CN116898955A - 稳定性优异的含有特立帕肽的液态药物组合物 - Google Patents

稳定性优异的含有特立帕肽的液态药物组合物 Download PDF

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Publication number
CN116898955A
CN116898955A CN202311111773.2A CN202311111773A CN116898955A CN 116898955 A CN116898955 A CN 116898955A CN 202311111773 A CN202311111773 A CN 202311111773A CN 116898955 A CN116898955 A CN 116898955A
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CN
China
Prior art keywords
component
salt
teriparatide
liquid pharmaceutical
pharmaceutical formulation
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Pending
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CN202311111773.2A
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English (en)
Chinese (zh)
Inventor
宫部康平
山口贵宏
松绳保宏
渡边成实
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Asahi Kasei Pharma Corp
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Asahi Kasei Pharma Corp
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Publication of CN116898955A publication Critical patent/CN116898955A/zh
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    • 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
    • A61K47/06—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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN202311111773.2A 2017-09-22 2018-09-20 稳定性优异的含有特立帕肽的液态药物组合物 Pending CN116898955A (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2017182611 2017-09-22
JP2017-182611 2017-09-22
CN201880053788.9A CN110996988A (zh) 2017-09-22 2018-09-20 稳定性优异的含有特立帕肽的液态药物组合物
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 Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201880053788.9A Division CN110996988A (zh) 2017-09-22 2018-09-20 稳定性优异的含有特立帕肽的液态药物组合物

Publications (1)

Publication Number Publication Date
CN116898955A true CN116898955A (zh) 2023-10-20

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CN202311111773.2A Pending CN116898955A (zh) 2017-09-22 2018-09-20 稳定性优异的含有特立帕肽的液态药物组合物
CN201880053788.9A Pending CN110996988A (zh) 2017-09-22 2018-09-20 稳定性优异的含有特立帕肽的液态药物组合物

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Country Status (6)

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

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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
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JP2020040995A (ja) 2020-03-19
JP2019089862A (ja) 2019-06-13
JP6646173B2 (ja) 2020-02-14
JP6825034B2 (ja) 2021-02-03
JP2019116495A (ja) 2019-07-18
WO2019059302A1 (ja) 2019-03-28
JP2021036000A (ja) 2021-03-04
JP2019081812A (ja) 2019-05-30
US20200289621A1 (en) 2020-09-17
JP6585317B2 (ja) 2019-10-02
JP6826140B2 (ja) 2021-02-03
JP6714738B2 (ja) 2020-06-24
JP6634175B2 (ja) 2020-01-22
JP6781790B2 (ja) 2020-11-04
JP2019089863A (ja) 2019-06-13
JP2019089865A (ja) 2019-06-13
JP2020186270A (ja) 2020-11-19
JP2019065042A (ja) 2019-04-25
EP3685849A4 (en) 2021-12-22
CA3075977C (en) 2024-10-29
JP2020114843A (ja) 2020-07-30
JP6817358B2 (ja) 2021-01-20
JP2019081811A (ja) 2019-05-30
CA3075977A1 (en) 2019-03-28
US20210205418A1 (en) 2021-07-08
JP2019116513A (ja) 2019-07-18
JP6766286B2 (ja) 2020-10-07
JP2021046452A (ja) 2021-03-25
JP2019089864A (ja) 2019-06-13
JP6977137B2 (ja) 2021-12-08
JP6739612B2 (ja) 2020-08-12
JP6818928B2 (ja) 2021-01-27
EP3685849A1 (en) 2020-07-29
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