DK3102184T3 - Stabile formuleringer af peptider og fremgangsmåder til fremstilling - Google Patents

Stabile formuleringer af peptider og fremgangsmåder til fremstilling Download PDF

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Publication number
DK3102184T3
DK3102184T3 DK15706976.6T DK15706976T DK3102184T3 DK 3102184 T3 DK3102184 T3 DK 3102184T3 DK 15706976 T DK15706976 T DK 15706976T DK 3102184 T3 DK3102184 T3 DK 3102184T3
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DK
Denmark
Prior art keywords
peptides
procedures
preparation
stable formulations
formulations
Prior art date
Application number
DK15706976.6T
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English (en)
Inventor
Steven Prestrelski
Martin Donovan
Original Assignee
Xeris Pharmaceuticals Inc
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Filing date
Publication date
Application filed by Xeris Pharmaceuticals Inc filed Critical Xeris Pharmaceuticals Inc
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Publication of DK3102184T3 publication Critical patent/DK3102184T3/da

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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
    • A61K38/04—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
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (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)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (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)
DK15706976.6T 2014-02-06 2015-02-06 Stabile formuleringer af peptider og fremgangsmåder til fremstilling DK3102184T3 (da)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
DK3102184T3 true DK3102184T3 (da) 2019-05-06

Family

ID=52595433

Family Applications (1)

Application Number Title Priority Date Filing Date
DK15706976.6T DK3102184T3 (da) 2014-02-06 2015-02-06 Stabile formuleringer af peptider og fremgangsmåder til fremstilling

Country Status (7)

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

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CA2957399C (en) 2014-08-06 2023-09-26 Xeris Pharmaceuticals, Inc. Syringes, kits, and methods for intracutaneous and/or subcutaneous injection of pastes
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
CN109803672A (zh) 2016-09-13 2019-05-24 阿勒根公司 稳定的非蛋白质梭菌毒素组合物
WO2018222922A1 (en) 2017-06-02 2018-12-06 Xeris Pharmaceuticals, Inc. Precipitation resistant small molecule drug formulations
KR20200103029A (ko) * 2017-12-22 2020-09-01 엑스에리스 파머수티클스, 인크. 1 형 당뇨병 및 인슐린을 사용하는 2 형 당뇨병에서 운동-유발성 저혈당증의 치료
KR20200134213A (ko) 2018-01-23 2020-12-01 엑스에리스 파머수티클스, 인크. 소 용량의 안정한 글루카곤을 사용한 베리아트릭 후 저혈당증의 치료
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
WO2023013755A1 (ja) * 2021-08-06 2023-02-09 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
KR20240057428A (ko) 2021-09-09 2024-05-02 엑스에리스 파머수티클스, 인크. 주사 가능한 고농도 약제학적 제형 및 이의 제조 및 사용 방법

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
EP2526996B1 (en) * 2002-12-20 2019-09-11 Xeris Pharmaceuticals, Inc. Formulation for intracutaneous injection
WO2007084460A2 (en) * 2006-01-18 2007-07-26 Qps, Llc 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
SG193389A1 (en) * 2011-03-10 2013-10-30 Xeris Pharmaceuticals Inc Stable formulations for parenteral injection of peptide drugs
CN103930096B (zh) * 2011-10-31 2017-05-31 Xeris药物公司 用于治疗糖尿病的制剂
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
WO2015120231A3 (en) 2015-12-23
KR20160118292A (ko) 2016-10-11
US20170007675A1 (en) 2017-01-12
WO2015120231A8 (en) 2015-10-29
JP2017505331A (ja) 2017-02-16
EP3102184A2 (en) 2016-12-14
WO2015120231A2 (en) 2015-08-13
EP3102184B1 (en) 2019-01-30
JP6763777B2 (ja) 2020-09-30
KR102327754B1 (ko) 2021-11-17
CN106132430A (zh) 2016-11-16

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