JP7148642B2 - 安定したアザシチジン含有医薬組成物の製造方法 - Google Patents

安定したアザシチジン含有医薬組成物の製造方法 Download PDF

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Publication number
JP7148642B2
JP7148642B2 JP2020566917A JP2020566917A JP7148642B2 JP 7148642 B2 JP7148642 B2 JP 7148642B2 JP 2020566917 A JP2020566917 A JP 2020566917A JP 2020566917 A JP2020566917 A JP 2020566917A JP 7148642 B2 JP7148642 B2 JP 7148642B2
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Prior art keywords
azacitidine
pharmaceutical composition
solution
temperature
acetonitrile
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JP2020566917A
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English (en)
Japanese (ja)
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JP2022500350A (ja
Inventor
チョ，ジュンウン
キム，ギョンヒェ
イ，イルウン
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Samyang Holdings Corp
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Samyang Holdings Corp
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Priority to JP2022152920A priority Critical patent/JP2022185009A/ja
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    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2020566917A 2018-05-30 2019-05-29 安定したアザシチジン含有医薬組成物の製造方法 Active JP7148642B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022152920A JP2022185009A (ja) 2018-05-30 2022-09-26 安定したアザシチジン含有医薬組成物の製造方法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2018-0061784 2018-05-30
KR1020180061784A KR20190136284A (ko) 2018-05-30 2018-05-30 안정한 아자시티딘-함유 약제학적 조성물의 제조방법
PCT/KR2019/006415 WO2019231225A1 (ko) 2018-05-30 2019-05-29 안정한 아자시티딘-함유 약제학적 조성물의 제조방법

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022152920A Division JP2022185009A (ja) 2018-05-30 2022-09-26 安定したアザシチジン含有医薬組成物の製造方法

Publications (2)

Publication Number Publication Date
JP2022500350A JP2022500350A (ja) 2022-01-04
JP7148642B2 true JP7148642B2 (ja) 2022-10-05

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JP2020566917A Active JP7148642B2 (ja) 2018-05-30 2019-05-29 安定したアザシチジン含有医薬組成物の製造方法
JP2022152920A Pending JP2022185009A (ja) 2018-05-30 2022-09-26 安定したアザシチジン含有医薬組成物の製造方法

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JP2022152920A Pending JP2022185009A (ja) 2018-05-30 2022-09-26 安定したアザシチジン含有医薬組成物の製造方法

Country Status (3)

Country Link
JP (2) JP7148642B2 (ko)
KR (2) KR20190136284A (ko)
WO (1) WO2019231225A1 (ko)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110042247A1 (en) 2009-06-25 2011-02-24 Chandrasekhar Kocherlakota Formulations of azacitidine and its derivatives
WO2013117969A1 (en) 2012-02-06 2013-08-15 Fresenius Kabi Oncology Ltd. Process for preparing stable pharmaceutical compositions of compounds susceptible to hydrolysis
JP2014510755A (ja) 2011-03-31 2014-05-01 セルジーン インターナショナル サルル ５−アザシチジンの合成
WO2014076616A2 (en) 2012-11-19 2014-05-22 Shilpa Medicare Limited Formulations of 5-azacytidine

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101286802B1 (ko) * 2011-07-15 2013-07-23 보령제약 주식회사 아자시티딘의 전―동결건조 제제, 아자시티딘의 동결건조 제제 및 이의 제조방법

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110042247A1 (en) 2009-06-25 2011-02-24 Chandrasekhar Kocherlakota Formulations of azacitidine and its derivatives
JP2014510755A (ja) 2011-03-31 2014-05-01 セルジーン インターナショナル サルル ５−アザシチジンの合成
WO2013117969A1 (en) 2012-02-06 2013-08-15 Fresenius Kabi Oncology Ltd. Process for preparing stable pharmaceutical compositions of compounds susceptible to hydrolysis
WO2014076616A2 (en) 2012-11-19 2014-05-22 Shilpa Medicare Limited Formulations of 5-azacytidine

Also Published As

Publication number Publication date
KR20210078462A (ko) 2021-06-28
JP2022185009A (ja) 2022-12-13
KR20190136284A (ko) 2019-12-10
JP2022500350A (ja) 2022-01-04
WO2019231225A1 (ko) 2019-12-05

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