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 PDFInfo
- 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
- Authority
- 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
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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)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2017182615 | 2017-09-22 | ||
| JP2017-182615 | 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 (enExample) |
| EP (1) | EP3685850A4 (enExample) |
| JP (5) | JP6637220B2 (enExample) |
| CN (1) | CN111032073A (enExample) |
| CA (2) | CA3075984C (enExample) |
| WO (1) | WO2019059303A1 (enExample) |
Cited By (1)
| 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)
| 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 |
Family Cites Families (15)
| 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 |
| EP1301200A2 (en) | 2000-05-19 | 2003-04-16 | Bionebraska, Inc. | Peptide pharmaceutical formulations |
| US7521528B2 (en) * | 2003-01-24 | 2009-04-21 | The General Hospital Corporation | 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 |
| CA2625084A1 (en) * | 2005-10-06 | 2007-04-19 | Nastech Pharmaceutical Company Inc. | Pth formulations and methods of use |
| 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 |
| KR101978527B1 (ko) | 2011-03-10 | 2019-09-03 | 엑스에리스 파머수티클스, 인크. | 펩티드 약물의 비경구 주입을 위한 안정한 제형 |
| ES2761635T3 (es) | 2011-06-07 | 2020-05-20 | Asahi Kasei Pharma Corp | Preparación liofilizada que contiene PTH de alta pureza y método para producirla |
| AU2013210689A1 (en) | 2012-01-20 | 2014-07-31 | 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 |
| SMT202100411T1 (it) * | 2015-10-09 | 2021-11-12 | Radius Health Inc | Formulazioni di analoghi di pthrp, loro cerotti transdermici, e loro usi |
-
2018
- 2018-09-20 US US16/649,325 patent/US20200289622A1/en active Pending
- 2018-09-20 CN CN201880053861.2A patent/CN111032073A/zh active Pending
- 2018-09-20 EP EP18859527.6A patent/EP3685850A4/en active Pending
- 2018-09-20 CA CA3075984A patent/CA3075984C/en active Active
- 2018-09-20 CA CA3167644A patent/CA3167644A1/en active Pending
- 2018-09-20 WO PCT/JP2018/034889 patent/WO2019059303A1/ja not_active Ceased
- 2018-09-20 JP JP2019516021A patent/JP6637220B2/ja active Active
-
2019
- 2019-12-19 JP JP2019229592A patent/JP2020040998A/ja active Pending
-
2021
- 2021-07-27 JP JP2021122390A patent/JP2021167354A/ja active Pending
-
2023
- 2023-04-04 JP JP2023060783A patent/JP2023082167A/ja active Pending
-
2024
- 2024-04-08 JP JP2024062188A patent/JP2024086815A/ja active Pending
Patent Citations (7)
| 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)
| 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)
| 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 |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2020040998A (ja) | 2020-03-19 |
| JPWO2019059303A1 (ja) | 2019-11-14 |
| CA3075984C (en) | 2024-10-01 |
| EP3685850A4 (en) | 2021-06-16 |
| JP2021167354A (ja) | 2021-10-21 |
| JP2023082167A (ja) | 2023-06-13 |
| EP3685850A1 (en) | 2020-07-29 |
| JP2024086815A (ja) | 2024-06-28 |
| CA3167644A1 (en) | 2019-03-28 |
| US20200289622A1 (en) | 2020-09-17 |
| WO2019059303A1 (ja) | 2019-03-28 |
| CA3075984A1 (en) | 2019-03-28 |
| JP6637220B2 (ja) | 2020-01-29 |
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