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)
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

    • 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
    • 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
    • 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
    • A61K9/14—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
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • 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
    • A61K9/5084—Mixtures 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
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

Landscapes

  • 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)

Abstract

Composiciones que comprenden una mezcla de al menos dos tipos de partículas en las que a) el primer tipo de partículas comprenden dabigatrán etexilato en forma de la base libre o en forma de sales, polimorfos, solvatos o hidratos farmacéuticamente aceptables del mismo; y b) el segundo tipo de partículas comprende al menos un ácido orgánico farmacéuticamente aceptable, uso de dichas composiciones en la reducción del riesgo de desarrollar accidente cerebrovascular y embolia sistémica en pacientes con fibrilación auricular no valvular y/o en la prevención de acontecimientos tromboembólicos venosos en pacientes adultos que se han sometido a cirugía de artroplastia total de rodilla o cirugía de artroplastia total de cadera programada y procedimientos para la preparación de dichas composiciones.
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 (es)
EP (2) EP3858337A3 (es)
JP (1) JP6215239B2 (es)
KR (1) KR102090242B1 (es)
CN (2) CN110123774A (es)
AU (1) AU2013224146B2 (es)
BR (1) BR112014020474B1 (es)
CA (1) CA2864423C (es)
CY (1) CY1124678T1 (es)
DK (1) DK2817000T3 (es)
ES (1) ES2895918T3 (es)
HK (1) HK1203832A1 (es)
HR (1) HRP20211606T1 (es)
HU (1) HUE056194T2 (es)
IL (1) IL234032B (es)
IN (1) IN2014DN06734A (es)
JO (1) JO3616B1 (es)
LT (1) LT2817000T (es)
MX (1) MX368868B (es)
NZ (1) NZ628301A (es)
PL (1) PL2817000T3 (es)
PT (1) PT2817000T (es)
RS (1) RS62566B1 (es)
RU (1) RU2633482C2 (es)
SI (1) SI2817000T1 (es)
WO (1) WO2013124340A1 (es)
ZA (1) ZA201405855B (es)

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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
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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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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
WO2019004980A2 (en) * 2017-05-10 2019-01-03 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi SOLID ORAL PHARMACEUTICAL COMPOSITIONS OF DABIGATRAN DEXILATE
TR201706848A2 (tr) * 2017-05-10 2018-11-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Dabigatran eteksi̇lat i̇çeren kati oral farmasöti̇k kompozi̇syonlar
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 (es) 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
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ZA201405855B (en) 2015-11-25
CN104114158A (zh) 2014-10-22
PT2817000T (pt) 2021-11-02
HUE056194T2 (hu) 2022-01-28
US20240139168A1 (en) 2024-05-02
JO3616B1 (ar) 2020-08-27
ES2895918T3 (es) 2022-02-23
US20210244719A1 (en) 2021-08-12
NZ628301A (en) 2015-07-31
RU2014138036A (ru) 2016-04-20
US11752142B2 (en) 2023-09-12
HK1203832A1 (en) 2015-11-06
IL234032A0 (en) 2014-09-30
EP3858337A2 (en) 2021-08-04
CN110123774A (zh) 2019-08-16
RU2633482C2 (ru) 2017-10-12
CA2864423A1 (en) 2013-08-29
BR112014020474A2 (pt) 2020-02-11
BR112014020474B1 (pt) 2022-03-29
RS62566B1 (sr) 2021-12-31
US11013729B2 (en) 2021-05-25
MX2014010040A (es) 2014-11-10
US20150030680A1 (en) 2015-01-29
DK2817000T3 (da) 2021-10-11
WO2013124340A1 (en) 2013-08-29
AU2013224146B2 (en) 2017-06-08
PL2817000T3 (pl) 2022-03-28
SI2817000T1 (sl) 2022-02-28
KR20140135216A (ko) 2014-11-25
IN2014DN06734A (es) 2015-05-22
AU2013224146A1 (en) 2014-08-28
LT2817000T (lt) 2021-11-10
EP2817000B1 (en) 2021-08-04
CY1124678T1 (el) 2022-07-22
JP6215239B2 (ja) 2017-10-18
EP3858337A3 (en) 2021-09-29
JP2015511241A (ja) 2015-04-16
EP2817000A1 (en) 2014-12-31
HRP20211606T1 (hr) 2022-01-21
CA2864423C (en) 2021-08-10
IL234032B (en) 2020-06-30
KR102090242B1 (ko) 2020-03-18

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