ECSP20009533A - Preparación que comprende vonoprazán - Google Patents

Preparación que comprende vonoprazán

Info

Publication number
ECSP20009533A
ECSP20009533A ECSENADI20209533A ECDI202009533A ECSP20009533A EC SP20009533 A ECSP20009533 A EC SP20009533A EC SENADI20209533 A ECSENADI20209533 A EC SENADI20209533A EC DI202009533 A ECDI202009533 A EC DI202009533A EC SP20009533 A ECSP20009533 A EC SP20009533A
Authority
EC
Ecuador
Prior art keywords
organic acid
acid salt
preparation
vonoprazán
vonoprazole
Prior art date
Application number
ECSENADI20209533A
Other languages
English (en)
Inventor
Hiroyuki Fujii
Akira Suzuki
Original Assignee
Takeda Pharmaceuticals Co
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=63209641&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ECSP20009533(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Takeda Pharmaceuticals Co filed Critical Takeda Pharmaceuticals Co
Publication of ECSP20009533A publication Critical patent/ECSP20009533A/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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/2027—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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

La presente invención tiene por objeto proporcionar una preparación de la que se espera que mejore el sabor amargo de una sal de ácido orgánico de vonoprazán y permita una rápida disolución de la sal de ácido orgánico de vonoprazán después de la administración. La presente invención proporciona una preparación que contiene gránulos finos o gránulos que contienen una sal de ácido orgánico de vonoprazán, (2) una capa intermedia que contiene el mismo ácido orgánico que el ácido orgánico que forma la sal de vonoprazán en (1), o una de sus sales, y (3) una capa de recubrimiento que contiene un polímero insoluble en agua.
ECSENADI20209533A 2017-07-10 2020-02-07 Preparación que comprende vonoprazán ECSP20009533A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2017135046 2017-07-10
PCT/JP2018/026416 WO2019013310A1 (en) 2017-07-10 2018-07-09 PREPARATION COMPRISING VONOPRAZAN

Publications (1)

Publication Number Publication Date
ECSP20009533A true ECSP20009533A (es) 2020-04-22

Family

ID=63209641

Family Applications (1)

Application Number Title Priority Date Filing Date
ECSENADI20209533A ECSP20009533A (es) 2017-07-10 2020-02-07 Preparación que comprende vonoprazán

Country Status (18)

Country Link
US (1) US11696893B2 (es)
EP (1) EP3651735B1 (es)
JP (1) JP7228535B2 (es)
KR (1) KR102747118B1 (es)
CN (1) CN110831579A (es)
AR (1) AR112269A1 (es)
BR (1) BR112020000318A2 (es)
CA (1) CA3069563A1 (es)
CO (1) CO2020000490A2 (es)
EC (1) ECSP20009533A (es)
ES (1) ES2921931T3 (es)
MX (1) MX394584B (es)
MY (1) MY200542A (es)
PE (1) PE20200442A1 (es)
PH (1) PH12020500068A1 (es)
SG (1) SG11202000136YA (es)
TW (1) TWI838340B (es)
WO (1) WO2019013310A1 (es)

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CN109900822A (zh) * 2019-03-12 2019-06-18 康诚科瑞医药研发（武汉）有限公司 一种血浆中沃诺拉赞的定量检测方法
CN110538153B (zh) * 2019-09-26 2022-04-26 扬子江药业集团四川海蓉药业有限公司 一种高稳定性、快速释放的固体制剂及其制备方法
GB202001237D0 (en) * 2020-01-29 2020-03-11 Sisteks D O O Granular pharmaceutical product for oral administration from a pre-filled straw and method of manufacturing such pharmaceutical product
CN113633616B (zh) * 2020-05-11 2024-08-23 鲁南制药集团股份有限公司 一种生物利用度高的固体制剂
CN115884968B (zh) 2020-06-17 2024-06-21 日东制药株式会社 新型酸分泌抑制剂及其用途
CN111973565A (zh) * 2020-07-07 2020-11-24 南京海纳医药科技股份有限公司 一种含有富马酸沃诺拉赞的片剂及其溶出度测定方法
CN112353802A (zh) * 2020-11-26 2021-02-12 山东诚创蓝海医药科技有限公司 一种富马酸伏诺拉生掩味组合物及其应用
CN113390983B (zh) * 2021-05-26 2022-06-07 株洲千金药业股份有限公司 一种同时测定富马酸伏诺拉生中3种杂质的检测方法
CN113827574A (zh) * 2021-10-18 2021-12-24 沈阳药科大学 一种富马酸沃诺拉赞口腔速溶片及其制备方法
CN116966180B (zh) * 2022-11-10 2024-05-14 山东道合药业有限公司 沃诺拉赞焦谷氨酸盐的片剂、注射剂、复方制剂
CN117503707B (zh) * 2022-08-05 2024-08-23 哈尔滨市康隆药业有限责任公司 一种掩味微球及其制备工艺和应用
CN115721611B (zh) * 2022-12-09 2025-03-25 北京斯利安药业有限公司 富马酸伏诺拉生干混悬剂及其制备方法
CN116036035A (zh) * 2023-02-28 2023-05-02 山东诚创蓝海医药科技有限公司 一种不含二氧化钛的富马酸伏诺拉生片剂制备方法
CN116687873A (zh) * 2023-05-26 2023-09-05 四川制药制剂有限公司 一种富马酸伏诺拉生片及其制备方法
KR20250005906A (ko) 2023-07-03 2025-01-10 주식회사 제뉴원사이언스 보노프라잔푸마르산염을 포함하는 약학 조성물 및 그 제조방법
KR20250145530A (ko) 2024-03-28 2025-10-13 주식회사 유영제약 보노프라잔의 니트로사민 불순물 생성 저감을 위한 약제학적 조성물 및 이의 제조방법
CN118236338B (zh) * 2024-05-29 2024-09-17 寿光富康制药有限公司 一种富马酸伏诺拉生制剂的制备方法
KR20250173705A (ko) 2024-06-04 2025-12-11 주식회사 피지티 2-플루오로페닐 2-옥소에틸 말로노나이트릴을 제조하는 방법

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JP2017135046A (ja) 2016-01-29 2017-08-03 株式会社荏原製作所 検査装置

Also Published As

Publication number Publication date
CA3069563A1 (en) 2019-01-17
MY200542A (en) 2024-01-02
KR102747118B1 (ko) 2024-12-26
MX394584B (es) 2025-03-19
US11696893B2 (en) 2023-07-11
ES2921931T3 (es) 2022-09-02
JP2020526486A (ja) 2020-08-31
BR112020000318A2 (pt) 2020-07-14
TWI838340B (zh) 2024-04-11
US20200163881A1 (en) 2020-05-28
EP3651735A1 (en) 2020-05-20
SG11202000136YA (en) 2020-02-27
AR112269A1 (es) 2019-10-09
RU2020105670A (ru) 2021-08-10
EP3651735B1 (en) 2022-04-13
MX2020000332A (es) 2020-07-13
CN110831579A (zh) 2020-02-21
CO2020000490A2 (es) 2020-02-28
JP7228535B2 (ja) 2023-02-24
PE20200442A1 (es) 2020-02-28
PH12020500068A1 (en) 2020-09-28
TW201907919A (zh) 2019-03-01
KR20200026964A (ko) 2020-03-11
RU2020105670A3 (es) 2021-10-26
WO2019013310A1 (en) 2019-01-17

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