HRP20200664T1 - Čvrsti oblici 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il) ciklopropankarboksamido)-3-metilpiridin-2-il) benzojeve kiseline - Google Patents
Čvrsti oblici 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il) ciklopropankarboksamido)-3-metilpiridin-2-il) benzojeve kiseline Download PDFInfo
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- UFSKUSARDNFIRC-UHFFFAOYSA-N lumacaftor Chemical compound N1=C(C=2C=C(C=CC=2)C(O)=O)C(C)=CC=C1NC(=O)C1(C=2C=C3OC(F)(F)OC3=CC=2)CC1 UFSKUSARDNFIRC-UHFFFAOYSA-N 0.000 title claims 9
- 239000007787 solid Substances 0.000 title 1
- 239000003814 drug Substances 0.000 claims 20
- 239000008194 pharmaceutical composition Substances 0.000 claims 17
- 229940124597 therapeutic agent Drugs 0.000 claims 11
- 229940079593 drug Drugs 0.000 claims 9
- PURKAOJPTOLRMP-UHFFFAOYSA-N ivacaftor Chemical group C1=C(O)C(C(C)(C)C)=CC(C(C)(C)C)=C1NC(=O)C1=CNC2=CC=CC=C2C1=O PURKAOJPTOLRMP-UHFFFAOYSA-N 0.000 claims 8
- 241000124008 Mammalia Species 0.000 claims 7
- 201000003883 Cystic fibrosis Diseases 0.000 claims 6
- 102000012605 Cystic Fibrosis Transmembrane Conductance Regulator Human genes 0.000 claims 4
- 108010079245 Cystic Fibrosis Transmembrane Conductance Regulator Proteins 0.000 claims 4
- 239000013078 crystal Substances 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 239000000843 powder Substances 0.000 claims 3
- 230000005855 radiation Effects 0.000 claims 3
- 239000003242 anti bacterial agent Substances 0.000 claims 1
- 239000002260 anti-inflammatory agent Substances 0.000 claims 1
- 229940121363 anti-inflammatory agent Drugs 0.000 claims 1
- 229960005475 antiinfective agent Drugs 0.000 claims 1
- 239000004599 antimicrobial Substances 0.000 claims 1
- 230000003115 biocidal effect Effects 0.000 claims 1
- 229940124630 bronchodilator Drugs 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000003172 expectorant agent Substances 0.000 claims 1
- 229940066491 mucolytics Drugs 0.000 claims 1
- 235000016709 nutrition Nutrition 0.000 claims 1
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- C07D405/12—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings linked by a chain containing hetero atoms as chain links
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- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/443—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
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- A61K31/47—Quinolines; Isoquinolines
- A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
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Claims (27)
1. Farmaceutski sastav koji sadrži:
3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metilpiridin-2-il)benzojevu kiselinu karakteriziranu kao oblik I;
farmaceutski prihvatljiv nosač; i
dodatno terapeutsko sredstvo izabrano između mukolitičnog sredstva, bronhodilatora, antibiotika, anti-infektivnog sredstva, anti-upalnog sredstva, modulatora regulatora transmembranske provodljivosti u cističnoj fibrozi (CFTR), ili nutritivnog sredstva,
gdje je oblik I karakteriziran kao kristalni oblik koji ima monoklinični kristalni sistem, prostornu grupu P21/n, i sljedeće dimenzije jedinične stanice:
a = 4.9626 (7) Å α = 90°
b = 12.2994 (18) Å β = 93.938 (9)°
c = 33.075 (4) Å γ = 90°, i/ili
gdje je oblik I karakteriziran s jednim ili više vrhova na 15.4 stupnjeva ± 0.2 stupnja, 16.3 stupnjeva ± 0.2 stupnja, i 14.5 stupnjeva ± 0.2 stupnja u difrakciji redgneskih zraka na prahu dobivenih pomoću Cu K alfa zračenja na 40 kV, 35 mA.
2. Farmaceutski sastav prema zahtjevu 1, gdje je dodatno terapeutsko sredstvo CFTR modulator.
3. Farmaceutski sastav prema zahtjevu 1 ili zahtjevu 2, gdje je CFTR modulator N-(5-hidroksi-2,4-diterc-butil-fenil)-4-okso-1H-kinolin-3-karboksamid.
4. Farmaceutski sastav prema bilo kojem od zahtjeva 1 do 3, za upotrebu u postupku liječenja cistične fibroze.
5. Upotreba farmaceutskog sastava prema bilo kojem od zahtjeva 1 do 3, u proizvodnji lijeka za liječenje cistične fibroze.
6. 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeva kiselina karakterizirana kao oblik I,
za upotrebu u postupku liječenja cistične fibroze kod sisavca,
gdje postupak obuhvaća davanje sisavcu efikasne količine oblika I; i
gdje postupak obuhvaća davanje dodatnog terapeutskog sredstva;
gdje je oblik I kao što je definirano u zahtjevu 1.
7. 3-(6-(1-(2,2-Difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeva kiselina karakterizirana kao oblik I za upotrebu prema zahtjevu 6, gdje je dodatno terapeutsko sredstvo N-(5-hidroksi-2,4-diterc-butilfenil)-4-okso-1H-kinolin-3-karboksamid.
8. 3-(6-(1-(2,2-Difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeva kiselina karakterizirana kao oblik I za upotrebu prema zahtjevu 6 ili zahtjevu 7, gdje je oblik I davan zajedno sa, prije ili poslije dodatnog terapeutskog sredstva.
9. N-(5-hidroksi-2,4-diterc-butil-fenil)-4-okso-1H-kinolin-3-karboksamid za upotrebu u postupku liječenja cistične fibroze kod sisavca,
gdje postupak obuhvaća davanje sisavcu efikasne količine N-(5-hidroksi-2,4-diterc-butilfenil)-4-okso-1H-kinolin-3-karboksamida; i
gdje postupak obuhvaća davanje dodatnog terapeutskog sredstva koje je 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il) ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeva kiselina karakterizirana kao oblik I;
gdje je oblik I kao što je definirano u zahtjevu 1.
10. N-(5-hidroksi-2,4-diterc-butil-fenil)-4-okso-1H-kinolin-3-karboksamid za upotrebu kao u zahtjevu 9, gdje je N-(5-hidroksi-2,4-diterc-butil-fenil)-4-okso-1H-kinolin-3-karboksamid davan zajedno, prije ili poslije 3-(6-(1-(2,2-Difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeve kiseline karakterizirane kao oblik I.
11. Upotreba 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeve kiseline karakterizirane kao oblik I u proizvodnji lijeka za liječenje cistične fibroze kod sisavca,
gdje je lijek pripremljen za davanje sisavcu u efikasnoj količini; i
gdje je lijek pripremljen za davanje s dodatnim terapeutskim sredstvom;
gdje je oblik I kao što je definirano u zahtjevu 1.
12. Upotreba prema zahtjevu 11, gdje je dodatno terapeutsko sredstvo N-(5-hidroksi-2,4-diterc-butil-fenil)-4-okso-1H-kinolin-3-karboksamid.
13. Upotreba prema zahtjevu 11 ili zahtjevu 12, gdje je lijek pripremljen za davanje zajedno sa, prije ili poslije dodatnog terapeutskog sredstva.
14. Upotreba N-(5-hidroksi-2,4-diterc-butil-fenil)-4-okso-1H-kinolin-3-karboksamida u proizvodnji lijeka za liječenje cistične fibroze kod sisavaca,
gdje je lijek pripremljen za davanje u efikasnoj količini ; i
gdje je lijek pripremljen za davanje sa dodatnim terapeutskim sredstvom koje je 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeva kiselina karakterizirana kao oblik I;
gdje je oblik I kao što je definirano u zahtjevu 1 .
15. Upotreba prema zahtjevu 14, gdje je lijek pripremljen za davanje zajedno, prije ili poslije dodatnog terapeutskog sredstva.
16. Farmaceutski sastav prema zahtjevu 1, gdje je oblik I karakteriziran kao kristalni oblik koji ima monoklinični kristalni sistem, prostornu grupu P21/n, i sljedeće dimenzije jedinične stanice:
a = 4.9626 (7) Å α = 90°
b = 12.2994 (18) Å β = 93.938 (9)°
c = 33.075 (4) Å γ = 90°.
17. Farmaceutski sastav prema zahtjevu 1, gdje je oblik I karakteriziran sa jednim ili više vrhova na 15.4 stupnjeva ± 0.2 stupnja, 16.3 stupnjeva ± 0.2 stupnja, i 14.5 stupnjeva ± 0.2 stupnja u difrakciji redgneskih zraka na prahu dobivenih pomoću Cu K alfa zračenja na 40 kV, 35 mA.
18. Farmaceutski sastav prema zahtjevu 1, gdje je oblik I karakteriziran kao kristalni oblik koji ima monoklinični kristalni sistem, prostornu grupu P21/n, i sljedeće dimenzije jedinične stanice:
a = 4.9626 (7) Å α = 90°
b = 12.2994 (18) Å β = 93.938 (9)°
c = 33.075 (4) Å γ = 90°, i
gdje je oblik I karakteriziran sa jednim ili više vrhova na 15.4 stupnjeva ± 0.2 stupnja, 16.3 stupnjeva ± 0.2 stupnja, i 14.5 stupnjeva ± 0.2 stupnja u difrakciji redgneskih zraka na prahu dobivenih pomoću Cu K alfa zračenja na 40 kV, 35 mA.
19. Farmaceutski sastav prema bilo kojem od zahtjeva 1, 17, ili 18, gdje je oblik 1 karakteriziran vrhovima na 15.4 stupnjeva ± 0.2 stupnja, 16.3 stupnjeva ± 0.2 stupnja, i 14.5 stupnjeva ± 0.2 stupnja.
20. Farmaceutski sastav prema prema bilo kojem od zahtjeva 1, ili 17-19, gdje je oblik 1 dalje karakteriziran vrhom na 14.8 stupnjeva ± 0.2 stupnja.
21. Farmaceutski sastav prema bilo kojem od zahtjeva 1, ili 17-20, gdje je oblik 1 dalje karakteriziran vrhom na 17.8 stupnjeva ± 0.2 stupnja.
22. Farmaceutski sastav prema bilo kojem od zahtjeva 1, ili 17-21, gdje je oblik 1 dalje karakteriziran vrhom na 16.6 stupnjeva ± 0.2 stupnja.
23. Farmaceutski sastav prema bilo kojem od zahtjeva 1, ili 17-22, gdje je oblik 1 dalje karakteriziran vrhom na 7.8 stupnjeva ± 0.2 stupnja.
24. Farmaceutski sastav prema bilo kojem od zahtjeva 1, ili 17-23, gdje je oblik 1 dalje karakteriziran vrhom na 26.0 stupnjeva ± 0.2 stupnja.
25. Farmaceutski sastav prema bilo kojem od zahtjeva 1, ili 17-24, gdje je oblik 1 dalje karakteriziran vrhom na 21.6 stupnjeva ± 0.2 stupnja.
26. Farmaceutski sastav prema bilo kojem od zahtjeva 1, ili 17-25, gdje je oblik 1 dalje karakteriziran vrhom na 23.3 stupnjeva ± 0.2 stupnja.
27. Farmaceutski sastav prema bilo kojem od zahtjeva 1, ili 17-19, gdje je oblik 1 dalje karakteriziran vrhom na 14.8 stupnjeva ± 0.2 stupnja, 17.8 stupnjeva ± 0.2 stupnja, 16.6 stupnjeva ± 0.2 stupnja, 7.8 stupnjeva ± 0.2 stupnja, 26.0 stupnjeva ± 0.2 stupnja, 21.6 stupnjeva ± 0.2 stupnja, i 23.3 stupnjeva ± 0.2 stupnja.
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US1216207P | 2007-12-07 | 2007-12-07 | |
EP16198922.3A EP3170818B1 (en) | 2007-12-07 | 2008-12-04 | Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid |
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HRP20200664T1 true HRP20200664T1 (hr) | 2020-07-24 |
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HRP20170241TT HRP20170241T2 (hr) | 2007-12-07 | 2017-02-14 | Čvrsti oblici 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeve kiseline |
HRP20200664TT HRP20200664T1 (hr) | 2007-12-07 | 2020-04-24 | Čvrsti oblici 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il) ciklopropankarboksamido)-3-metilpiridin-2-il) benzojeve kiseline |
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