MX368868B - Composiciones farmacéuticas orales de dabigatrán etexilato. - Google Patents

Composiciones farmacéuticas orales de dabigatrán etexilato.

Info

Publication number
MX368868B
MX368868B MX2014010040A MX2014010040A MX368868B MX 368868 B MX368868 B MX 368868B MX 2014010040 A MX2014010040 A MX 2014010040A MX 2014010040 A MX2014010040 A MX 2014010040A MX 368868 B MX368868 B MX 368868B
Authority
MX
Mexico
Prior art keywords
compositions
dabigatran etexilate
pharmaceutical compositions
pharmaceutically acceptable
oral pharmaceutical
Prior art date
Application number
MX2014010040A
Other languages
English (en)
Spanish (es)
Other versions
MX2014010040A (es
Inventor
S Pilgaonkar Pratibha
T Rustomjee Maharukh
S Gandhi Anilkumar
Original Assignee
Esteve Pharmaceuticals Sa
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=47739283&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX368868(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Esteve Pharmaceuticals Sa filed Critical Esteve Pharmaceuticals Sa
Publication of MX2014010040A publication Critical patent/MX2014010040A/es
Publication of MX368868B publication Critical patent/MX368868B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833Encapsulating processes; Filling of capsules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
MX2014010040A 2012-02-21 2013-02-21 Composiciones farmacéuticas orales de dabigatrán etexilato. MX368868B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN461MU2012 2012-02-21
PCT/EP2013/053426 WO2013124340A1 (en) 2012-02-21 2013-02-21 Oral pharmaceutical compositions of dabigatran etexilate

Publications (2)

Publication Number Publication Date
MX2014010040A MX2014010040A (es) 2014-11-10
MX368868B true MX368868B (es) 2019-10-11

Family

ID=47739283

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2014010040A MX368868B (es) 2012-02-21 2013-02-21 Composiciones farmacéuticas orales de dabigatrán etexilato.

Country Status (27)

Country Link
US (3) US11013729B2 (enExample)
EP (2) EP3858337A3 (enExample)
JP (1) JP6215239B2 (enExample)
KR (1) KR102090242B1 (enExample)
CN (2) CN110123774A (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)

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PT2817000T (pt) 2012-02-21 2021-11-02 Towa Pharmaceutical Europe S L Composições farmacêuticas de dabigatrano etexilato
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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
WO2015113324A1 (zh) * 2014-01-30 2015-08-06 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
IN2014MU01042A (enExample) 2014-03-26 2015-10-02 Cadila Healthcare Ltd
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
US10675276B2 (en) * 2014-11-03 2020-06-09 Hangzhou Solipharma Co., Ltd. Dosing preparation of dabigatran etexilate or a salt thereof and a preparation method thereof
WO2016107605A1 (zh) 2014-12-31 2016-07-07 昆明积大制药股份有限公司 药物组合物及其制备方法
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
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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
TR201722353A2 (tr) * 2017-12-27 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Dabi̇gatran eteksi̇lat i̇çeren oral uygulama i̇çi̇n farmasöti̇k formülasyon
TR201722323A2 (tr) 2017-12-27 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Dabi̇gatranin oral farmasöti̇k kompozi̇syonlari
TR201722630A2 (enExample) 2017-12-28 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi
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
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Also Published As

Publication number Publication date
MX2014010040A (es) 2014-11-10
AU2013224146A1 (en) 2014-08-28
NZ628301A (en) 2015-07-31
AU2013224146B2 (en) 2017-06-08
IL234032A0 (en) 2014-09-30
JP2015511241A (ja) 2015-04-16
IN2014DN06734A (enExample) 2015-05-22
RS62566B1 (sr) 2021-12-31
CN110123774A (zh) 2019-08-16
DK2817000T3 (da) 2021-10-11
CA2864423A1 (en) 2013-08-29
JO3616B1 (ar) 2020-08-27
HUE056194T2 (hu) 2022-01-28
PL2817000T3 (pl) 2022-03-28
SI2817000T1 (sl) 2022-02-28
RU2633482C2 (ru) 2017-10-12
HRP20211606T1 (hr) 2022-01-21
BR112014020474A2 (pt) 2020-02-11
WO2013124340A1 (en) 2013-08-29
LT2817000T (lt) 2021-11-10
CN104114158A (zh) 2014-10-22
EP3858337A3 (en) 2021-09-29
BR112014020474B1 (pt) 2022-03-29
HK1203832A1 (en) 2015-11-06
CA2864423C (en) 2021-08-10
JP6215239B2 (ja) 2017-10-18
US20240139168A1 (en) 2024-05-02
KR102090242B1 (ko) 2020-03-18
EP3858337A2 (en) 2021-08-04
EP2817000B1 (en) 2021-08-04
RU2014138036A (ru) 2016-04-20
US11752142B2 (en) 2023-09-12
EP2817000A1 (en) 2014-12-31
CY1124678T1 (el) 2022-07-22
PT2817000T (pt) 2021-11-02
US20150030680A1 (en) 2015-01-29
KR20140135216A (ko) 2014-11-25
US11013729B2 (en) 2021-05-25
US20210244719A1 (en) 2021-08-12
ES2895918T3 (es) 2022-02-23
IL234032B (en) 2020-06-30
SMT202100608T1 (it) 2021-11-12
ZA201405855B (en) 2015-11-25

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