BRPI0915942A2 - método para produção de compostos medicinais contendo dabigatrana - Google Patents
método para produção de compostos medicinais contendo dabigatranaInfo
- Publication number
- BRPI0915942A2 BRPI0915942A2 BRPI0915942-8A BRPI0915942A BRPI0915942A2 BR PI0915942 A2 BRPI0915942 A2 BR PI0915942A2 BR PI0915942 A BRPI0915942 A BR PI0915942A BR PI0915942 A2 BRPI0915942 A2 BR PI0915942A2
- Authority
- BR
- Brazil
- Prior art keywords
- medicinal compounds
- compounds containing
- dabigatran
- producing medicinal
- containing dabigatran
- Prior art date
Links
Classifications
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K9/1682—Processes
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
-
- 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
- A61K9/4816—Wall or shell material
-
- 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
- A61K9/485—Inorganic 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
- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
método para produção de compostos medicinais contendo dabigatrana a presente invenção refere-se a um processo aperfeiçoado para preparar uma nova formulação de medicamento de etexilato 5 de dabigatrana de substância ativa de fórmula i na forma de sal de ácido metanossulfônico da mesma, e essa nova formulação de medicamento como tal.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08160335 | 2008-07-14 | ||
EP08160335.9 | 2008-07-14 | ||
PCT/EP2009/058900 WO2010007016A1 (en) | 2008-07-14 | 2009-07-13 | Method for manufacturing medicinal compounds containing dabigatran |
Publications (1)
Publication Number | Publication Date |
---|---|
BRPI0915942A2 true BRPI0915942A2 (pt) | 2019-04-09 |
Family
ID=40030321
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BRPI0915942-8A BRPI0915942A2 (pt) | 2008-07-14 | 2009-07-13 | método para produção de compostos medicinais contendo dabigatrana |
Country Status (16)
Country | Link |
---|---|
US (2) | US20110123635A1 (pt) |
EP (2) | EP2638897A1 (pt) |
JP (1) | JP2011527318A (pt) |
KR (1) | KR20110039261A (pt) |
CN (1) | CN102099012A (pt) |
AR (1) | AR072557A1 (pt) |
AU (1) | AU2009272796A1 (pt) |
BR (1) | BRPI0915942A2 (pt) |
CA (1) | CA2730218A1 (pt) |
CL (1) | CL2010001588A1 (pt) |
IL (1) | IL209346A0 (pt) |
MX (1) | MX2011000480A (pt) |
NZ (1) | NZ589746A (pt) |
RU (1) | RU2529798C2 (pt) |
TW (1) | TWI436994B (pt) |
WO (1) | WO2010007016A1 (pt) |
Families Citing this family (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102005061623A1 (de) | 2005-12-21 | 2007-06-28 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verbessertes Verfahren zur Herstellung von 4-(Benzimidazolylmethylamino)-Benzamidinen und deren Salzen |
BRPI0907598A2 (pt) * | 2008-03-28 | 2015-07-21 | Boehringer Ingelheim Int | Processo para o preparo de formulações de dabigatrana administradas por via oral |
AU2009259440B2 (en) * | 2008-06-16 | 2014-05-29 | Boehringer Ingelheim International Gmbh | Method for producing an intermediate product of dabigatran etexilate |
CN103356614A (zh) | 2008-11-11 | 2013-10-23 | 贝林格尔.英格海姆国际有限公司 | 使用达比加群酯或其盐治疗或预防血栓形成且与常规华法林疗法相比具有改良安全性的方法 |
US8399678B2 (en) | 2009-11-18 | 2013-03-19 | Boehringer Ingelheim International Gmbh | Process for the manufacture of dabigatran etexilate |
EA201201202A1 (ru) * | 2010-03-01 | 2013-04-30 | Рациофарм Гмбх | Пероральная фармацевтическая композиция, содержащая этексилат дабигатрана |
WO2012001156A2 (en) | 2010-07-01 | 2012-01-05 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Pharmaceutical oral dosage forms comprising dabigatran etexilate and its pharmaceutically acceptable salts |
US20130183384A1 (en) | 2011-12-22 | 2013-07-18 | Boehringer Ingelheim International Gmbh | Immediate release multi unit pellet system |
LT2817000T (lt) * | 2012-02-21 | 2021-11-10 | Towa Pharmaceutical Europe, S.L. | Peroralinės dabigatrano eteksilato farmacinės kompozicijos |
US20130345262A1 (en) | 2012-06-25 | 2013-12-26 | Boehringer Ingelheim International Gmbh | Method for prevention of stroke |
CN103127109B (zh) * | 2013-02-05 | 2014-08-13 | 南京华威医药科技开发有限公司 | 含达比加群酯或其盐和水合物的药用组合 |
CN111012756B (zh) * | 2013-06-21 | 2023-06-13 | 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 |
CN105640909B (zh) * | 2014-11-14 | 2019-09-20 | 正大天晴药业集团股份有限公司 | 一种含有达比加群酯的药用组合物 |
CN109125274A (zh) * | 2017-06-28 | 2019-01-04 | 上海美悦生物科技发展有限公司 | 注射用苯并咪唑类药用酸组合物及其制备方法和用途 |
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 |
CN111840245B (zh) * | 2019-04-28 | 2023-07-18 | 成都倍特药业股份有限公司 | 一种达比加群酯药物组合物及其制备方法 |
EP3771465A1 (en) | 2019-08-01 | 2021-02-03 | Zaklady Farmaceutyczne Polpharma SA | Pharmaceutical composition comprising dabigatran etexilate |
CN111150714A (zh) * | 2020-03-17 | 2020-05-15 | 南京嘉晨医药科技有限公司 | 一种甲磺酸达比加群酯固体药物制剂及其制备方法 |
WO2023139243A1 (en) | 2022-01-21 | 2023-07-27 | Adamed Pharma S.A | A process for preparation of tartaric acid cores for dabigatran pellets and the pellets containing dabigatran |
GR1010399B (el) * | 2022-04-05 | 2023-02-03 | Φαρματεν Α.Β.Ε.Ε., | Φαρμακευτικο σκευασμα που περιλαμβανει εναν αντιπηκτικο παραγοντα και μεθοδος παραγωγης αυτου |
Family Cites Families (29)
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 |
US4145308A (en) * | 1977-07-07 | 1979-03-20 | General Electric Company | Anti-foam silicone emulsion, and preparation and use thereof |
US4191741A (en) * | 1978-09-22 | 1980-03-04 | Eli Lilly And Company | Removable drug implant |
US5422121A (en) * | 1990-11-14 | 1995-06-06 | Rohm Gmbh | Oral dosage unit form |
PE121699A1 (es) * | 1997-02-18 | 1999-12-08 | Boehringer Ingelheim Pharma | Heterociclos biciclicos disustituidos como inhibidores de la trombina |
US6414008B1 (en) * | 1997-04-29 | 2002-07-02 | Boehringer Ingelheim Pharma Kg | Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions |
GB0003782D0 (en) * | 2000-02-17 | 2000-04-05 | Dumex Ltd As | Process |
CN100528157C (zh) * | 2002-03-07 | 2009-08-19 | 贝林格尔英格海姆法玛两合公司 | 3-[(2-{[4-(己氧羰基氨基-亚氨基-甲基)-苯基氨基]-甲基}-1-甲基-1h-苯并咪唑-5-羰基)-吡啶-2-基-氨基]-丙酸乙酯及其盐的口服施用的投药剂型 |
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 |
MXPA04008304A (es) | 2002-03-13 | 2004-11-26 | Pablo Fuchsberger | Envase para medicamentos en capsula, pastillas o similar. |
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 |
US20050107438A1 (en) * | 2003-09-03 | 2005-05-19 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition comprising 3-[(2-{[4-(Hexyloxycarbonylaminoiminomethyl) phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionic acid ethyl ester or a salt therefore |
EP1609784A1 (de) * | 2004-06-25 | 2005-12-28 | Boehringer Ingelheim Pharma GmbH & Co.KG | Verfahren zur Herstellung von 4-(Benzimidazolylmethylamino)-Benzamidinen |
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 |
DE102005061624A1 (de) * | 2005-12-21 | 2007-06-28 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verbessertes Verfahren zur Herstellung von Salzen von 4-(Benzimidazolylmethylamino)-Benzamidinen |
DE102005061623A1 (de) * | 2005-12-21 | 2007-06-28 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verbessertes Verfahren zur Herstellung von 4-(Benzimidazolylmethylamino)-Benzamidinen und deren Salzen |
EP2043632A2 (en) | 2006-07-17 | 2009-04-08 | Boehringer Ingelheim International GmbH | New indications for direct thrombin inhibitors |
AR062058A1 (es) | 2006-07-17 | 2008-10-15 | Boehringer Ingelheim Int | Nuevas indicaciones pediatricas para los inhibidores directos de la trombina |
EP2074112A1 (en) * | 2006-10-10 | 2009-07-01 | Boehringer Ingelheim International GmbH | Physiologically acceptable salts of 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-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 (de) * | 2007-02-06 | 2008-08-13 | Boehringer Ingelheim Pharma GmbH & Co. KG | Verfahren zur Herstellung eines Benzimidazolderivats |
BRPI0907598A2 (pt) * | 2008-03-28 | 2015-07-21 | Boehringer Ingelheim Int | Processo para o preparo de formulações de dabigatrana administradas por via oral |
CA2716642C (en) | 2008-03-28 | 2017-02-28 | Boehringer Ingelheim International Gmbh | Method for manufacturing acid pellets |
CA2728057C (en) * | 2008-06-16 | 2016-09-27 | Boehringer Ingelheim International Gmbh | Process for the manufacture of an intermediate in the synthesis of dabigatran |
AU2009259440B2 (en) * | 2008-06-16 | 2014-05-29 | Boehringer Ingelheim International Gmbh | Method for producing an intermediate product of dabigatran etexilate |
PL2391893T3 (pl) * | 2009-02-02 | 2015-03-31 | Boehringer Ingelheim Int | Dabigatran liofiliozowany |
US8399678B2 (en) * | 2009-11-18 | 2013-03-19 | Boehringer Ingelheim International Gmbh | Process for the manufacture of dabigatran etexilate |
-
2009
- 2009-07-13 US US13/003,645 patent/US20110123635A1/en not_active Abandoned
- 2009-07-13 MX MX2011000480A patent/MX2011000480A/es not_active Application Discontinuation
- 2009-07-13 CN CN2009801274877A patent/CN102099012A/zh active Pending
- 2009-07-13 CA CA 2730218 patent/CA2730218A1/en not_active Abandoned
- 2009-07-13 KR KR20117000975A patent/KR20110039261A/ko not_active Application Discontinuation
- 2009-07-13 JP JP2011517176A patent/JP2011527318A/ja active Pending
- 2009-07-13 AR ARP090102638 patent/AR072557A1/es unknown
- 2009-07-13 RU RU2011105056/15A patent/RU2529798C2/ru not_active IP Right Cessation
- 2009-07-13 TW TW98123642A patent/TWI436994B/zh not_active IP Right Cessation
- 2009-07-13 EP EP20130170832 patent/EP2638897A1/en not_active Ceased
- 2009-07-13 NZ NZ58974609A patent/NZ589746A/xx not_active IP Right Cessation
- 2009-07-13 EP EP09797482A patent/EP2296631A1/en not_active Withdrawn
- 2009-07-13 BR BRPI0915942-8A patent/BRPI0915942A2/pt not_active IP Right Cessation
- 2009-07-13 AU AU2009272796A patent/AU2009272796A1/en not_active Abandoned
- 2009-07-13 WO PCT/EP2009/058900 patent/WO2010007016A1/en active Application Filing
-
2010
- 2010-11-16 IL IL209346A patent/IL209346A0/en unknown
- 2010-12-27 CL CL2010001588A patent/CL2010001588A1/es unknown
-
2013
- 2013-05-21 US US13/898,741 patent/US9089488B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
AR072557A1 (es) | 2010-09-08 |
US20130251811A1 (en) | 2013-09-26 |
MX2011000480A (es) | 2011-05-02 |
KR20110039261A (ko) | 2011-04-15 |
CL2010001588A1 (es) | 2011-06-17 |
JP2011527318A (ja) | 2011-10-27 |
CN102099012A (zh) | 2011-06-15 |
TWI436994B (zh) | 2014-05-11 |
US9089488B2 (en) | 2015-07-28 |
NZ589746A (en) | 2012-10-26 |
EP2296631A1 (en) | 2011-03-23 |
EP2638897A1 (en) | 2013-09-18 |
IL209346A0 (en) | 2011-01-31 |
US20110123635A1 (en) | 2011-05-26 |
TW201006818A (en) | 2010-02-16 |
AU2009272796A1 (en) | 2010-01-21 |
RU2529798C2 (ru) | 2014-09-27 |
RU2011105056A (ru) | 2012-08-20 |
WO2010007016A1 (en) | 2010-01-21 |
CA2730218A1 (en) | 2010-01-21 |
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