HRP20191439T1 - Formulacije 3-(6-(1-(2.2-difluorobenzo[d][1,3]dioksol-5-il) ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeve kiseline - Google Patents

Formulacije 3-(6-(1-(2.2-difluorobenzo[d][1,3]dioksol-5-il) ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeve kiseline Download PDF

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Publication number
HRP20191439T1
HRP20191439T1 HRP20191439T HRP20191439T1 HR P20191439 T1 HRP20191439 T1 HR P20191439T1 HR P20191439 T HRP20191439 T HR P20191439T HR P20191439 T1 HRP20191439 T1 HR P20191439T1
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Croatia
Prior art keywords
tablet
cyclopropanecarboxamido
difluorobenzo
dioxol
methylpyridin
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Application number
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English (en)
Inventor
Marinus Jacobus Verwijis
Original Assignee
Vertex Pharma
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Publication date
Application filed by Vertex Pharma filed Critical Vertex Pharma
Publication of HRP20191439T1 publication Critical patent/HRP20191439T1/hr

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    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
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Claims (5)

1. Kontinuirani postupak za pripremanje tablete koja sadrži spoj 1, koji sadrži korake: a) miješanje spoja 1, punila, i sredstva za raspadanje u uređaju za miješanje da bi se dobila smjesa; b) pripremanje granulacijske otopine s vodom, vezivnim sredstvom, i površinski aktivnom tvari; c) dovođenje smjese iz koraka a) u kontinuirani dvostruki pužni granulator dok se dodaje granulacijska otopina iz koraka b) da bi se proizvele granule; d) sušenje granula iz koraka c) i njihovo mljevenje; e) miješanje samljevenih granula iz koraka d) s punilom, sredstvom za raspadanje, i lubrikantom da bi se dobila smjesa; i f) sažimanje smjese iz koraka e) u tabletu; gdje je spoj 1 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il) ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeva kiselina.
2. Postupak prema zahtjevu 1, gdje postupak dalje obuhvaća korak oblaganja tablete iz koraka f).
3. Postupak prema zahtjevu 2, gdje je tableta obložena filmom ili sredstvom za bojenje.
4. Postupak prema zahtjevu 1, zahtjevu 2, ili zahtjevu 3, gdje je spoj 1 (3-(6-(1-(2,2-difluorobenzo[d][1,3]dioksol-5-il)ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeva kiselina) u obliku I, gdje je oblik I karakteriziran jednim ili više signala na 15.2 do 15.6 stupnjeva, 16.1 do 16.5 stupnjeva, i 14.3 do 14.7 stupnjeva difrakcijom X-zraka na prahu dobivenoj upotrebom Cu K alfa zračenja.
5. Postupak prema bilo kojem od zahtjeva 1 do 4, gdje tableta dalje sadrži N-(5-hidroksi-2,4-diterc-butil-fenil)-4-okso-1H-hinolin-3-karboksamid.
HRP20191439 2012-01-25 2019-08-08 Formulacije 3-(6-(1-(2.2-difluorobenzo[d][1,3]dioksol-5-il) ciklopropankarboksamido)-3-metilpiridin-2-il)benzojeve kiseline HRP20191439T1 (hr)

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DK2806859T3 (da) 2019-08-05
IL233830B (en) 2019-03-31
CA2862859C (en) 2022-08-02
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HK1255336A1 (zh) 2019-08-16
RS59262B1 (sr) 2019-10-31
CN108066306A (zh) 2018-05-25
ZA201405590B (en) 2016-08-31
KR20140117612A (ko) 2014-10-07
HUE044676T2 (hu) 2019-11-28
UA114619C2 (uk) 2017-07-10
CA3128556A1 (en) 2013-08-01
LT2806859T (lt) 2019-10-25
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US20160324788A1 (en) 2016-11-10

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