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WO2019004979A3 - Solid oral pharmaceutical compositions of dabigatran etexilate - Google Patents

Solid oral pharmaceutical compositions of dabigatran etexilate Download PDF

Info

Publication number
WO2019004979A3
WO2019004979A3 PCT/TR2018/050220 TR2018050220W WO2019004979A3 WO 2019004979 A3 WO2019004979 A3 WO 2019004979A3 TR 2018050220 W TR2018050220 W TR 2018050220W WO 2019004979 A3 WO2019004979 A3 WO 2019004979A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical compositions
solid oral
oral pharmaceutical
dabigatran etexilate
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
PCT/TR2018/050220
Other languages
French (fr)
Other versions
WO2019004979A2 (en
Inventor
Ezel URAZ
Ali TÜRKYILMAZ
Arzu Palantöken
Yildiz GÜLKOK
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=WO2019004979(A3) "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 to EP18811674.3A priority Critical patent/EP3621599A2/en
Publication of WO2019004979A2 publication Critical patent/WO2019004979A2/en
Publication of WO2019004979A3 publication Critical patent/WO2019004979A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • 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
    • A61K9/5005—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
    • 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)

Abstract

The present invention relates to solid oral pharmaceutical compositions, comprising dabigatran etexilate in the form of the free base or in the form of pharmaceutically acceptable salts, polymorphs, solvates, hydrates or esters thereof.
PCT/TR2018/050220 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate Ceased WO2019004979A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP18811674.3A EP3621599A2 (en) 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2017/06848A TR201706848A2 (en) 2017-05-10 2017-05-10 SOLID ORAL PHARMACEUTICAL COMPOSITIONS CONTAINING DABIGATRAN ETEXCLATE
TR2017/06848 2017-05-10

Publications (2)

Publication Number Publication Date
WO2019004979A2 WO2019004979A2 (en) 2019-01-03
WO2019004979A3 true WO2019004979A3 (en) 2019-04-11

Family

ID=64559741

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2018/050220 Ceased WO2019004979A2 (en) 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate

Country Status (8)

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

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012001156A2 (en) * 2010-07-01 2012-01-05 Krka, Tovarna Zdravil, D.D., Novo Mesto Pharmaceutical oral dosage forms comprising dabigatran etexilate and its pharmaceutically acceptable salts
WO2013124340A1 (en) * 2012-02-21 2013-08-29 Laboratorios Del Dr. Esteve, S.A. Oral pharmaceutical compositions of dabigatran etexilate
CN104095830A (en) * 2014-05-22 2014-10-15 万特制药(海南)有限公司 Preparation method for mesylate dabigatran capsule
CN104784147A (en) * 2014-01-20 2015-07-22 成都苑东药业有限公司 A dabigatran etexilate mesylate capsule pharmaceutical composition and a preparing method thereof
EP2929884A1 (en) * 2014-04-11 2015-10-14 Sanovel Ilac Sanayi ve Ticaret A.S. Pharmaceutical combinations of dabigatran and h2-receptor antagonists
CN105560206A (en) * 2014-10-13 2016-05-11 重庆圣华曦药业股份有限公司 Preparation of Pradaxa capsule
WO2016142821A2 (en) * 2015-03-09 2016-09-15 Alphamed Formulations Pvt. Ltd Compositions containing a thrombin inhibitor

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE121699A1 (en) 1997-02-18 1999-12-08 Boehringer Ingelheim Pharma BICYCLE HETERO CYCLES DISSTITUTED AS INHIBITORS OF THROMBIN
DE10337697A1 (en) 2003-08-16 2005-03-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg Tablet containing 3 - [(2 - {[4- (hexyloxycarbonylamino-iminomethyl) -phenyl-amino] -methyl} -1-methyl-1H-benzimidazole-5-carbonyl) -pyridin-2-yl-amino] - propionic acid ethyl ester or its salts
EP2740471B1 (en) 2012-12-07 2015-05-27 Hexal AG Oral pharmaceutical composition comprising dabigatran etexilate
WO2015145462A1 (en) 2014-03-26 2015-10-01 Cadila Healthcare Limited Pharmaceutical compositions of dabigatran
IN2015CH01145A (en) * 2015-03-09 2016-09-16

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012001156A2 (en) * 2010-07-01 2012-01-05 Krka, Tovarna Zdravil, D.D., Novo Mesto Pharmaceutical oral dosage forms comprising dabigatran etexilate and its pharmaceutically acceptable salts
WO2013124340A1 (en) * 2012-02-21 2013-08-29 Laboratorios Del Dr. Esteve, S.A. Oral pharmaceutical compositions of dabigatran etexilate
CN104784147A (en) * 2014-01-20 2015-07-22 成都苑东药业有限公司 A dabigatran etexilate mesylate capsule pharmaceutical composition and a preparing method thereof
EP2929884A1 (en) * 2014-04-11 2015-10-14 Sanovel Ilac Sanayi ve Ticaret A.S. Pharmaceutical combinations of dabigatran and h2-receptor antagonists
CN104095830A (en) * 2014-05-22 2014-10-15 万特制药(海南)有限公司 Preparation method for mesylate dabigatran capsule
CN105560206A (en) * 2014-10-13 2016-05-11 重庆圣华曦药业股份有限公司 Preparation of Pradaxa capsule
WO2016142821A2 (en) * 2015-03-09 2016-09-15 Alphamed Formulations Pvt. Ltd Compositions containing a thrombin inhibitor

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Section Ch Week 201675, Derwent World Patents Index; Class A96, AN 2016-637397, XP002789451, BALANAGU H B; BALEBOINA S; BEJAWADA S; CHERUVU R; HILL L A: "Capsule dosage form of direct thrombin inhibitor, useful e.g. for treating deep venous thrombosis and pulmonary embolism, and for reducing risk of stroke and systemic embolism, comprises two types of solid unit dosage forms" *

Also Published As

Publication number Publication date
NZ759901A (en) 2021-12-24
AU2018293361A1 (en) 2020-01-02
TR201806309A2 (en) 2018-11-21
AU2018293361B2 (en) 2021-09-16
EP3634388A2 (en) 2020-04-15
BR112019023781A2 (en) 2020-06-02
CO2019013649A2 (en) 2020-05-15
EA201992644A1 (en) 2020-04-07
WO2019004979A2 (en) 2019-01-03
TR201706848A2 (en) 2018-11-21
EP3621599A2 (en) 2020-03-18

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