WO2022270935A1 - Préparation d'une combinaison pharmaceutique comprenant du candésartan, de l'amlodipine et de l'atorvastatine - Google Patents

Préparation d'une combinaison pharmaceutique comprenant du candésartan, de l'amlodipine et de l'atorvastatine Download PDF

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Publication number
WO2022270935A1
WO2022270935A1 PCT/KR2022/008921 KR2022008921W WO2022270935A1 WO 2022270935 A1 WO2022270935 A1 WO 2022270935A1 KR 2022008921 W KR2022008921 W KR 2022008921W WO 2022270935 A1 WO2022270935 A1 WO 2022270935A1
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WO
WIPO (PCT)
Prior art keywords
pharmaceutical combination
atorvastatin
candesartan
pharmaceutically acceptable
acceptable salt
Prior art date
Application number
PCT/KR2022/008921
Other languages
English (en)
Inventor
Min Young Kim
Min Kwan Cho
Min Soo Kim
Shin Jung Park
Original Assignee
Chong Kun Dang Pharmaceutical Corp.
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 Chong Kun Dang Pharmaceutical Corp. filed Critical Chong Kun Dang Pharmaceutical Corp.
Publication of WO2022270935A1 publication Critical patent/WO2022270935A1/fr

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    • 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
    • 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
    • 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
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne la préparation d'une combinaison pharmaceutique comprenant du candésartan, de l'amlodipine et de l'atorvastatine en tant que principes actifs. La formulation de la combinaison pharmaceutique selon la présente invention, qui comprend simultanément du candésartan, de l'amlodipine et de l'atorvastatine, peut présenter des effets pharmacologiques comparables à ceux de la co-administration de Lipitor® Tab, qui est un comprimé unique d'atorvastatine, et Cantabell® Tab, qui est un comprimé associant le candésartan et l'amlodipine, car le profil de dissolution et le profil pharmacocinétique de chacun des principes actifs sont équivalents à ceux de l'administration simultanée. De plus, puisque les teneurs en substances apparentées individuelles et totales dans la préparation de combinaison pharmaceutique n'augmentent pas significativement dans des conditions à long terme et accélérées, la formulation de la combinaison pharmaceutique est hautement stable et peut améliorer de manière significative la commodité de l'administration du médicament.
PCT/KR2022/008921 2021-06-24 2022-06-23 Préparation d'une combinaison pharmaceutique comprenant du candésartan, de l'amlodipine et de l'atorvastatine WO2022270935A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2021-0082309 2021-06-24
KR1020210082309A KR20230000506A (ko) 2021-06-24 2021-06-24 칸데사르탄, 암로디핀 및 아트로바스타틴을 포함하는 약제학적 복합제제

Publications (1)

Publication Number Publication Date
WO2022270935A1 true WO2022270935A1 (fr) 2022-12-29

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ID=84545782

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2022/008921 WO2022270935A1 (fr) 2021-06-24 2022-06-23 Préparation d'une combinaison pharmaceutique comprenant du candésartan, de l'amlodipine et de l'atorvastatine

Country Status (2)

Country Link
KR (1) KR20230000506A (fr)
WO (1) WO2022270935A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050119270A1 (en) * 2000-08-04 2005-06-02 Mason R. P. Synergistic effect of amlodipine and atorvastatin on aortic endothelial cell nitric oxide release
US20060177504A1 (en) * 2005-02-08 2006-08-10 Renjit Sundharadas Combination pain medication
EP2165702A1 (fr) * 2008-09-17 2010-03-24 Helm AG Compositions dissoutes facilement et stables de candesartan cilexetil préparé avec une granulation par voie humide
US20100267679A1 (en) * 2009-04-15 2010-10-21 Jacques Benoit Pharmaceutical combination of medication to be used by patients for the purpose of preventing or reducing the evolution of atherosclerosis and thus preventing coronary heart disease and cerebro-vascular accidents.
US10588859B2 (en) * 2007-03-22 2020-03-17 Berg Llc Topical formulations having enhanced bioavailability

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4681893A (en) 1986-05-30 1987-07-21 Warner-Lambert Company Trans-6-[2-(3- or 4-carboxamido-substituted pyrrol-1-yl)alkyl]-4-hydroxypyran-2-one inhibitors of cholesterol synthesis
WO2006059217A1 (fr) 2004-12-01 2006-06-08 Ranbaxy Laboratories Limited Formes posologiques solides stables d'amlodipine bezylate, et procedes d'elaboration correspondants

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050119270A1 (en) * 2000-08-04 2005-06-02 Mason R. P. Synergistic effect of amlodipine and atorvastatin on aortic endothelial cell nitric oxide release
US20060177504A1 (en) * 2005-02-08 2006-08-10 Renjit Sundharadas Combination pain medication
US10588859B2 (en) * 2007-03-22 2020-03-17 Berg Llc Topical formulations having enhanced bioavailability
EP2165702A1 (fr) * 2008-09-17 2010-03-24 Helm AG Compositions dissoutes facilement et stables de candesartan cilexetil préparé avec une granulation par voie humide
US20100267679A1 (en) * 2009-04-15 2010-10-21 Jacques Benoit Pharmaceutical combination of medication to be used by patients for the purpose of preventing or reducing the evolution of atherosclerosis and thus preventing coronary heart disease and cerebro-vascular accidents.

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Publication number Publication date
KR20230000506A (ko) 2023-01-03

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