CA3075977C - LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT STABILITY - Google Patents

LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT STABILITY

Info

Publication number
CA3075977C
CA3075977C CA3075977A CA3075977A CA3075977C CA 3075977 C CA3075977 C CA 3075977C CA 3075977 A CA3075977 A CA 3075977A CA 3075977 A CA3075977 A CA 3075977A CA 3075977 C CA3075977 C CA 3075977C
Authority
CA
Canada
Prior art keywords
component
liquid pharmaceutical
pharmaceutical preparation
teriparatide
formulation
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.)
Active
Application number
CA3075977A
Other languages
English (en)
French (fr)
Other versions
CA3075977A1 (en
Inventor
Kohei MIYABE
Takahiro Yamaguchi
Yasuhiro MATSUNAWA
Narumi Watanabe
Original Assignee
Asahi Kasei Pharma Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Asahi Kasei Pharma Corp filed Critical Asahi Kasei Pharma Corp
Publication of CA3075977A1 publication Critical patent/CA3075977A1/en
Application granted granted Critical
Publication of CA3075977C publication Critical patent/CA3075977C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K47/16—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
    • A61K47/06—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
    • 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
    • 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

Landscapes

  • 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)
CA3075977A 2017-09-22 2018-09-20 LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT STABILITY Active CA3075977C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2017-182611 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

Publications (2)

Publication Number Publication Date
CA3075977A1 CA3075977A1 (en) 2019-03-28
CA3075977C true CA3075977C (en) 2024-10-29

Family

ID=65811407

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3075977A Active CA3075977C (en) 2017-09-22 2018-09-20 LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT STABILITY

Country Status (6)

Country Link
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
CA3157981C (en) * 2019-12-18 2024-03-26 Daewoong Pharmaceutical Co., Ltd. Liquid pharmaceutical composition of 1-(5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-1h-pyrrol-3-yl)-n-methylmethanamine
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
WO2025032376A1 (en) * 2023-08-04 2025-02-13 Precise Biopharma Pvt Ltd A room temperature stable solution for injection of abaloparatide

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Also Published As

Publication number Publication date
JP6977137B2 (ja) 2021-12-08
JP2019116513A (ja) 2019-07-18
JP2020040995A (ja) 2020-03-19
JP2020114843A (ja) 2020-07-30
JP6781790B2 (ja) 2020-11-04
JP2019081812A (ja) 2019-05-30
JP2019081811A (ja) 2019-05-30
JP6825034B2 (ja) 2021-02-03
JP6577683B2 (ja) 2019-09-18
JP6581741B2 (ja) 2019-09-25
JP2019116495A (ja) 2019-07-18
JP2021088606A (ja) 2021-06-10
JP2019065042A (ja) 2019-04-25
WO2019059302A1 (ja) 2019-03-28
JP2019089865A (ja) 2019-06-13
JP6634175B2 (ja) 2020-01-22
CN116898955A (zh) 2023-10-20
JP6585317B2 (ja) 2019-10-02
JP2019089862A (ja) 2019-06-13
JP2021036000A (ja) 2021-03-04
EP3685849A1 (en) 2020-07-29
JP6739612B2 (ja) 2020-08-12
JP6851536B2 (ja) 2021-03-31
JP2019089864A (ja) 2019-06-13
JP6817358B2 (ja) 2021-01-20
JP6826140B2 (ja) 2021-02-03
JPWO2019059302A1 (ja) 2019-11-14
EP3685849A4 (en) 2021-12-22
CA3075977A1 (en) 2019-03-28
JP2021046452A (ja) 2021-03-25
JP2019089863A (ja) 2019-06-13
JP6766286B2 (ja) 2020-10-07
US20200289621A1 (en) 2020-09-17
CN110996988A (zh) 2020-04-10
JP2019073543A (ja) 2019-05-16
JP6646173B2 (ja) 2020-02-14
JP6818928B2 (ja) 2021-01-27
US20210205418A1 (en) 2021-07-08
JP2020186270A (ja) 2020-11-19
JP6714738B2 (ja) 2020-06-24

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