AU2021293941B2 - Pharmaceutical granulations of water-soluble active pharmaceutical ingredients - Google Patents

Pharmaceutical granulations of water-soluble active pharmaceutical ingredients Download PDF

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Publication number
AU2021293941B2
AU2021293941B2 AU2021293941A AU2021293941A AU2021293941B2 AU 2021293941 B2 AU2021293941 B2 AU 2021293941B2 AU 2021293941 A AU2021293941 A AU 2021293941A AU 2021293941 A AU2021293941 A AU 2021293941A AU 2021293941 B2 AU2021293941 B2 AU 2021293941B2
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AU
Australia
Prior art keywords
granulation
wet
active pharmaceutical
rpm
granules
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AU2021293941A
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English (en)
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AU2021293941A1 (en
Inventor
Daniel M. Canafax
Sami Karaborni
Jia-Ning Xiang
William W. Xiang
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XWPharma Ltd
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XWPharma Ltd
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Publication of AU2021293941A1 publication Critical patent/AU2021293941A1/en
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Publication of AU2021293941B2 publication Critical patent/AU2021293941B2/en
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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
    • A61K9/48—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
    • 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
    • A61K31/185—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

Landscapes

  • 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)
AU2021293941A 2020-06-18 2021-06-17 Pharmaceutical granulations of water-soluble active pharmaceutical ingredients Active AU2021293941B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
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

Publications (2)

Publication Number Publication Date
AU2021293941A1 AU2021293941A1 (en) 2023-01-19
AU2021293941B2 true AU2021293941B2 (en) 2024-03-28

Family

ID=76859782

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021293941A Active AU2021293941B2 (en) 2020-06-18 2021-06-17 Pharmaceutical granulations of water-soluble active pharmaceutical ingredients

Country Status (9)

Country Link
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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Also Published As

Publication number Publication date
JP2023537192A (ja) 2023-08-31
JP7659580B2 (ja) 2025-04-09
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
WO2021257832A1 (en) 2021-12-23
US20210393537A1 (en) 2021-12-23
TW202203903A (zh) 2022-02-01

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