JP6577683B2 - 安定性に優れるテリパラチド含有液状医薬組成物 - Google Patents

安定性に優れるテリパラチド含有液状医薬組成物 Download PDF

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Publication number
JP6577683B2
JP6577683B2 JP2018558440A JP2018558440A JP6577683B2 JP 6577683 B2 JP6577683 B2 JP 6577683B2 JP 2018558440 A JP2018558440 A JP 2018558440A JP 2018558440 A JP2018558440 A JP 2018558440A JP 6577683 B2 JP6577683 B2 JP 6577683B2
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component
liquid pharmaceutical
teriparatide
pharmaceutical preparation
salt
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JPWO2019059302A1 (ja
Inventor
康平 宮部
康平 宮部
山口　貴宏
貴宏 山口
保宏 松縄
保宏 松縄
成実 渡邉
成実 渡邉
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Asahi Kasei Pharma Corp
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Asahi Kasei Pharma Corp
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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
    • A61K47/06—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
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/20—Organic 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
JP2018558440A 2017-09-22 2018-09-20 安定性に優れるテリパラチド含有液状医薬組成物 Active JP6577683B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2017182611 2017-09-22
JP2017182611 2017-09-22
PCT/JP2018/034887 WO2019059302A1 (ja) 2017-09-22 2018-09-20 安定性に優れるテリパラチド含有液状医薬組成物

Related Child Applications (4)

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JP2019008790A Division JP6585317B2 (ja) 2017-09-22 2019-01-22 安定性に優れるテリパラチド含有液状医薬組成物
JP2019008797A Division JP6714738B2 (ja) 2017-09-22 2019-01-22 安定性に優れるテリパラチド含有液状医薬組成物
JP2019040987A Division JP6826140B2 (ja) 2017-09-22 2019-03-06 安定性に優れるテリパラチド含有液状医薬組成物
JP2019041011A Division JP6817358B2 (ja) 2017-09-22 2019-03-06 安定性に優れるテリパラチド含有液状医薬組成物

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JP6577683B2 true JP6577683B2 (ja) 2019-09-18
JPWO2019059302A1 JPWO2019059302A1 (ja) 2019-11-14

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JP2018558440A Active JP6577683B2 (ja) 2017-09-22 2018-09-20 安定性に優れるテリパラチド含有液状医薬組成物
JP2019008790A Active JP6585317B2 (ja) 2017-09-22 2019-01-22 安定性に優れるテリパラチド含有液状医薬組成物
JP2019008797A Active JP6714738B2 (ja) 2017-09-22 2019-01-22 安定性に優れるテリパラチド含有液状医薬組成物
JP2019041011A Active JP6817358B2 (ja) 2017-09-22 2019-03-06 安定性に優れるテリパラチド含有液状医薬組成物
JP2019040987A Active JP6826140B2 (ja) 2017-09-22 2019-03-06 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057412A Active JP6781790B2 (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057408A Active JP6634175B2 (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057398A Active JP6581741B2 (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057434A Active JP6646173B2 (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057438A Pending JP2019089865A (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019085817A Active JP6825034B2 (ja) 2017-09-22 2019-04-26 安定性に優れるテリパラチド含有液状医薬組成物
JP2019228968A Active JP6739612B2 (ja) 2017-09-22 2019-12-19 安定性に優れるテリパラチド含有液状医薬組成物
JP2020053255A Active JP6766286B2 (ja) 2017-09-22 2020-03-24 安定性に優れるテリパラチド含有液状医薬組成物
JP2020139570A Active JP6818928B2 (ja) 2017-09-22 2020-08-20 安定性に優れるテリパラチド含有液状医薬組成物
JP2020201121A Active JP6851536B2 (ja) 2017-09-22 2020-12-03 安定性に優れるテリパラチド含有液状医薬組成物
JP2020218741A Active JP6977137B2 (ja) 2017-09-22 2020-12-28 安定性に優れるテリパラチド含有液状医薬組成物
JP2021036829A Pending JP2021088606A (ja) 2017-09-22 2021-03-09 安定性に優れるテリパラチド含有液状医薬組成物

Family Applications After (16)

Application Number Title Priority Date Filing Date
JP2019008790A Active JP6585317B2 (ja) 2017-09-22 2019-01-22 安定性に優れるテリパラチド含有液状医薬組成物
JP2019008797A Active JP6714738B2 (ja) 2017-09-22 2019-01-22 安定性に優れるテリパラチド含有液状医薬組成物
JP2019041011A Active JP6817358B2 (ja) 2017-09-22 2019-03-06 安定性に優れるテリパラチド含有液状医薬組成物
JP2019040987A Active JP6826140B2 (ja) 2017-09-22 2019-03-06 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057412A Active JP6781790B2 (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057408A Active JP6634175B2 (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057398A Active JP6581741B2 (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057434A Active JP6646173B2 (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019057438A Pending JP2019089865A (ja) 2017-09-22 2019-03-25 安定性に優れるテリパラチド含有液状医薬組成物
JP2019085817A Active JP6825034B2 (ja) 2017-09-22 2019-04-26 安定性に優れるテリパラチド含有液状医薬組成物
JP2019228968A Active JP6739612B2 (ja) 2017-09-22 2019-12-19 安定性に優れるテリパラチド含有液状医薬組成物
JP2020053255A Active JP6766286B2 (ja) 2017-09-22 2020-03-24 安定性に優れるテリパラチド含有液状医薬組成物
JP2020139570A Active JP6818928B2 (ja) 2017-09-22 2020-08-20 安定性に優れるテリパラチド含有液状医薬組成物
JP2020201121A Active JP6851536B2 (ja) 2017-09-22 2020-12-03 安定性に優れるテリパラチド含有液状医薬組成物
JP2020218741A Active JP6977137B2 (ja) 2017-09-22 2020-12-28 安定性に優れるテリパラチド含有液状医薬組成物
JP2021036829A Pending JP2021088606A (ja) 2017-09-22 2021-03-09 安定性に優れるテリパラチド含有液状医薬組成物

Country Status (6)

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US (2) US20200289621A1 (https=)
EP (1) EP3685849A4 (https=)
JP (17) JP6577683B2 (https=)
CN (2) CN116898955A (https=)
CA (1) CA3075977C (https=)
WO (1) WO2019059302A1 (https=)

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JP6577683B2 (ja) * 2017-09-22 2019-09-18 旭化成ファーマ株式会社 安定性に優れるテリパラチド含有液状医薬組成物
JP6618139B1 (ja) * 2018-10-29 2019-12-11 旭化成ファーマ株式会社 週２回の頻度でテリパラチド又はその塩を投与することを特徴とする、骨粗鬆症の予防又は治療方法
JP7240407B2 (ja) * 2019-09-05 2023-03-15 旭化成ファーマ株式会社 テリパラチド又はその塩を含有する無菌注射剤を製造する方法
JP6965474B1 (ja) * 2019-12-09 2021-11-10 旭化成ファーマ株式会社 テリパラチド又はその塩を含有するプレフィルドシリンジまたはカートリッジ製剤の振盪による白濁を抑制する方法
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WO2021229835A1 (ja) * 2020-05-11 2021-11-18 旭化成ファーマ株式会社 テリパラチド又はその塩を含有する安定な液状医薬製剤
CN114306249A (zh) * 2020-09-28 2022-04-12 深圳翰宇药业股份有限公司 一种特立帕肽冻干药物组合物及其制备方法
CN114031680B (zh) * 2021-09-01 2024-03-26 浙江湃肽生物有限公司 一种索玛鲁肽钠盐及其制备方法与应用
CN114316021A (zh) * 2021-12-29 2022-04-12 江苏诺泰澳赛诺生物制药股份有限公司 一种特立帕肽及的纯化方法
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