JP2015511241A5 - - Google Patents
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- Publication number
- JP2015511241A5 JP2015511241A5 JP2014558094A JP2014558094A JP2015511241A5 JP 2015511241 A5 JP2015511241 A5 JP 2015511241A5 JP 2014558094 A JP2014558094 A JP 2014558094A JP 2014558094 A JP2014558094 A JP 2014558094A JP 2015511241 A5 JP2015511241 A5 JP 2015511241A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutically acceptable
- granules
- organic acid
- composition according
- acceptable excipient
- 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 37
- 239000008187 granular material Substances 0.000 claims 16
- 150000007524 organic acids Chemical class 0.000 claims 16
- 239000000546 pharmaceutical excipient Substances 0.000 claims 14
- 239000002245 particle Substances 0.000 claims 13
- KSGXQBZTULBEEQ-UHFFFAOYSA-N dabigatran etexilate Chemical compound C1=CC(C(N)=NC(=O)OCCCCCC)=CC=C1NCC1=NC2=CC(C(=O)N(CCC(=O)OCC)C=3N=CC=CC=3)=CC=C2N1C KSGXQBZTULBEEQ-UHFFFAOYSA-N 0.000 claims 10
- 229960000288 dabigatran etexilate Drugs 0.000 claims 9
- 238000002156 mixing Methods 0.000 claims 9
- 239000010410 layer Substances 0.000 claims 6
- 238000000034 method Methods 0.000 claims 6
- 239000011253 protective coating Substances 0.000 claims 6
- 239000011230 binding agent Substances 0.000 claims 5
- 238000009472 formulation Methods 0.000 claims 5
- 239000002552 dosage form Substances 0.000 claims 4
- 239000012458 free base Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 239000012453 solvate Substances 0.000 claims 4
- 206010003658 Atrial Fibrillation Diseases 0.000 claims 3
- 208000005189 Embolism Diseases 0.000 claims 3
- 208000006011 Stroke Diseases 0.000 claims 3
- 239000011248 coating agent Substances 0.000 claims 3
- 238000000576 coating method Methods 0.000 claims 3
- 239000007902 hard capsule Substances 0.000 claims 3
- 238000013150 knee replacement Methods 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 230000001050 lubricating effect Effects 0.000 claims 3
- 239000008188 pellet Substances 0.000 claims 3
- 238000001356 surgical procedure Methods 0.000 claims 3
- 230000009885 systemic effect Effects 0.000 claims 3
- 238000011541 total hip replacement Methods 0.000 claims 3
- 239000007931 coated granule Substances 0.000 claims 2
- 235000005985 organic acids Nutrition 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 206010014522 Embolism venous Diseases 0.000 claims 1
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims 1
- 229960003850 dabigatran Drugs 0.000 claims 1
- YBSJFWOBGCMAKL-UHFFFAOYSA-N dabigatran Chemical compound N=1C2=CC(C(=O)N(CCC(O)=O)C=3N=CC=CC=3)=CC=C2N(C)C=1CNC1=CC=C(C(N)=N)C=C1 YBSJFWOBGCMAKL-UHFFFAOYSA-N 0.000 claims 1
- 229960004951 dabigatran etexilate mesylate Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 208000004043 venous thromboembolism Diseases 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN461/MUM/2012 | 2012-02-21 | ||
| IN461MU2012 | 2012-02-21 | ||
| PCT/EP2013/053426 WO2013124340A1 (en) | 2012-02-21 | 2013-02-21 | Oral pharmaceutical compositions of dabigatran etexilate |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2015511241A JP2015511241A (ja) | 2015-04-16 |
| JP2015511241A5 true JP2015511241A5 (enExample) | 2016-03-31 |
| JP6215239B2 JP6215239B2 (ja) | 2017-10-18 |
Family
ID=47739283
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014558094A Active JP6215239B2 (ja) | 2012-02-21 | 2013-02-21 | ダビガトランエテキシラートの経口医薬組成物 |
Country Status (27)
| Country | Link |
|---|---|
| US (3) | US11013729B2 (enExample) |
| EP (2) | EP2817000B1 (enExample) |
| JP (1) | JP6215239B2 (enExample) |
| KR (1) | KR102090242B1 (enExample) |
| CN (2) | CN104114158A (enExample) |
| AU (1) | AU2013224146B2 (enExample) |
| BR (1) | BR112014020474B1 (enExample) |
| CA (1) | CA2864423C (enExample) |
| CY (1) | CY1124678T1 (enExample) |
| DK (1) | DK2817000T3 (enExample) |
| ES (1) | ES2895918T3 (enExample) |
| HR (1) | HRP20211606T1 (enExample) |
| HU (1) | HUE056194T2 (enExample) |
| IL (1) | IL234032B (enExample) |
| IN (1) | IN2014DN06734A (enExample) |
| JO (1) | JO3616B1 (enExample) |
| LT (1) | LT2817000T (enExample) |
| MX (1) | MX368868B (enExample) |
| NZ (1) | NZ628301A (enExample) |
| PL (1) | PL2817000T3 (enExample) |
| PT (1) | PT2817000T (enExample) |
| RS (1) | RS62566B1 (enExample) |
| RU (1) | RU2633482C2 (enExample) |
| SI (1) | SI2817000T1 (enExample) |
| SM (1) | SMT202100608T1 (enExample) |
| WO (1) | WO2013124340A1 (enExample) |
| ZA (1) | ZA201405855B (enExample) |
Families Citing this family (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR112014020474B1 (pt) | 2012-02-21 | 2022-03-29 | Esteve Pharmaceuticals, S.A. | Composições farmacêuticas orais de etexilato de dabigatrana |
| CN104224754A (zh) * | 2013-06-21 | 2014-12-24 | 四川海思科制药有限公司 | 一种达比加群酯药物组合物及其制备方法 |
| CN104414995A (zh) * | 2013-09-04 | 2015-03-18 | 天津汉瑞药业有限公司 | 甲磺酸达比加群酯的药用组合物 |
| EP2853260A1 (en) * | 2013-09-27 | 2015-04-01 | ratiopharm GmbH | Pharmaceutical preparation comprising dabigatran etexilate bismesylate |
| WO2015071841A1 (en) | 2013-11-12 | 2015-05-21 | Druggability Technologies Holdings Limited | Complexes of dabigatran and its derivatives, process for the preparation thereof and pharmaceutical compositions containing them |
| CN104784147B (zh) * | 2014-01-20 | 2018-01-23 | 成都苑东生物制药股份有限公司 | 一种甲磺酸达比加群酯胶囊药物组合物及其制备方法 |
| CN104994856A (zh) * | 2014-01-30 | 2015-10-21 | 杭州领业医药科技有限公司 | 达比加群酯及其盐的投药制剂及其制备方法 |
| CN104922092A (zh) * | 2014-03-19 | 2015-09-23 | 陕西天森药物研究开发有限公司 | 一种通过包裹法制备的达比加群酯或其盐和水合物的药物组合 |
| WO2015145462A1 (en) | 2014-03-26 | 2015-10-01 | Cadila Healthcare Limited | Pharmaceutical compositions of dabigatran |
| CN104095830A (zh) * | 2014-05-22 | 2014-10-15 | 万特制药(海南)有限公司 | 一种甲磺酸盐达比加群酯胶囊的制备方法 |
| CN104825422B (zh) * | 2014-09-29 | 2017-12-12 | 普济生物科技（台州）有限公司 | 含达比加群酯甲磺酸盐的药物组合物及其制备方法 |
| CN105560206A (zh) * | 2014-10-13 | 2016-05-11 | 重庆圣华曦药业股份有限公司 | 一种达比加群酯胶囊的制备 |
| WO2016070696A1 (zh) * | 2014-11-03 | 2016-05-12 | 杭州领业医药科技有限公司 | 达比加群酯或其盐的投药制剂及其制备方法 |
| EP3251672B1 (en) | 2014-12-31 | 2023-02-01 | Shenzhen Pharmacin Co., Ltd. | Pharmaceutical composition comprising dabigatran etexilate and preparation method therefor |
| WO2017103945A1 (en) * | 2015-12-15 | 2017-06-22 | Strides Shasun Limited | Pharmaceutical compositions |
| CN106890148A (zh) * | 2015-12-21 | 2017-06-27 | 青岛黄海制药有限责任公司 | 一种达比加群酯片剂及其制备 |
| WO2017111637A1 (en) | 2015-12-23 | 2017-06-29 | Zaklady Farmaceutyczne Polpharma Sa | Pharmaceutical composition comprising dabigatran or a pharmaceutically acceptable salt thereof |
| JP2018184375A (ja) * | 2017-04-27 | 2018-11-22 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | ダビガトランエテキシラート又は医薬的に許容されるその塩を含む錠剤及びその製造方法 |
| TR201706848A2 (tr) * | 2017-05-10 | 2018-11-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dabigatran eteksi̇lat i̇çeren kati oral farmasöti̇k kompozi̇syonlar |
| WO2019004980A2 (en) * | 2017-05-10 | 2019-01-03 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | SOLID ORAL PHARMACEUTICAL COMPOSITIONS OF DABIGATRAN DEXILATE |
| TR201722323A2 (tr) | 2017-12-27 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dabi̇gatranin oral farmasöti̇k kompozi̇syonlari |
| TR201722353A2 (tr) * | 2017-12-27 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Dabi̇gatran eteksi̇lat i̇çeren oral uygulama i̇çi̇n farmasöti̇k formülasyon |
| TR201722630A2 (enExample) | 2017-12-28 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | |
| US12673049B2 (en) | 2018-04-04 | 2026-07-07 | Shanghai Wd Pharmaceutical Co., Ltd | Pharmaceutical composition containing dabigatran etexilate and preparation method thereof |
| CN110339193B (zh) | 2018-04-04 | 2022-04-29 | 上海汉都医药科技有限公司 | 含达比加群酯的药物组合物及其制备方法 |
| WO2020032885A2 (en) | 2018-05-04 | 2020-02-13 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Capsule-in-capsule compositions of dabigatran etexilate |
| TR201905308A2 (tr) * | 2019-04-09 | 2020-10-21 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A capsule formulation of dabigatran etexilate |
| CN113577067B (zh) * | 2021-06-03 | 2023-08-15 | 北京福元医药股份有限公司 | 一种甲磺酸达比加群酯药物制剂 |
| CN115006363A (zh) * | 2022-06-23 | 2022-09-06 | 上海信谊万象药业股份有限公司 | 一种牡蛎碳酸钙咀嚼片及其制备方法 |
| WO2024175036A1 (zh) * | 2023-02-21 | 2024-08-29 | 广州玻思韬控释药业有限公司 | 达比加群酯或其药物可接受的盐的微丸 |
Family Cites Families (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6087380A (en) | 1949-11-24 | 2000-07-11 | Boehringer Ingelheim Pharma Kg | Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions |
| JPH04103525A (ja) * | 1990-08-22 | 1992-04-06 | Sanwa Kagaku Kenkyusho Co Ltd | 難水溶性薬物の持続性製剤化方法 |
| PE121699A1 (es) | 1997-02-18 | 1999-12-08 | Boehringer Ingelheim Pharma | Heterociclos biciclicos disustituidos como inhibidores de la trombina |
| WO1998050019A1 (en) | 1997-05-09 | 1998-11-12 | Sage Pharmaceuticals, Inc. | Stable oral pharmaceutical dosage forms |
| US6174548B1 (en) | 1998-08-28 | 2001-01-16 | Andrx Pharmaceuticals, Inc. | Omeprazole formulation |
| ES2381862T3 (es) * | 2000-09-06 | 2012-06-01 | Mitsubishi Tanabe Pharma Corporation | Preparaciones para administración por vía oral |
| NZ527585A (en) | 2001-02-15 | 2005-04-29 | Tanabe Seiyaku Co | Tablets quickly disintegrated in oral cavity |
| DE10209985A1 (de) * | 2002-03-07 | 2003-09-25 | Boehringer Ingelheim Pharma | Oral zu applizierende Darreichungsform für 3-[(2-{[4-(Hexyloxycarbonylaminoimino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propinsäure-ethylester und dessen Salze |
| US20030181488A1 (en) * | 2002-03-07 | 2003-09-25 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionic acid ethyl ester and the salts thereof |
| EP1485094B2 (de) | 2002-03-07 | 2020-03-25 | Boehringer Ingelheim International GmbH | Oral zu applizierende darreichungsform für 3- [(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1h-benzimidazol-5-carbonyl)-pyridin-2-yl-amino] -propionsäure-ethylester oder dessen salze |
| DE10337697A1 (de) | 2003-08-16 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Tablette enthaltend 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenyl-amino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester oder dessen Salze |
| DE10339862A1 (de) | 2003-08-29 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)- phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester-Methansulfonat und dessen Verwendung als Arzneimittel |
| US8709476B2 (en) | 2003-11-04 | 2014-04-29 | Supernus Pharmaceuticals, Inc. | Compositions of quaternary ammonium compounds containing bioavailability enhancers |
| CA2569170A1 (en) | 2004-06-02 | 2005-12-22 | Pharmacyclics, Inc. | Factor viia inhibitor |
| EP1781664B1 (en) | 2004-07-30 | 2013-09-04 | MethylGene Inc. | Inhibitors of vegf receptor and hgf receptor signaling |
| DE602006000819T2 (de) | 2006-02-09 | 2009-04-09 | Teva Pharmaceutical Industries Ltd. | Dipyridamol enthaltende Zusammensetzungen mit verlängerter Freisetzung und Verfahren zu deren Herstellung |
| US20080069891A1 (en) * | 2006-09-15 | 2008-03-20 | Cima Labs, Inc. | Abuse resistant drug formulation |
| KR20100129281A (ko) * | 2008-03-28 | 2010-12-08 | 베링거 인겔하임 인터내셔날 게엠베하 | 경구 투여되는 다비가트란 제형의 제조 방법 |
| EP2271317B1 (de) | 2008-03-28 | 2017-04-19 | Boehringer Ingelheim International GmbH | Verfahren zur herstellung von säurepellets |
| AU2009272796A1 (en) * | 2008-07-14 | 2010-01-21 | Boehringer Ingelheim International Gmbh | Method for manufacturing medicinal compounds containing dabigatran |
| CA2791561A1 (en) * | 2010-03-01 | 2011-09-09 | Ratiopharm Gmbh | Dabigatran etexilate-containing oral pharmaceutical composition |
| ES2631980T3 (es) * | 2010-07-01 | 2017-09-07 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Formas de dosificación orales farmacéuticas que comprenden dabigatrán etexilato y sus sales farmacéuticamente aceptables |
| WO2012162492A1 (en) | 2011-05-24 | 2012-11-29 | Teva Pharmaceutical Industries Ltd. | Compressed core comprising organic acids for a pharmaceutical composition |
| BR112014020474B1 (pt) | 2012-02-21 | 2022-03-29 | Esteve Pharmaceuticals, S.A. | Composições farmacêuticas orais de etexilato de dabigatrana |
| CN102793699B (zh) | 2012-08-06 | 2014-06-04 | 严轶东 | 一种含有达比加群酯的药用组合物 |
-
2013
- 2013-02-21 BR BR112014020474-8A patent/BR112014020474B1/pt active IP Right Grant
- 2013-02-21 AU AU2013224146A patent/AU2013224146B2/en active Active
- 2013-02-21 CA CA2864423A patent/CA2864423C/en active Active
- 2013-02-21 JP JP2014558094A patent/JP6215239B2/ja active Active
- 2013-02-21 MX MX2014010040A patent/MX368868B/es active IP Right Grant
- 2013-02-21 CN CN201380010066.2A patent/CN104114158A/zh active Pending
- 2013-02-21 CN CN201910336600.8A patent/CN110123774A/zh active Pending
- 2013-02-21 RU RU2014138036A patent/RU2633482C2/ru active
- 2013-02-21 SM SM20210608T patent/SMT202100608T1/it unknown
- 2013-02-21 KR KR1020147026330A patent/KR102090242B1/ko not_active Expired - Fee Related
- 2013-02-21 DK DK13704974.8T patent/DK2817000T3/da active
- 2013-02-21 WO PCT/EP2013/053426 patent/WO2013124340A1/en not_active Ceased
- 2013-02-21 ES ES13704974T patent/ES2895918T3/es active Active
- 2013-02-21 NZ NZ628301A patent/NZ628301A/en unknown
- 2013-02-21 RS RS20211239A patent/RS62566B1/sr unknown
- 2013-02-21 SI SI201331940T patent/SI2817000T1/sl unknown
- 2013-02-21 EP EP13704974.8A patent/EP2817000B1/en active Active
- 2013-02-21 IN IN6734DEN2014 patent/IN2014DN06734A/en unknown
- 2013-02-21 JO JOP/2013/0057A patent/JO3616B1/ar active
- 2013-02-21 HU HUE13704974A patent/HUE056194T2/hu unknown
- 2013-02-21 US US14/379,613 patent/US11013729B2/en active Active
- 2013-02-21 LT LTEPPCT/EP2013/053426T patent/LT2817000T/lt unknown
- 2013-02-21 PT PT137049748T patent/PT2817000T/pt unknown
- 2013-02-21 PL PL13704974T patent/PL2817000T3/pl unknown
- 2013-02-21 EP EP21164447.1A patent/EP3858337A3/en active Pending
- 2013-02-21 HR HRP20211606TT patent/HRP20211606T1/hr unknown
-
2014
- 2014-08-10 IL IL234032A patent/IL234032B/en active IP Right Grant
- 2014-08-11 ZA ZA2014/05855A patent/ZA201405855B/en unknown
-
2021
- 2021-04-27 US US17/241,793 patent/US11752142B2/en active Active
- 2021-10-29 CY CY20211100933T patent/CY1124678T1/el unknown
-
2023
- 2023-07-21 US US18/356,642 patent/US20240139168A1/en not_active Abandoned
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