CN108135980B - 在非质子极性溶剂中制备稳定的胰高血糖素治疗制剂的方法 - Google Patents

在非质子极性溶剂中制备稳定的胰高血糖素治疗制剂的方法 Download PDF

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CN108135980B
CN108135980B CN201680056000.0A CN201680056000A CN108135980B CN 108135980 B CN108135980 B CN 108135980B CN 201680056000 A CN201680056000 A CN 201680056000A CN 108135980 B CN108135980 B CN 108135980B
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glucagon
formulation
peptide
aprotic polar
polar solvent
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CN108135980A (zh
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史蒂文·普莱斯特斯基
马丁·多诺万
迈克尔·桑多瓦尔
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Xeris Pharmaceuticals Inc
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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    • 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
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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CN201680056000.0A 2015-09-25 2016-09-25 在非质子极性溶剂中制备稳定的胰高血糖素治疗制剂的方法 Active CN108135980B (zh)

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CN202211268333.3A CN115531523A (zh) 2015-09-25 2016-09-25 在非质子极性溶剂中制备稳定的普兰林肽治疗制剂的方法

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US201562233032P 2015-09-25 2015-09-25
US62/233,032 2015-09-25
US15/136,650 2016-04-22
US15/136,650 US9649364B2 (en) 2015-09-25 2016-04-22 Methods for producing stable therapeutic formulations in aprotic polar solvents
PCT/US2016/053628 WO2017053922A1 (en) 2015-09-25 2016-09-25 Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents

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CN202211268333.3A Pending CN115531523A (zh) 2015-09-25 2016-09-25 在非质子极性溶剂中制备稳定的普兰林肽治疗制剂的方法

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EP (2) EP4327804B1 (https=)
JP (1) JP6835831B2 (https=)
KR (2) KR102769685B1 (https=)
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AU (1) AU2016326749B2 (https=)
CA (2) CA3204984A1 (https=)
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AU2020284104B2 (en) * 2019-05-31 2025-02-27 Xeris Pharmaceuticals, Inc. Stable therapeutic compositions in aprotic polar solvents and methods of manufacturing the same
CN112807281A (zh) * 2019-10-31 2021-05-18 南京海维医药科技有限公司 包含血管紧张素ii的稳定组合物及其制备方法、使用方法
IL299337A (en) * 2020-06-26 2023-02-01 Xeris Pharmaceuticals Inc Pharmaceutical compounds with stable sustained release in polar aprotic solvents and methods of making them
US12128089B2 (en) * 2022-05-26 2024-10-29 Slayback Pharma Llc Stable liquid compositions of glucagon
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JP2025535354A (ja) 2022-10-19 2025-10-24 ゼリス ファーマシューティカルズ インコーポレイテッド 非プロトン性極性溶媒中の安定なレボチロキシン組成物
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