JP6637220B2 - 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 - Google Patents

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 Download PDF

Info

Publication number
JP6637220B2
JP6637220B2 JP2019516021A JP2019516021A JP6637220B2 JP 6637220 B2 JP6637220 B2 JP 6637220B2 JP 2019516021 A JP2019516021 A JP 2019516021A JP 2019516021 A JP2019516021 A JP 2019516021A JP 6637220 B2 JP6637220 B2 JP 6637220B2
Authority
JP
Japan
Prior art keywords
liquid pharmaceutical
component
teriparatide
pharmaceutical preparation
less
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
JP2019516021A
Other languages
English (en)
Japanese (ja)
Other versions
JPWO2019059303A1 (ja
Inventor
康平 宮部
康平 宮部
淳 尾瀬
淳 尾瀬
佐藤　友紀
友紀 佐藤
俊幸 児玉
俊幸 児玉
保宏 松縄
保宏 松縄
山本　光
光 山本
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
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 JPWO2019059303A1 publication Critical patent/JPWO2019059303A1/ja
Application granted granted Critical
Publication of JP6637220B2 publication Critical patent/JP6637220B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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

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)
JP2019516021A 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 Active JP6637220B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2017182615 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
JP2019229592A Division JP2020040998A (ja) 2017-09-22 2019-12-19 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 (2)

Publication Number Publication Date
JPWO2019059303A1 JPWO2019059303A1 (ja) 2019-11-14
JP6637220B2 true JP6637220B2 (ja) 2020-01-29

Family

ID=65811294

Family Applications (6)

Application Number Title Priority Date Filing Date
JP2019516021A Active JP6637220B2 (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
JP2019229592A Pending JP2020040998A (ja) 2017-09-22 2019-12-19 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
JP2021122390A Pending JP2021167354A (ja) 2017-09-22 2021-07-27 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
JP2023060783A Pending JP2023082167A (ja) 2017-09-22 2023-04-04 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
JP2024062188A Pending JP2024086815A (ja) 2017-09-22 2024-04-08 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
JP2026007473A Pending JP2026063281A (ja) 2017-09-22 2026-01-20 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

Family Applications After (5)

Application Number Title Priority Date Filing Date
JP2019229592A Pending JP2020040998A (ja) 2017-09-22 2019-12-19 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
JP2021122390A Pending JP2021167354A (ja) 2017-09-22 2021-07-27 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
JP2023060783A Pending JP2023082167A (ja) 2017-09-22 2023-04-04 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
JP2024062188A Pending JP2024086815A (ja) 2017-09-22 2024-04-08 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
JP2026007473A Pending JP2026063281A (ja) 2017-09-22 2026-01-20 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

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=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

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.
AU785444B2 (en) 2000-05-19 2007-06-14 Jefferson Pharmaceuticals, Llc 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
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
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
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
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
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.

Also Published As

Publication number Publication date
JP2020040998A (ja) 2020-03-19
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
CN111032073A (zh) 2020-04-17

Similar Documents

Publication Publication Date Title
JP2025102837A (ja) Ｇｉｐ／ｇｌｐ１アゴニスト組成物
Rossignol et al. Antagonism of in vivo and ex vivo response to endotoxin by E5564, a synthetic lipid A analogue
RU2733464C2 (ru) Препараты tpp1 и способы лечения заболевания cln2
BRPI1014760B1 (pt) Preparação compreendendo insulina, nicotinamida e arginina
EA026712B1 (ru) Применение ингибитора sglt2
CN109069595A (zh) 标靶医疗性溶酶体酵素融合蛋白质、其相关调配物与用途
CA2585482C (en) Treatment of short bowel syndrome patients with colon-in-continuity
KR20140030125A (ko) 인슐린, 니코틴아미드 및 아미노산을 포함하는 제제
JP2009024026A (ja) 血管形成的に有効なｆｇｆ−２の単位用量および使用方法
BR112020001101A2 (pt) composição farmacêutica do complexo de proteína il-15 e usos da mesma
JP2026063281A (ja) 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
CA3201847A1 (en) Pharmaceutical composition comprising frataxin fusion protein and methods of use thereof
JP2023166014A (ja) コラーゲン７組成物及びそれを用いる方法
CN113440599A (zh) MOTS-c肽及其衍生物在制备妊娠期糖尿病治疗药物中的应用
BR112021009225A2 (pt) Análogos de gdf15 e métodos para uso na diminuição do peso corporal e/ou na redução da ingestão de alimentos
CN108434439B (zh) 钙网蛋白的医药用途
JP2002524420A (ja) 脈管形成に有効な単位用量のｆｇｆ−２および使用方法
JP2026500069A (ja) ＡｃｔＲＩＩＡタンパク質変異体を含む製剤
US9610324B2 (en) Apolipoprotein mixtures
EP3630166A1 (en) Rapid-acting insulin compositions
AU763575B2 (en) Use of soluble tumor necrosis factor receptor for treatment heart failure
HK40017160A (en) Teriparatide-containing liquid pharmaceutical composition having excellent pharmacodynamics and/or stability
EP3539561A1 (en) Therapeutic agent for cerebral infarction
Haider Insulin and Insulin Treatment
AU2023409566A1 (en) Novel solutions

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20190322

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20190322

A975 Report on accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A971005

Effective date: 20190411

RD02 Notification of acceptance of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7422

Effective date: 20190411

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20190417

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190528

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190723

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190801

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190925

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20191129

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20191219

R150 Certificate of patent or registration of utility model

Ref document number: 6637220

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150