JP2013521226A5 - - Google Patents
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- Publication number
- JP2013521226A5 JP2013521226A5 JP2012555127A JP2012555127A JP2013521226A5 JP 2013521226 A5 JP2013521226 A5 JP 2013521226A5 JP 2012555127 A JP2012555127 A JP 2012555127A JP 2012555127 A JP2012555127 A JP 2012555127A JP 2013521226 A5 JP2013521226 A5 JP 2013521226A5
- Authority
- JP
- Japan
- Prior art keywords
- composition
- mixture
- apixaban
- granulation
- tablets
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000203 mixture Substances 0.000 claims 26
- 238000000034 method Methods 0.000 claims 13
- QNZCBYKSOIHPEH-UHFFFAOYSA-N Apixaban Chemical compound C1=CC(OC)=CC=C1N1C(C(=O)N(CC2)C=3C=CC(=CC=3)N3C(CCCC3)=O)=C2C(C(N)=O)=N1 QNZCBYKSOIHPEH-UHFFFAOYSA-N 0.000 claims 7
- 229960003886 apixaban Drugs 0.000 claims 7
- 239000002245 particle Substances 0.000 claims 7
- 238000005469 granulation Methods 0.000 claims 5
- 230000003179 granulation Effects 0.000 claims 5
- 238000002356 laser light scattering Methods 0.000 claims 5
- 239000002994 raw material Substances 0.000 claims 5
- 238000007908 dry granulation Methods 0.000 claims 4
- 238000002156 mixing Methods 0.000 claims 4
- 239000000314 lubricant Substances 0.000 claims 3
- 238000005550 wet granulation Methods 0.000 claims 3
- 239000002775 capsule Substances 0.000 claims 2
- 239000007884 disintegrant Substances 0.000 claims 2
- 239000007888 film coating Substances 0.000 claims 2
- 238000009501 film coating Methods 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical group [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 1
- 208000001435 Thromboembolism Diseases 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 238000004513 sizing Methods 0.000 claims 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US30805610P | 2010-02-25 | 2010-02-25 | |
| US61/308,056 | 2010-02-25 | ||
| PCT/US2011/025994 WO2011106478A2 (en) | 2010-02-25 | 2011-02-24 | Apixaban formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015226794A Division JP6033945B2 (ja) | 2010-02-25 | 2015-11-19 | アピキサバン製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2013521226A JP2013521226A (ja) | 2013-06-10 |
| JP2013521226A5 true JP2013521226A5 (enExample) | 2014-04-10 |
| JP5846647B2 JP5846647B2 (ja) | 2016-01-20 |
Family
ID=43901603
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012555127A Active JP5846647B2 (ja) | 2010-02-25 | 2011-02-24 | アピキサバン製剤 |
| JP2015226794A Active JP6033945B2 (ja) | 2010-02-25 | 2015-11-19 | アピキサバン製剤 |
| JP2016209347A Active JP6192078B2 (ja) | 2010-02-25 | 2016-10-26 | アピキサバン製剤 |
| JP2017149644A Active JP6577980B2 (ja) | 2010-02-25 | 2017-08-02 | アピキサバン製剤 |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015226794A Active JP6033945B2 (ja) | 2010-02-25 | 2015-11-19 | アピキサバン製剤 |
| JP2016209347A Active JP6192078B2 (ja) | 2010-02-25 | 2016-10-26 | アピキサバン製剤 |
| JP2017149644A Active JP6577980B2 (ja) | 2010-02-25 | 2017-08-02 | アピキサバン製剤 |
Country Status (31)
| Country | Link |
|---|---|
| US (5) | US9326945B2 (enExample) |
| EP (7) | EP3017811B1 (enExample) |
| JP (4) | JP5846647B2 (enExample) |
| KR (4) | KR20230149861A (enExample) |
| CN (3) | CN109602713A (enExample) |
| AU (1) | AU2011220775B2 (enExample) |
| BR (1) | BR112012021337A8 (enExample) |
| CA (1) | CA2791171C (enExample) |
| CO (1) | CO6640207A2 (enExample) |
| CY (5) | CY1117434T1 (enExample) |
| DK (5) | DK3251660T3 (enExample) |
| ES (5) | ES2757603T3 (enExample) |
| HK (2) | HK1243947B (enExample) |
| HR (5) | HRP20160179T1 (enExample) |
| HU (4) | HUE027168T2 (enExample) |
| IL (3) | IL309564A (enExample) |
| IN (1) | IN2012DN06587A (enExample) |
| LT (4) | LT3246021T (enExample) |
| MX (3) | MX364938B (enExample) |
| NZ (1) | NZ601738A (enExample) |
| PE (3) | PE20130378A1 (enExample) |
| PL (5) | PL3257500T3 (enExample) |
| PT (5) | PT2538925E (enExample) |
| RS (5) | RS59593B1 (enExample) |
| RU (1) | RU2685724C2 (enExample) |
| SG (2) | SG182750A1 (enExample) |
| SI (5) | SI3251660T1 (enExample) |
| SM (5) | SMT201900650T1 (enExample) |
| TR (1) | TR201903195T4 (enExample) |
| WO (1) | WO2011106478A2 (enExample) |
| ZA (1) | ZA201205807B (enExample) |
Families Citing this family (51)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SMT201900650T1 (it) | 2010-02-25 | 2020-01-14 | Pfizer | Formulazioni di apixaban |
| US20150018386A1 (en) * | 2012-03-06 | 2015-01-15 | Cadila Healthcare Limited | Amorphous form of apixaban, process of preparation and compositions thereof |
| WO2013174498A1 (en) * | 2012-05-24 | 2013-11-28 | Ratiopharm Gmbh | Dosage forms comprising apixaban and matrix former |
| JP6248112B2 (ja) * | 2012-09-26 | 2017-12-13 | ブリストル−マイヤーズ・スクイブ・ホールディングス・アイルランドＢｒｉｓｔｏｌ−Ｍｙｅｒｓ Ｓｑｕｉｂｂ Ｈｏｌｄｉｎｇｓ Ｉｒｅｌａｎｄ | アピキサバン液体製剤 |
| CN102908324A (zh) * | 2012-10-31 | 2013-02-06 | 南京正科制药有限公司 | 一种阿哌沙班片 |
| EP2752414A1 (en) | 2013-01-04 | 2014-07-09 | Sandoz AG | Crystalline form of apixaban |
| CZ2013305A3 (cs) | 2013-04-23 | 2014-11-05 | Zentiva, K.S. | Nové krystalické formy APIXABANU a způsob jejich přípravy |
| WO2014203275A2 (en) * | 2013-06-18 | 2014-12-24 | Cadila Healthcare Limited | An improved process for the preparation of apixaban and intermediates thereof |
| EP2907507A1 (en) * | 2014-02-17 | 2015-08-19 | Sandoz Ag | Pharmaceutical composition comprising apixaban |
| CN103830199A (zh) * | 2014-03-24 | 2014-06-04 | 重庆东得医药科技有限公司 | 含阿哌沙班的药用制剂及其制备方法 |
| DK3172209T3 (da) | 2014-07-25 | 2021-02-22 | Novartis Ag | Tabletformulering med 2-fluor-n-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamid |
| CN104316637B (zh) * | 2014-10-30 | 2016-08-17 | 江苏宝众宝达药业有限公司 | 高效液相色谱法测定阿哌沙班清洗残留量 |
| US9603846B2 (en) | 2014-11-25 | 2017-03-28 | Cadila Healthcare Limited | Process for the preparation of apixaban |
| RU2017134106A (ru) * | 2015-05-08 | 2019-04-05 | Вокхардт Лимитед | Стабильные фармацевтические композиции, включающие антибактериальный реагент |
| WO2017088841A1 (en) | 2015-11-26 | 2017-06-01 | Zentiva, K.S. | Preparation of a drug form containing amorphous apixaban |
| CN106913528A (zh) * | 2015-12-25 | 2017-07-04 | 中美华世通生物医药科技（武汉）有限公司 | 阿哌沙班微丸及其制备方法 |
| WO2017121340A1 (zh) * | 2016-01-12 | 2017-07-20 | 广东东阳光药业有限公司 | 阿哌沙班固体组合物及其制备方法 |
| EP3195860A1 (de) * | 2016-01-22 | 2017-07-26 | STADA Arzneimittel AG | Verfahren zur herstellung eines apixaban-granulates |
| WO2017163170A1 (en) * | 2016-03-21 | 2017-09-28 | Sun Pharmaceutical Industries Limited | Pharmaceutical composition comprising apixaban |
| WO2017182908A1 (en) * | 2016-04-18 | 2017-10-26 | Emcure Pharmaceuticals Limited | Pharmaceutical compositions of apixaban |
| EP3243505A1 (en) | 2016-05-13 | 2017-11-15 | Zaklady Farmaceutyczne Polpharma SA | A pharmaceutical composition comprising amorphous apixaban |
| CN106822006B (zh) * | 2016-06-08 | 2020-08-28 | 北京普德康利医药科技发展有限公司 | 一种阿哌沙班片及其制备方法 |
| WO2017221209A1 (en) | 2016-06-23 | 2017-12-28 | Lupin Limited | Pharmaceutical formulations of apixaban |
| MX391602B (es) * | 2016-09-24 | 2025-03-21 | Novo Nordisk As | Composicion farmaceutica con antagonista del receptor de mineralocorticoides y su uso |
| CN106420651B (zh) * | 2016-09-28 | 2019-03-08 | 乐普药业股份有限公司 | 一种阿哌沙班片的制备方法 |
| WO2018150286A1 (en) | 2017-02-17 | 2018-08-23 | Unichem Laboratories Ltd | Pharmaceutical composition of apixaban |
| KR102576414B1 (ko) | 2017-11-27 | 2023-09-08 | 미쯔비시 케미컬 주식회사 | 고무 함유 그래프트 중합체, 고무 함유 그래프트 중합체 함유 수지 조성물 및 그의 성형체 |
| KR20190075566A (ko) | 2017-12-21 | 2019-07-01 | 전자부품연구원 | 다중 센서를 활용한 용변 습관 모니터링 시스템 및 방법 |
| TR201722523A2 (tr) | 2017-12-28 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Api̇ksaban i̇çeren kati oral farmasöti̇k kompozi̇syonlar |
| CN108236604A (zh) * | 2018-02-07 | 2018-07-03 | 中国药科大学 | 阿哌沙班柔性脂质体 |
| RS65428B1 (sr) | 2018-04-16 | 2024-05-31 | Bristol Myers Squibb Co | Formulacije apiksabana |
| KR20190130411A (ko) | 2018-05-14 | 2019-11-22 | 신일제약주식회사 | 아픽사반 약제학적 제제 및 그의 제조방법 |
| EP3838265A4 (en) | 2018-08-14 | 2022-05-11 | Jiangsu Hengrui Medicine Co., Ltd. | INJECTABLE PHARMACEUTICAL COMPOSITION AND METHOD FOR PREPARATION |
| EP3666773A1 (en) | 2018-12-11 | 2020-06-17 | KRKA, D.D., Novo Mesto | Process for preparing apixaban |
| EP3669866A1 (en) | 2018-12-19 | 2020-06-24 | KRKA, d.d., Novo mesto | Pharmaceutical composition comprising apixaban |
| CN111377915B (zh) * | 2018-12-30 | 2023-10-24 | 鲁南制药集团股份有限公司 | 一种吡唑并-吡啶酮化合物晶型d |
| CN109464415B (zh) * | 2019-01-09 | 2021-08-17 | 常州恒邦药业有限公司 | 阿哌沙班药物组合物及其制备方法 |
| PL3946277T3 (pl) | 2019-11-13 | 2025-10-06 | Unison Pharmaceuticals Pvt. Ltd. | Rozpadające się w jamie ustnej farmaceutyczne kompozycje apiksabanu |
| CN111214442B (zh) * | 2020-02-13 | 2021-12-10 | 山东百诺医药股份有限公司 | 一种阿哌沙班共微粉化物 |
| CN111494326A (zh) * | 2020-04-11 | 2020-08-07 | 南京正大天晴制药有限公司 | 一种阿哌沙班片及其制备方法 |
| WO2022115052A1 (en) | 2020-11-27 | 2022-06-02 | Santa Farma Ilac Sanayii A.S. | Improved wet granulation processes for apixaban comprising formulations |
| WO2022115051A1 (en) | 2020-11-27 | 2022-06-02 | Santa Farma Ilac Sanayii A.S. | Direct compression method for non-micronised apixaban formulations |
| WO2022150030A2 (en) | 2021-01-08 | 2022-07-14 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A film coated tablet of apixaban |
| TR202100250A2 (tr) | 2021-01-08 | 2022-07-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Api̇ksaban i̇çeren fi̇lm kapli tablet |
| JP2022112698A (ja) * | 2021-01-22 | 2022-08-03 | 東和薬品株式会社 | アピキサバン含有医薬組成物 |
| GB202102575D0 (en) | 2021-02-23 | 2021-04-07 | Teva Pharmaceutical Industries Ltd | Fixed-dose pharmaceutical compositions |
| US12036216B2 (en) * | 2021-06-08 | 2024-07-16 | Taho Pharmaceuticals Ltd. | Apixaban film product and uses thereof |
| US12214075B2 (en) | 2021-10-27 | 2025-02-04 | Pharma-Data Research And Development Single Member S.A. | Apixaban suspension and preparation method |
| JP7834007B2 (ja) * | 2022-10-12 | 2026-03-23 | 日本ジェネリック株式会社 | アピキサバンを含有する錠剤 |
| KR102760108B1 (ko) | 2024-04-09 | 2025-01-24 | 에바바이오 주식회사 | 수용해도와 투과도를 향상시켜 생체이용률이 개선된 무정형 아픽사반 고체분산체 제제 및 그의 서방성 정제 |
| JP7854233B2 (ja) * | 2024-10-10 | 2026-05-01 | 富士化学工業株式会社 | アピキサバン含有組成物、アピキサバン含有固形製剤、及びアピキサバン含有固形製剤の製造方法 |
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-
2011
- 2011-02-24 SM SM20190650T patent/SMT201900650T1/it unknown
- 2011-02-24 PL PL17178613T patent/PL3257500T3/pl unknown
- 2011-02-24 PL PL17175864T patent/PL3246021T3/pl unknown
- 2011-02-24 MX MX2017016605A patent/MX364938B/es unknown
- 2011-02-24 RS RS20191493A patent/RS59593B1/sr unknown
- 2011-02-24 SI SI201131811T patent/SI3251660T1/sl unknown
- 2011-02-24 SM SM20190212T patent/SMT201900212T1/it unknown
- 2011-02-24 HU HUE11707284A patent/HUE027168T2/en unknown
- 2011-02-24 MX MX2012009244A patent/MX2012009244A/es active IP Right Grant
- 2011-02-24 DK DK17175788T patent/DK3251660T3/da active
- 2011-02-24 RS RS20191468A patent/RS59576B1/sr unknown
- 2011-02-24 LT LTEP17175864.2T patent/LT3246021T/lt unknown
- 2011-02-24 SI SI201131813T patent/SI3257500T1/sl unknown
- 2011-02-24 ES ES17178613T patent/ES2757603T3/es active Active
- 2011-02-24 DK DK15190823.3T patent/DK3017811T3/en active
- 2011-02-24 RS RS20200017A patent/RS59810B1/sr unknown
- 2011-02-24 MX MX2015007763A patent/MX353145B/es unknown
- 2011-02-24 PL PL15190823T patent/PL3017811T3/pl unknown
- 2011-02-24 CN CN201811354155.XA patent/CN109602713A/zh active Pending
- 2011-02-24 LT LTEP15190823.3T patent/LT3017811T/lt unknown
- 2011-02-24 HR HRP20160179TT patent/HRP20160179T1/hr unknown
- 2011-02-24 IN IN6587DEN2012 patent/IN2012DN06587A/en unknown
- 2011-02-24 US US13/579,796 patent/US9326945B2/en active Active
- 2011-02-24 JP JP2012555127A patent/JP5846647B2/ja active Active
- 2011-02-24 RS RS20190290A patent/RS58699B1/sr unknown
- 2011-02-24 HU HUE15190823A patent/HUE043932T2/hu unknown
- 2011-02-24 RS RS20160088A patent/RS54559B1/sr unknown
- 2011-02-24 HU HUE17178613A patent/HUE047140T2/hu unknown
- 2011-02-24 PT PT117072843T patent/PT2538925E/pt unknown
- 2011-02-24 SG SG2012055547A patent/SG182750A1/en unknown
- 2011-02-24 EP EP15190823.3A patent/EP3017811B1/en not_active Revoked
- 2011-02-24 PE PE2012001362A patent/PE20130378A1/es not_active Application Discontinuation
- 2011-02-24 LT LT17175788T patent/LT3251660T/lt unknown
- 2011-02-24 EP EP20151141.7A patent/EP3662899A1/en not_active Withdrawn
- 2011-02-24 ES ES15190823T patent/ES2714363T3/es active Active
- 2011-02-24 ES ES17175864T patent/ES2767848T3/es active Active
- 2011-02-24 EP EP17175864.2A patent/EP3246021B1/en not_active Revoked
- 2011-02-24 PT PT171786130T patent/PT3257500T/pt unknown
- 2011-02-24 SI SI201130742T patent/SI2538925T1/sl unknown
- 2011-02-24 SI SI201131827T patent/SI3246021T1/sl unknown
- 2011-02-24 RU RU2012140690A patent/RU2685724C2/ru active
- 2011-02-24 PL PL11707284T patent/PL2538925T3/pl unknown
- 2011-02-24 CN CN201810769647.9A patent/CN109602716A/zh active Pending
- 2011-02-24 SG SG10201501349VA patent/SG10201501349VA/en unknown
- 2011-02-24 PE PE2015002402A patent/PE20160042A1/es unknown
- 2011-02-24 LT LT17178613T patent/LT3257500T/lt unknown
- 2011-02-24 SM SM20200034T patent/SMT202000034T1/it unknown
- 2011-02-24 KR KR1020237035193A patent/KR20230149861A/ko not_active Ceased
- 2011-02-24 EP EP17175788.3A patent/EP3251660B1/en not_active Revoked
- 2011-02-24 TR TR2019/03195T patent/TR201903195T4/tr unknown
- 2011-02-24 NZ NZ601738A patent/NZ601738A/en unknown
- 2011-02-24 EP EP19199147.0A patent/EP3643301A1/en not_active Withdrawn
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