CA3075984C - LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT PHARMACOKINETIC AND/OR SAFETY PROPERTIES - Google Patents

LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT PHARMACOKINETIC AND/OR SAFETY PROPERTIES

Info

Publication number
CA3075984C
CA3075984C CA3075984A CA3075984A CA3075984C CA 3075984 C CA3075984 C CA 3075984C CA 3075984 A CA3075984 A CA 3075984A CA 3075984 A CA3075984 A CA 3075984A CA 3075984 C CA3075984 C CA 3075984C
Authority
CA
Canada
Prior art keywords
formulation
teriparatide
liquid pharmaceutical
preparation
component
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
CA3075984A
Other languages
English (en)
French (fr)
Other versions
CA3075984A1 (en
Inventor
Kohei MIYABE
Atsushi OSE
Yuki Sato
Toshiyuki Kodama
Yasuhiro MATSUNAWA
Hikaru Yamamoto
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
Priority to CA3167644A priority Critical patent/CA3167644A1/en
Publication of CA3075984A1 publication Critical patent/CA3075984A1/en
Application granted granted Critical
Publication of CA3075984C publication Critical patent/CA3075984C/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
    • A61K47/06—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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CA3075984A 2017-09-22 2018-09-20 LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT PHARMACOKINETIC AND/OR SAFETY PROPERTIES Active CA3075984C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3167644A CA3167644A1 (en) 2017-09-22 2018-09-20 Teriparatide-containing liquid pharmaceutical composition having excellent pharmacokinetics and/or safety

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2017-182615 2017-09-22
JP2017182615 2017-09-22
PCT/JP2018/034889 WO2019059303A1 (ja) 2017-09-22 2018-09-20 薬物動態及び／又は安全性に優れるテリパラチド含有液状医薬組成物

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3167644A Division CA3167644A1 (en) 2017-09-22 2018-09-20 Teriparatide-containing liquid pharmaceutical composition having excellent pharmacokinetics and/or safety

Publications (2)

Publication Number Publication Date
CA3075984A1 CA3075984A1 (en) 2019-03-28
CA3075984C true CA3075984C (en) 2024-10-01

Family

ID=65811294

Family Applications (2)

Application Number Title Priority Date Filing Date
CA3075984A Active CA3075984C (en) 2017-09-22 2018-09-20 LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT PHARMACOKINETIC AND/OR SAFETY PROPERTIES
CA3167644A Pending CA3167644A1 (en) 2017-09-22 2018-09-20 Teriparatide-containing liquid pharmaceutical composition having excellent pharmacokinetics and/or safety

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA3167644A Pending CA3167644A1 (en) 2017-09-22 2018-09-20 Teriparatide-containing liquid pharmaceutical composition having excellent pharmacokinetics and/or safety

Country Status (6)

Country Link
US (1) US20200289622A1 (enExample)
EP (1) EP3685850A4 (enExample)
JP (5) JP6637220B2 (enExample)
CN (1) CN111032073A (enExample)
CA (2) CA3075984C (enExample)
WO (1) WO2019059303A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119258199A (zh) * 2018-10-29 2025-01-07 旭化成制药株式会社 特立帕肽或其盐在骨质疏松症治疗和/或预防剂的制备中的应用

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6357527A (ja) 1986-08-28 1988-03-12 Toyo Jozo Co Ltd 薬剤の吸着防止方法
JPH0669956B2 (ja) 1988-09-30 1994-09-07 旭化成工業株式会社 ポリペプタイド類の吸着防止剤
JP2662842B2 (ja) * 1991-12-09 1997-10-15 旭化成工業株式会社 パラサイロイドホルモンの安定化組成物
JPH0873376A (ja) * 1994-09-07 1996-03-19 Asahi Chem Ind Co Ltd 骨粗鬆症治療薬
ZA9811127B (en) 1997-12-09 2000-07-11 Lilly Co Eli Stabilized teriparatide solutions.
IL147731A0 (en) 2000-05-19 2002-08-14 Bionebraska Inc Peptide pharmaceutical formulations
JP4931306B2 (ja) * 2001-09-27 2012-05-16 旭化成ファーマ株式会社 骨形成を安全に促進させる医薬複合剤
JP4252260B2 (ja) * 2002-06-05 2009-04-08 旭化成ファーマ株式会社 Ｐｔｈの安定化水溶液注射剤
WO2004067021A1 (en) * 2003-01-24 2004-08-12 Gardella Thomas J Conformationally constrained parathyroid hormone (pth) analogs with lactam bridges
JP4707327B2 (ja) 2004-01-27 2011-06-22 旭化成ファーマ株式会社 ポリペプタイド類の吸着防止剤
JP4951344B2 (ja) 2004-08-24 2012-06-13 第一三共株式会社 生理活性ペプチド液状製剤
JP2009511472A (ja) * 2005-10-06 2009-03-19 エムディーアールエヌエー，インコーポレイテッド Ｐｔｈ剤形及びその使用方法
JP5522879B2 (ja) 2006-01-16 2014-06-18 旭化成ファーマ株式会社 樹脂容器中の生理活性ペプチドの安定性改善方法
CA2659846A1 (en) * 2006-07-31 2008-02-07 Zelos Therapeutics, Inc. Parathyroid hormone analogues and methods of use
KR20150021590A (ko) * 2009-09-09 2015-03-02 아사히 가세이 파마 가부시키가이샤 1회당 100∼200 단위의 ｐｔｈ가 주 1회 투여되는 것을 특징으로 하는, ｐｔｈ 함유 골다공증 치료/예방제
WO2011139838A2 (en) 2010-04-28 2011-11-10 Zelos Therapeutics, Inc. Intranasal formulations
SG193389A1 (en) 2011-03-10 2013-10-30 Xeris Pharmaceuticals Inc Stable formulations for parenteral injection of peptide drugs
CN103561757B (zh) 2011-06-07 2016-01-06 旭化成制药株式会社 高纯度含pth冷冻干燥制剂及其制造方法
MX2014008668A (es) 2012-01-20 2014-10-06 Lupin Ltd Formulacion de pth estabilizada.
CN103301058A (zh) * 2013-06-17 2013-09-18 深圳翰宇药业股份有限公司 一种特立帕肽注射用组合物及其制备方法和制剂
JP6634758B2 (ja) * 2015-09-25 2020-01-22 ニプロ株式会社 液体組成物及び凍結乾燥製剤
SMT202100411T1 (it) * 2015-10-09 2021-11-12 Radius Health Inc Formulazioni di analoghi di pthrp, loro cerotti transdermici, e loro usi

Also Published As

Publication number Publication date
WO2019059303A1 (ja) 2019-03-28
JP2021167354A (ja) 2021-10-21
JPWO2019059303A1 (ja) 2019-11-14
JP2024086815A (ja) 2024-06-28
JP2023082167A (ja) 2023-06-13
CA3075984A1 (en) 2019-03-28
EP3685850A1 (en) 2020-07-29
US20200289622A1 (en) 2020-09-17
JP6637220B2 (ja) 2020-01-29
CN111032073A (zh) 2020-04-17
JP2020040998A (ja) 2020-03-19
EP3685850A4 (en) 2021-06-16
CA3167644A1 (en) 2019-03-28

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