KR102090242B1 - 다비가트란 이텍실레이트의 경구형 약학 조성물 - Google Patents

다비가트란 이텍실레이트의 경구형 약학 조성물 Download PDF

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KR102090242B1
KR102090242B1 KR1020147026330A KR20147026330A KR102090242B1 KR 102090242 B1 KR102090242 B1 KR 102090242B1 KR 1020147026330 A KR1020147026330 A KR 1020147026330A KR 20147026330 A KR20147026330 A KR 20147026330A KR 102090242 B1 KR102090242 B1 KR 102090242B1
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acid
dabigatran
particles
itexylate
pharmaceutically acceptable
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KR20140135216A (ko
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프라티바 에스. 필가온카르
마하루크 티. 러스톰지
아닐쿠마르 에스. 간디
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에스테베 파마슈티칼스 에스에이
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    • 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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020147026330A 2012-02-21 2013-02-21 다비가트란 이텍실레이트의 경구형 약학 조성물 Active KR102090242B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN461/MUM/2012 2012-02-21
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
KR20140135216A KR20140135216A (ko) 2014-11-25
KR102090242B1 true KR102090242B1 (ko) 2020-03-18

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US (3) US11013729B2 (enExample)
EP (2) EP3858337A3 (enExample)
JP (1) JP6215239B2 (enExample)
KR (1) KR102090242B1 (enExample)
CN (2) CN104114158A (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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DK2817000T3 (da) 2012-02-21 2021-10-11 Towa Pharmaceutical Europe S L Orale farmaceutiske sammensætninger af dabigatranetexilat
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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
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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
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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
WO2017111637A1 (en) 2015-12-23 2017-06-29 Zaklady Farmaceutyczne Polpharma Sa Pharmaceutical composition comprising dabigatran or a pharmaceutically acceptable salt thereof
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
TR201722323A2 (tr) 2017-12-27 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Dabi̇gatranin oral farmasöti̇k kompozi̇syonlari
TR201722353A2 (tr) * 2017-12-27 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Dabi̇gatran eteksi̇lat i̇çeren oral uygulama i̇çi̇n farmasöti̇k formülasyon
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
EP3787624A4 (en) 2018-05-04 2022-03-30 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
CN113577067B (zh) * 2021-06-03 2023-08-15 北京福元医药股份有限公司 一种甲磺酸达比加群酯药物制剂
CN115006363A (zh) * 2022-06-23 2022-09-06 上海信谊万象药业股份有限公司 一种牡蛎碳酸钙咀嚼片及其制备方法
WO2024175037A1 (zh) * 2023-02-21 2024-08-29 广州玻思韬控释药业有限公司 达比加群酯或其药物可接受的盐的微丸

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JP2005519099A (ja) 2002-03-07 2005-06-30 ベーリンガー インゲルハイム ファルマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト 3−[(2−{[4−(ヘキシルオキシカルボニルアミノ−イミノ−メチル)−フェニルアミノ]−メチル}−1−メチル−1h−ベンゾイミダゾール−5−カルボニル)−ピリジン−2−イル−アミノ]−プロピオン酸エチルエステル及びその塩の経口適用の投与形態
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BR112014020474A2 (pt) 2020-02-11
CY1124678T1 (el) 2022-07-22
AU2013224146B2 (en) 2017-06-08
HUE056194T2 (hu) 2022-01-28
RU2014138036A (ru) 2016-04-20
WO2013124340A1 (en) 2013-08-29
LT2817000T (lt) 2021-11-10
ES2895918T3 (es) 2022-02-23
HRP20211606T1 (hr) 2022-01-21
EP3858337A3 (en) 2021-09-29
SMT202100608T1 (it) 2021-11-12
JP2015511241A (ja) 2015-04-16
US20240139168A1 (en) 2024-05-02
CA2864423C (en) 2021-08-10
SI2817000T1 (sl) 2022-02-28
CA2864423A1 (en) 2013-08-29
JP6215239B2 (ja) 2017-10-18
EP3858337A2 (en) 2021-08-04
MX2014010040A (es) 2014-11-10
EP2817000A1 (en) 2014-12-31
NZ628301A (en) 2015-07-31
CN110123774A (zh) 2019-08-16
US11013729B2 (en) 2021-05-25
CN104114158A (zh) 2014-10-22
US11752142B2 (en) 2023-09-12
RU2633482C2 (ru) 2017-10-12
MX368868B (es) 2019-10-11
BR112014020474B1 (pt) 2022-03-29
IN2014DN06734A (enExample) 2015-05-22
ZA201405855B (en) 2015-11-25
JO3616B1 (ar) 2020-08-27
AU2013224146A1 (en) 2014-08-28
PL2817000T3 (pl) 2022-03-28
HK1203832A1 (en) 2015-11-06
DK2817000T3 (da) 2021-10-11
US20210244719A1 (en) 2021-08-12
IL234032A0 (en) 2014-09-30
EP2817000B1 (en) 2021-08-04
PT2817000T (pt) 2021-11-02
US20150030680A1 (en) 2015-01-29
IL234032B (en) 2020-06-30
RS62566B1 (sr) 2021-12-31
KR20140135216A (ko) 2014-11-25

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