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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (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 (6) 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
CN111447943A (zh) * 2018-10-29 2020-07-24 旭化成制药株式会社 以按每周2次的频率给予特立帕肽或其盐为特征的骨质疏松症的预防或治疗方法

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
MY120063A (en) * 1997-12-09 2005-08-30 Lilly Co Eli Stabilized teriparatide solutions
EP1301200A2 (en) 2000-05-19 2003-04-16 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
JP4541899B2 (ja) * 2003-01-24 2010-09-08 ザ ジェネラル ホスピタル コーポレイション ラクタム架橋を有する、コンホメーションが制限された副甲状腺ホルモン（ｐｔｈ）アナログ
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
BRPI0514408B8 (pt) 2004-08-24 2021-05-25 Asubio Pharma Co Ltd preparação liquida de peptídeo fisiologicamente ativo
KR20080059430A (ko) * 2005-10-06 2008-06-27 나스텍 파마수티컬 컴퍼니 인코포레이티드 부갑상선 호르몬 제형 및 그 사용 방법
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
WO2008016404A2 (en) * 2006-07-31 2008-02-07 Zelos Therapeutics, Inc. Parathyroid hormone analogues and uses thereof
ES2662018T3 (es) * 2009-09-09 2018-04-05 Asahi Kasei Pharma Corporation Agente terapéutico/profiláctico que contiene PTH para la osteoporosis, caracterizado porque la PTH se administra una vez por semana en una dosis unitaria de 200 unidades
WO2011139838A2 (en) 2010-04-28 2011-11-10 Zelos Therapeutics, Inc. Intranasal formulations
WO2012122535A2 (en) 2011-03-10 2012-09-13 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs
CN108195965B (zh) 2011-06-07 2021-02-23 旭化成制药株式会社 含pth肽冷冻干燥制剂的检査方法及包含该含pth肽冷冻干燥制剂的医药品的制造方法
US20150011473A1 (en) 2012-01-20 2015-01-08 Lupin Limited Stabilized pth formulation
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
HRP20211127T1 (hr) * 2015-10-09 2021-10-15 Radius Health, Inc. Formulacije analoga pthrp, njihovi transdermalni flasteri, i njihova uporaba

Also Published As

Publication number Publication date
CA3075984A1 (en) 2019-03-28
CA3167644A1 (en) 2019-03-28
EP3685850A1 (en) 2020-07-29
JP2020040998A (ja) 2020-03-19
JP6637220B2 (ja) 2020-01-29
WO2019059303A1 (ja) 2019-03-28
JP2021167354A (ja) 2021-10-21
CN111032073A (zh) 2020-04-17
JP2024086815A (ja) 2024-06-28
US20200289622A1 (en) 2020-09-17
EP3685850A4 (en) 2021-06-16
JP2026063281A (ja) 2026-04-10
JP2023082167A (ja) 2023-06-13
JPWO2019059303A1 (ja) 2019-11-14

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