JP6763777B2 - 安定なペプチド製剤、および調製のための方法 - Google Patents

安定なペプチド製剤、および調製のための方法 Download PDF

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JP6763777B2
JP6763777B2 JP2016550716A JP2016550716A JP6763777B2 JP 6763777 B2 JP6763777 B2 JP 6763777B2 JP 2016550716 A JP2016550716 A JP 2016550716A JP 2016550716 A JP2016550716 A JP 2016550716A JP 6763777 B2 JP6763777 B2 JP 6763777B2
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peptide
formulation
aqueous solution
dried
stable
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JP2017505331A5 (enExample
JP2017505331A (ja
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スティーヴン プレストレルスキ
スティーヴン プレストレルスキ
マーティン ドノバン
マーティン ドノバン
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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
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
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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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Biochemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
JP2016550716A 2014-02-06 2015-02-06 安定なペプチド製剤、および調製のための方法 Active JP6763777B2 (ja)

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 (3)

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JP2017505331A JP2017505331A (ja) 2017-02-16
JP2017505331A5 JP2017505331A5 (enExample) 2018-03-15
JP6763777B2 true JP6763777B2 (ja) 2020-09-30

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JP2016550716A Active JP6763777B2 (ja) 2014-02-06 2015-02-06 安定なペプチド製剤、および調製のための方法

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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)

* 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
US9125805B2 (en) 2012-06-27 2015-09-08 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of small molecule drugs
KR102428675B1 (ko) 2014-08-06 2022-08-02 엑스에리스 파머수티클스, 인크. 페이스트의 피내 및／또는 피하 주사를 위한 주사기, 키트, 및 방법
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
JP7217700B2 (ja) 2016-09-13 2023-02-03 アラーガン、インコーポレイテッド 安定化非タンパク質クロストリジウム毒素組成物
CN117085022A (zh) 2017-06-02 2023-11-21 Xeris药物公司 抗沉淀的小分子药物制剂
WO2019126753A1 (en) * 2017-12-22 2019-06-27 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
JPWO2022025093A1 (enExample) * 2020-07-29 2022-02-03
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
EP4398874A1 (en) 2021-09-09 2024-07-17 Xeris Pharmaceuticals, Inc. Injectable high concentration pharmaceutical formulations and methods of manufacturing and use thereof
WO2025089467A1 (ko) * 2023-10-27 2025-05-01 주식회사 엔솔바이오사이언스 염형태 변형 펩타이드의 제조방법 및 그를 이용하여 제조된 펩타이드
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

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5932547A (en) * 1996-07-03 1999-08-03 Alza Corporation Non-aqueous polar aprotic peptide formulations
EP1589901A4 (en) * 2002-12-20 2006-08-09 Generipharm Inc INTRAKUTANE INJECTION
CA2637569C (en) * 2006-01-18 2013-01-08 Yuhua Li Pharmaceutical compositions with enhanced stability
US9084849B2 (en) * 2011-01-26 2015-07-21 Kaleo, Inc. Medicament delivery devices for administration of a medicament within a prefilled syringe
WO2012122535A2 (en) * 2011-03-10 2012-09-13 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs
JP6117811B2 (ja) * 2011-10-31 2017-04-19 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 糖尿病を処置するための製剤
US9522235B2 (en) * 2012-05-22 2016-12-20 Kaleo, Inc. Devices and methods for delivering medicaments from a multi-chamber container

Also Published As

Publication number Publication date
WO2015120231A8 (en) 2015-10-29
WO2015120231A3 (en) 2015-12-23
JP2017505331A (ja) 2017-02-16
US20170007675A1 (en) 2017-01-12
KR102327754B1 (ko) 2021-11-17
KR20160118292A (ko) 2016-10-11
EP3102184A2 (en) 2016-12-14
EP3102184B1 (en) 2019-01-30
WO2015120231A2 (en) 2015-08-13
CN106132430A (zh) 2016-11-16
DK3102184T3 (da) 2019-05-06

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