RU2018126354A - Фармацевтический комбинированный состав - Google Patents

Фармацевтический комбинированный состав Download PDF

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Publication number
RU2018126354A
RU2018126354A RU2018126354A RU2018126354A RU2018126354A RU 2018126354 A RU2018126354 A RU 2018126354A RU 2018126354 A RU2018126354 A RU 2018126354A RU 2018126354 A RU2018126354 A RU 2018126354A RU 2018126354 A RU2018126354 A RU 2018126354A
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RU
Russia
Prior art keywords
tablet
layer
candesartan
hydroxystearate
macrogol
Prior art date
Application number
RU2018126354A
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English (en)
Other versions
RU2018126354A3 (ru
RU2736942C2 (ru
Inventor
Чеи-Ман РЮ
Воо-Иле ПАК
Кхёун-Хван КАН
Воо-Кюн КИМ
Ах-Рым ЧХЭ
Соо-Вон КИМ
Хюн-Воо ЧУН
Чэ-Ёун ЛИ
Original Assignee
Син Пхун Фармасьютикал Ко., Лтд.
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.)
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=58543052&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=RU2018126354(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Син Пхун Фармасьютикал Ко., Лтд. filed Critical Син Пхун Фармасьютикал Ко., Лтд.
Publication of RU2018126354A publication Critical patent/RU2018126354A/ru
Publication of RU2018126354A3 publication Critical patent/RU2018126354A3/ru
Application granted granted Critical
Publication of RU2736942C2 publication Critical patent/RU2736942C2/ru

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A61K9/204Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/41641,3-Diazoles
    • A61K31/41841,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4418Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

Landscapes

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

Claims (8)

1. Таблетка, содержащая кандесартан или кандесартана цилексетил в качестве первого активного ингредиента и амлодипин или его фармацевтически приемлемую соль в качестве второго активного ингредиента, отличающаяся тем, что она содержит макрогол-15-гидроксистеарат в качестве солюбилизатора.
2. Таблетка по п. 1, где первый активный ингредиент представляет собой кандесартана цилексетил.
3. Таблетка по п. 1, где она не содержит какого-либо сахарного спирта.
4. Таблетка по п. 1, где весовое соотношение кандесартана или кандесартана цилексетила и макрогол-15-гидроксистеарата составляет 1:0,03-1:2.
5. Таблетка по п. 1, где она представляет собой однослойную таблетку, многослойную таблетку или ядросодержащую таблетку.
6. Таблетка по п. 5, где многослойная таблетка представляет собой двухслойную таблетку.
7. Таблетка по п. 6, где двухслойная таблетка состоит из первого слоя и второго слоя, при этом первый слой содержит кандесартан или кандесартана цилексетил и макрогол-15-гидроксистеарат, и второй слой содержит амлодипин или его фармацевтически приемлемую соль.
8. Таблетка по п. 1, где период ее хранения составляет от 6 недель до 3 лет.
RU2018126354A 2015-12-28 2016-12-28 Фармацевтический комбинированный состав RU2736942C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020150187679A KR101710441B1 (ko) 2015-12-28 2015-12-28 안정성 및 용출성이 향상된 정제
KR10-2015-0187679 2015-12-28
PCT/KR2016/015439 WO2017116150A1 (ko) 2015-12-28 2016-12-28 약제학적 복합제제

Publications (3)

Publication Number Publication Date
RU2018126354A true RU2018126354A (ru) 2020-01-31
RU2018126354A3 RU2018126354A3 (ru) 2020-05-12
RU2736942C2 RU2736942C2 (ru) 2020-11-23

Family

ID=58543052

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2018126354A RU2736942C2 (ru) 2015-12-28 2016-12-28 Фармацевтический комбинированный состав

Country Status (14)

Country Link
US (1) US20190015339A1 (ru)
EP (1) EP3398589B1 (ru)
JP (1) JP6797924B2 (ru)
KR (1) KR101710441B1 (ru)
CN (1) CN108472257B (ru)
CA (1) CA3009468A1 (ru)
CO (1) CO2018007821A2 (ru)
ES (1) ES2868602T3 (ru)
MX (1) MX2018007976A (ru)
MY (1) MY194591A (ru)
PE (1) PE20181374A1 (ru)
PH (1) PH12018501392A1 (ru)
RU (1) RU2736942C2 (ru)
WO (1) WO2017116150A1 (ru)

Family Cites Families (21)

* Cited by examiner, † Cited by third party
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US6294192B1 (en) * 1999-02-26 2001-09-25 Lipocine, Inc. Triglyceride-free compositions and methods for improved delivery of hydrophobic therapeutic agents
ITMI20012366A1 (it) * 2001-11-09 2003-05-09 Farmatron Ltd Sistemi terapeutici stabilizzati a rilascio immediato e/o modificato per la somministrazione orale di principi attivi e/o eccipienti e/o ali
WO2005084648A1 (en) 2004-02-27 2005-09-15 Ranbaxy Laboratories Limited Pharmaceutical compositions comprising candesartan cilexetil
RS53141B (en) * 2004-11-05 2014-06-30 Boehringer Ingelheim International Gmbh TWO-LAYER TABLE CONTAINING TELMISARTAN AND AMLODIPINE
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KR101247583B1 (ko) * 2006-12-08 2013-03-26 한미사이언스 주식회사 암로디핀 또는 이의 약제학적 허용가능한 염, 및 로자탄또는 이의 약제학적 허용가능한 염을 함유하는 약제학적조성물
DK2165702T3 (da) * 2008-09-17 2012-03-05 Helm Ag Stabile og let opløselige sammensætninger af candesartancilexetil fremstillet ved vådgranulering
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DE102008059206A1 (de) 2008-11-27 2010-06-10 Bayer Schering Pharma Aktiengesellschaft Pharmazeutische Darreichungsform enthaltend Nifedipin oder Nisoldipin und einen Angiotensin-II Antagonisten und/oder ein Diuretikum
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KR101171375B1 (ko) * 2010-01-20 2012-08-13 한올바이오파마주식회사 난용성 약물을 함유하는 경구 제형
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CN102688236B (zh) * 2012-06-06 2014-03-26 石药集团中诺药业(石家庄)有限公司 一种坎地沙坦酯氨氯地平片剂组合物及其制备方法
KR101302883B1 (ko) * 2012-07-23 2013-09-05 삼일제약주식회사 텔미사르탄을 유효성분으로 포함하는 안정성이 증가된 약제학적 조성물 및 그 제조방법
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PL236001B1 (pl) * 2012-12-21 2020-11-30 Adamed Spolka Z Ograniczona Odpowiedzialnoscia Złożona kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu oraz amlodypinę, sposób jej wytwarzania oraz jednostkowa postać dawkowania zawierająca tę kompozycję

Also Published As

Publication number Publication date
CO2018007821A2 (es) 2018-08-10
PE20181374A1 (es) 2018-08-28
CN108472257B (zh) 2020-12-04
RU2018126354A3 (ru) 2020-05-12
US20190015339A1 (en) 2019-01-17
WO2017116150A1 (ko) 2017-07-06
PH12018501392A1 (en) 2019-02-27
KR101710441B1 (ko) 2017-02-28
JP2019500392A (ja) 2019-01-10
ES2868602T3 (es) 2021-10-21
EP3398589B1 (en) 2021-01-27
MY194591A (en) 2022-12-05
CN108472257A (zh) 2018-08-31
BR112018013121A2 (pt) 2018-12-11
EP3398589A4 (en) 2019-08-28
RU2736942C2 (ru) 2020-11-23
MX2018007976A (es) 2019-03-28
JP6797924B2 (ja) 2020-12-09
CA3009468A1 (en) 2017-07-06
EP3398589A1 (en) 2018-11-07

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