DK2585445T3 - Polymorfer af en aktiv farmaceutisk bestanddel. - Google Patents
Polymorfer af en aktiv farmaceutisk bestanddel. Download PDFInfo
- Publication number
- DK2585445T3 DK2585445T3 DK11727454.8T DK11727454T DK2585445T3 DK 2585445 T3 DK2585445 T3 DK 2585445T3 DK 11727454 T DK11727454 T DK 11727454T DK 2585445 T3 DK2585445 T3 DK 2585445T3
- Authority
- DK
- Denmark
- Prior art keywords
- febuxostat
- pharmaceutical composition
- crystalline form
- tert
- solvate
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D277/00—Heterocyclic compounds containing 1,3-thiazole or hydrogenated 1,3-thiazole rings
- C07D277/02—Heterocyclic compounds containing 1,3-thiazole or hydrogenated 1,3-thiazole rings not condensed with other rings
- C07D277/20—Heterocyclic compounds containing 1,3-thiazole or hydrogenated 1,3-thiazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members
- C07D277/32—Heterocyclic compounds containing 1,3-thiazole or hydrogenated 1,3-thiazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D277/56—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmacology & Pharmacy (AREA)
- Physical Education & Sports Medicine (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
Claims (7)
1. Farmaceutisk sammensætning omfattende en krystallinsk form af Febuxostat, der har et røntgenstrålepulverdiffraktionsmønster som målt ved anvendelse af CuKoii2-stråling, der har en bølgelængde på 0,15419 nm omfattende maksima ved 2-teta-vinkler på 6,6 ± 0,2°, 12,8 ± 0,2°, 24,5 ± 0,2, 25,8 ± 0,2°, 26,6 ± 0,2°, og som er kendetegnet ved et IR-spektrum omfattende absorptionsbånd ved bølgetal på 2960 ± 2 cm"1, 2874 ± 2 cm"1, 2535 ± 2 cm"1, 2229 ± 2 cm"1, 1673 ± 2 cm"1, 1605 ± 2 cm"1, 1509 ± 2 cm"1, 1422 ± 2 cm"1, 1368 ± 2 cm"1, 1323 ± 2 cm"1, 1274 ± 2 cm"1, 1166 ± 2 cm"1, 1116 ± 2 cm"1, 1045 ± 2 cm"1, 1013 ± 2 cm"1, 911 ± 2 cm"1, 820 ± 2 cm1, 763 ± 2 cm"1 og 725 ± 2 cm"1, når der måles ved anvendelse af en diamant-svækket-total-refleksions-(ATR)-celle og yderligere omfattende mindst ét farmaceutisk acceptabelt excipiens.
2. Farmaceutisk sammensætning ifølge krav 1, hvor den krystallinske form af Febuxostat er, kendetegnet ved en fugtigheds-sorption/desorptionskurve som vist på figur 3, når der måles ved en temperatur på 25 ± 0,1 °C.
3. Farmaceutisk sammensætning ifølge krav 1 eller 2, som er en oral doseringsform.
4. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, som er en kapsel eller en tablet.
5. Farmaceutisk sammensætning ifølge krav 1, hvor det mindst éne farmaceutisk acceptable excipiens er valgt fra gruppen bestående af fyldstoffer, sødestoffer, buffermidler, glidemidler, flydemidler, smagsstoffer, smøremidler, konserveringsmidler, surfaktanter, befugtningsmidler, bindemidler, desintegrationsmidler og fortykningsmidler.
6. Fremgangsmåde til fremstilling af en farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, omfattende trinnet at blande en krystallinsk form af Febuxostat ifølge krav 1 eller 2 med et farmaceutisk acceptabelt excipiens.
7. Farmaceutisk sammensætning som defineret i hvilke som helst af kravene 1 til 5 til anvendelse i behandling af hyperurikæmi og/eller gigt.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10167344.0A EP2399911B1 (en) | 2010-06-25 | 2010-06-25 | Polymorphs of Febuxostat |
| PCT/EP2011/060630 WO2011161245A2 (en) | 2010-06-25 | 2011-06-24 | Polymorphs of an active pharmaceutical ingredient |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2585445T3 true DK2585445T3 (da) | 2015-09-07 |
Family
ID=43033242
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10167344.0T DK2399911T3 (da) | 2010-06-25 | 2010-06-25 | Polymorfer af Febuxostat. |
| DK11727454.8T DK2585445T3 (da) | 2010-06-25 | 2011-06-24 | Polymorfer af en aktiv farmaceutisk bestanddel. |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10167344.0T DK2399911T3 (da) | 2010-06-25 | 2010-06-25 | Polymorfer af Febuxostat. |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US8946441B2 (da) |
| EP (3) | EP2399911B1 (da) |
| CA (1) | CA2802937C (da) |
| DK (2) | DK2399911T3 (da) |
| ES (2) | ES2553584T3 (da) |
| PL (2) | PL2399911T3 (da) |
| WO (1) | WO2011161245A2 (da) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2399911B1 (en) * | 2010-06-25 | 2015-08-19 | Sandoz Ag | Polymorphs of Febuxostat |
| CN103396378B (zh) * | 2013-07-29 | 2015-06-10 | 杭州朱养心药业有限公司 | 非布司他结晶 |
| CZ27857U1 (cs) | 2014-12-12 | 2015-02-23 | Zentiva, K.S. | Formulace obsahující tuhý roztok febuxostatu |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU748026B2 (en) | 1998-06-19 | 2002-05-30 | Teijin Limited | Polymorphic modifications of 2-(3-cyano-4-isobutyloxyphenyl)- 4-methyl-5-thiazole-carboxylic acid and processes for the preparation thereof |
| AU2003220909B2 (en) | 2002-03-28 | 2008-09-18 | Teijin Limited | Solid preparation containing single crystal form |
| ES2395381T3 (es) * | 2009-06-10 | 2013-02-12 | Teva Pharmaceutical Industries Ltd. | Formas cristalinas de Febuxostat |
| CN101648926B (zh) * | 2009-07-09 | 2011-11-16 | 石药集团欧意药业有限公司 | 一种非布司他晶型及其制备方法 |
| CN101817801A (zh) | 2009-08-12 | 2010-09-01 | 北京红惠新医药科技有限公司 | 2-(3-氰基-4-异丁氧基苯基)-4-甲基-5-噻唑甲酸新晶型k及其他晶型的制备方法 |
| EP2399911B1 (en) * | 2010-06-25 | 2015-08-19 | Sandoz Ag | Polymorphs of Febuxostat |
-
2010
- 2010-06-25 EP EP10167344.0A patent/EP2399911B1/en not_active Revoked
- 2010-06-25 DK DK10167344.0T patent/DK2399911T3/da active
- 2010-06-25 ES ES10167344.0T patent/ES2553584T3/es active Active
- 2010-06-25 PL PL10167344T patent/PL2399911T3/pl unknown
-
2011
- 2011-06-24 WO PCT/EP2011/060630 patent/WO2011161245A2/en active Application Filing
- 2011-06-24 ES ES11727454.8T patent/ES2553574T3/es active Active
- 2011-06-24 CA CA2802937A patent/CA2802937C/en not_active Expired - Fee Related
- 2011-06-24 DK DK11727454.8T patent/DK2585445T3/da active
- 2011-06-24 PL PL11727454T patent/PL2585445T3/pl unknown
- 2011-06-24 US US13/702,077 patent/US8946441B2/en active Active
- 2011-06-24 EP EP11727454.8A patent/EP2585445B1/en not_active Revoked
- 2011-06-24 EP EP15181097.5A patent/EP2977372B1/en not_active Revoked
Also Published As
| Publication number | Publication date |
|---|---|
| EP2399911A1 (en) | 2011-12-28 |
| DK2399911T3 (da) | 2015-09-07 |
| WO2011161245A2 (en) | 2011-12-29 |
| PL2399911T3 (pl) | 2016-01-29 |
| ES2553574T3 (es) | 2015-12-10 |
| US20130137734A1 (en) | 2013-05-30 |
| CA2802937C (en) | 2020-02-25 |
| CA2802937A1 (en) | 2011-12-29 |
| EP2585445B1 (en) | 2015-08-19 |
| EP2977372A1 (en) | 2016-01-27 |
| EP2977372B1 (en) | 2019-05-08 |
| WO2011161245A3 (en) | 2012-03-08 |
| EP2399911B1 (en) | 2015-08-19 |
| ES2553584T3 (es) | 2015-12-10 |
| US8946441B2 (en) | 2015-02-03 |
| PL2585445T3 (pl) | 2016-01-29 |
| EP2585445A2 (en) | 2013-05-01 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP2785702B1 (en) | Crystalline dapagliflozin hydrate | |
| JP2017505347A (ja) | ２−ヒドロキシ−６−（（２−（１−イソプロピル−１ｈ−ピラゾール−５−イル）ピリジン−３−イル）メトキシ）ベンズアルデヒドの遊離塩基の結晶多形 | |
| CA2757934C (en) | Crystal forms of saxagliptin | |
| AU2012252380A1 (en) | Polymorph of Linagliptin benzoate | |
| EP2590970B1 (en) | Crystalline form of rivaroxaban dihydrate | |
| CA2767489A1 (en) | A crystalline form of posaconazole | |
| RU2370489C2 (ru) | Кристаллическая форма хинолинового соединения и способ получения данного соединения в указанной форме | |
| DK2585445T3 (da) | Polymorfer af en aktiv farmaceutisk bestanddel. | |
| EP3390358B1 (en) | Crystalline eravacycline bis-hydrochloride | |
| JP5669748B2 (ja) | １１−（２−ピロリジン−１−イル−エトキシ）−１４，１９−ジオキサ−５，７，２６−トリアザ−テトラシクロ［１９．３．１．１（２，６）．１（８，１２）］ヘプタコサ−１（２５），２（２６），３，５，８，１０，１２（２７），１６，２１，２３−デカエンクエン酸塩 | |
| JP5847567B2 (ja) | 活性医薬成分の結晶形態 | |
| EP2502920A1 (en) | Crystallization process of Febuxostat from A | |
| JP2017530107A (ja) | ナトリウム・グルコース共輸送体２阻害薬のｌ−プロリン化合物、およびｌ−プロリン化合物の一水和物および結晶 | |
| EP3181565A1 (en) | Crystalline omarigliptin salts | |
| WO2017032705A1 (en) | Crystalline form of omarigliptin | |
| TW201625593A (zh) | （２ｓ，４ｒ）－４－［４－（１－甲基－１ｈ－吡唑－４－基）－２－三氟甲基－苯磺醯基］－１－（１－三氟甲基－環丙烷羰基）－吡咯啶－２－羧酸（１－氰基－環丙基）－醯胺之固體形式 | |
| EP2980091A1 (en) | Novel hydrates of dolutegravir sodium | |
| EP3510019A1 (en) | Crystalline salts of betrixaban | |
| JP2016503033A (ja) | 多形体 |