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AU2018293361B2 - Solid oral pharmaceutical compositions of dabigatran etexilate - Google Patents

Solid oral pharmaceutical compositions of dabigatran etexilate Download PDF

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Publication number
AU2018293361B2
AU2018293361B2 AU2018293361A AU2018293361A AU2018293361B2 AU 2018293361 B2 AU2018293361 B2 AU 2018293361B2 AU 2018293361 A AU2018293361 A AU 2018293361A AU 2018293361 A AU2018293361 A AU 2018293361A AU 2018293361 B2 AU2018293361 B2 AU 2018293361B2
Authority
AU
Australia
Prior art keywords
capsule
formulation
pellets
granules
dabigatran etexilate
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
AU2018293361A
Other languages
English (en)
Other versions
AU2018293361A1 (en
Inventor
Yildiz GÜLKOK
Arzu Palantöken
Ali TÜRKYILMAZ
Ezel URAZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanovel Ilac Sanayi ve Ticaret AS
Original Assignee
Sanovel Ilac Sanayi ve Ticaret AS
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=64559741&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2018293361(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanovel Ilac Sanayi ve Ticaret AS filed Critical Sanovel Ilac Sanayi ve Ticaret AS
Priority claimed from PCT/TR2018/050221 external-priority patent/WO2019004980A2/fr
Publication of AU2018293361A1 publication Critical patent/AU2018293361A1/en
Application granted granted Critical
Publication of AU2018293361B2 publication Critical patent/AU2018293361B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K9/1611—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
    • A61K9/48—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
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/1629—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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/50—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
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2018293361A 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate Ceased AU2018293361B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
TR2017/06848A TR201706848A2 (tr) 2017-05-10 2017-05-10 Dabigatran eteksi̇lat i̇çeren kati oral farmasöti̇k kompozi̇syonlar
TR2017/06848 2017-05-10
TR2018/06309 2018-05-04
TR2018/06309A TR201806309A2 (tr) 2017-05-10 2018-05-04 Dabigatran eteksi̇lat i̇çeren kati oral farmasöti̇k kompozi̇syonlar
PCT/TR2018/050221 WO2019004980A2 (fr) 2017-05-10 2018-05-10 Compositions pharmaceutiques orales solides d'étéxilate de dabigatran

Publications (2)

Publication Number Publication Date
AU2018293361A1 AU2018293361A1 (en) 2020-01-02
AU2018293361B2 true AU2018293361B2 (en) 2021-09-16

Family

ID=64559741

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018293361A Ceased AU2018293361B2 (en) 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate

Country Status (8)

Country Link
EP (2) EP3634388A2 (fr)
AU (1) AU2018293361B2 (fr)
BR (1) BR112019023781A2 (fr)
CO (1) CO2019013649A2 (fr)
EA (1) EA201992644A1 (fr)
NZ (1) NZ759901A (fr)
TR (2) TR201706848A2 (fr)
WO (1) WO2019004979A2 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012001156A2 (fr) * 2010-07-01 2012-01-05 Krka, Tovarna Zdravil, D.D., Novo Mesto Formes pharmaceutiques posologiques orales comprenant de l'étéxilate de dabigatran et ses sels pharmaceutiquement acceptables
WO2013124340A1 (fr) * 2012-02-21 2013-08-29 Laboratorios Del Dr. Esteve, S.A. Compositions pharmaceutiques orales de dabigatran étexilate
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
CN104784147A (zh) * 2014-01-20 2015-07-22 成都苑东药业有限公司 一种甲磺酸达比加群酯胶囊药物组合物及其制备方法
EP2929884A1 (fr) * 2014-04-11 2015-10-14 Sanovel Ilac Sanayi ve Ticaret A.S. Combinaisons pharmaceutiques de dabigatran et antagonistes du récepteur de h2
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
WO2016142821A2 (fr) * 2015-03-09 2016-09-15 Alphamed Formulations Pvt. Ltd Compositions contenant un inhibiteur de la thrombine
IN2015CH01145A (fr) * 2015-03-09 2016-09-16

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE121699A1 (es) 1997-02-18 1999-12-08 Boehringer Ingelheim Pharma Heterociclos biciclicos disustituidos como inhibidores de la trombina
DE10337697A1 (de) 2003-08-16 2005-03-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg Tablette enthaltend 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenyl-amino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester oder dessen Salze
EP2740471B1 (fr) 2012-12-07 2015-05-27 Hexal AG Composition pharmaceutique orale comprenant le dabigatran etexilate
WO2015145462A1 (fr) 2014-03-26 2015-10-01 Cadila Healthcare Limited Compositions pharmaceutiques de dabigatran

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012001156A2 (fr) * 2010-07-01 2012-01-05 Krka, Tovarna Zdravil, D.D., Novo Mesto Formes pharmaceutiques posologiques orales comprenant de l'étéxilate de dabigatran et ses sels pharmaceutiquement acceptables
WO2013124340A1 (fr) * 2012-02-21 2013-08-29 Laboratorios Del Dr. Esteve, S.A. Compositions pharmaceutiques orales de dabigatran étexilate
CN104784147A (zh) * 2014-01-20 2015-07-22 成都苑东药业有限公司 一种甲磺酸达比加群酯胶囊药物组合物及其制备方法
EP2929884A1 (fr) * 2014-04-11 2015-10-14 Sanovel Ilac Sanayi ve Ticaret A.S. Combinaisons pharmaceutiques de dabigatran et antagonistes du récepteur de h2
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
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
WO2016142821A2 (fr) * 2015-03-09 2016-09-15 Alphamed Formulations Pvt. Ltd Compositions contenant un inhibiteur de la thrombine
IN2015CH01145A (fr) * 2015-03-09 2016-09-16

Also Published As

Publication number Publication date
NZ759901A (en) 2021-12-24
AU2018293361A1 (en) 2020-01-02
TR201806309A2 (tr) 2018-11-21
EP3634388A2 (fr) 2020-04-15
BR112019023781A2 (pt) 2020-06-02
WO2019004979A3 (fr) 2019-04-11
CO2019013649A2 (es) 2020-05-15
EA201992644A1 (ru) 2020-04-07
WO2019004979A2 (fr) 2019-01-03
TR201706848A2 (tr) 2018-11-21
EP3621599A2 (fr) 2020-03-18

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired