KR102327754B1 - 안정한 펩티드 제형물 및 제조 방법 - Google Patents

안정한 펩티드 제형물 및 제조 방법 Download PDF

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KR102327754B1
KR102327754B1 KR1020167023950A KR20167023950A KR102327754B1 KR 102327754 B1 KR102327754 B1 KR 102327754B1 KR 1020167023950 A KR1020167023950 A KR 1020167023950A KR 20167023950 A KR20167023950 A KR 20167023950A KR 102327754 B1 KR102327754 B1 KR 102327754B1
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peptide
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KR20160118292A (ko
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스티븐 프리스트릴스키
마틴 도노반
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엑스에리스 파머수티클스, 인크.
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    • 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
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • 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
    • 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
    • A61K38/25—Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
    • 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
    • A61K38/28—Insulins
    • 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
    • A61K38/30—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/20—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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • 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
    • 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
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Reproductive Health (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Biochemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
KR1020167023950A 2014-02-06 2015-02-06 안정한 펩티드 제형물 및 제조 방법 Active KR102327754B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461936675P 2014-02-06 2014-02-06
US61/936,675 2014-02-06
PCT/US2015/014756 WO2015120231A2 (en) 2014-02-06 2015-02-06 Stable peptide formulations and methods for preparation

Publications (2)

Publication Number Publication Date
KR20160118292A KR20160118292A (ko) 2016-10-11
KR102327754B1 true KR102327754B1 (ko) 2021-11-17

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Country Link
US (1) US20170007675A1 (enExample)
EP (1) EP3102184B1 (enExample)
JP (1) JP6763777B2 (enExample)
KR (1) KR102327754B1 (enExample)
CN (1) CN106132430A (enExample)
DK (1) DK3102184T3 (enExample)
WO (1) WO2015120231A2 (enExample)

Families Citing this family (17)

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SG193389A1 (en) 2011-03-10 2013-10-30 Xeris Pharmaceuticals Inc Stable formulations for parenteral injection of peptide drugs
US9125805B2 (en) 2012-06-27 2015-09-08 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of small molecule drugs
JP6982495B2 (ja) 2014-08-06 2021-12-17 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 ペーストの皮内および／または皮下注射のためのシリンジ、キット、および方法
US9649364B2 (en) * 2015-09-25 2017-05-16 Xeris Pharmaceuticals, Inc. Methods for producing stable therapeutic formulations in aprotic polar solvents
US11590205B2 (en) 2015-09-25 2023-02-28 Xeris Pharmaceuticals, Inc. Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
CN117959415A (zh) 2016-09-13 2024-05-03 阿勒根公司 非蛋白质梭菌毒素组合物
US11020403B2 (en) 2017-06-02 2021-06-01 Xeris Pharmaceuticals, Inc. Precipitation resistant small molecule drug formulations
AU2018388417C1 (en) * 2017-12-22 2025-07-10 Xeris Pharmaceuticals, Inc. Treatment of exercise-induced hypoglycemia in type 1 and insulin using type 2 diabetes
CN111936159A (zh) * 2018-01-23 2020-11-13 Xeris药物公司 使用微剂量的稳定胰高血糖素治疗减肥术后低血糖症
KR102146555B1 (ko) * 2018-11-27 2020-08-20 국방과학연구소 탄저균 특이적 항균능을 갖는 약학적 조성물 및 이의 제조방법
WO2022025093A1 (ja) * 2020-07-29 2022-02-03 ブライトパス・バイオ株式会社 がんペプチドワクチンおよびその製造方法
CN112353934B (zh) * 2020-11-23 2023-05-19 中国人民解放军军事科学院军事医学研究院 一种芋螺毒素药物组合物及其冻干制剂
JP2024149926A (ja) * 2021-08-06 2024-10-23 ブライトパス・バイオ株式会社 がんペプチドワクチンカクテル製剤、及びその製造方法
JP2024534963A (ja) 2021-09-09 2024-09-26 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 注射可能な高濃度の薬学的製剤ならびにその製造および使用の方法
WO2025089463A1 (ko) * 2023-10-27 2025-05-01 주식회사 엔솔바이오사이언스 펩타이드 정제방법 및 그를 이용하여 정제된 펩타이드
WO2025089465A1 (ko) * 2023-10-27 2025-05-01 주식회사 엔솔바이오사이언스 펩타이드 제조방법 및 그를 이용하여 제조된 펩타이드
WO2025089467A1 (ko) * 2023-10-27 2025-05-01 주식회사 엔솔바이오사이언스 염형태 변형 펩타이드의 제조방법 및 그를 이용하여 제조된 펩타이드

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012122535A2 (en) 2011-03-10 2012-09-13 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs

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US5932547A (en) * 1996-07-03 1999-08-03 Alza Corporation Non-aqueous polar aprotic peptide formulations
DK2526996T3 (da) * 2002-12-20 2019-12-02 Xeris Pharmaceuticals Inc Formulering til intrakutan injektion
RU2427383C2 (ru) * 2006-01-18 2011-08-27 КьюПиЭс, ЭлЭлСи Фармацевтические композиции с повышенной стабильностью
US9173999B2 (en) * 2011-01-26 2015-11-03 Kaleo, Inc. Devices and methods for delivering medicaments from a multi-chamber container
AU2012332556B2 (en) * 2011-10-31 2016-05-26 Xeris Pharmaceuticals, Inc. Formulations for the treatment of diabetes
US9522235B2 (en) * 2012-05-22 2016-12-20 Kaleo, Inc. Devices and methods for delivering medicaments from a multi-chamber container

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012122535A2 (en) 2011-03-10 2012-09-13 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs
US20120232001A1 (en) * 2011-03-10 2012-09-13 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs

Also Published As

Publication number Publication date
EP3102184A2 (en) 2016-12-14
CN106132430A (zh) 2016-11-16
DK3102184T3 (da) 2019-05-06
WO2015120231A3 (en) 2015-12-23
JP2017505331A (ja) 2017-02-16
WO2015120231A8 (en) 2015-10-29
JP6763777B2 (ja) 2020-09-30
EP3102184B1 (en) 2019-01-30
WO2015120231A2 (en) 2015-08-13
US20170007675A1 (en) 2017-01-12
KR20160118292A (ko) 2016-10-11

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