CN111032073A - 药物动力学和/或安全性优异的含有特立帕肽的液态药物组合物 - Google Patents

药物动力学和/或安全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
CN111032073A
CN111032073A CN201880053861.2A CN201880053861A CN111032073A CN 111032073 A CN111032073 A CN 111032073A CN 201880053861 A CN201880053861 A CN 201880053861A CN 111032073 A CN111032073 A CN 111032073A
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CN
China
Prior art keywords
liquid pharmaceutical
pharmaceutical preparation
component
formulation
teriparatide
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.)
Pending
Application number
CN201880053861.2A
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English (en)
Chinese (zh)
Inventor
宫部康平
尾濑淳
佐藤友纪
儿玉俊幸
松绳保宏
山本光
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Asahi Kasei Pharma Corp
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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 CN111032073A publication Critical patent/CN111032073A/zh
Pending legal-status Critical Current

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    • 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
    • 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
    • A61K9/08—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

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  • 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)
CN201880053861.2A 2017-09-22 2018-09-20 药物动力学和/或安全性优异的含有特立帕肽的液态药物组合物 Pending CN111032073A (zh)

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

Publications (1)

Publication Number Publication Date
CN111032073A true CN111032073A (zh) 2020-04-17

Family

ID=65811294

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201880053861.2A Pending CN111032073A (zh) 2017-09-22 2018-09-20 药物动力学和/或安全性优异的含有特立帕肽的液态药物组合物

Country Status (6)

Country Link
US (1) US20200289622A1 (https=)
EP (1) EP3685850A4 (https=)
JP (6) JP6637220B2 (https=)
CN (1) CN111032073A (https=)
CA (2) CA3167644A1 (https=)
WO (1) WO2019059303A1 (https=)

Cited By (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

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05306235A (ja) * 1991-12-09 1993-11-19 Asahi Chem Ind Co Ltd パラサイロイドホルモン類の安定化組成物
JPH0873376A (ja) * 1994-09-07 1996-03-19 Asahi Chem Ind Co Ltd 骨粗鬆症治療薬
CN1281370A (zh) * 1997-12-09 2001-01-24 伊莱利利公司 稳定的特立帕肽溶液
JP2003095974A (ja) * 2001-09-27 2003-04-03 Asahi Kasei Corp 骨形成を安全に促進させる医薬複合剤
JP2004010511A (ja) * 2002-06-05 2004-01-15 Asahi Kasei Corp Ｐｔｈの安定化水溶液注射剤
CN102470164A (zh) * 2009-09-09 2012-05-23 旭化成制药株式会社 以每周给药1次每次为100单位～200单位的pth为特征的、含有pth的骨质疏松症治疗/预防剂
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

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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
AU785444B2 (en) 2000-05-19 2007-06-14 Jefferson Pharmaceuticals, Llc Peptide pharmaceutical formulations
AU2003217243A1 (en) * 2003-01-24 2004-08-23 Thomas J. Gardella 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
CN101022822B (zh) 2004-08-24 2012-06-27 第一三共株式会社 生理学活性肽的液体制剂
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
JP2010501476A (ja) * 2006-07-31 2010-01-21 ゼロス セラピューティクス， インコーポレイテッド 副甲状腺ホルモン類似体およびその使用方法
WO2011139838A2 (en) 2010-04-28 2011-11-10 Zelos Therapeutics, Inc. Intranasal formulations
EP2683364B1 (en) 2011-03-10 2017-01-18 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs
WO2012169435A1 (ja) 2011-06-07 2012-12-13 旭化成ファーマ株式会社 高純度ｐｔｈ含有凍結乾燥製剤およびその製造方法
WO2013108235A1 (en) 2012-01-20 2013-07-25 Lupin Limited Stabilized pth formulation
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
MX2018004192A (es) * 2015-10-09 2018-09-26 Radius Health Inc Formulaciones de análogos de proteína relacionada con la hormona paratiroidea (pthrp), parches transdérmicos de las mismas y usos de las mismas.

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05306235A (ja) * 1991-12-09 1993-11-19 Asahi Chem Ind Co Ltd パラサイロイドホルモン類の安定化組成物
JPH0873376A (ja) * 1994-09-07 1996-03-19 Asahi Chem Ind Co Ltd 骨粗鬆症治療薬
CN1281370A (zh) * 1997-12-09 2001-01-24 伊莱利利公司 稳定的特立帕肽溶液
JP2003095974A (ja) * 2001-09-27 2003-04-03 Asahi Kasei Corp 骨形成を安全に促進させる医薬複合剤
JP2004010511A (ja) * 2002-06-05 2004-01-15 Asahi Kasei Corp Ｐｔｈの安定化水溶液注射剤
CN102470164A (zh) * 2009-09-09 2012-05-23 旭化成制药株式会社 以每周给药1次每次为100单位～200单位的pth为特征的、含有pth的骨质疏松症治疗/预防剂
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

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
M.SHIRAKI.T等: "Effects of a single injection of teriparatide on bone turnovermarkers in postmenopausal women", 《OSTEOPOROS INT》 *
M.SHIRAKI.T等: "Effects of a single injection of teriparatide on bone turnovermarkers in postmenopausal women", 《OSTEOPOROS INT》, vol. 24, no. 1, 24 October 2012 (2012-10-24), pages 219 - 226, XP035158413, DOI: 10.1007/s00198-012-2159-7 *

Cited By (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

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JP2020040998A (ja) 2020-03-19
JP6637220B2 (ja) 2020-01-29
CA3075984A1 (en) 2019-03-28
US20200289622A1 (en) 2020-09-17
JP2021167354A (ja) 2021-10-21
JP2023082167A (ja) 2023-06-13
CA3075984C (en) 2024-10-01
EP3685850A1 (en) 2020-07-29
EP3685850A4 (en) 2021-06-16
JPWO2019059303A1 (ja) 2019-11-14
JP2026063281A (ja) 2026-04-10
CA3167644A1 (en) 2019-03-28
JP2024086815A (ja) 2024-06-28
WO2019059303A1 (ja) 2019-03-28

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