JP7834709B2 - 非晶質体及び当該非晶質体を含む組成物 - Google Patents

非晶質体及び当該非晶質体を含む組成物

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Publication number
JP7834709B2
JP7834709B2 JP2023500872A JP2023500872A JP7834709B2 JP 7834709 B2 JP7834709 B2 JP 7834709B2 JP 2023500872 A JP2023500872 A JP 2023500872A JP 2023500872 A JP2023500872 A JP 2023500872A JP 7834709 B2 JP7834709 B2 JP 7834709B2
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Japan
Prior art keywords
amorphous solid
acid
solid dispersion
amorphous
compound
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JP2023500872A
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English (en)
Japanese (ja)
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JPWO2022176877A1 (https=
Inventor
直興 鎌田
元靖 吉村
万里子 木本
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.)
Otsuka Pharmaceutical Co Ltd
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Otsuka Pharmaceutical Co Ltd
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Publication of JPWO2022176877A1 publication Critical patent/JPWO2022176877A1/ja
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Classifications

    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D409/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms
    • C07D409/14—Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms containing three or more hetero rings
    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • A61K9/141—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
    • A61K9/1635—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
    • A61K9/16—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2023500872A 2021-02-16 2022-02-16 非晶質体及び当該非晶質体を含む組成物 Active JP7834709B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PCT/JP2021/005721 WO2022176017A1 (ja) 2021-02-16 2021-02-16 非晶質体及び当該非晶質体を含む組成物
JPPCT/JP2021/005721 2021-02-16
PCT/JP2022/006064 WO2022176877A1 (ja) 2021-02-16 2022-02-16 非晶質体及び当該非晶質体を含む組成物

Publications (2)

Publication Number Publication Date
JPWO2022176877A1 JPWO2022176877A1 (https=) 2022-08-25
JP7834709B2 true JP7834709B2 (ja) 2026-03-24

Family

ID=82930564

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023500872A Active JP7834709B2 (ja) 2021-02-16 2022-02-16 非晶質体及び当該非晶質体を含む組成物

Country Status (5)

Country Link
US (1) US20240158380A1 (https=)
EP (1) EP4296269A4 (https=)
JP (1) JP7834709B2 (https=)
CN (1) CN116829553A (https=)
WO (2) WO2022176017A1 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025154730A1 (ja) * 2024-01-18 2025-07-24 沢井製薬株式会社 固体分散体、固体分散体を含む製剤、及び固体分散体の製造方法

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003506329A (ja) 1999-07-30 2003-02-18 ランバクシー ラボラトリーズ リミテッド セフポドキシメプロキセチルの改良アモルファス形態
JP2005521636A (ja) 2001-10-18 2005-07-21 シプラ・リミテッド 薬剤的に許容されるアモルファス形態のアレンドロ酸塩
JP2013139441A (ja) 2011-12-28 2013-07-18 Otsuka Pharmaceut Co Ltd マイクロスフェア
JP2014526435A (ja) 2011-09-08 2014-10-06 大塚製薬株式会社 複素環化合物及びその用途
JP2015514677A (ja) 2012-04-23 2015-05-21 大塚製薬株式会社 ベンゾチオフェン化合物又はその塩の、二水和物、及びその製造方法
JP2015515959A (ja) 2012-04-30 2015-06-04 大塚製薬株式会社 経口製剤
WO2016021707A1 (ja) 2014-08-08 2016-02-11 中外製薬株式会社 ４環性化合物の非晶質体
US20190160005A1 (en) 2017-11-24 2019-05-30 Biophore India Pharmaceuticals Pvt. Ltd. Method of Preparing Solid Dispersions of Active Pharmaceutical Ingredients
JP2019529564A (ja) 2016-09-23 2019-10-17 デルポー・インコーポレイテッドＤｅｌｐｏｒ， Ｉｎｃ． 小分子治療剤化合物のための組成物

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003506329A (ja) 1999-07-30 2003-02-18 ランバクシー ラボラトリーズ リミテッド セフポドキシメプロキセチルの改良アモルファス形態
JP2005521636A (ja) 2001-10-18 2005-07-21 シプラ・リミテッド 薬剤的に許容されるアモルファス形態のアレンドロ酸塩
JP2014526435A (ja) 2011-09-08 2014-10-06 大塚製薬株式会社 複素環化合物及びその用途
JP2013139441A (ja) 2011-12-28 2013-07-18 Otsuka Pharmaceut Co Ltd マイクロスフェア
JP2015514677A (ja) 2012-04-23 2015-05-21 大塚製薬株式会社 ベンゾチオフェン化合物又はその塩の、二水和物、及びその製造方法
JP2015515959A (ja) 2012-04-30 2015-06-04 大塚製薬株式会社 経口製剤
WO2016021707A1 (ja) 2014-08-08 2016-02-11 中外製薬株式会社 ４環性化合物の非晶質体
JP2019529564A (ja) 2016-09-23 2019-10-17 デルポー・インコーポレイテッドＤｅｌｐｏｒ， Ｉｎｃ． 小分子治療剤化合物のための組成物
US20190160005A1 (en) 2017-11-24 2019-05-30 Biophore India Pharmaceuticals Pvt. Ltd. Method of Preparing Solid Dispersions of Active Pharmaceutical Ingredients

Also Published As

Publication number Publication date
WO2022176017A1 (ja) 2022-08-25
WO2022176877A1 (ja) 2022-08-25
EP4296269A4 (en) 2025-02-19
EP4296269A1 (en) 2023-12-27
JPWO2022176877A1 (https=) 2022-08-25
CN116829553A (zh) 2023-09-29
US20240158380A1 (en) 2024-05-16

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