JP2020534320A - アビラテロン環状オリゴマー薬学的製剤ならびにその形成法および投与法 - Google Patents

アビラテロン環状オリゴマー薬学的製剤ならびにその形成法および投与法 Download PDF

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JP2020534320A
JP2020534320A JP2020516620A JP2020516620A JP2020534320A JP 2020534320 A JP2020534320 A JP 2020534320A JP 2020516620 A JP2020516620 A JP 2020516620A JP 2020516620 A JP2020516620 A JP 2020516620A JP 2020534320 A JP2020534320 A JP 2020534320A
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avilateron
pharmaceutical formulation
excipient
tablet
patient
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JP2020534320A5 (https=
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デイヴ ミラー
デイヴ ミラー
ウーヴィ ガラ
ウーヴィ ガラ
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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
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
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    • 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
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/2095—Tabletting processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2020516620A 2017-09-22 2018-09-20 アビラテロン環状オリゴマー薬学的製剤ならびにその形成法および投与法 Pending JP2020534320A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023167274A JP2023182674A (ja) 2017-09-22 2023-09-28 アビラテロン環状オリゴマー薬学的製剤ならびにその形成法および投与法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762562081P 2017-09-22 2017-09-22
US62/562,081 2017-09-22
PCT/US2018/051914 WO2019060525A1 (en) 2017-09-22 2018-09-20 PHARMACEUTICAL FORMULATIONS OF CYCLIC OLIGOMER AND ABIRATERONE AND METHODS OF FORMATION AND ADMINISTRATION THEREOF

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JP2023167274A Division JP2023182674A (ja) 2017-09-22 2023-09-28 アビラテロン環状オリゴマー薬学的製剤ならびにその形成法および投与法

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JP2020534320A true JP2020534320A (ja) 2020-11-26
JP2020534320A5 JP2020534320A5 (https=) 2021-10-28

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JP2020516620A Pending JP2020534320A (ja) 2017-09-22 2018-09-20 アビラテロン環状オリゴマー薬学的製剤ならびにその形成法および投与法
JP2023167274A Pending JP2023182674A (ja) 2017-09-22 2023-09-28 アビラテロン環状オリゴマー薬学的製剤ならびにその形成法および投与法

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Country Status (10)

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US (1) US20190091339A1 (https=)
EP (1) EP3684371A4 (https=)
JP (2) JP2020534320A (https=)
KR (1) KR20200064993A (https=)
CN (1) CN111107852A (https=)
AU (1) AU2018335391A1 (https=)
CA (1) CA3075095A1 (https=)
IL (1) IL273125A (https=)
MA (1) MA50189A (https=)
WO (1) WO2019060525A1 (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2020240017A1 (en) * 2019-03-18 2021-11-04 AustinPx, LLC Abiraterone-cyclic oligomer pharmaceutical formulations and methods of formation and administration thereof
CN110141556B (zh) * 2019-06-24 2021-07-13 李建恒 一种阿比特龙包合物片剂及其制备方法
WO2021086565A1 (en) * 2019-11-01 2021-05-06 Dispersol Technologies, Llc Weakly basic drug and ionic polymer pharmaceutical formulations and methods of formation and administration thereof
CA3160834C (en) * 2019-11-14 2024-06-11 Suven Life Sciences Limited Amorphous pharmaceutical compositions of abiraterone acetate
US20220401579A1 (en) * 2019-11-30 2022-12-22 Dispersol Technologies, Llc Inclusion complexes of pharmaceuticals and cyclic oligomers
KR102363026B1 (ko) * 2019-12-26 2022-02-16 보령제약 주식회사 아비라테론 아세테이트 또는 이의 약제학적으로 허용 가능한 염을 포함하는 전립선암 예방 또는 치료용 약학적 조성물
CA3203975A1 (en) 2020-12-03 2022-06-09 Battelle Memorial Institute Polymer nanoparticle and dna nanostructure compositions and methods for non-viral delivery
CA3216359A1 (en) 2021-04-07 2022-10-13 Battelle Memorial Institute Rapid design, build, test, and learn technologies for identifying and using non-viral carriers
AU2024353375A1 (en) 2023-09-29 2026-04-09 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
WO2025122954A1 (en) 2023-12-08 2025-06-12 Battelle Memorial Institute Use of dna origami nanostructures for molecular information based data storage systems

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014523445A (ja) * 2011-07-18 2014-09-11 トーカイ ファーマシューティカルズ，インク． 前立腺癌を処置するための新規な組成物及び方法
WO2016051368A1 (en) * 2014-10-01 2016-04-07 Mylan Laboratories Ltd Complex of amorphous empagliflozin and a cyclodextrin
WO2017037647A1 (en) * 2015-09-02 2017-03-09 Leiutis Pharmaceuticals Pvt Ltd Stable pharmaceutical compositions of abiraterone

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6073043B2 (ja) * 2007-08-21 2017-02-01 ボード・オブ・リージエンツ，ザ・ユニバーシテイ・オブ・テキサス・システム 医薬品適用のための熱−動力学的混合
US9040080B2 (en) * 2008-10-21 2015-05-26 Southwest Research Institute Processing of heat-sensitive active agents
HRP20191982T4 (hr) * 2011-11-30 2023-01-06 Astrazeneca Ab Kombinacijsko liječenje raka
GB201207886D0 (en) * 2012-05-04 2012-06-20 Jagotec Ag Improvements in or relating to organic compounds
WO2014009437A1 (en) * 2012-07-11 2014-01-16 Sandoz Ag Oxidation stability of abiraterone acetate
US20140287039A1 (en) * 2013-03-15 2014-09-25 Iceutica Inc. Abiraterone Acetate Formulation
WO2015032873A1 (en) * 2013-09-06 2015-03-12 Synthon B.V. High-load pharmaceutical compositions comprising abiraterone acetate

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014523445A (ja) * 2011-07-18 2014-09-11 トーカイ ファーマシューティカルズ，インク． 前立腺癌を処置するための新規な組成物及び方法
WO2016051368A1 (en) * 2014-10-01 2016-04-07 Mylan Laboratories Ltd Complex of amorphous empagliflozin and a cyclodextrin
WO2017037647A1 (en) * 2015-09-02 2017-03-09 Leiutis Pharmaceuticals Pvt Ltd Stable pharmaceutical compositions of abiraterone

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
AAPS PHARMSCITECH, vol. 11, JPN6022035258, 2010, pages 885 - 893, ISSN: 0004856380 *
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, vol. 35, JPN6022035257, 2009, pages 727 - 734, ISSN: 0005068986 *

Also Published As

Publication number Publication date
JP2023182674A (ja) 2023-12-26
IL273125A (en) 2020-04-30
WO2019060525A1 (en) 2019-03-28
US20190091339A1 (en) 2019-03-28
EP3684371A4 (en) 2021-05-19
CN111107852A (zh) 2020-05-05
MA50189A (fr) 2021-05-19
CA3075095A1 (en) 2019-03-28
AU2018335391A1 (en) 2020-03-26
KR20200064993A (ko) 2020-06-08
EP3684371A1 (en) 2020-07-29

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