JP2023510258A - 安定なシクロデキストリン不含カルフィルゾミブ処方物 - Google Patents

安定なシクロデキストリン不含カルフィルゾミブ処方物 Download PDF

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Publication number
JP2023510258A
JP2023510258A JP2022541814A JP2022541814A JP2023510258A JP 2023510258 A JP2023510258 A JP 2023510258A JP 2022541814 A JP2022541814 A JP 2022541814A JP 2022541814 A JP2022541814 A JP 2022541814A JP 2023510258 A JP2023510258 A JP 2023510258A
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Prior art keywords
cyclodextrin
free
solution
pharmaceutical composition
carfilzomib
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JP2022541814A
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Japanese (ja)
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JP2023510258A5 (https=
JPWO2021142360A5 (https=
Inventor
カクー,サバハ
ムナイム,カヘラ
カラハン,ウィリアム・ジェイ
テラン,アロナ
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アムジエン・インコーポレーテツド
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Publication of JP2023510258A publication Critical patent/JP2023510258A/ja
Publication of JP2023510258A5 publication Critical patent/JP2023510258A5/ja
Publication of JPWO2021142360A5 publication Critical patent/JPWO2021142360A5/ja
Priority to JP2025175228A priority Critical patent/JP2026016486A/ja
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/07Tetrapeptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K5/00Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof
    • C07K5/04Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing only normal peptide links
    • C07K5/10Tetrapeptides
    • C07K5/1024Tetrapeptides with the first amino acid being heterocyclic

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
JP2022541814A 2020-01-10 2021-01-08 安定なシクロデキストリン不含カルフィルゾミブ処方物 Pending JP2023510258A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025175228A JP2026016486A (ja) 2020-01-10 2025-10-17 安定なシクロデキストリン不含カルフィルゾミブ処方物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062959829P 2020-01-10 2020-01-10
US62/959,829 2020-01-10
PCT/US2021/012826 WO2021142360A1 (en) 2020-01-10 2021-01-08 Stable cyclodextrin free carfilzomib formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025175228A Division JP2026016486A (ja) 2020-01-10 2025-10-17 安定なシクロデキストリン不含カルフィルゾミブ処方物

Publications (3)

Publication Number Publication Date
JP2023510258A true JP2023510258A (ja) 2023-03-13
JP2023510258A5 JP2023510258A5 (https=) 2024-01-16
JPWO2021142360A5 JPWO2021142360A5 (https=) 2024-01-16

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JP2022541814A Pending JP2023510258A (ja) 2020-01-10 2021-01-08 安定なシクロデキストリン不含カルフィルゾミブ処方物
JP2025175228A Pending JP2026016486A (ja) 2020-01-10 2025-10-17 安定なシクロデキストリン不含カルフィルゾミブ処方物

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JP2025175228A Pending JP2026016486A (ja) 2020-01-10 2025-10-17 安定なシクロデキストリン不含カルフィルゾミブ処方物

Country Status (5)

Country Link
US (1) US20250345384A1 (https=)
EP (1) EP4087538A1 (https=)
JP (2) JP2023510258A (https=)
CN (1) CN115279339A (https=)
WO (1) WO2021142360A1 (https=)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015516416A (ja) * 2012-05-08 2015-06-11 オニキス セラピューティクス, インク.Onyx Therapeutics, Inc. ペプチドプロテアソーム阻害剤を調合するためのシクロデキストリン錯体形成法
WO2016116882A2 (en) * 2015-01-23 2016-07-28 Leiutis Pharmaceuticals Pvt Ltd Novel compositions of carfilzomib
JP2016534060A (ja) * 2013-10-22 2016-11-04 メダック ゲゼルシャフト フィア クリニッシェ スペツィアルプレパラーテ ミット ベシュレンクタ ハフトゥンク ある含有量のマイトマイシンcを有する凍結乾燥医薬組成物を製造する方法
JP2017537974A (ja) * 2014-10-30 2017-12-21 ビッグ ディーエヌエイ リミテッドBig Dna Ltd 併用療法
JP2019519530A (ja) * 2016-05-24 2019-07-11 アムジエン・インコーポレーテツド ペグ化されたカルフィルゾミブ化合物

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5340736A (en) 1991-05-13 1994-08-23 The President & Fellows Of Harvard College ATP-dependent protease and use of inhibitors for same in the treatment of cachexia and muscle wasting
AU4499697A (en) 1996-09-13 1998-04-02 New York University Method for treating parasitic diseases with proteasome inhibitors
TWI674262B (zh) * 2011-01-10 2019-10-11 美商英菲尼提製藥股份有限公司 製備異喹啉酮之方法及異喹啉酮之固體形式
EP2914296B2 (en) * 2012-11-01 2021-09-29 Infinity Pharmaceuticals, Inc. Treatment of cancers using pi3 kinase isoform modulators
WO2015198257A1 (en) * 2014-06-26 2015-12-30 Intas Pharmaceuticals Ltd. Stable carfilzomib injection

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015516416A (ja) * 2012-05-08 2015-06-11 オニキス セラピューティクス, インク.Onyx Therapeutics, Inc. ペプチドプロテアソーム阻害剤を調合するためのシクロデキストリン錯体形成法
JP2016534060A (ja) * 2013-10-22 2016-11-04 メダック ゲゼルシャフト フィア クリニッシェ スペツィアルプレパラーテ ミット ベシュレンクタ ハフトゥンク ある含有量のマイトマイシンcを有する凍結乾燥医薬組成物を製造する方法
JP2017537974A (ja) * 2014-10-30 2017-12-21 ビッグ ディーエヌエイ リミテッドBig Dna Ltd 併用療法
WO2016116882A2 (en) * 2015-01-23 2016-07-28 Leiutis Pharmaceuticals Pvt Ltd Novel compositions of carfilzomib
JP2019519530A (ja) * 2016-05-24 2019-07-11 アムジエン・インコーポレーテツド ペグ化されたカルフィルゾミブ化合物

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CARDIOVASC TOXICOL, vol. 17, JPN6024047221, 2017, pages 58 - 66, ISSN: 0005469069 *
J BIOCHEM MOLECULAR TOXICOLOGY, vol. 28, no. 9, JPN6024047222, 2014, pages 400 - 406, ISSN: 0005469068 *
J PHARM SCI, vol. 88, no. 5, JPN6024047220, 1999, pages 501 - 506, ISSN: 0005469070 *

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Publication number Publication date
WO2021142360A1 (en) 2021-07-15
US20250345384A1 (en) 2025-11-13
EP4087538A1 (en) 2022-11-16
JP2026016486A (ja) 2026-02-03
CN115279339A (zh) 2022-11-01

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