CN115279339A - 稳定的无环糊精的卡非佐米配制品 - Google Patents

稳定的无环糊精的卡非佐米配制品 Download PDF

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Publication number
CN115279339A
CN115279339A CN202180020091.3A CN202180020091A CN115279339A CN 115279339 A CN115279339 A CN 115279339A CN 202180020091 A CN202180020091 A CN 202180020091A CN 115279339 A CN115279339 A CN 115279339A
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CN
China
Prior art keywords
cyclodextrin
free
solution
pharmaceutical composition
carfilzomib
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202180020091.3A
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English (en)
Chinese (zh)
Inventor
S·卡库
Q·穆奈姆
W·J·卡拉罕
A·特兰
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Amgen Inc
Original Assignee
Amgen Inc
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Publication date
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of CN115279339A publication Critical patent/CN115279339A/zh
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)
CN202180020091.3A 2020-01-10 2021-01-08 稳定的无环糊精的卡非佐米配制品 Pending CN115279339A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062959829P 2020-01-10 2020-01-10
US62/959829 2020-01-10
PCT/US2021/012826 WO2021142360A1 (en) 2020-01-10 2021-01-08 Stable cyclodextrin free carfilzomib formulation

Publications (1)

Publication Number Publication Date
CN115279339A true CN115279339A (zh) 2022-11-01

Family

ID=74626106

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180020091.3A Pending CN115279339A (zh) 2020-01-10 2021-01-08 稳定的无环糊精的卡非佐米配制品

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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120184568A1 (en) * 2011-01-10 2012-07-19 Pingda Ren Processes for preparing isoquinolinones and solid forms of isoquinolinones
WO2016116882A2 (en) * 2015-01-23 2016-07-28 Leiutis Pharmaceuticals Pvt Ltd Novel compositions of carfilzomib
US20180015093A1 (en) * 2012-11-01 2018-01-18 Infinity Pharmaceuticals, Inc. Treatment of cancers using pi3 kinase isoform modulators

Family Cites Families (7)

* 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
PH12012502259A1 (en) * 2012-05-08 2019-07-03 Onyx Therapeutics Inc Cylodextrin complexation methods for formulating peptide proteasome inhibitors
PT2865391T (pt) * 2013-10-22 2017-12-22 Medac Ges Für Klinische Spezialpräparate Mbh Processo para a produção de uma composição farmacêutica liofilizada com um conteúdo de mitomicina c
WO2015198257A1 (en) * 2014-06-26 2015-12-30 Intas Pharmaceuticals Ltd. Stable carfilzomib injection
CA2966288A1 (en) * 2014-10-30 2016-05-06 Big Dna Ltd Combination therapy
TWI759301B (zh) * 2016-05-24 2022-04-01 美商安美基公司 聚乙二醇化卡非佐米化合物

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120184568A1 (en) * 2011-01-10 2012-07-19 Pingda Ren Processes for preparing isoquinolinones and solid forms of isoquinolinones
US20180015093A1 (en) * 2012-11-01 2018-01-18 Infinity Pharmaceuticals, Inc. Treatment of cancers using pi3 kinase isoform modulators
WO2016116882A2 (en) * 2015-01-23 2016-07-28 Leiutis Pharmaceuticals Pvt Ltd Novel compositions of carfilzomib

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
熊方武等主编: "中国临床药物大辞典 化学药卷 上》", vol. 2018, 31 August 2018, 北京:中国医药科技出版社, pages: 863 *

Also Published As

Publication number Publication date
WO2021142360A1 (en) 2021-07-15
JP2023510258A (ja) 2023-03-13
US20250345384A1 (en) 2025-11-13
EP4087538A1 (en) 2022-11-16
JP2026016486A (ja) 2026-02-03

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