KR20260059683A - 과립 및 그것을 이용한 제제 - Google Patents

과립 및 그것을 이용한 제제

Info

Publication number
KR20260059683A
KR20260059683A KR1020267012313A KR20267012313A KR20260059683A KR 20260059683 A KR20260059683 A KR 20260059683A KR 1020267012313 A KR1020267012313 A KR 1020267012313A KR 20267012313 A KR20267012313 A KR 20267012313A KR 20260059683 A KR20260059683 A KR 20260059683A
Authority
KR
South Korea
Prior art keywords
polymer
molten component
granules
molten
raw material
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
KR1020267012313A
Other languages
English (en)
Korean (ko)
Inventor
나오키 요시하라
쇼타 하시모토
료타 키마타
Original Assignee
사와이세이야쿠 가부시키가이샤
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 사와이세이야쿠 가부시키가이샤 filed Critical 사와이세이야쿠 가부시키가이샤
Publication of KR20260059683A publication Critical patent/KR20260059683A/ko
Pending legal-status Critical Current

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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Glanulating (AREA)
KR1020267012313A 2020-03-11 2021-03-09 과립 및 그것을 이용한 제제 Pending KR20260059683A (ko)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202062988083P 2020-03-11 2020-03-11
US62/988,083 2020-03-11
KR1020227026916A KR20220123689A (ko) 2020-03-11 2021-03-09 과립 및 그것을 이용한 제제
PCT/JP2021/009284 WO2021182467A1 (ja) 2020-03-11 2021-03-09 顆粒及びそれを用いた製剤

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020227026916A Division KR20220123689A (ko) 2020-03-11 2021-03-09 과립 및 그것을 이용한 제제

Publications (1)

Publication Number Publication Date
KR20260059683A true KR20260059683A (ko) 2026-04-30

Family

ID=77670617

Family Applications (3)

Application Number Title Priority Date Filing Date
KR1020267012313A Pending KR20260059683A (ko) 2020-03-11 2021-03-09 과립 및 그것을 이용한 제제
KR1020267012314A Pending KR20260077761A (ko) 2020-03-11 2021-03-09 과립 및 그것을 이용한 제제
KR1020227026916A Ceased KR20220123689A (ko) 2020-03-11 2021-03-09 과립 및 그것을 이용한 제제

Family Applications After (2)

Application Number Title Priority Date Filing Date
KR1020267012314A Pending KR20260077761A (ko) 2020-03-11 2021-03-09 과립 및 그것을 이용한 제제
KR1020227026916A Ceased KR20220123689A (ko) 2020-03-11 2021-03-09 과립 및 그것을 이용한 제제

Country Status (7)

Country Link
US (1) US20230014578A1 (enExample)
EP (1) EP4119129A4 (enExample)
JP (2) JP7487290B2 (enExample)
KR (3) KR20260059683A (enExample)
CN (1) CN115209876A (enExample)
TW (1) TWI850539B (enExample)
WO (1) WO2021182467A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7817300B2 (ja) * 2023-02-14 2026-02-18 沢井製薬株式会社 コーティング顆粒、コーティング顆粒を含む製剤及びそれらの製造方法

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2915653B2 (ja) * 1991-11-14 1999-07-05 第一製薬株式会社 マスクされた粒状物
JP3265680B2 (ja) * 1992-03-12 2002-03-11 大正製薬株式会社 経口製剤用組成物
US5965161A (en) * 1994-11-04 1999-10-12 Euro-Celtique, S.A. Extruded multi-particulates
UA80393C2 (uk) * 2000-12-07 2007-09-25 Алтана Фарма Аг Фармацевтична композиція, яка містить інгібітор фде 4, диспергований в матриці
JP4310605B2 (ja) * 2001-05-25 2009-08-12 大塚製薬株式会社 医薬用組成物
CN1301104C (zh) * 2002-02-21 2007-02-21 大塚制药株式会社 缓释制剂及其制造方法
US8420115B2 (en) * 2004-06-03 2013-04-16 Taisho Pharmaceutical Co., Ltd. Oral preparations and process for production thereof
US9884022B2 (en) * 2010-04-07 2018-02-06 Lupin Limited Controlled release pharmaceutical compositions of tapentadol
FR2999937B1 (fr) * 2012-12-21 2015-01-09 Sanofi Sa Unite solide a haute teneur en fexofenadine et son procede de preparation
JP2015054822A (ja) * 2013-09-10 2015-03-23 ニプロ株式会社 クロピドグレル含有錠剤およびその製造方法
CN109069460A (zh) * 2016-05-09 2018-12-21 分散技术有限责任公司 改进的药物制剂
JP2018083809A (ja) * 2016-11-16 2018-05-31 沢井製薬株式会社 シロドシン含有粒子の製造方法及びシロドシン含有口腔内崩壊錠の製造方法
JP6895779B2 (ja) * 2017-03-17 2021-06-30 東和薬品株式会社 アジルサルタン含有固形医薬組成物

Also Published As

Publication number Publication date
US20230014578A1 (en) 2023-01-19
CN115209876A (zh) 2022-10-18
EP4119129A4 (en) 2024-01-24
TWI850539B (zh) 2024-08-01
KR20220123689A (ko) 2022-09-08
JP2024063111A (ja) 2024-05-10
JP7487290B2 (ja) 2024-05-20
WO2021182467A1 (ja) 2021-09-16
KR20260077761A (ko) 2026-05-28
JPWO2021182467A1 (enExample) 2021-09-16
TW202200118A (zh) 2022-01-01
EP4119129A1 (en) 2023-01-18

Similar Documents

Publication Publication Date Title
JP5122823B2 (ja) 微粒子
EP1166776A2 (de) Verfahren zur Herstellung fester oraler Darreichungsformen mit retardierender Wirkstofffreisetzung
CN1942174A (zh) 微粒
JP3725474B2 (ja) 固体成形品製造用の緩衝ワックスビーズ
CN102525879B (zh) 制备阿瑞匹坦固体分散组合物的方法
JPH0847521A (ja) 熱的細粒化方法
CN102525880B (zh) 一种阿瑞匹坦固体分散组合物
JP2024063111A (ja) 顆粒及びそれを用いた製剤
KR20260059682A (ko) 과립 및 그것을 이용한 제제
CA2397942C (en) Controlled release pharmaceutical composition containing tramadol hydrochloride and method for its preparation
JP2019518740A (ja) 可塑剤としてのアミノ糖の使用
JPS61151133A (ja) 遅延放出性被覆組成物及びこれにより被覆した被覆製剤
FR2814366A1 (fr) Procede de granulation de matieres actives par extrusion basse pression pour l'obtention de granules directement compressibles
JPWO2021182467A5 (enExample)
HK40082230A (en) Granules and preparation using same
CZ2012108A3 (en) A method for the manufacture of a polymorphously stable pharmaceutical composition containing agomelatine
JP4997741B2 (ja) 低融点薬物含有粉粒体及びその製造方法
JP4779192B2 (ja) 溶出制御された製剤用粒子
CN104994842A (zh) 高剂量柠檬酸钾蜡基质缓释片剂
JP7482645B2 (ja) 核粒子を含む顆粒の製造方法
CN104684545B (zh) 包含至少一种水溶性维生素e衍生物和至少一种亲水聚合物的储存稳定的无粉尘均质颗粒状配制剂
JP6506810B2 (ja) フェノフィブラートの固体分散体
Pourmand et al. Evaluation of Lipophilic Properties of Thermoplastic Granule in Formulation of Sustained Release Matrix in Solid Dosage Forms
Alshetaili Solubility enhancement, mechanical properties and taste masking of poorly water soluble compounds by optimizing hot melt extrusion processing

Legal Events

Date Code Title Description
A16 Divisional, continuation or continuation in part application filed

Free format text: ST27 STATUS EVENT CODE: A-0-1-A10-A16-DIV-PA0104 (AS PROVIDED BY THE NATIONAL OFFICE)

A18 Application divided or continuation or continuation in part accepted

Free format text: ST27 STATUS EVENT CODE: A-0-1-A10-A18-DIV-PA0104 (AS PROVIDED BY THE NATIONAL OFFICE)

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D11-EXM-PA0201 (AS PROVIDED BY THE NATIONAL OFFICE)

PA0104 Divisional application for international application

St.27 status event code: A-0-1-A10-A18-div-PA0104

St.27 status event code: A-0-1-A10-A16-div-PA0104

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

Q12 Application published

Free format text: ST27 STATUS EVENT CODE: A-1-1-Q10-Q12-NAP-PG1501 (AS PROVIDED BY THE NATIONAL OFFICE)