CA3075977A1 - Teriparatide-containing liquid pharmaceutical composition having excellent stability - Google Patents

Teriparatide-containing liquid pharmaceutical composition having excellent stability Download PDF

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Publication number
CA3075977A1
CA3075977A1 CA3075977A CA3075977A CA3075977A1 CA 3075977 A1 CA3075977 A1 CA 3075977A1 CA 3075977 A CA3075977 A CA 3075977A CA 3075977 A CA3075977 A CA 3075977A CA 3075977 A1 CA3075977 A1 CA 3075977A1
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CA
Canada
Prior art keywords
component
liquid pharmaceutical
pharmaceutical preparation
teriparatide
salt
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.)
Granted
Application number
CA3075977A
Other languages
English (en)
French (fr)
Other versions
CA3075977C (en
Inventor
Kohei MIYABE
Takahiro Yamaguchi
Yasuhiro MATSUNAWA
Narumi Watanabe
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.)
Asahi Kasei Pharma Corp
Original Assignee
Asahi Kasei Pharma Corp
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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

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Classifications

    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (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 true CA3075977A1 (en) 2019-03-28
CA3075977C 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 (enExample)
EP (1) EP3685849A4 (enExample)
JP (17) JP6577683B2 (enExample)
CN (2) CN110996988A (enExample)
CA (1) CA3075977C (enExample)
WO (1) WO2019059302A1 (enExample)

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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
WO2021117735A1 (ja) * 2019-12-09 2021-06-17 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
CN114845701A (zh) * 2019-12-18 2022-08-02 株式会社大熊制药 1-(5-(2,4-二氟苯基)-1-((3-氟苯基)磺酰基)-4-甲氧基-1h-吡咯-3-基)-n-甲基甲胺的液体药物组合物
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
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Also Published As

Publication number Publication date
JP2021046452A (ja) 2021-03-25
JP6581741B2 (ja) 2019-09-25
JP2020114843A (ja) 2020-07-30
US20200289621A1 (en) 2020-09-17
JP6817358B2 (ja) 2021-01-20
JP6851536B2 (ja) 2021-03-31
CA3075977C (en) 2024-10-29
JP6977137B2 (ja) 2021-12-08
JP6825034B2 (ja) 2021-02-03
JP6781790B2 (ja) 2020-11-04
JP2021088606A (ja) 2021-06-10
EP3685849A4 (en) 2021-12-22
JP6577683B2 (ja) 2019-09-18
JP2019116513A (ja) 2019-07-18
JP6766286B2 (ja) 2020-10-07
JP2020040995A (ja) 2020-03-19
US20210205418A1 (en) 2021-07-08
JP6585317B2 (ja) 2019-10-02
CN116898955A (zh) 2023-10-20
JP2019065042A (ja) 2019-04-25
EP3685849A1 (en) 2020-07-29
JP6646173B2 (ja) 2020-02-14
JP2019089862A (ja) 2019-06-13
JP6739612B2 (ja) 2020-08-12
JP2021036000A (ja) 2021-03-04
JP6634175B2 (ja) 2020-01-22
WO2019059302A1 (ja) 2019-03-28
JP2019073543A (ja) 2019-05-16
JP2019089863A (ja) 2019-06-13
JP2019081811A (ja) 2019-05-30
JP6818928B2 (ja) 2021-01-27
JP2019081812A (ja) 2019-05-30
CN110996988A (zh) 2020-04-10
JPWO2019059302A1 (ja) 2019-11-14
JP2019089864A (ja) 2019-06-13
JP6714738B2 (ja) 2020-06-24
JP6826140B2 (ja) 2021-02-03
JP2020186270A (ja) 2020-11-19
JP2019089865A (ja) 2019-06-13
JP2019116495A (ja) 2019-07-18

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Effective date: 20200316

EEER Examination request

Effective date: 20200316

EEER Examination request

Effective date: 20200316

EEER Examination request

Effective date: 20200316

EEER Examination request

Effective date: 20200316

EEER Examination request

Effective date: 20200316