BR112019008402A2 - cápsula compósita e método para preparar a cápsula compósita - Google Patents

cápsula compósita e método para preparar a cápsula compósita

Info

Publication number
BR112019008402A2
BR112019008402A2 BR112019008402A BR112019008402A BR112019008402A2 BR 112019008402 A2 BR112019008402 A2 BR 112019008402A2 BR 112019008402 A BR112019008402 A BR 112019008402A BR 112019008402 A BR112019008402 A BR 112019008402A BR 112019008402 A2 BR112019008402 A2 BR 112019008402A2
Authority
BR
Brazil
Prior art keywords
coating layer
layer formed
core
composite capsule
methacrylic acid
Prior art date
Application number
BR112019008402A
Other languages
English (en)
Inventor
Taek Im Ho
Hyun Park Jae
Soo Woo Jong
Hun Chang Seung
Kwan Kwon Taek
Il Kim Yong
Original Assignee
Hanmi Pharm Ind 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 Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of BR112019008402A2 publication Critical patent/BR112019008402A2/pt

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)
  • 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

um aspecto da presente invenção fornece uma cápsula complexa e um método de preparação para a mesma, em que a cápsula complexa compreende uma primeira parte de dissolução que compreende: um núcleo que contém, como um ingrediente ativo, esomeprazol ou um sal farmaceuticamente aceitável do mesmo; uma camada de revestimento interno formada no núcleo; e uma primeira camada de revestimento entérico formada na camada de revestimento interno, e uma segunda parte de dissolução que compreende: um núcleo que contém, como um ingrediente ativo, esomeprazol ou um sal farmaceuticamente aceitável do mesmo; uma camada de revestimento interno formada no núcleo; e uma segunda camada de revestimento entérico formada na camada de revestimento interno, em que a primeira camada de revestimento entérico compreende, como uma base de revestimento, um copolímero de ácido metacrílico ld em uma quantidade de 5 a 50% (p/p) do núcleo que tem a camada de revestimento interno formada no mesmo, e a segunda camada de revestimento entérico compreende, como uma base de revestimento, uma mistura de 1,5:1 a 3,5:1 (p/p) de um copolímero de ácido metacrílico s e um copolímero de ácido metacrílico l em uma quantidade de 15 a 40% (p/p) do núcleo que tem a camada de revestimento interno formada no mesmo.
BR112019008402A 2016-10-28 2017-10-19 cápsula compósita e método para preparar a cápsula compósita BR112019008402A2 (pt)

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
BR112019008402A2 true BR112019008402A2 (pt) 2019-07-09

Family

ID=62023771

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019008402A BR112019008402A2 (pt) 2016-10-28 2017-10-19 cápsula compósita e método para preparar a cápsula compósita

Country Status (12)

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

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
EA201990704A1 (ru) 2019-09-30
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
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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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]