JP7659580B2 - 水溶性医薬品有効成分の医薬造粒物 - Google Patents

水溶性医薬品有効成分の医薬造粒物 Download PDF

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Publication number
JP7659580B2
JP7659580B2 JP2022578763A JP2022578763A JP7659580B2 JP 7659580 B2 JP7659580 B2 JP 7659580B2 JP 2022578763 A JP2022578763 A JP 2022578763A JP 2022578763 A JP2022578763 A JP 2022578763A JP 7659580 B2 JP7659580 B2 JP 7659580B2
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weight
granules
granulation
wet
rpm
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JP2023537192A (ja
Inventor
カラボルニ、サミ
ダブリュー． シャン、ウィリアム
エム． カナファックス、ダニエル
－ ニン シャン、ジア
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XWPharma Ltd
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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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/223—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/1611—Inorganic 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
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2022578763A 2020-06-18 2021-06-17 水溶性医薬品有効成分の医薬造粒物 Active JP7659580B2 (ja)

Priority Applications (1)

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JP2024208863A JP7824387B2 (ja) 2020-06-18 2024-11-29 水溶性医薬品有効成分の医薬造粒物

Applications Claiming Priority (3)

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US202063040780P 2020-06-18 2020-06-18
US63/040,780 2020-06-18
PCT/US2021/037830 WO2021257832A1 (en) 2020-06-18 2021-06-17 Pharmaceutical granulations of water-soluble active pharmaceutical ingredients

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JP7659580B2 true JP7659580B2 (ja) 2025-04-09

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US (2) US11357734B2 (https=)
EP (1) EP4167966A1 (https=)
JP (2) JP7659580B2 (https=)
KR (1) KR20230008190A (https=)
CN (1) CN115803017A (https=)
AU (1) AU2021293941B2 (https=)
CA (1) CA3183185A1 (https=)
TW (1) TWI834044B (https=)
WO (1) WO2021257832A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2021292406B2 (en) 2020-06-18 2024-03-14 XWPharma Ltd. Controlled release granulations of water-soluble active pharmaceutical ingredients
CN116261451A (zh) 2020-07-24 2023-06-13 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的药物组合物和药物动力学
KR20230058151A (ko) 2020-10-05 2023-05-02 엑스더블유파마 리미티드 감마-하이드록시부티르산 유도체의 변형된 방출 조성물
EP4588471A3 (en) 2021-03-19 2025-09-24 XWPharma Ltd. Pharmacokinetics of combined release formulations of a gamma-hydroxybutyric acid derivative
US20240092727A1 (en) * 2022-09-06 2024-03-21 XWPharma Ltd. Crystalline 4-((l-valyl)oxy)butanoic acid
TW202519199A (zh) 2023-07-31 2025-05-16 凱瑞康寧生技股份有限公司 γ－羥基丁酸衍生物之醫藥組合物

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JP2007508292A (ja) 2003-10-10 2007-04-05 エティファルム イチョウ・エキスを含む放出持続性の微小顆粒およびそのような顆粒の製造方法
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Also Published As

Publication number Publication date
JP2023537192A (ja) 2023-08-31
CN115803017A (zh) 2023-03-14
EP4167966A1 (en) 2023-04-26
US11357734B2 (en) 2022-06-14
TWI834044B (zh) 2024-03-01
US20220323366A1 (en) 2022-10-13
JP2025029042A (ja) 2025-03-05
CA3183185A1 (en) 2021-12-23
AU2021293941A1 (en) 2023-01-19
KR20230008190A (ko) 2023-01-13
JP7824387B2 (ja) 2026-03-04
AU2021293941B2 (en) 2024-03-28
WO2021257832A1 (en) 2021-12-23
US20210393537A1 (en) 2021-12-23
TW202203903A (zh) 2022-02-01

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