EA033291B1 - Dosage unit comprising ramipril and bisoprolol hemifumarate, process for the preparation thereof and method of treating hypertension - Google Patents

Dosage unit comprising ramipril and bisoprolol hemifumarate, process for the preparation thereof and method of treating hypertension

Info

Publication number
EA033291B1
EA033291B1 EA201690395A EA201690395A EA033291B1 EA 033291 B1 EA033291 B1 EA 033291B1 EA 201690395 A EA201690395 A EA 201690395A EA 201690395 A EA201690395 A EA 201690395A EA 033291 B1 EA033291 B1 EA 033291B1
Authority
EA
Eurasian Patent Office
Prior art keywords
dosage unit
ramipril
active ingredients
preparation
bisoprolol hemifumarate
Prior art date
Application number
EA201690395A
Other languages
Russian (ru)
Other versions
EA201690395A1 (en
Inventor
Эва Гутине Мольнар
Жольт Жигмонд
Зольтанне Тот
Адам Орбан
Original Assignee
Эгиш Дьёдьсердьяр Зрт.
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
Application filed by Эгиш Дьёдьсердьяр Зрт. filed Critical Эгиш Дьёдьсердьяр Зрт.
Publication of EA201690395A1 publication Critical patent/EA201690395A1/en
Publication of EA033291B1 publication Critical patent/EA033291B1/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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/50—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to a dosage unit comprising ramipril or a pharmaceutically acceptable salt thereof and bisoprolol hemifumarate as active ingredients, wherein particles of said active ingredients are separated from each other in the dosage unit by that at least one of the two active ingredients is in form of granules or coated compacts, and wherein the dosage unit is in tablet or capsule form. The invention also relates to a process for the preparation of said dosage unit, a method of treating hypertension using the same and to the use of bisoprolol hemifumarate and ramipril or salts thereof for the preparation of said dosage unit. The invention allows to obtain a dosage unit comprising ramipril and bisoprolol hemifumarate as active ingredients, characterised with the stability of the active ingredients, the bioavailability similar to that measured in case of simultaneous administration of two corresponding mono compositions and the dissolution profile which does not change during storage.
EA201690395A 2013-08-16 2014-08-15 Dosage unit comprising ramipril and bisoprolol hemifumarate, process for the preparation thereof and method of treating hypertension EA033291B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
HU1300496A HUP1300496A2 (en) 2013-08-16 2013-08-16 Stable pharmaceutical composition
PCT/HU2014/000072 WO2015022560A1 (en) 2013-08-16 2014-08-15 Stable pharmaceutical composition containing bisoprolol and ramipril

Publications (2)

Publication Number Publication Date
EA201690395A1 EA201690395A1 (en) 2016-07-29
EA033291B1 true EA033291B1 (en) 2019-09-30

Family

ID=89991232

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201690395A EA033291B1 (en) 2013-08-16 2014-08-15 Dosage unit comprising ramipril and bisoprolol hemifumarate, process for the preparation thereof and method of treating hypertension

Country Status (3)

Country Link
EA (1) EA033291B1 (en)
HU (2) HUP1300496A2 (en)
WO (2) WO2015022559A1 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3501502A1 (en) * 2017-12-20 2019-06-26 Midas Pharma GmbH Fixed dosed pharmaceutical compositions comprising amlodipine, ramipril and atorvastatin
WO2021162562A2 (en) 2020-02-10 2021-08-19 Adamed Pharma S.A. Stable ramipril composition and fixed dose composition comprising thereof
CN115068434B (en) * 2022-08-03 2023-05-09 昆山龙灯瑞迪制药有限公司 Preparation method of ramipril tablet

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007056442A1 (en) * 2005-11-07 2007-05-18 King Pharmaceuticals Research & Development, Inc. Compositions of stabilized ramipril in combination with another active agent

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DE3226768A1 (en) 1981-11-05 1983-05-26 Hoechst Ag, 6230 Frankfurt DERIVATIVES OF CIS, ENDO-2-AZABICYCLO- (3.3.0) -OCTAN-3-CARBONIC ACID, METHOD FOR THE PRODUCTION THEREOF, THE MEANS CONTAINING THEM AND THE USE THEREOF
DE3739690A1 (en) 1987-11-24 1989-06-08 Hoechst Ag STABILIZED MEDICINAL PRODUCTS, METHOD FOR THEIR PRODUCTION AND STABLE MEDICAL PREPARATIONS
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Also Published As

Publication number Publication date
WO2015022559A1 (en) 2015-02-19
WO2015022560A8 (en) 2015-05-14
EA201690395A1 (en) 2016-07-29
HU231052B1 (en) 2020-02-28
HUP1600414A2 (en) 2016-09-28
WO2015022560A1 (en) 2015-02-19
HUP1300496A2 (en) 2015-03-02

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Legal Events

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ KG TJ TM