MX2020001760A - Composicion farmaceutica que incluye un comprimido esferoide de multiples unidades que contiene esomeprazol y una sal farmaceuticamente aceptable esferoide de este, y metodo para preparar la composicion farmaceutica. - Google Patents

Composicion farmaceutica que incluye un comprimido esferoide de multiples unidades que contiene esomeprazol y una sal farmaceuticamente aceptable esferoide de este, y metodo para preparar la composicion farmaceutica.

Info

Publication number
MX2020001760A
MX2020001760A MX2020001760A MX2020001760A MX2020001760A MX 2020001760 A MX2020001760 A MX 2020001760A MX 2020001760 A MX2020001760 A MX 2020001760A MX 2020001760 A MX2020001760 A MX 2020001760A MX 2020001760 A MX2020001760 A MX 2020001760A
Authority
MX
Mexico
Prior art keywords
pharmaceutical composition
spheroidal
preparing
pharmaceutically acceptable
acceptable salt
Prior art date
Application number
MX2020001760A
Other languages
English (en)
Inventor
Yong Il Kim
Ho Taek Im
Hyuk Jun Cho
Min Wook Kim
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 MX2020001760A publication Critical patent/MX2020001760A/es

Links

Classifications

    • 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
    • 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
    • A61K9/20—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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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

Landscapes

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

Abstract

Se proporciona una composición farmacéutica que incluye un núcleo en forma de un comprimido esferoide de múltiples unidades (MUST) que contiene esomeprazol o una sal farmacéuticamente aceptable de este, donde la composición farmacéutica se disuelve en un 50 por ciento (%) o más dentro de un periodo de 15 minutos de una prueba de disolución in vitro; y un método para preparar la composición farmacéutica. De acuerdo con esto, en caso de que la composición farmacéutica se desarrolle como el comprimido esferoide de múltiples unidades, la disolución se puede ver acelerada en una condición de una tasa de agitación lenta en comparación con una formulación de pellet o un comprimido único convencional. Además, los fármacos basados en inhibidores de la bomba de protones (PPI), incluido el esomeprazol, pueden ser disociados por el ácido gástrico que tiene un pH bajo, lo que induce como consecuencia una reducción en la biodisponibilidad del fármaco, pero la composición farmacéutica de acuerdo con la presente puede minimizar esto.
MX2020001760A 2017-09-28 2018-09-28 Composicion farmaceutica que incluye un comprimido esferoide de multiples unidades que contiene esomeprazol y una sal farmaceuticamente aceptable esferoide de este, y metodo para preparar la composicion farmaceutica. MX2020001760A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20170126426 2017-09-28
PCT/KR2018/011528 WO2019066555A1 (en) 2017-09-28 2018-09-28 PHARMACEUTICAL COMPOSITION COMPRISING MULTI-UNIT SPHEREOIDAL TABLET CONTAINING ESOMEPRAZOLE AND PHARMACEUTICAL QUALITY SALT THEREOF, AND PROCESS FOR PREPARING THE PHARMACEUTICAL COMPOSITION

Publications (1)

Publication Number Publication Date
MX2020001760A true MX2020001760A (es) 2020-07-29

Family

ID=65903124

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2020001760A MX2020001760A (es) 2017-09-28 2018-09-28 Composicion farmaceutica que incluye un comprimido esferoide de multiples unidades que contiene esomeprazol y una sal farmaceuticamente aceptable esferoide de este, y metodo para preparar la composicion farmaceutica.

Country Status (11)

Country Link
US (1) US20200368219A1 (es)
EP (1) EP3648745B1 (es)
JP (1) JP2020535113A (es)
KR (1) KR20190037182A (es)
CN (1) CN111032020A (es)
AU (1) AU2018341729A1 (es)
BR (1) BR112020003077A2 (es)
CA (1) CA3071623A1 (es)
EA (1) EA202090166A1 (es)
MX (1) MX2020001760A (es)
WO (1) WO2019066555A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102080023B1 (ko) 2018-01-29 2020-02-21 주식회사 종근당 에스오메프라졸 및 탄산수소나트륨을 포함하는 안정한 약제학적 조성물
KR102006777B1 (ko) 2018-01-29 2019-10-08 주식회사 종근당 에스오메프라졸 및 탄산수소나트륨을 포함하는 약제학적 제제
JP2022541948A (ja) * 2019-07-26 2022-09-28 チョン クン ダン ファーマシューティカル コーポレイション エソメプラゾール及び炭酸水素ナトリウムを含む安定した薬学的組成物

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN101888834A (zh) * 2007-12-08 2010-11-17 拜耳先灵制药股份公司 口服分散片
KR101084659B1 (ko) * 2008-12-30 2011-11-22 한미홀딩스 주식회사 에스오메프라졸의 과립 및 그 장용성 과립의 제조방법
CN102805735A (zh) * 2011-06-21 2012-12-05 寿光富康制药有限公司 一种埃索美拉唑肠溶微丸片及其制备方法
KR101378973B1 (ko) * 2012-04-13 2014-03-28 한미약품 주식회사 구형에 가까운 형태의 다중 투여 단위 정제를 포함하는 경질 캡슐 복합 제형 및 이의 제조방법
KR102060738B1 (ko) * 2012-12-13 2019-12-30 한미약품 주식회사 에스오메프라졸 유리염기 또는 그의 알칼리염을 포함하는 고미가 차폐된 약학 제제 및 이의 제조방법
KR101907116B1 (ko) * 2016-07-25 2018-10-11 한미약품 주식회사 에스오메프라졸, 또는 약학적으로 허용 가능한 그의 염을 포함하는, pH-의존성 약물 방출 특성이 개선된 제형
KR101877350B1 (ko) * 2016-10-28 2018-08-09 한미약품 주식회사 에스오메프라졸 함유 복합 캡슐제 및 그 제조방법

Also Published As

Publication number Publication date
EA202090166A1 (ru) 2020-06-29
AU2018341729A1 (en) 2020-02-06
WO2019066555A1 (en) 2019-04-04
EP3648745A4 (en) 2021-05-12
US20200368219A1 (en) 2020-11-26
JP2020535113A (ja) 2020-12-03
CA3071623A1 (en) 2019-04-04
EP3648745A1 (en) 2020-05-13
KR20190037182A (ko) 2019-04-05
EP3648745B1 (en) 2024-06-26
BR112020003077A2 (pt) 2020-08-25
CN111032020A (zh) 2020-04-17

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