-(1-metiletil)-N-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamin bazu.
5. Postupak prevencije, odlaganja, usporavanja ili umanjenja transformacije N-(3,5-dimetoksifenil)-N'-(1-metiletil)-N-[3-(1-metil-1H-pirazol-4-il))kvinoksalin-6-il]etan-1,2-diamina, njegove farmaceutski prihvatljive soli ili njegovog solvata, sadržanog u farmaceutskoj kompoziciji, u 6,8-dimetoksi-4-(1-metiletil)-1-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]-2,3,4,5-tetrahidro-1H-1,4-benzodiazepin, njegovu farmaceutski prihvatljivu sol ili njegov solvat, naznačen time što sadrži dodavanje meglumina navedenoj kompoziciji.
6. Postupak u skladu sa patentnim zahtjevom 5, naznačeno time što je farmaceutska kompozicija tableta ili kapsula.
7. Postupak u skladu sa patentnim zahtjevom 5 ili 6, naznačeno time što kompozicija sadrži N-(3,5-dimetoksifenil)-Nꞌ-(1-metiletil)-N-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamin bazu.
8. Farmaceutska kompozicija koja sadrži N-(3,5-dimetoksifenil)-N'-(1-metiletil)-N-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamin, njegovu farmaceutski prihvatljivu sol ili njegov solvat; meglumin; i farmaceutski prihvatljiv nosač.
9. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 8, naznačena time što sadrži od 0,1 do 3% tež./tež. meglumina.
10. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 8 ili 9, naznačena time što je kompozicija tableta ili kapsula.
11. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 8 do 10, naznačena time što kompozicija sadrži od 0-2% tež./tež. 6,8-dimetoksi-4-(1-metiletil)-1-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]-2,3,4,5-tetrahidro-1H-1,4-benzodiazepina, njegove farmaceutski prihvatljive soli ili njegovog solvata.
12. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 11, naznačena time što kompozicija sadrži od 0-0,05% tež./tež. 6,8-dimetoksi-4-(1-metiletil)-1-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]-2,3,4,5-tetrahidro-1H-1,4-benzodiazepina, njegove farmaceutski prihvatljive soli ili njegovog solvata.
13. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 8 do 12, naznačena time što sadrži od 2 mg do 6 mg ekvivalenta baze N-(3,5-dimetoksifenil)-N'-(1-metiletil)-N-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamina, njegove farmaceutski prihvatljive soli ili njegovog solvata.
14. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 8 do 13, naznačena time što kompozicija sadrži N-(3,5-dimetoksifenil)-N'-(1-metiletil)-N-[3-(1-metil-1H-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamin bazu.
15. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 10, koja je obložena filmom sa film oblogom na vodenoj bazi.
16. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 15, naznačeno time što je film obloga na vodenoj bazi sistem trenutnog oslobađanja na bazi PVA, bez polietilen glikola.
17. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 8 do 14 za uporabu u liječenju raka, naznačeno time što se lijek treba primjenjivati dnevno tokom 3 tjedna (3 tjedna sa), praćeno 1 tjednom tokom kojeg se kompozicija ne primjenjuje (1 tjedan bez), i ponavljanjem ovog ciklusa od 3 tjedna sa, 1 tjedan bez.
18. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 8 do 14 za uporabu u liječenju raka, naznačeno time što se lijek treba primjenjivati dnevno tokom 1 tjedna (1 tjedan sa), praćeno 1 tjednom tokom kojeg se kompozicija ne primjenjuje (1 tjedan bez), i ponavljanjem ovog ciklusa od 1 tjedna sa, 1 tjedan bez.
19. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 8 do 14 za uporabu u liječenju raka, naznačeno time što kompozicija treba da se primjenjuje dnevno.
20. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 19 za uporabu u liječenju raka, naznačeno time što se kompozicija treba primjenjivati jednom dnevno.
21. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 17 do 20, (i) za uporabu u liječenju raka, pri čemu je dnevna doza 6 mg ekvivalenta baze; (ii) za uporabu u liječenju raka, pri čemu je dnevna doza 7 mg ekvivalenta baze; (iii) za uporabu u liječenju raka, pri čemu je dnevna doza 8 mg ekvivalenta baze; ili (iv) za uporabu u liječenju raka, pri čemu je dnevna doza 9 mg ekvivalenta baze.
22. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 17 do 21, (i) za uporabu u liječenju raka, pri čemu je rak rak mokraćnog mjehura; (ii) za uporabu u liječenju raka, pri čemu je rak urotelni rak; (iii) za uporabu u liječenju raka, pri čemu je rak metastatski urotelni rak; (iv) za uporabu u liječenju raka, pri čemu je rak kirurški neresektabilan urotelni rak; (v) za uporabu u liječenju raka, pri čemu je rak kolangiokarcinom; ili (vi) za uporabu u liječenju raka, pri čemu je rak nemišićno-invazivni rak mokraćnog mjehura.
23. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 22, dijelovi (ii) do (vi) za uporabu u liječenju raka, naznačeno time što je rak rak sa FGFR genomskim izmjenama.
24. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 23 za uporabu u liječenju raka, naznačeno time što su FGFR genomske izmjene translokacije, fuzije i/ili mutacije.
25. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 24 za uporabu u liječenju raka, naznačeno time što je izmjena FGFR3-TACC3 translokacija.
26. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 24 za uporabu u liječenju raka, naznačeno time što je izmjena mutacija.
27. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 26 za uporabu u liječenju raka, naznačeno time što je mutacija R248C.
28. Farmaceutska kompozicija u skladu sa patentnim zahtjevom 26 za uporabu u liječenju raka, naznačeno time što je mutacija S249C.
29. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 17 do 21 za uporabu u liječenju raka, naznačeno time što je rak uznapredovali ili refraktorni nesitnostanični rak pluća (NSCLC), rak dojke, multiformni glioblastom, urotelni rak, rak jajnika, rak glave i vrata, rak jednjaka, gastrični rak i kolangiokarcinom.
30. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 17 do 21 za uporabu u liječenju raka, naznačeno time što je rak multipli mijelom, mijeloproliferativni poremećaji, rak endometrija, rak prostate, rak mokraćnog mjehura, rak pluća, rak jajnika, rak dojke, gastrični rak, kolorektalni rak, i karcinom pločastih stanica usne šupljine.
31. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 17 do 21 za uporabu u liječenju raka, naznačeno time što je rak rak endometrija, jajnika, želučani, hepatocelularni, maternice, grlića maternice i kolorektalni.
32. Farmaceutska kompozicija u skladu sa bilo kojim od patentnih zahtjeva 17 do 21 za uporabu u liječenju bolesnog stanja ili stanja posredovanog FGFR kinazom.
HRP20211244TT 2015-02-10 2021-08-03 Farmaceutske kompozicije koje sadrže n-(3,5-dimetoksifenil)-n'-(1-metiletil)-n-[3-(1-metil-1h-pirazol-4-il)kvinoksalin-6-il]etan-1,2-diamin HRP20211244T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP15154554 2015-02-10
EP15188982 2015-10-08
EP16706551.5A EP3256109B1 (en) 2015-02-10 2016-02-09 Pharmaceutical compositions comprising n-(3,5-dimethoxyphenyl)-n'-(1-methylethyl)-n-[3-(1-methyl-1h-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine
PCT/EP2016/052743 WO2016128411A1 (en) 2015-02-10 2016-02-09 Pharmaceutical compositions comprising n-(3,5-dimethoxyphenyl)-n'-(1-methylethyl)-n-[3-(1-methyl-1h-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine

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US (3) US10898482B2 (hr)
EP (2) EP3949954A1 (hr)
JP (3) JP6796588B2 (hr)
KR (1) KR20170110145A (hr)
CN (2) CN107427511B (hr)
AU (3) AU2016218000B2 (hr)
BR (1) BR112017017009B1 (hr)
CA (1) CA2976356A1 (hr)
CL (1) CL2017002022A1 (hr)
CO (1) CO2017008862A2 (hr)
CR (1) CR20170411A (hr)
CY (1) CY1124432T1 (hr)
DK (1) DK3256109T3 (hr)
ES (1) ES2883829T3 (hr)
HR (1) HRP20211244T1 (hr)
HU (1) HUE056761T2 (hr)
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MA (2) MA55571A (hr)
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PL (1) PL3256109T3 (hr)
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GB201020179D0 (en) 2010-11-29 2011-01-12 Astex Therapeutics Ltd New compounds
GB201118654D0 (en) 2011-10-28 2011-12-07 Astex Therapeutics Ltd New compounds
GB201118652D0 (en) 2011-10-28 2011-12-07 Astex Therapeutics Ltd New compounds
GB201118675D0 (en) 2011-10-28 2011-12-14 Astex Therapeutics Ltd New compounds
GB201118656D0 (en) 2011-10-28 2011-12-07 Astex Therapeutics Ltd New compounds
GB201209609D0 (en) 2012-05-30 2012-07-11 Astex Therapeutics Ltd New compounds
GB201209613D0 (en) 2012-05-30 2012-07-11 Astex Therapeutics Ltd New compounds
GB201307577D0 (en) 2013-04-26 2013-06-12 Astex Therapeutics Ltd New compounds
KR102479693B1 (ko) 2014-03-26 2022-12-22 아스텍스 테라퓨틱스 리미티드 조합물
JO3512B1 (ar) 2014-03-26 2020-07-05 Astex Therapeutics Ltd مشتقات كينوكسالين مفيدة كمعدلات لإنزيم fgfr كيناز
WO2015144808A1 (en) 2014-03-26 2015-10-01 Astex Therapeutics Ltd Combinations of an fgfr inhibitor and an igf1r inhibitor
JOP20200201A1 (ar) 2015-02-10 2017-06-16 Astex Therapeutics Ltd تركيبات صيدلانية تشتمل على n-(3.5- ثنائي ميثوكسي فينيل)-n'-(1-ميثيل إيثيل)-n-[3-(ميثيل-1h-بيرازول-4-يل) كينوكسالين-6-يل]إيثان-1.2-ثنائي الأمين
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