MX385644B - Cápsula compleja que contiene esomeprazol y método de preparación de esta. - Google Patents

Cápsula compleja que contiene esomeprazol y método de preparación de esta.

Info

Publication number
MX385644B
MX385644B MX2019004938A MX2019004938A MX385644B MX 385644 B MX385644 B MX 385644B MX 2019004938 A MX2019004938 A MX 2019004938A MX 2019004938 A MX2019004938 A MX 2019004938A MX 385644 B MX385644 B MX 385644B
Authority
MX
Mexico
Prior art keywords
coating layer
layer formed
core
complex capsule
inner coating
Prior art date
Application number
MX2019004938A
Other languages
English (en)
Other versions
MX2019004938A (es
Inventor
Ho Taek Im
Jae Hyun Park
Jong Soo Woo
Seung Hun Chang
Taek Kwan Kwon
Kim Yong Ii
Original Assignee
Hanmi Pharmaceutical Co Ltd
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 Hanmi Pharmaceutical Co Ltd filed Critical Hanmi Pharmaceutical Co Ltd
Publication of MX2019004938A publication Critical patent/MX2019004938A/es
Publication of MX385644B publication Critical patent/MX385644B/es

Links

Classifications

    • 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
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833Encapsulating processes; Filling of capsules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (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

Se proporciona una cápsula compuesta y un método de preparación de esta, comprendiendo la cápsula compuesta: una primera parte que se disuelve que comprende un núcleo que comprende, como principio activo, esomeprazol o una sal farmacéuticamente aceptable de este, una capa de recubrimiento interno sobre el núcleo y una primera capa de recubrimiento entérico sobre la capa de recubrimiento interno; y una segunda parte que se disuelve que comprende un núcleo que comprende, como principio activo, esomeprazol o una sal farmacéuticamente aceptable de este, una capa de recubrimiento interno sobre el núcleo y una segunda capa de recubrimiento entérico sobre la capa de recubrimiento interno, donde la primera capa de recubrimiento entérico comprende, como material base de recubrimiento, copolímero de ácido metacrílico LD en una cantidad de aproximadamente un 5% (p/p) a aproximadamente un 50% (p/p) del núcleo sobre el cual se forma la capa de recubrimiento interno, y la segunda capa de recubrimiento entérico comprende, como material base de recubrimiento, una mezcla que contiene copolimero de ácido metacrílieo S y biopolímero de ácido metacrílico L en una relación de aproximadamente l.5:1 (p/p) a aproximadamente 3.5:1 (p/p) en una cantidad de aproximadamente un 15% (p/p) a aproximadamente un 40% (p/p) del núcleo sobre el cual la capa de recubrimiento interno.
MX2019004938A 2016-10-28 2017-10-19 Cápsula compleja que contiene esomeprazol y método de preparación de esta. MX385644B (es)

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 (2)

Publication Number Publication Date
MX2019004938A MX2019004938A (es) 2019-10-09
MX385644B true MX385644B (es) 2025-03-18

Family

ID=62023771

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019004938A MX385644B (es) 2016-10-28 2017-10-19 Cápsula compleja que contiene esomeprazol y método de preparación de esta.

Country Status (12)

Country Link
US (1) US11052048B2 (es)
EP (1) EP3513784A4 (es)
JP (1) JP2019532960A (es)
KR (1) KR101877350B1 (es)
CN (1) CN109890372B (es)
AU (1) AU2017349091A1 (es)
EA (1) EA201990704A1 (es)
MX (1) MX385644B (es)
MY (1) MY205729A (es)
PH (1) PH12019500919A1 (es)
WO (1) WO2018080104A1 (es)
ZA (1) ZA201902867B (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020535113A (ja) * 2017-09-28 2020-12-03 ハンミ ファーマシューティカルズ カンパニー リミテッド エソメプラゾール、及びその薬学的に許容可能な塩を含むマルチユニット球状錠剤を含む薬剤学的組成物、並びにその製造方法
WO2020204609A1 (ko) * 2019-04-02 2020-10-08 한미약품 주식회사 에스오메프라졸 또는 이의 약학적으로 허용 가능한 염을 포함하고 이중방출 프로파일을 갖는 약학적 조성물
KR102312604B1 (ko) * 2020-02-04 2021-10-15 한국유나이티드제약 주식회사 장용성의 프로톤펌프억제제 및 서방성의 모사프리드 제제를 포함하는 경질캡슐 제제

Family Cites Families (14)

* Cited by examiner, † Cited by third party
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WO1996001623A1 (en) 1994-07-08 1996-01-25 Astra Aktiebolag Multiple unit tableted dosage form i
MY148805A (en) * 2002-10-16 2013-05-31 Takeda Pharmaceutical Controlled release preparation
EP2112920B1 (en) * 2003-06-26 2018-07-25 Intellipharmaceutics Corp. Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient
BRPI0412697A (pt) * 2003-07-17 2006-10-03 Reddys Lab Inc Dr composições farmacêuticas que apresentam um revestimento expansìvel
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
US7670624B2 (en) * 2004-01-29 2010-03-02 Astella Pharma Inc. Gastrointestinal-specific multiple drug release system
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
JP2019532960A (ja) 2019-11-14
PH12019500919A1 (en) 2019-08-19
EP3513784A4 (en) 2020-06-03
EA201990704A1 (ru) 2019-09-30
BR112019008402A2 (pt) 2019-07-09
ZA201902867B (en) 2020-08-26
MX2019004938A (es) 2019-10-09
US11052048B2 (en) 2021-07-06
CN109890372A (zh) 2019-06-14
EP3513784A1 (en) 2019-07-24
CN109890372B (zh) 2022-06-24
MY205729A (en) 2024-11-08
KR101877350B1 (ko) 2018-08-09
AU2017349091A1 (en) 2019-05-16
US20190247316A1 (en) 2019-08-15
WO2018080104A1 (ko) 2018-05-03
KR20180046682A (ko) 2018-05-09

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