HRP20160682T1 - Čvrsti oblici 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksiamido)-3-metilpiridin-2-il)benzojeve kiseline - Google Patents

Čvrsti oblici 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksiamido)-3-metilpiridin-2-il)benzojeve kiseline Download PDF

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HRP20160682T1
HRP20160682T1 HRP20160682TT HRP20160682T HRP20160682T1 HR P20160682 T1 HRP20160682 T1 HR P20160682T1 HR P20160682T T HRP20160682T T HR P20160682TT HR P20160682 T HRP20160682 T HR P20160682T HR P20160682 T1 HRP20160682 T1 HR P20160682T1
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Croatia
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compound
disease
degrees
solvate form
solvate
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HRP20160682TT
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Ali Keshavarz-Shokri
Beili Zhang
Mariusz Krawiec
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Vertex Pharmaceuticals Incorporated
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Publication of HRP20160682T1 publication Critical patent/HRP20160682T1/hr

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Claims (23)

1. Čvrsti oblik 3-(6-(1-(2,2-Difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metil piridin-2-il)benzojeva kiselina (Spoj 1), karakterizirano kao Spoj 1, Solvatni Oblik A.
2. Spoj 1, Solvatni Oblik A iz zahtjeva 1, u kojem je Spoj 1, Solvatni Oblik A karakteriziran kao: a. kristalna rešetka Spoja 1 koja sadrži više ponavljajućih praznina koje su prazne ili bar djelomično zauzete solvatom; ili b. kristalna rešetka Spoja 1 koja sadrži više ponavljajućih praznina, pri čemu su mnoge šupljine prazne.
3. Spoj 1, Solvatni Oblik A prema zahtjevu 1 ili 2, naznačeno time što pri rendgenskoj difrakciji praha Cu K alfa zračenjem, ima jedan ili više pikova na: a) 21.5 do 21.9 stupnjeva, 8.8 do 9.2 stupnjeva, i 10.8 do 11.2; b) 21.5 do 21.9 stupnjeva, 8.8 do 9.2 stupnjeva, i 10.08 do 11.2 stupnjeva, 18.0 do 18.4 stupnjeva, i 22.9 do 23.3. c) 21.70, 8.98, 11.04, 18.16, 23.06 i stupnjeva; d) 21.5 do 21.9 stupnjeva; e) 21.70 stupnjeva; f) 8.8 do 9.2 stupnjeva; g) 8.98 stupnjeva; h) 10.8 do 11.2 stupnjeva; i) 11.40 stupnjeva; j) 18.0 do 18.4 stupnjeva; ili k) 18.16 stupnjeva.
4. Spoj 1, Solvatni Oblik A prema bilo kojem od zahtjeva 1 do 3 dodatno naznačeno time što pri rendgenskoj difrakciji Cu K alfa zračenjem ima pikove na: a) 22.9 do 23.3 stupnjeva; ili b) 23.06 stupnjeva.
5. Spoj 1, Solvatni Oblik A prema zahtjevu 2, pri čemu je Spoj 1, Solvatni Oblik A naznačeno difraktogramom koji je značajno sličan prikazanom na Slici 1.
6. Spoj 1, Solvatni Oblik A prema zahtjevu 2, pri čemu je solvat odabran iz grupe koju čine organski solvati veličine dovoljne da stanu u većinu ponavljajućih praznina.
7. Spoj 1, Solvatni Oblik A prema patentnom zahtjevu 6, u kojem je solvat izabran iz grupe koju čine metanol, etanol, aceton, izopropanol, acetonitril, tetrahidrofuran, metil acetat, 2-butanon, etil format, etil acetat i 2- metiltetrahidrofuran.
8. Spoj 1, Solvatni Oblik A prema zahtjevu 6, pri čemu Spoj 1, Solvatni Oblik A sadrži: a) 1 do 10 tež. % solvata kako je utvrđeno pomoću TGA; ili b) 2 do 5 tež. % solvata kako je utvrđeno pomoću TGA.
9. Spoj 1, Solvatni Oblik A prema zahtjevu 2, pri čemu je njegova točka topljenja od 185°C do 190°C.
10. Spoj 1, Solvatni Oblik A prema zahtjevu 2, koje ima P21/n prostornu grupu i slijedeće dimenzije jedinične ćelije: a = 16.5235 (10) α = 90° b = 12.7425 (8) β = 103.736 (4)° c = 20.5512 (13) a γ = 90°.
11. Spoj 1, Solvatni Oblik A prema zahtjevu 1, pri čemu Spoj 1, Solvatni Oblik A ima veličinu čestica: a) 0.1 mikrona do 50 mikrona; b) 0.1 mikrona do 20 mikrona; c) 0.1 mikrona do 10 mikrona; d) 1.0 mikrona do 5 mikrona; ili e) D50 od 2.0 mikrona.
12. Farmaceutski sastav koji sadrži Spoj 1, Solvatni Oblik A, prema zahtjevu 1 i farmaceutski prihvatljiv nosač.
13. Farmaceutski sastav prema patentnom zahtjevu 12, koji zatim sadrži i dodatni terapeutski agens.
14. Spoj 1, Solvatni Oblik A prema zahtjevu 1, za upotrebu u liječenju CFTR posredovane bolesti kod sisavaca.
15. Spoj za upotrebu prema zahtjevu 14, pri čemu je CFTR posredovana bolest izabrana od slijedećih bolesti: cistična fibroza, astma, dimom inducirana kronična opstruktivna bolest pluća, kronični bronhitis, rinosinusitis, konstipacija, pankreatitis, insuficijencija pankreasa, muška neplodnost uzrokovana kongenitalnim bilateralnim odsustvom VAS deferensa (CBAVD), umjerena bolest pluća, idiopatski pankreatitis, alergijska bronhopulmonalna aspergiloza (ABPA), bolesti jetre, nasljedni emfizem, nasljedna hemokromatoza, nedostatak koagulacije-fibrinoliza, nedostatak proteina C, nasljedni angioedem tip 1, nedostaci obrade lipida, familijarna hiperkolesterolemija, hilomikronemija Tip 1, abetalipoproteinemija, lizosomske bolesti nakupljanja, bolest I-ćelija/pseudo-Hurler, mukopolisaharidoze, Sandhof/Tai-Saksova bolest, Crigler-Najjar sindrom tip II, poliendokrinopatija/ hiperinsulemija, dijabetes melitus, Laron patuljasti rast, nedostatak mijeloperoksidaze, primarni hipoparatiroidizam, melanom, glikanoza CDG tip 1, urođena hipotireoza, bolest krhkih kostiju, nasljedna hipofibrinogenemija, nedostatak ACT, insipidni dijabetes (DI), neurofizealni DI, nefrogeni DI, Charcot-Marie Tooth-ova bolest, Pelizaeus-Merzbacher bolest, neurodegenerativne bolesti, Alzheimerova bolest, Parkinsonova bolest, amiotropska lateralna skleroza, progresivna supranuklearna paraliza, Pick-ova bolest, poliglutaminski neurološki poremećaji, Huntingtonova bolest, spinocerebralna ataksija tip 1, spinalna i bulbarna mišićna atrofija, Dentatorubral-Pallidoluysian atrofija, Miotonična distrofija, spongiformne encefalopatije, nasljedna Creutzfeldt-Jakobova bolest uslijed nedostataka u preradi proteina, Fabrijeva bolest, Gertsmann-Straussler-Scheinker-ova bolest, kronična opstruktivna bolest pluća COPD, bolest suhog oka, Sjogrenova bolest, osteoporoza, Osteopenija, Gorhamov sindrom, kloridne kanalopatije, kongenitalna miotonija (Thomson i Becker oblika), Barterov sindrom tip III, Dentova bolest, hiperekpleksija, epilepsija, hiperekpleksija, lizozomske bolesti nakupljanja, Angelmanov sindrom, primarna cilijarna diskinezija (PCD), nasljedna oboljenja od strukture i/ili funkcije cilija, PCD sa situs inversus, PCD bez situs inversus, ili cilijarna aplazija.
16. Spoj za upotrebu prema Zahtjevu 15, pri čemu je CFTR posredovana bolest cistična fibroza, emfizem, COPD, bolest suhog oka ili osteoporoza.
17. Spoj za upotrebu prema Zahtjevu 15, pri čemu je CFTR posredovana bolest cistična fibroza.
18. Spoj za upotrebu prema bilo kojem od patentnih zahtjeva 15 do 17, pri čemu spomenuti pacijent ima transmembranski receptor cistične fibroze (CFTR) sa ΔF508 mutacijom.
19. Spoj za upotrebu prema bilo kojem od zahtjeva 15 do 17, pri čemu spomenuti pacijent ima transmembranski receptor cistične fibroze (CFTR) sa R117H mutacijom.
20. Spoj za upotrebu prema bilo kojem od patentnih zahtjeva 15 do 17, pri čemu spomenuti pacijent ima transmembranski receptor cistične fibroze (CFTR) sa G551D mutacijom.
21. Spoj za upotrebu prema bilo kojem od patentnih zahtjeva 15 do 17, pri čemu postupak obuhvaća davanje dodatnog terapeutskog agensa.
22. Komplet koji sadrži Spoj 1, Solvatni Oblik A prema zahtjevu 1 i uputstvo za upotrebu.
23. Farmaceutska formulacija prema zahtjevu 13, u kojoj je dodatni terapeutski agens N-(5-hidroksi-2,4-diterebutil-fenil)-4-okso-1H-hinolin-3-karboksamid.
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