EA201990704A1 - Составная капсула, содержащая эзомепразол, и способ ее получения - Google Patents

Составная капсула, содержащая эзомепразол, и способ ее получения

Info

Publication number
EA201990704A1
EA201990704A1 EA201990704A EA201990704A EA201990704A1 EA 201990704 A1 EA201990704 A1 EA 201990704A1 EA 201990704 A EA201990704 A EA 201990704A EA 201990704 A EA201990704 A EA 201990704A EA 201990704 A1 EA201990704 A1 EA 201990704A1
Authority
EA
Eurasian Patent Office
Prior art keywords
layer
core
coating
inner coating
methacrylic acid
Prior art date
Application number
EA201990704A
Other languages
English (en)
Inventor
Тэк Кван Квон
Сын Хун Чан
Хо Тэк Им
Йонг Ил Ким
Дже Хён Пак
Джон Су Ву
Original Assignee
Ханми Фарм. 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.)
Filing date
Publication date
Application filed by Ханми Фарм. Ко., Лтд. filed Critical Ханми Фарм. Ко., Лтд.
Publication of EA201990704A1 publication Critical patent/EA201990704A1/ru

Links

Classifications

    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • 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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Landscapes

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

Abstract

В одном аспекте настоящего изобретения предложена составная капсула и способ ее получения, где составная капсула содержит первую растворяющуюся часть, включающую ядро, содержащее в качестве активного ингредиента эзомепразол или его фармацевтически приемлемую соль; слой внутреннего покрытия, образованного на данном ядре; слой первого кишечнорастворимого покрытия, образованного на данном слое внутреннего покрытия; и вторую растворяющуюся часть, включающую ядро, содержащее в качестве активного ингредиента эзомепразол или его фармацевтически приемлемую соль; слой внутреннего покрытия, образованного на данном ядре; и слой второго кишечнорастворимого покрытия, образованного на данном слое внутреннего покрытия, где указанный слой первого кишечнорастворимого покрытия включает в качестве материала основы покрытия сополимер LD метакриловой кислоты в количестве 5-50% (мас./мас.) относительно ядра, на котором образован данный слой внутреннего покрытия, и указанный слой второго кишечнорастворимого покрытия включает в качестве материала основы покрытия смесь из сополимера S метакриловой кислоты и сополимера L метакриловой кислоты в соотношении от 1,5:1 до 3,5:1 (мас./мас.) в количестве 15-40% (мас./мас.) относительно ядра, на котором образован данный слой внутреннего покрытия.
EA201990704A 2016-10-28 2017-10-19 Составная капсула, содержащая эзомепразол, и способ ее получения EA201990704A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020160142156A KR101877350B1 (ko) 2016-10-28 2016-10-28 에스오메프라졸 함유 복합 캡슐제 및 그 제조방법
PCT/KR2017/011571 WO2018080104A1 (ko) 2016-10-28 2017-10-19 에스오메프라졸 함유 복합 캡슐제 및 그 제조방법

Publications (1)

Publication Number Publication Date
EA201990704A1 true EA201990704A1 (ru) 2019-09-30

Family

ID=62023771

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201990704A EA201990704A1 (ru) 2016-10-28 2017-10-19 Составная капсула, содержащая эзомепразол, и способ ее получения

Country Status (12)

Country Link
US (1) US11052048B2 (ru)
EP (1) EP3513784A4 (ru)
JP (1) JP2019532960A (ru)
KR (1) KR101877350B1 (ru)
CN (1) CN109890372B (ru)
AU (1) AU2017349091A1 (ru)
BR (1) BR112019008402A2 (ru)
EA (1) EA201990704A1 (ru)
MX (1) MX2019004938A (ru)
PH (1) PH12019500919A1 (ru)
WO (1) WO2018080104A1 (ru)
ZA (1) ZA201902867B (ru)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200368219A1 (en) * 2017-09-28 2020-11-26 Hanmi Pharm. Co., Ltd. Pharmaceutical composition including multi-unit spheroidal tablet containing esomeprazole and spheroidal pharmaceutically acceptable salt thereof, and method of preparing the pharmaceutical composition
CN113597302A (zh) * 2019-04-02 2021-11-02 韩美药品株式会社 一种包括埃索美拉唑或其药学上可接受的盐并具有双重释放特性的药物组合物
KR102312604B1 (ko) * 2020-02-04 2021-10-15 한국유나이티드제약 주식회사 장용성의 프로톤펌프억제제 및 서방성의 모사프리드 제제를 포함하는 경질캡슐 제제

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK1078628T3 (da) 1994-07-08 2009-02-23 Astrazeneca Ab Tabletteret flerenhedsdoseringsform
MY148805A (en) * 2002-10-16 2013-05-31 Takeda Pharmaceutical Controlled release preparation
NZ544608A (en) 2003-07-17 2008-07-31 Reddys Lab Ltd Dr Pharmaceutical compositions having a swellable coating comprising prolamin
WO2005051362A2 (en) * 2003-11-28 2005-06-09 Ranbaxy Laboratories Limited Oral benzimidazole compositions comprising an active core, an optional separating layer and an enteric coating
AR052225A1 (es) 2004-11-04 2007-03-07 Astrazeneca Ab Formulaciones de tabletas de liberacion modificada par inhibidores de la bomba de protones
EP2319504A1 (en) * 2009-11-07 2011-05-11 Laboratorios Del. Dr. Esteve, S.A. Pharmaceutical solid dosage form
WO2012001705A2 (en) * 2010-06-29 2012-01-05 Cadila Healthcare Limited Pharmaceutical compositions of (r)-lansoprazole
CN102100671B (zh) * 2011-01-14 2013-04-24 寿光富康制药有限公司 一种埃索美拉唑镁肠溶微丸的制备方法
CN102670521B (zh) * 2012-05-18 2014-05-21 珠海润都制药股份有限公司 一种埃索美拉唑镁肠溶微丸及其制备方法
CN102940611B (zh) * 2012-11-26 2017-02-22 康普药业股份有限公司 一种含有埃索美拉唑镁的肠溶片剂
CN103040774B (zh) * 2012-11-30 2015-03-04 上海信谊万象药业股份有限公司 埃索美拉唑镁肠溶片中埃索美拉唑镁的制粒包衣工艺
CN104940170A (zh) * 2015-07-23 2015-09-30 浙江亚太药业股份有限公司 一种埃索美拉唑镁肠溶胶囊及其制备方法

Also Published As

Publication number Publication date
EP3513784A1 (en) 2019-07-24
PH12019500919A1 (en) 2019-08-19
WO2018080104A1 (ko) 2018-05-03
EP3513784A4 (en) 2020-06-03
KR101877350B1 (ko) 2018-08-09
JP2019532960A (ja) 2019-11-14
BR112019008402A2 (pt) 2019-07-09
US11052048B2 (en) 2021-07-06
MX2019004938A (es) 2019-10-09
CN109890372B (zh) 2022-06-24
CN109890372A (zh) 2019-06-14
ZA201902867B (en) 2020-08-26
KR20180046682A (ko) 2018-05-09
AU2017349091A1 (en) 2019-05-16
US20190247316A1 (en) 2019-08-15

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