JP7487290B2 - 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
JP7487290B2
JP7487290B2 JP2022507218A JP2022507218A JP7487290B2 JP 7487290 B2 JP7487290 B2 JP 7487290B2 JP 2022507218 A JP2022507218 A JP 2022507218A JP 2022507218 A JP2022507218 A JP 2022507218A JP 7487290 B2 JP7487290 B2 JP 7487290B2
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Prior art keywords
polymer
granules
component
molten component
active pharmaceutical
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JP2022507218A
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English (en)
Japanese (ja)
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JPWO2021182467A5 (https=
JPWO2021182467A1 (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 JPWO2021182467A1 publication Critical patent/JPWO2021182467A1/ja
Publication of JPWO2021182467A5 publication Critical patent/JPWO2021182467A5/ja
Priority to JP2024029031A priority Critical patent/JP2024063111A/ja
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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
    • A61K9/1605Excipients; 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
    • A61K9/1617Organic 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
    • A61K9/141Intimate 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
    • A61K9/145Intimate 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
    • 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
    • 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
    • A61K9/141Intimate 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
    • A61K9/146Intimate 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (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)
JP2022507218A 2020-03-11 2021-03-09 顆粒及びそれを用いた製剤 Active JP7487290B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024029031A JP2024063111A (ja) 2020-03-11 2024-02-28 顆粒及びそれを用いた製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062988083P 2020-03-11 2020-03-11
US62/988,083 2020-03-11
PCT/JP2021/009284 WO2021182467A1 (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
JP2024029031A Division JP2024063111A (ja) 2020-03-11 2024-02-28 顆粒及びそれを用いた製剤

Publications (3)

Publication Number Publication Date
JPWO2021182467A1 JPWO2021182467A1 (https=) 2021-09-16
JPWO2021182467A5 JPWO2021182467A5 (https=) 2022-11-08
JP7487290B2 true JP7487290B2 (ja) 2024-05-20

Family

ID=77670617

Family Applications (2)

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JP2022507218A Active JP7487290B2 (ja) 2020-03-11 2021-03-09 顆粒及びそれを用いた製剤
JP2024029031A Withdrawn JP2024063111A (ja) 2020-03-11 2024-02-28 顆粒及びそれを用いた製剤

Family Applications After (1)

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JP2024029031A Withdrawn JP2024063111A (ja) 2020-03-11 2024-02-28 顆粒及びそれを用いた製剤

Country Status (7)

Country Link
US (1) US20230014578A1 (https=)
EP (1) EP4119129A4 (https=)
JP (2) JP7487290B2 (https=)
KR (1) KR20220123689A (https=)
CN (1) CN115209876A (https=)
TW (1) TWI850539B (https=)
WO (1) WO2021182467A1 (https=)

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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005117845A1 (ja) 2004-06-03 2005-12-15 Taisho Pharmaceutical Co., Ltd. 経口製剤およびその製造方法
JP2016511223A (ja) 2012-12-21 2016-04-14 サノフイ フェキソフェナジン高含有固形単位およびその製造法
JP2019514993A (ja) 2016-05-09 2019-06-06 ディスパーソル テクノロジーズ リミテッド ライアビリティ カンパニー 改善された薬物製剤

Family Cites Families (10)

* 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
KR100913281B1 (ko) * 2002-02-21 2009-08-21 오츠카 세이야쿠 가부시키가이샤 서방 제제 및 그의 제조 방법
JP5905872B2 (ja) * 2010-04-07 2016-04-20 ルピン・リミテッド タペンタドールの制御放出医薬組成物
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
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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005117845A1 (ja) 2004-06-03 2005-12-15 Taisho Pharmaceutical Co., Ltd. 経口製剤およびその製造方法
JP2016511223A (ja) 2012-12-21 2016-04-14 サノフイ フェキソフェナジン高含有固形単位およびその製造法
JP2019514993A (ja) 2016-05-09 2019-06-06 ディスパーソル テクノロジーズ リミテッド ライアビリティ カンパニー 改善された薬物製剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
PAWAR Ashok Harshal et al.,Development and Evaluation of Taste Masked Granular Formulation of Satranidazole by Melt Granulation,Journal of Pharmaceutics,2014年,Volume 2014, Article ID 789676,p.1-7,Abstract, Conclusion

Also Published As

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

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