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AR071569A1 - Proceso para preparar formulaciones de dabigatran para administracion oral - Google Patents

Proceso para preparar formulaciones de dabigatran para administracion oral

Info

Publication number
AR071569A1
AR071569A1 ARP090101103A ARP090101103A AR071569A1 AR 071569 A1 AR071569 A1 AR 071569A1 AR P090101103 A ARP090101103 A AR P090101103A AR P090101103 A ARP090101103 A AR P090101103A AR 071569 A1 AR071569 A1 AR 071569A1
Authority
AR
Argentina
Prior art keywords
dabigatran
dabigatran etexilate
oral administration
suspension
polymorphic form
Prior art date
Application number
ARP090101103A
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.)
Filing date
Publication date
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=AR071569(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Ingelheim Int filed Critical Boehringer Ingelheim Int
Publication of AR071569A1 publication Critical patent/AR071569A1/es

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
    • A61K9/14—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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Reivindicacion 1: Proceso para preparar una suspension 4 de la forma polimorfica 1 de la sal del ácido metanosulfonico del etexilato de dabigatrán de formula 1 caracterizado porque la forma polimorfica 1 del metanosulfonato del etexilato de dabigatrán se suspende junto con talco en una disolucion de hidroxipropilcelulosa en isopropanol, llevándose a cabo la preparacion de la suspension a una temperatura que no sobrepasa los 30°C. Reivindicacion 2: Proceso segun la reivindicacion 1, caracterizado porque en primer lugar se disuelve hidroxipropilcelulosa en isopropanol y a continuacion se suspenden la forma polimorfica 1 del metanosulfonato de etexilato de dabigatrán y el talco en esta disolucion. Reivindicacion 9: Uso de una suspension 4 segun una de las reivindicaciones 6 a 8, como material de partida caracterizado porque es para preparar pellets 5 de metanosulfonato de etexilato de dabigatrán.
ARP090101103A 2008-03-28 2009-03-27 Proceso para preparar formulaciones de dabigatran para administracion oral AR071569A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP08153667 2008-03-28

Publications (1)

Publication Number Publication Date
AR071569A1 true AR071569A1 (es) 2010-06-30

Family

ID=39705326

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP090101103A AR071569A1 (es) 2008-03-28 2009-03-27 Proceso para preparar formulaciones de dabigatran para administracion oral

Country Status (17)

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

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US8399678B2 (en) 2009-11-18 2013-03-19 Boehringer Ingelheim International Gmbh Process for the manufacture of dabigatran etexilate
PL2588090T3 (pl) 2010-07-01 2017-12-29 Krka, Tovarna Zdravil, D.D., Novo Mesto Doustne farmaceutyczne postacie dawkowania zawierające eteksylan dabigatranu i jego farmaceutycznie dopuszczalne sole
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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
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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
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
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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
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Also Published As

Publication number Publication date
CA2711766A1 (en) 2009-10-01
US20110129538A1 (en) 2011-06-02
AU2009228795A1 (en) 2009-10-01
BRPI0907598A2 (pt) 2015-07-21
MX2010010647A (es) 2010-10-20
ZA201004550B (en) 2011-03-30
TW200944513A (en) 2009-11-01
IL206718A0 (en) 2010-12-30
RU2010143901A (ru) 2012-05-10
WO2009118322A1 (en) 2009-10-01
CN101980697A (zh) 2011-02-23
NZ586868A (en) 2012-02-24
US20130251810A1 (en) 2013-09-26
JP2011515439A (ja) 2011-05-19
AU2009228795B2 (en) 2014-02-13
EP2288335A1 (en) 2011-03-02
KR20100129281A (ko) 2010-12-08
CL2009000771A1 (es) 2010-03-05

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