JP7467596B2 - 顆粒及びそれを用いた製剤 - Google Patents

顆粒及びそれを用いた製剤 Download PDF

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Publication number
JP7467596B2
JP7467596B2 JP2022507220A JP2022507220A JP7467596B2 JP 7467596 B2 JP7467596 B2 JP 7467596B2 JP 2022507220 A JP2022507220 A JP 2022507220A JP 2022507220 A JP2022507220 A JP 2022507220A JP 7467596 B2 JP7467596 B2 JP 7467596B2
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Prior art keywords
molten component
core material
component
layer
drug substance
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JP2022507220A
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Japanese (ja)
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JPWO2021182469A1 (https=
JPWO2021182469A5 (https=
Inventor
尚輝 吉原
翔太 橋本
崚太 木全
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Sawai Pharmaceutical Co Ltd
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Sawai Pharmaceutical Co Ltd
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Publication of JPWO2021182469A1 publication Critical patent/JPWO2021182469A1/ja
Publication of JPWO2021182469A5 publication Critical patent/JPWO2021182469A5/ja
Priority to JP2024060090A priority Critical patent/JP7738697B2/ja
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    • 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
    • A61K9/14—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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Glanulating (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2022507220A 2020-03-11 2021-03-09 顆粒及びそれを用いた製剤 Active JP7467596B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024060090A JP7738697B2 (ja) 2020-03-11 2024-04-03 顆粒及びそれを用いた製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062988077P 2020-03-11 2020-03-11
US62/988,077 2020-03-11
PCT/JP2021/009297 WO2021182469A1 (ja) 2020-03-11 2021-03-09 顆粒及びそれを用いた製剤

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2024060090A Division JP7738697B2 (ja) 2020-03-11 2024-04-03 顆粒及びそれを用いた製剤

Publications (3)

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JPWO2021182469A1 JPWO2021182469A1 (https=) 2021-09-16
JPWO2021182469A5 JPWO2021182469A5 (https=) 2022-11-08
JP7467596B2 true JP7467596B2 (ja) 2024-04-15

Family

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JP2022507220A Active JP7467596B2 (ja) 2020-03-11 2021-03-09 顆粒及びそれを用いた製剤
JP2024060090A Active JP7738697B2 (ja) 2020-03-11 2024-04-03 顆粒及びそれを用いた製剤

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JP2024060090A Active JP7738697B2 (ja) 2020-03-11 2024-04-03 顆粒及びそれを用いた製剤

Country Status (7)

Country Link
US (1) US20230000777A1 (https=)
EP (1) EP4119130A4 (https=)
JP (2) JP7467596B2 (https=)
KR (1) KR20220124747A (https=)
CN (1) CN115209877B (https=)
TW (1) TWI859428B (https=)
WO (1) WO2021182469A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024081778A (ja) * 2020-03-11 2024-06-18 沢井製薬株式会社 顆粒及びそれを用いた製剤

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

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000084927A (ja) 1998-09-09 2000-03-28 Pauretsuku:Kk 加熱により溶融する物質を用いた粒子加工方法
JP2004323409A (ja) 2003-04-24 2004-11-18 Dalton Corp 造粒物および造粒方法
JP2005075826A (ja) 2003-08-29 2005-03-24 Boehringer Ingelheim Internatl Gmbh 多孔質シリカ担体を含有する徐放性製剤
JP2015071542A (ja) 2012-09-10 2015-04-16 エーザイ・アール・アンド・ディー・マネジメント株式会社 固体分散体の製造方法
JP2015199721A (ja) 2014-03-31 2015-11-12 富山化学工業株式会社 セファロスポリンエステルを含む粒状固形製剤およびその製造方法
JP2017001999A (ja) 2015-06-12 2017-01-05 富士フイルム株式会社 薬物含有粒子の製造方法、薬物含有粒子、医薬組成物、及び口腔内崩壊錠

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5290569A (en) * 1990-04-12 1994-03-01 Shionogi & Co., Ltd. Coated composition and its preparation process
KR0168849B1 (ko) * 1990-04-12 1999-01-15 요시또시 가즈오 피목 조성물 및 그의 제조방법
JPH06256169A (ja) * 1993-02-18 1994-09-13 Amano Pharmaceut Co Ltd 顆粒の製造法
KR101168189B1 (ko) * 2003-10-29 2012-07-25 시오노기세이야쿠가부시키가이샤 불쾌미를 개선한 피복 제제의 제조 방법
KR20090038431A (ko) * 2006-06-19 2009-04-20 맥네일-피피씨, 인코포레이티드 활성 성분을 함유하는 장용 피복된 입자
JP2012087073A (ja) * 2010-10-15 2012-05-10 Pharma Polytech:Kk コーティング粒子の製造方法、及び該製造方法で製造されたコーティング粒子
FR2999937B1 (fr) * 2012-12-21 2015-01-09 Sanofi Sa Unite solide a haute teneur en fexofenadine et son procede de preparation
KR101553348B1 (ko) 2013-12-18 2015-09-15 김예주 주먹밥 포장 시트와 이를 이용한 스틱 주먹밥의 제조 방법
JP6196730B2 (ja) * 2014-03-31 2017-09-13 富山化学工業株式会社 セファロスポリンエステルを含む粒状固形製剤およびその製造方法
KR20170001999A (ko) 2015-06-29 2017-01-06 주식회사 엘지유플러스 셋탑 단말, 셋탑 단말을 위한 어플리케이션, 및 서버의 동작 방법
US11135340B2 (en) * 2016-02-08 2021-10-05 The Johns Hopkins University Compositions and methods for preparation of composite polymer coatings on medical implants, and their use for co-delivery of multiple antimicrobial agents
EP4119130A4 (en) * 2020-03-11 2024-01-31 Sawai Pharmaceutical Co., Ltd. GRANULES AND THEIR USE

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000084927A (ja) 1998-09-09 2000-03-28 Pauretsuku:Kk 加熱により溶融する物質を用いた粒子加工方法
JP2004323409A (ja) 2003-04-24 2004-11-18 Dalton Corp 造粒物および造粒方法
JP2005075826A (ja) 2003-08-29 2005-03-24 Boehringer Ingelheim Internatl Gmbh 多孔質シリカ担体を含有する徐放性製剤
JP2015071542A (ja) 2012-09-10 2015-04-16 エーザイ・アール・アンド・ディー・マネジメント株式会社 固体分散体の製造方法
JP2015199721A (ja) 2014-03-31 2015-11-12 富山化学工業株式会社 セファロスポリンエステルを含む粒状固形製剤およびその製造方法
JP2017001999A (ja) 2015-06-12 2017-01-05 富士フイルム株式会社 薬物含有粒子の製造方法、薬物含有粒子、医薬組成物、及び口腔内崩壊錠

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024081778A (ja) * 2020-03-11 2024-06-18 沢井製薬株式会社 顆粒及びそれを用いた製剤
JP7738697B2 (ja) 2020-03-11 2025-09-12 沢井製薬株式会社 顆粒及びそれを用いた製剤

Also Published As

Publication number Publication date
CN115209877A (zh) 2022-10-18
TW202200117A (zh) 2022-01-01
JPWO2021182469A1 (https=) 2021-09-16
TWI859428B (zh) 2024-10-21
JP7738697B2 (ja) 2025-09-12
WO2021182469A1 (ja) 2021-09-16
EP4119130A1 (en) 2023-01-18
EP4119130A4 (en) 2024-01-31
KR20220124747A (ko) 2022-09-14
CN115209877B (zh) 2025-02-11
US20230000777A1 (en) 2023-01-05
JP2024081778A (ja) 2024-06-18

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