CN115209877B - 颗粒和使用该颗粒的制剂 - Google Patents

颗粒和使用该颗粒的制剂 Download PDF

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Publication number
CN115209877B
CN115209877B CN202180018225.8A CN202180018225A CN115209877B CN 115209877 B CN115209877 B CN 115209877B CN 202180018225 A CN202180018225 A CN 202180018225A CN 115209877 B CN115209877 B CN 115209877B
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China
Prior art keywords
molten component
drug substance
layer
core material
molten
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CN202180018225.8A
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English (en)
Chinese (zh)
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CN115209877A (zh
Inventor
吉原尚辉
桥本翔太
木全崚太
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Sawai Pharmaceutical Co Ltd
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Sawai Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • 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
    • A61K31/495Heterocyclic 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
    • A61K31/4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; 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
    • A61K9/1676Agglomerates; 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

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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)
CN202180018225.8A 2020-03-11 2021-03-09 颗粒和使用该颗粒的制剂 Active CN115209877B (zh)

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

Publications (2)

Publication Number Publication Date
CN115209877A CN115209877A (zh) 2022-10-18
CN115209877B true CN115209877B (zh) 2025-02-11

Family

ID=77670626

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180018225.8A Active CN115209877B (zh) 2020-03-11 2021-03-09 颗粒和使用该颗粒的制剂

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=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4119130A4 (en) * 2020-03-11 2024-01-31 Sawai Pharmaceutical Co., Ltd. GRANULES AND THEIR USE
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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06256169A (ja) * 1993-02-18 1994-09-13 Amano Pharmaceut Co Ltd 顆粒の製造法
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 (15)

* 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
JP3685625B2 (ja) 1998-09-09 2005-08-24 株式会社パウレック 加熱により溶融する物質を用いた粒子加工方法
JP4521654B2 (ja) 2003-04-24 2010-08-11 株式会社ダルトン 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
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
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
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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06256169A (ja) * 1993-02-18 1994-09-13 Amano Pharmaceut Co Ltd 顆粒の製造法
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

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
JP7467596B2 (ja) 2024-04-15
EP4119130A4 (en) 2024-01-31
KR20220124747A (ko) 2022-09-14
US20230000777A1 (en) 2023-01-05
JP2024081778A (ja) 2024-06-18

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