CN115209876A - 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
CN115209876A
CN115209876A CN202180017989.5A CN202180017989A CN115209876A CN 115209876 A CN115209876 A CN 115209876A CN 202180017989 A CN202180017989 A CN 202180017989A CN 115209876 A CN115209876 A CN 115209876A
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CN
China
Prior art keywords
polymer
molten
component
particle
drug substance
Prior art date
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Pending
Application number
CN202180017989.5A
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English (en)
Chinese (zh)
Inventor
吉原尚辉
桥本翔太
木全崚太
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sawai Pharmaceutical Co Ltd
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Sawai Pharmaceutical Co Ltd
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.)
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Application filed by Sawai Pharmaceutical Co Ltd filed Critical Sawai Pharmaceutical Co Ltd
Publication of CN115209876A publication Critical patent/CN115209876A/zh
Pending legal-status Critical Current

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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
    • A61K9/141—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
    • A61K9/14—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
    • 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
    • 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

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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)
CN202180017989.5A 2020-03-11 2021-03-09 颗粒和使用该颗粒的制剂 Pending CN115209876A (zh)

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

Publications (1)

Publication Number Publication Date
CN115209876A true CN115209876A (zh) 2022-10-18

Family

ID=77670617

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180017989.5A Pending CN115209876A (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) 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 (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05194193A (ja) * 1991-11-14 1993-08-03 Dai Ichi Seiyaku Co Ltd マスクされた粒状物
CN1509185A (zh) * 2001-05-25 2004-06-30 ��V��ҩ��ʽ���� 医药用组合物
CN1638742A (zh) * 2002-02-21 2005-07-13 大塚制药株式会社 缓释制剂及其制造方法
CN1960716A (zh) * 2004-06-03 2007-05-09 大正制药株式会社 口服制剂及其制造方法
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
US20150313885A1 (en) * 2012-12-21 2015-11-05 Sanofi Solid unit with high fexofenadine content and process for the preparation thereof
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

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US9884022B2 (en) * 2010-04-07 2018-02-06 Lupin Limited Controlled release pharmaceutical compositions of tapentadol
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
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 (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05194193A (ja) * 1991-11-14 1993-08-03 Dai Ichi Seiyaku Co Ltd マスクされた粒状物
CN1509185A (zh) * 2001-05-25 2004-06-30 ��V��ҩ��ʽ���� 医药用组合物
US20040175422A1 (en) * 2001-05-25 2004-09-09 Yuso Tomohira Medicinal composition
CN1638742A (zh) * 2002-02-21 2005-07-13 大塚制药株式会社 缓释制剂及其制造方法
CN1960716A (zh) * 2004-06-03 2007-05-09 大正制药株式会社 口服制剂及其制造方法
US20150313885A1 (en) * 2012-12-21 2015-11-05 Sanofi Solid unit with high fexofenadine content and process for the preparation thereof
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
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

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
国家药典委员会: "《中药固体制剂技术理论与实践》", 31 March 2017, 中国医药科技出版社, pages: 194 - 195 *
国家药典委员会: "《各国药用辅料标准对比手册》", 中国医药科技出版社 *

Also Published As

Publication number Publication date
US20230014578A1 (en) 2023-01-19
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
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

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