JP7166309B2 - 安定性の良好な医薬組成物 - Google Patents

安定性の良好な医薬組成物 Download PDF

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Publication number
JP7166309B2
JP7166309B2 JP2020066699A JP2020066699A JP7166309B2 JP 7166309 B2 JP7166309 B2 JP 7166309B2 JP 2020066699 A JP2020066699 A JP 2020066699A JP 2020066699 A JP2020066699 A JP 2020066699A JP 7166309 B2 JP7166309 B2 JP 7166309B2
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Prior art keywords
pharmaceutical composition
compound
dialysis
acid
composition according
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JP2020066699A
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English (en)
Japanese (ja)
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JP2020169168A (ja
Inventor
良道 牧田
大輔 片岡
和雄 久山
謙司 浅野
僚太郎 芝崎
愛希子 山本
広貴 我妻
敦 鶴田
俊之 鷹橋
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.)
Sanwa Kagaku Kenkyusho Co Ltd
EA Pharma Co Ltd
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Sanwa Kagaku Kenkyusho Co Ltd
EA Pharma Co Ltd
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Publication of JP2020169168A publication Critical patent/JP2020169168A/ja
Priority to JP2022170262A priority Critical patent/JP7549633B2/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/26Carbohydrates, 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • A61P5/20Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2020066699A 2019-04-03 2020-04-02 安定性の良好な医薬組成物 Active JP7166309B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022170262A JP7549633B2 (ja) 2019-04-03 2022-10-25 安定性の良好な医薬組成物

Applications Claiming Priority (2)

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JP2019071168 2019-04-03
JP2019071168 2019-04-03

Related Child Applications (1)

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JP2022170262A Division JP7549633B2 (ja) 2019-04-03 2022-10-25 安定性の良好な医薬組成物

Publications (2)

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JP2020169168A JP2020169168A (ja) 2020-10-15
JP7166309B2 true JP7166309B2 (ja) 2022-11-07

Family

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JP2020066699A Active JP7166309B2 (ja) 2019-04-03 2020-04-02 安定性の良好な医薬組成物
JP2022170262A Active JP7549633B2 (ja) 2019-04-03 2022-10-25 安定性の良好な医薬組成物

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JP2022170262A Active JP7549633B2 (ja) 2019-04-03 2022-10-25 安定性の良好な医薬組成物

Country Status (8)

Country Link
US (1) US20220142958A1 (enExample)
EP (1) EP3950058A4 (enExample)
JP (2) JP7166309B2 (enExample)
KR (1) KR20210146280A (enExample)
CN (1) CN113260416A (enExample)
BR (1) BR112021013002A2 (enExample)
CA (1) CA3124687A1 (enExample)
WO (1) WO2020204117A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117247339B (zh) * 2023-11-16 2024-03-12 潍坊富邦药业有限公司 一种烷基胺衍生物的制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013063971A (ja) 2011-09-02 2013-04-11 Ajinomoto Co Inc アルキルアミン誘導体を有効成分とする医薬
WO2014119643A1 (ja) 2013-01-31 2014-08-07 千寿製薬株式会社 澄明な水性液剤

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4154900B1 (en) 2009-07-29 2024-08-28 Kai Pharmaceuticals, Inc. Therapeutic agents for reducing parathyroid hormone levels
ES2712048T3 (es) * 2010-03-04 2019-05-09 Ea Pharma Co Ltd Derivado de alquilamina
WO2011108724A1 (ja) * 2010-03-04 2011-09-09 味の素株式会社 糖尿病又は肥満症の予防又は治療剤
CN107614486A (zh) * 2015-06-01 2018-01-19 味之素株式会社 烷基胺衍生物的制造方法及其制造中间体
CN109200024A (zh) * 2017-07-07 2019-01-15 江苏恒瑞医药股份有限公司 西那卡塞药物组合物及其医药用途
TWI859130B (zh) * 2017-12-20 2024-10-21 日商Ea製藥股份有限公司 維持透析下之二次性副甲狀腺機能亢進症之預防或治療用醫藥組成物

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013063971A (ja) 2011-09-02 2013-04-11 Ajinomoto Co Inc アルキルアミン誘導体を有効成分とする医薬
WO2014119643A1 (ja) 2013-01-31 2014-08-07 千寿製薬株式会社 澄明な水性液剤

Also Published As

Publication number Publication date
US20220142958A1 (en) 2022-05-12
JP2022186861A (ja) 2022-12-15
BR112021013002A2 (pt) 2021-10-13
CN113260416A (zh) 2021-08-13
JP2020169168A (ja) 2020-10-15
EP3950058A1 (en) 2022-02-09
EP3950058A4 (en) 2023-01-04
WO2020204117A1 (ja) 2020-10-08
CA3124687A1 (en) 2020-10-08
JP7549633B2 (ja) 2024-09-11
KR20210146280A (ko) 2021-12-03

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