DK2409975T3 - Faste dispersioner omfattende et amorf legeme bestående af en heterocyklisk anti-tumor-forbindelse - Google Patents
Faste dispersioner omfattende et amorf legeme bestående af en heterocyklisk anti-tumor-forbindelse Download PDFInfo
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- DK2409975T3 DK2409975T3 DK11168461.9T DK11168461T DK2409975T3 DK 2409975 T3 DK2409975 T3 DK 2409975T3 DK 11168461 T DK11168461 T DK 11168461T DK 2409975 T3 DK2409975 T3 DK 2409975T3
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- C07D403/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings
- C07D403/04—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings directly linked by a ring-member-to-ring-member bond
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- C07D413/14—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing three or more hetero rings
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- C07D—HETEROCYCLIC COMPOUNDS
- C07D417/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00
- C07D417/14—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing three or more hetero rings
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- Plural Heterocyclic Compounds (AREA)
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Claims (8)
1. Fast dispersion omfattende: et amorf legeme bestående af en heterocyklisk forbindelse, som repræsenteres med den generelle formel (I): [Chem. 1]
- (I) hvor X står for et nitrogenatom eller CH; Ri og R2, begge eller hver især, står for et hydrogenatom, en hydroxylgrup-pe, et halogen, en aminogruppe, en Ci-C6 alkylaminogruppe, en Ci-C6 al-koxygruppe, en CrC6 alkylgruppe eller en cyanogruppe; R3 står for et hydrogenatom, en difluoromethylgruppe, en aminogruppe, en CrC6 alkylaminogruppe, en methyl- eller en hydroxymethylgruppe; R4 og R5 står for et hydrogenatom eller en C1-C6 alkylgruppe; og R6 står for en morpholino (eventuelt substitueret med 1 til 2 C1-C6 alkylgrup-per), en pyrrolidinyl (eventuelt substitueret med en hydroxy C1-C6 alkylgruppe), en piperidino (eventuelt substitueret med 1 til 2 oxygenatomer, en hy-droxylgruppe, en formyl-, eller en CrC6 alkylgruppe), en piperazinyl (eventuelt substitueret med 1 til 2 oxygenatomer, hvor nitrogen ved position 4 eventuelt substitueres med en substituent udvalgt fra gruppen bestående af formyl, hydroxyl C-i-Ce alkyl, CrC6 alkoxycarbonyl, oxo CrC6 alkyl, aromatisk carbonyl, benzylcarbonyl og substitueret carbamoyl), eller en 1,4-diazepano (eventuelt substitueret med 1 til 2 oxygenatomer, hvor nitrogen ved position 4 eventuelt substitueres med en substituent udvalgt fra gruppen bestående af formyl, hydroxy CrCe alkyl, CrC6 alkoxycarbonyl, oxo CrC6 alkyl, aromatisk carbonyl, benzylcarbonyl og substituteret carbamoyl); eller et hydrat deraf, et solvat deraf eller et farmaceutisk acceptabelt salt deraf; og en fast polymer udvalgt blandt hydroxypropylcellulose og hypromellose, hvor masseforholdet af den heterocykliske forbindelse, hydratet deraf; solvatet deraf eller det farmaceutisk acceptable salt deraf og den faste polymer er 1:1 til 1:5.
2. Fast dispersion ifølge krav 1, hvor det amorfe legeme fremstilles med en sprøjtetørringsfremgangsmåde, en blandet slibningsfremgangsmåde, en fusionsfremgangsmåde eller en opløsningsfremgangsmåde.
3. Fast dispersion ifølge krav 1, hvor masseforholdet er 1:2 til 2:5.
4. Fast dispersion ifølge et af kravene 1 til 3, yderligere omfattende et hjælpestof, et sprængningsmiddel eller et smøremiddel.
5. Formulering omfattende den faste dispersion ifølge et af kravene 1 til 4, tilvejebragt i form af et pulver, et fint granulat, et granulat, en tablet eller en kapsel.
6. Fremgangsmåde til fremstilling af en fast dispersion ifølge krav 1, omfattende de følgende trin: i) opløse hydroxypropylcellulose eller hypromellose og en heterocyklisk forbindelse repræsenteret med den generelle formel (I): [Chem.2]
- (I) hvor X står for et nitrogenatom eller CH; Ri og R2, begge eller hver især, står for et hydrogenatom, en hydroxylgrup-pe, et halogen, en aminogruppe, en C1-C6 alkylaminogruppe, en CrC6 al-koxygruppe, en CrC6 alkylgruppe eller en cyanogruppe; R3 står for et hydrogenatom, en difluoromethylgruppe, en aminogruppe, en CrC6 alkylaminogruppe, en methyl- eller en hydroxymethylgruppe; R4 og R5 står for et hydrogenatom eller en CrC6 alkylgruppe; og R6 står for en morpholino (eventuelt substitueret med 1 til 2 CrC6 alkylgrup-per), en pyrrolidinyl (eventuelt substitueret med en hydroxy Ci-C6 alkylgruppe), en piperidino (eventuelt substitueret med 1 til 2 oxygenatomer, en hy-droxylgruppe, en formyl-, eller en CrC6 alkylgruppe), en piperazinyl (eventu elt substitueret med 1 til 2 oxygenatomer, hvor nitrogen ved position 4 eventuelt substitueres med en substituent udvalgt fra gruppen bestående af formyl, hydroxyl C-i-C6 alkyl, CrC6 alkoxycarbonyl, oxo CrC6 alkyl, aromatisk carbonyl, benzylcarbonyl og substitueret carbamoyl), eller en 1,4-diazepano (eventuelt substitueret med 1 til 2 oxygenatomer, hvor nitrogen ved position 4 eventuelt substitueres med en substituent udvalgt fra gruppen bestående af formyl, hydroxy CrC6 alkyl, CrC6 alkoxycarbonyl, oxo CrC6 alkyl, aromatisk carbonyl, benzylcarbonyl og substituteret carbamoyl); eller et hydrat deraf, et solvat deraf eller et farmaceutisk acceptabelt salt deraf; i et opløsningsmiddel til fremstilling af en forsyningsopløsning; ii) forstøvning af forsyningsopløsningen; og iii) tørring af den forstøvede forsyningsopløsning for at opnå den faste dispersion.
7. Fast dispersion ifølge et af kravene 1 til 4 til anvendelse i behandlingen af faste tumorer, sarkomer, carcinomer, hematologiske neoplasmer, autoimmune sygdomme, funktionsforstyrrelser i organ i forbindelse med autoimmune sygdomme, afvisningsreaktion, graft versus host sygdom, inflammatoriske tarmsygdomme, inflammatoriske eller allergiske hudsygdomme, inflammatoriske eller allergiske luftvejssygdomme, allergisk conjunctivitis og rhinitis, og sygdomme fremkaldt ved infektion af gramnegative bakterier eller coronavi-rus.
8. Formulering ifølge krav 5 til anvendelse i behandlingen af faste tumorer, sarkomer, carcinomer, hematologiske neoplasmer, autoimmune sygdomme, funktionsforstyrrelser i organ i forbindelse med autoimmune sygdomme, afvisningsreaktion, graft versus host sygdom, inflammatoriske tarmsygdomme, inflammatoriske eller allergiske hudsygdomme, inflammatoriske eller allergiske luftvejssygdomme, allergisk conjunctivitis og rhinitis, og sygdomme fremkaldt ved infektion af gramnegative bakterier eller coronavirus.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2007303332 | 2007-11-22 | ||
EP08852868A EP2218718A1 (en) | 2007-11-22 | 2008-11-21 | Amorphous form of heterocyclic compound, solid dispersion and medicinal preparation each comprising the same, and process for production of the same |
Publications (1)
Publication Number | Publication Date |
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DK2409975T3 true DK2409975T3 (da) | 2015-08-03 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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DK11168461.9T DK2409975T3 (da) | 2007-11-22 | 2008-11-21 | Faste dispersioner omfattende et amorf legeme bestående af en heterocyklisk anti-tumor-forbindelse |
Country Status (13)
Country | Link |
---|---|
US (1) | US8227463B2 (da) |
EP (2) | EP2409975B1 (da) |
JP (1) | JP5479912B2 (da) |
KR (1) | KR101576695B1 (da) |
CN (1) | CN101883765B (da) |
AU (1) | AU2008327095B2 (da) |
CA (1) | CA2706536C (da) |
DK (1) | DK2409975T3 (da) |
ES (1) | ES2539714T3 (da) |
HK (1) | HK1163079A1 (da) |
PT (1) | PT2409975E (da) |
TW (1) | TWI482768B (da) |
WO (1) | WO2009066775A1 (da) |
Families Citing this family (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7645789B2 (en) | 2006-04-07 | 2010-01-12 | Vertex Pharmaceuticals Incorporated | Indole derivatives as CFTR modulators |
SI2007756T1 (sl) | 2006-04-07 | 2015-11-30 | Vertex Pharmaceuticals Incorporated | Modulatorji prenašalcev z atp-vezavno kaseto |
US10022352B2 (en) | 2006-04-07 | 2018-07-17 | Vertex Pharmaceuticals Incorporated | Modulators of ATP-binding cassette transporters |
US8563573B2 (en) | 2007-11-02 | 2013-10-22 | Vertex Pharmaceuticals Incorporated | Azaindole derivatives as CFTR modulators |
EP2411387B1 (en) | 2009-03-27 | 2015-08-19 | VetDC, Inc. | Pyrimidinyl and 1,3,5-triazinyl benzimidazole sulfonamides and their use in cancer therapy |
EP3072890B1 (en) | 2009-07-07 | 2018-10-17 | MEI Pharma, Inc. | Pyrimidinyl and 1,3,5-triazinyl benzimidazoles and their use in cancer therapy |
US8802868B2 (en) | 2010-03-25 | 2014-08-12 | Vertex Pharmaceuticals Incorporated | Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxo1-5-yl)-N-(1-(2,3-dihydroxypropyl-6-fluoro-2-(1-hydroxy-2-methylpropan2-yl)-1H-Indol-5-yl)-Cyclopropanecarboxamide |
NZ700556A (en) * | 2010-03-25 | 2016-04-29 | Vertex Pharma | Solid forms of (r)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-n-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1h-indol-5-yl) cyclopropanecarboxamide |
SG10201913594UA (en) | 2010-04-22 | 2020-02-27 | Vertex Pharma | Process of producing cycloalkylcarboxamido-indole compounds |
JP5850576B2 (ja) * | 2010-07-06 | 2016-02-03 | 富士化学工業株式会社 | ボセンタン固体分散体 |
WO2012020762A1 (ja) * | 2010-08-10 | 2012-02-16 | アステラス製薬株式会社 | へテロ環化合物 |
RU2608742C2 (ru) | 2011-03-28 | 2017-01-23 | ЭмИАй ФАРМА, ИНК. | (альфа-замещенные аралкиламино- и гетероарилалкиламино)пиримидинил- и 1, 3, 5-триазинилбензимидазолы, их фармацевтические композиции и их применение в лечении пролиферативных заболеваний |
CA2878057A1 (en) | 2012-07-16 | 2014-01-23 | Rossitza Gueorguieva Alargova | Pharmaceutical compositions of (r)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-n-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1h-indol-5-yl) cyclopropanecarboxamide and administration thereof |
LT3424534T (lt) | 2014-04-15 | 2021-11-10 | Vertex Pharmaceuticals Incorporated | Farmacinės kompozicijos, skirtos gydyti ligas, kurių atsiradimui tarpininkauja cistinės fibrozės transmembraninio laidumo reguliatorius |
WO2016040952A2 (en) | 2014-09-12 | 2016-03-17 | Knopp Biosciences Llc | BENZOIMIDAZOL-1,2-YL AMIDES AS Kv7 CHANNEL ACTIVATORS |
CA3046879A1 (en) * | 2016-12-23 | 2018-06-28 | University Of Copenhagen | A co-amorphous form of a substance and a protein |
WO2018217787A1 (en) | 2017-05-23 | 2018-11-29 | Mei Pharma, Inc. | Combination therapy |
EP3668507A4 (en) | 2017-08-14 | 2021-05-12 | MEI Pharma, Inc. | COMBINATION THERAPY |
KR20200133259A (ko) | 2018-03-19 | 2020-11-26 | 놉 바이오사이언시스 엘엘씨 | Kv7 채널 활성화제 조성물 및 이의 사용 방법 |
JP7280111B2 (ja) | 2019-05-28 | 2023-05-23 | ファナック株式会社 | モータ制御装置 |
Family Cites Families (6)
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CN1129597C (zh) | 1997-07-24 | 2003-12-03 | 全药工业株式会社 | 杂环化合物和以其为有效成分的抗肿瘤剂 |
AU3078000A (en) | 1999-01-25 | 2000-08-07 | Zenyaku Kogyo Kabushiki Kaisha | Heterocyclic compounds and antitumor agents containing the same as the active ingredient |
WO2002088112A1 (fr) | 2001-04-27 | 2002-11-07 | Zenyaku Kogyo Kabushiki Kaisha | Compose heterocyclique et agent antitumoral contenant ce dernier en tant qu'ingredient actif |
EP1557415B1 (en) | 2002-10-25 | 2012-06-06 | Zenyaku Kogyo Kabushikikaisha | Heterocyclic compounds and antitumor drugs containing the same as the active ingredient |
ES2400056T3 (es) | 2004-03-31 | 2013-04-05 | Zenyaku Kogyo Kabushikikaisha | Compuesto heterocíclico y agente anti tumores malignos que comprende el mismo como componente eficaz |
AU2006221285B2 (en) | 2005-03-11 | 2011-03-31 | Zenyaku Kogyo Kabushikikaisha | Immunosuppressive agent and anti-tumor agent comprising heterocyclic compound as active ingredient |
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- 2008-11-21 PT PT111684619T patent/PT2409975E/pt unknown
- 2008-11-21 EP EP08852868A patent/EP2218718A1/en not_active Withdrawn
- 2008-11-21 DK DK11168461.9T patent/DK2409975T3/da active
- 2008-11-21 US US12/744,160 patent/US8227463B2/en not_active Expired - Fee Related
- 2008-11-21 KR KR1020107013811A patent/KR101576695B1/ko active IP Right Grant
-
2012
- 2012-04-12 HK HK12103623.5A patent/HK1163079A1/xx not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
PT2409975E (pt) | 2015-07-27 |
EP2409975B1 (en) | 2015-05-27 |
WO2009066775A1 (ja) | 2009-05-28 |
CA2706536C (en) | 2016-04-19 |
CN101883765A (zh) | 2010-11-10 |
ES2539714T3 (es) | 2015-07-03 |
EP2409975A1 (en) | 2012-01-25 |
HK1163079A1 (en) | 2012-09-07 |
AU2008327095A1 (en) | 2009-05-28 |
TW200930712A (en) | 2009-07-16 |
AU2008327095B2 (en) | 2013-07-25 |
KR101576695B1 (ko) | 2015-12-10 |
JP5479912B2 (ja) | 2014-04-23 |
CN101883765B (zh) | 2014-10-01 |
CA2706536A1 (en) | 2009-05-28 |
US8227463B2 (en) | 2012-07-24 |
EP2218718A1 (en) | 2010-08-18 |
US20100249063A1 (en) | 2010-09-30 |
TWI482768B (zh) | 2015-05-01 |
KR20100108533A (ko) | 2010-10-07 |
JPWO2009066775A1 (ja) | 2011-04-07 |
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