TN2011000228A1 - Method for treating or preventing thrombosis using dabigatran etexilate or a salt thereof with improved safety profile over conventional warfarin therapy - Google Patents
Method for treating or preventing thrombosis using dabigatran etexilate or a salt thereof with improved safety profile over conventional warfarin therapyInfo
- Publication number
- TN2011000228A1 TN2011000228A1 TN2011000228A TN2011000228A TN2011000228A1 TN 2011000228 A1 TN2011000228 A1 TN 2011000228A1 TN 2011000228 A TN2011000228 A TN 2011000228A TN 2011000228 A TN2011000228 A TN 2011000228A TN 2011000228 A1 TN2011000228 A1 TN 2011000228A1
- Authority
- TN
- Tunisia
- Prior art keywords
- salt
- treating
- dabigatran etexilate
- over conventional
- improved safety
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 3
- 229960000288 dabigatran etexilate Drugs 0.000 title abstract 2
- 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 title abstract 2
- 150000003839 salts Chemical class 0.000 title abstract 2
- 208000007536 Thrombosis Diseases 0.000 title 1
- 238000002560 therapeutic procedure Methods 0.000 title 1
- PJVWKTKQMONHTI-UHFFFAOYSA-N warfarin Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC(=O)C)C1=CC=CC=C1 PJVWKTKQMONHTI-UHFFFAOYSA-N 0.000 title 1
- 229960005080 warfarin Drugs 0.000 title 1
- 206010003658 Atrial Fibrillation Diseases 0.000 abstract 1
- 230000000740 bleeding effect Effects 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- 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
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Urology & Nephrology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Plural Heterocyclic Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11340408P | 2008-11-11 | 2008-11-11 | |
| US23755209P | 2009-08-27 | 2009-08-27 | |
| PCT/EP2009/064873 WO2010055021A1 (fr) | 2008-11-11 | 2009-11-10 | Procede de traitement et de prevention de la thrombose utilisant l'etexilate de dabigatran ou un sel de celui-ci avec un profil de securite ameliore par rapport a la therapie de la warfarine classique |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| TN2011000228A1 true TN2011000228A1 (en) | 2012-12-17 |
Family
ID=41463076
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TN2011000228A TN2011000228A1 (en) | 2008-11-11 | 2011-05-10 | Method for treating or preventing thrombosis using dabigatran etexilate or a salt thereof with improved safety profile over conventional warfarin therapy |
Country Status (21)
| Country | Link |
|---|---|
| US (3) | US8962574B2 (fr) |
| EP (1) | EP2358368A1 (fr) |
| JP (1) | JP2013510072A (fr) |
| KR (1) | KR20110086700A (fr) |
| CN (2) | CN102209544A (fr) |
| AR (1) | AR074313A1 (fr) |
| AU (1) | AU2009315729A1 (fr) |
| BR (1) | BRPI0921479A2 (fr) |
| CA (1) | CA2738883A1 (fr) |
| CL (1) | CL2011000798A1 (fr) |
| CO (1) | CO6361938A2 (fr) |
| EA (1) | EA201100756A1 (fr) |
| EC (1) | ECSP11011030A (fr) |
| IL (1) | IL211852A0 (fr) |
| MA (1) | MA32786B1 (fr) |
| MX (1) | MX2011004614A (fr) |
| NZ (1) | NZ592616A (fr) |
| PE (1) | PE20110431A1 (fr) |
| TN (1) | TN2011000228A1 (fr) |
| TW (1) | TW201022237A (fr) |
| WO (1) | WO2010055021A1 (fr) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2009315729A1 (en) | 2008-11-11 | 2010-05-20 | Boehringer Ingelheim International Gmbh | Method for treating or preventing thrombosis using dabigatran etexilate or a salt thereof with improved safety profile over conventional warfarin therapy |
| WO2012122024A2 (fr) * | 2011-03-04 | 2012-09-13 | Russell Medford | Procédé de criblage pour identifier des patients à risque de lésion hépatique induite par médicament |
| JP2015500853A (ja) * | 2011-12-22 | 2015-01-08 | 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 | 即時放出マルチユニットペレットシステム |
| WO2014001220A1 (fr) | 2012-06-25 | 2014-01-03 | Boehringer Ingelheim International Gmbh | Procédé de prévention d'un accident vasculaire cérébral |
| WO2014060561A1 (fr) * | 2012-10-19 | 2014-04-24 | Sanovel Ilac Sanayi Ve Ticaret A.S. | Formulations pharmaceutiques orales contenant du dabigatran |
| EP2722033A1 (fr) * | 2012-10-19 | 2014-04-23 | Sanovel Ilac Sanayi ve Ticaret A.S. | Compositions pharmaceutiques de Dabigatran sous forme de base libre |
| CN103788063B (zh) * | 2012-10-29 | 2016-01-20 | 天津药物研究院 | 四水合达比加群酯晶体及其制备方法和药物用途 |
| IN2013CH05441A (fr) * | 2013-11-26 | 2015-05-29 | Aurobindo Pharma Ltd | |
| CN104291789B (zh) * | 2014-09-28 | 2016-03-02 | 定远县绿苑新型建材有限公司 | 一种吸水性强的多孔砖及其制备方法 |
| CN105560236B (zh) * | 2014-10-30 | 2019-03-15 | 成都百裕制药股份有限公司 | 一种含有银杏内酯b和非肽类凝血酶抑制剂的药物组合物及其制备方法和用途 |
| CN108133754B (zh) * | 2017-12-19 | 2019-03-12 | 中国医学科学院阜外医院 | 一种溶栓后出血风险的预测系统 |
| 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 |
| US12396970B2 (en) | 2021-08-20 | 2025-08-26 | AltaThera Pharmaceuticals LLC | Anti-arrhythmic compositions and methods |
| US10512620B1 (en) | 2018-08-14 | 2019-12-24 | AltaThera Pharmaceuticals, LLC | Method of initiating and escalating sotalol hydrochloride dosing |
| US11344518B2 (en) | 2018-08-14 | 2022-05-31 | AltaThera Pharmaceuticals LLC | Method of converting atrial fibrillation to normal sinus rhythm and loading oral sotalol in a shortened time frame |
| US11696902B2 (en) | 2018-08-14 | 2023-07-11 | AltaThera Pharmaceuticals, LLC | Method of initiating and escalating sotalol hydrochloride dosing |
| US11610660B1 (en) | 2021-08-20 | 2023-03-21 | AltaThera Pharmaceuticals LLC | Antiarrhythmic drug dosing methods, medical devices, and systems |
| CN111983085B (zh) * | 2020-08-21 | 2022-05-31 | 江苏省食品药品监督检验研究院 | 一组血清代谢标志物在预测华法林个体药效和指导华法林个体化用药中的应用 |
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| US6087380A (en) | 1949-11-24 | 2000-07-11 | Boehringer Ingelheim Pharma Kg | Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions |
| US4145308A (en) | 1977-07-07 | 1979-03-20 | General Electric Company | Anti-foam silicone emulsion, and preparation and use thereof |
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| GB0003782D0 (en) | 2000-02-17 | 2000-04-05 | Dumex Ltd As | Process |
| US6620439B1 (en) | 2000-10-03 | 2003-09-16 | Atul M. Mehta | Chrono delivery formulations and method of use thereof |
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| 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 |
| 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 |
| WO2006045756A1 (fr) | 2004-10-25 | 2006-05-04 | Boehringer Ingelheim International Gmbh | Utilisation de dipyridamole en association avec des antithrombotiques pour traiter et prevenir des maladies thromboemboliques |
| US20060222640A1 (en) | 2005-03-29 | 2006-10-05 | Boehringer Ingelheim International Gmbh | New pharmaceutical compositions for treatment of thrombosis |
| DE102005020002A1 (de) | 2005-04-27 | 2006-11-02 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Physiologisch verträgliche Salze von 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester |
| DE102005025728A1 (de) | 2005-06-04 | 2006-12-07 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Polymorphe von 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-Propionsäure-ethylester |
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| EP2043691A1 (fr) | 2006-07-17 | 2009-04-08 | Boehringer Ingelheim International GmbH | Nouvelles indications pédiatriques pour des inhibiteurs directs de la thrombine |
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| US20100087488A1 (en) | 2006-10-10 | 2010-04-08 | Boehringer Ingelheim International Gmgh | Physiologically Acceptable Salts of 3-[(2--1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionic acid ethyl ester |
| DE102006054005A1 (de) | 2006-11-16 | 2008-05-21 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Neue Polymorphe von 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester |
| EP1956018A1 (fr) | 2007-02-06 | 2008-08-13 | Boehringer Ingelheim Pharma GmbH & Co. KG | Procédé de préparation d'un dérivé du benzimidazole |
| US20110129538A1 (en) | 2008-03-28 | 2011-06-02 | Boehringer Ingelheim International Gmbh | Process for preparing orally administered dabigatran formulations |
| EP2271317B1 (fr) | 2008-03-28 | 2017-04-19 | Boehringer Ingelheim International GmbH | Procédé de production de granules d'acide |
| JP5642670B2 (ja) | 2008-06-16 | 2014-12-17 | 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 | ダビガトランの合成の中間体の製造方法 |
| AR072143A1 (es) | 2008-06-16 | 2010-08-11 | Boehringer Ingelheim Int | Procedimiento para la preparacion de un producto intermedio para la sintesis de etexilato de dabigatran |
| JP2011527318A (ja) | 2008-07-14 | 2011-10-27 | 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 | ダビガトランを含有する医薬組成物の製造方法 |
| CA2734804A1 (fr) | 2008-08-19 | 2010-02-25 | Boehringer Ingelheim International Gmbh | Utilisation du dabigatran-etexilate pour le traitement de patients souffrant d'hypertension pulmonaire |
| NZ591108A (en) | 2008-08-19 | 2012-11-30 | Boehringer Ingelheim Int | Dabigatran for percutaneous interventional cardiac catheterisation |
| US20110306640A1 (en) | 2008-08-19 | 2011-12-15 | Boehringer Ingelheim International Gmbh | Dabigatran in tumour therapy |
| EP2358367A1 (fr) | 2008-11-11 | 2011-08-24 | Boehringer Ingelheim International GmbH | Procede de traitement ou de prevention de la thrombose utilisant l'etexilate de dabigatran ou un sel de celui-ci avec une meilleure efficacite que la therapie de la warfarine classique |
| AU2009315729A1 (en) | 2008-11-11 | 2010-05-20 | Boehringer Ingelheim International Gmbh | Method for treating or preventing thrombosis using dabigatran etexilate or a salt thereof with improved safety profile over conventional warfarin therapy |
| TW201031651A (en) | 2008-11-11 | 2010-09-01 | Boehringer Ingelheim Int | Method for treating or preventing thrombosis using dabigatran etexilate or a salt thereof with improved efficacy over conventional warfarin therapy |
| EP2391893B1 (fr) | 2009-02-02 | 2014-09-03 | Boehringer Ingelheim International GmbH | Dabigatran lyophilisé |
| US8399678B2 (en) | 2009-11-18 | 2013-03-19 | Boehringer Ingelheim International Gmbh | Process for the manufacture of dabigatran etexilate |
-
2009
- 2009-11-10 AU AU2009315729A patent/AU2009315729A1/en not_active Abandoned
- 2009-11-10 WO PCT/EP2009/064873 patent/WO2010055021A1/fr not_active Ceased
- 2009-11-10 EP EP09756704A patent/EP2358368A1/fr not_active Withdrawn
- 2009-11-10 CN CN2009801442124A patent/CN102209544A/zh active Pending
- 2009-11-10 CN CN2013101863297A patent/CN103356614A/zh active Pending
- 2009-11-10 NZ NZ592616A patent/NZ592616A/xx not_active IP Right Cessation
- 2009-11-10 MX MX2011004614A patent/MX2011004614A/es not_active Application Discontinuation
- 2009-11-10 JP JP2011535124A patent/JP2013510072A/ja active Pending
- 2009-11-10 KR KR1020117010630A patent/KR20110086700A/ko not_active Withdrawn
- 2009-11-10 PE PE2011001005A patent/PE20110431A1/es not_active Application Discontinuation
- 2009-11-10 CA CA2738883A patent/CA2738883A1/fr not_active Abandoned
- 2009-11-10 BR BRPI0921479A patent/BRPI0921479A2/pt not_active IP Right Cessation
- 2009-11-10 TW TW098138131A patent/TW201022237A/zh unknown
- 2009-11-10 AR ARP090104346A patent/AR074313A1/es unknown
- 2009-11-10 US US13/128,459 patent/US8962574B2/en active Active
- 2009-11-10 EA EA201100756A patent/EA201100756A1/ru unknown
-
2010
- 2010-06-17 US US12/817,347 patent/US20100322869A1/en not_active Abandoned
-
2011
- 2011-03-22 IL IL211852A patent/IL211852A0/en unknown
- 2011-04-11 CL CL2011000798A patent/CL2011000798A1/es unknown
- 2011-05-04 EC EC2011011030A patent/ECSP11011030A/es unknown
- 2011-05-10 TN TN2011000228A patent/TN2011000228A1/fr unknown
- 2011-05-11 MA MA33834A patent/MA32786B1/fr unknown
- 2011-05-11 CO CO11058047A patent/CO6361938A2/es not_active Application Discontinuation
-
2012
- 2012-07-13 US US13/548,423 patent/US20120282187A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| WO2010055021A1 (fr) | 2010-05-20 |
| TW201022237A (en) | 2010-06-16 |
| US20100322869A1 (en) | 2010-12-23 |
| PE20110431A1 (es) | 2011-07-13 |
| CN103356614A (zh) | 2013-10-23 |
| ECSP11011030A (es) | 2011-07-29 |
| EP2358368A1 (fr) | 2011-08-24 |
| CA2738883A1 (fr) | 2010-05-20 |
| CO6361938A2 (es) | 2012-01-20 |
| KR20110086700A (ko) | 2011-07-29 |
| US8962574B2 (en) | 2015-02-24 |
| AU2009315729A1 (en) | 2010-05-20 |
| US20110269703A1 (en) | 2011-11-03 |
| AR074313A1 (es) | 2011-01-05 |
| BRPI0921479A2 (pt) | 2016-01-12 |
| CL2011000798A1 (es) | 2012-01-27 |
| MX2011004614A (es) | 2011-05-31 |
| JP2013510072A (ja) | 2013-03-21 |
| EA201100756A1 (ru) | 2011-12-30 |
| MA32786B1 (fr) | 2011-11-01 |
| IL211852A0 (en) | 2011-06-30 |
| NZ592616A (en) | 2013-04-26 |
| CN102209544A (zh) | 2011-10-05 |
| US20120282187A1 (en) | 2012-11-08 |
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