BRPI0907598A2 - Processo para o preparo de formulações de dabigatrana administradas por via oral - Google Patents

Processo para o preparo de formulações de dabigatrana administradas por via oral

Info

Publication number: BRPI0907598A2
Authority: BR; Brazil
Prior art keywords: dabigatran; formulations; orally administered; preparing orally; preparing
Prior art date: 2008-03-28

Application number

BRPI0907598-4A

Other languages

English (en)

Inventor

Sabine Landerer

Thomas Friedl

Original Assignee

Boehringer Ingelheim Int

Priority date (The priority date 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 date listed.)

2008-03-28

Filing date

2009-03-24

Publication date

2015-07-21

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39705326&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0907598(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2009-03-24 Application filed by Boehringer Ingelheim Int filed Critical Boehringer Ingelheim Int

2015-07-21 Publication of BRPI0907598A2 publication Critical patent/BRPI0907598A2/pt

Links

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 title 1
229960003850 dabigatran Drugs 0.000 title 1
238000009472 formulation Methods 0.000 title 1
238000004519 manufacturing process Methods 0.000 title 1
239000000203 mixture Substances 0.000 title 1

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
- A61K9/14—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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- 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
- A61K9/5089—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
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—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
- A61K9/14—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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
- 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
- A61K9/4858—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
- 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)
Life Sciences & Earth Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Medicinal Chemistry (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Bioinformatics & Cheminformatics (AREA)
Engineering & Computer Science (AREA)
Epidemiology (AREA)
Inorganic Chemistry (AREA)
Chemical Kinetics & Catalysis (AREA)
Biophysics (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
General Chemical & Material Sciences (AREA)
Organic Chemistry (AREA)
Molecular Biology (AREA)
Urology & Nephrology (AREA)
Heart & Thoracic Surgery (AREA)
Hematology (AREA)
Diabetes (AREA)
Cardiology (AREA)
Vascular Medicine (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

BRPI0907598-4A 2008-03-28 2009-03-24 Processo para o preparo de formulações de dabigatrana administradas por via oral BRPI0907598A2 (pt)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
EP08153667		2008-03-28
PCT/EP2009/053469 WO2009118322A1 (en)	2008-03-28	2009-03-24	Process for preparing orally administered dabigatran formulations

Publications (1)

Publication Number	Publication Date
BRPI0907598A2 true BRPI0907598A2 (pt)	2015-07-21

Family

ID=39705326

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
BRPI0907598-4A BRPI0907598A2 (pt)	2008-03-28	2009-03-24	Processo para o preparo de formulações de dabigatrana administradas por via oral

Country Status (17)

Country	Link
US (2)	US20110129538A1 (pt)
EP (1)	EP2288335A1 (pt)
JP (1)	JP2011515439A (pt)
KR (1)	KR20100129281A (pt)
CN (1)	CN101980697A (pt)
AR (1)	AR071569A1 (pt)
AU (1)	AU2009228795B2 (pt)
BR (1)	BRPI0907598A2 (pt)
CA (1)	CA2711766A1 (pt)
CL (1)	CL2009000771A1 (pt)
IL (1)	IL206718A0 (pt)
MX (1)	MX2010010647A (pt)
NZ (1)	NZ586868A (pt)
RU (1)	RU2010143901A (pt)
TW (1)	TW200944513A (pt)
WO (1)	WO2009118322A1 (pt)
ZA (1)	ZA201004550B (pt)

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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
CN102066355B (zh)	2008-06-16	2015-07-01	贝林格尔.英格海姆国际有限公司	达比加群酯的中间体的制备方法
AU2009272796A1 (en)	2008-07-14	2010-01-21	Boehringer Ingelheim International Gmbh	Method for manufacturing medicinal compounds containing dabigatran
EP2358368A1 (en)	2008-11-11	2011-08-24	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
US8399678B2 (en)	2009-11-18	2013-03-19	Boehringer Ingelheim International Gmbh	Process for the manufacture of dabigatran etexilate
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
CA2860098A1 (en)	2011-12-22	2013-06-27	Boehringer Ingelheim International Gmbh	Immediate release multi unit pellet system
BR112014020474B1 (pt)	2012-02-21	2022-03-29	Esteve Pharmaceuticals, S.A.	Composições farmacêuticas orais de etexilato de dabigatrana
CN103420982B (zh) *	2012-05-24	2015-07-08	天津药物研究院	达比加群酯衍生物及其制备方法和用途
CN103420983B (zh) *	2012-05-24	2015-07-08	天津药物研究院	达比加群酯衍生物及其制备方法和用途
CN103420984B (zh) *	2012-05-24	2015-07-08	天津药物研究院	作为前药的达比加群酯衍生物及其制备方法和用途
CN103420985B (zh) *	2012-05-24	2015-09-23	天津药物研究院	作为前药的达比加群酯衍生物及其制备方法和用途
WO2014001220A1 (en)	2012-06-25	2014-01-03	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
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
CN104274410B (zh) *	2013-07-04	2019-04-26	江苏豪森药业集团有限公司	一种含达比加群酯或其盐的药物组合物
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
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
US9546154B2 (en) *	2014-08-07	2017-01-17	Boehringer Ingelheim International Gmbh	Method for producing dabigatran etexilate methansulphonate
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
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
WO2017111637A1 (en)	2015-12-23	2017-06-29	Zaklady Farmaceutyczne Polpharma Sa	Pharmaceutical composition comprising dabigatran or a pharmaceutically acceptable salt thereof
CN106727414B (zh) *	2016-12-27	2019-06-07	哈药集团技术中心	一种甲磺酸达比加群酯微丸及制备方法
CN108261409A (zh) *	2017-01-02	2018-07-10	齐鲁制药有限公司	一种达比加群酯的口服药物组合物及其制备方法
CN109276569B (zh) *	2017-07-21	2020-09-29	四川海思科制药有限公司	一种稳定的晶型药物组合物及其制备方法和用途
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
EP4465969A1 (en)	2022-01-21	2024-11-27	Adamed Pharma S.A.	A process for preparation of tartaric acid cores for dabigatran pellets and the pellets containing dabigatran
WO2024217830A1 (en)	2023-03-30	2024-10-24	Adamed Pharma S.A	A process for preparation of hard capsules filled with dabigatran pellets
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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
CN102066355B (zh) *	2008-06-16	2015-07-01	贝林格尔.英格海姆国际有限公司	达比加群酯的中间体的制备方法
EP2300431B1 (en) *	2008-06-16	2016-01-06	Boehringer Ingelheim International GmbH	Process for the manufacture of an intermediate in the synthesis of dabigatran
AU2009272796A1 (en) *	2008-07-14	2010-01-21	Boehringer Ingelheim International Gmbh	Method for manufacturing medicinal compounds containing dabigatran
MX2011007301A (es) *	2009-02-02	2011-08-03	Boehringer Ingelheim Int	Dabigatran liofilizado.
US8399678B2 (en) *	2009-11-18	2013-03-19	Boehringer Ingelheim International Gmbh	Process for the manufacture of dabigatran etexilate
WO2012027543A1 (en) *	2010-08-25	2012-03-01	Teva Pharmaceuticals Usa, Inc.	Solid state forms of dabigatran etexilate, dabigatran etexilate mesylate and processes for preparation thereof

2009
- 2009-03-24 KR KR1020107018919A patent/KR20100129281A/ko not_active Ceased
- 2009-03-24 WO PCT/EP2009/053469 patent/WO2009118322A1/en not_active Ceased
- 2009-03-24 JP JP2011501204A patent/JP2011515439A/ja active Pending
- 2009-03-24 RU RU2010143901/15A patent/RU2010143901A/ru unknown
- 2009-03-24 CA CA2711766A patent/CA2711766A1/en not_active Abandoned
- 2009-03-24 AU AU2009228795A patent/AU2009228795B2/en not_active Ceased
- 2009-03-24 MX MX2010010647A patent/MX2010010647A/es not_active Application Discontinuation
- 2009-03-24 EP EP09725292A patent/EP2288335A1/en not_active Ceased
- 2009-03-24 CN CN2009801113752A patent/CN101980697A/zh active Pending
- 2009-03-24 BR BRPI0907598-4A patent/BRPI0907598A2/pt not_active IP Right Cessation
- 2009-03-24 NZ NZ586868A patent/NZ586868A/en not_active IP Right Cessation
- 2009-03-24 US US12/934,727 patent/US20110129538A1/en not_active Abandoned
- 2009-03-27 TW TW098110299A patent/TW200944513A/zh unknown
- 2009-03-27 AR ARP090101103A patent/AR071569A1/es unknown
- 2009-03-27 CL CL2009000771A patent/CL2009000771A1/es unknown
2010
- 2010-06-28 ZA ZA2010/04550A patent/ZA201004550B/en unknown
- 2010-06-30 IL IL206718A patent/IL206718A0/en unknown
2013
- 2013-05-20 US US13/897,949 patent/US20130251810A1/en not_active Abandoned

Also Published As

Publication number	Publication date
CN101980697A (zh)	2011-02-23
KR20100129281A (ko)	2010-12-08
AR071569A1 (es)	2010-06-30
WO2009118322A1 (en)	2009-10-01
NZ586868A (en)	2012-02-24
JP2011515439A (ja)	2011-05-19
TW200944513A (en)	2009-11-01
US20130251810A1 (en)	2013-09-26
CA2711766A1 (en)	2009-10-01
US20110129538A1 (en)	2011-06-02
RU2010143901A (ru)	2012-05-10
EP2288335A1 (en)	2011-03-02
MX2010010647A (es)	2010-10-20
ZA201004550B (en)	2011-03-30
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