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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Japan
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 (enExample
JPWO2021182467A1 (enExample
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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Priority to JP2024029031A priority Critical patent/JP2024063111A/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
    • A61K9/1605—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
    • A61K9/141—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
    • A61K9/1652—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

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  • 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)
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 (enExample) 2021-09-16
JPWO2021182467A5 JPWO2021182467A5 (enExample) 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)

Application Number Title Priority Date Filing Date
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 (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

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
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
US9884022B2 (en) * 2010-04-07 2018-02-06 Lupin Limited Controlled release pharmaceutical compositions of tapentadol
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
US20230014578A1 (en) 2023-01-19
CN115209876A (zh) 2022-10-18
KR20260059683A (ko) 2026-04-30
EP4119129A4 (en) 2024-01-24
TWI850539B (zh) 2024-08-01
KR20220123689A (ko) 2022-09-08
JP2024063111A (ja) 2024-05-10
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

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