WO2019004980A3 - Solid oral pharmaceutical compositions of dabigatran etexilate - Google Patents

Solid oral pharmaceutical compositions of dabigatran etexilate Download PDF

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Publication number
WO2019004980A3
WO2019004980A3 PCT/TR2018/050221 TR2018050221W WO2019004980A3 WO 2019004980 A3 WO2019004980 A3 WO 2019004980A3 TR 2018050221 W TR2018050221 W TR 2018050221W WO 2019004980 A3 WO2019004980 A3 WO 2019004980A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical compositions
solid oral
oral pharmaceutical
dabigatran etexilate
etexilate
Prior art date
Application number
PCT/TR2018/050221
Other languages
French (fr)
Other versions
WO2019004980A2 (en
Inventor
Ali TÜRKYILMAZ
Arzu Palantöken
Ezel URAZ
Yildiz GÜLKOK
Original Assignee
Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi
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
Priority claimed from TR2017/06848A external-priority patent/TR201706848A2/en
Application filed by Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi filed Critical Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi
Priority to EP18811675.0A priority Critical patent/EP3634388A2/en
Priority to EA201992644A priority patent/EA201992644A1/en
Priority to BR112019023781-0A priority patent/BR112019023781A2/en
Priority to NZ759901A priority patent/NZ759901A/en
Priority to AU2018293361A priority patent/AU2018293361B2/en
Publication of WO2019004980A2 publication Critical patent/WO2019004980A2/en
Publication of WO2019004980A3 publication Critical patent/WO2019004980A3/en
Priority to CONC2019/0013649A priority patent/CO2019013649A2/en

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
    • A61K9/48—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
    • 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
    • A61K9/1611—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
    • A61K9/14—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
    • A61K9/50—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (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/TR2018/050221 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate WO2019004980A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
EP18811675.0A EP3634388A2 (en) 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate
EA201992644A EA201992644A1 (en) 2017-05-10 2018-05-10 SOLID PHARMACEUTICAL COMPOSITIONS BASED ON DABIGATRAN ETHEXILATE FOR ORAL USE
BR112019023781-0A BR112019023781A2 (en) 2017-05-10 2018-05-10 PHARMACEUTICAL COMPOSITION IN A DOSAGE UNIT FORM AND PROCESS FOR PREPARING THE PHARMACEUTICAL COMPOSITION
NZ759901A NZ759901A (en) 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate
AU2018293361A AU2018293361B2 (en) 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate
CONC2019/0013649A CO2019013649A2 (en) 2017-05-10 2019-12-03 Oral Solid Pharmaceutical Compositions of Dabigatran Etexilate

Applications Claiming Priority (4)

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
TR2018/06309 2018-05-04
TR2018/06309A TR201806309A2 (en) 2017-05-10 2018-05-04 Solid oral pharmaceutical compositions of dabigatran etexilate

Publications (2)

Publication Number Publication Date
WO2019004980A2 WO2019004980A2 (en) 2019-01-03
WO2019004980A3 true WO2019004980A3 (en) 2019-04-11

Family

ID=64559742

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2018/050221 WO2019004980A2 (en) 2017-05-10 2018-05-10 Solid oral pharmaceutical compositions of dabigatran etexilate

Country Status (1)

Country Link
WO (1) WO2019004980A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TR202000791A1 (en) * 2020-01-20 2021-07-26 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Capsule-in-capsule comprising dabigatran etexilate
CN113893356A (en) * 2020-11-27 2022-01-07 上海博志研新药物技术有限公司 Dabigatran etexilate mesylate inclusion compound, preparation method and application

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 (4)

* 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

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
WO2019004980A2 (en) 2019-01-03

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