KR20260008798A - 글루카곤-유사 펩타이드 2 (glp-2) 유사체의 제형 - Google Patents

글루카곤-유사 펩타이드 2 (glp-2) 유사체의 제형

Info

Publication number
KR20260008798A
KR20260008798A KR1020257041229A KR20257041229A KR20260008798A KR 20260008798 A KR20260008798 A KR 20260008798A KR 1020257041229 A KR1020257041229 A KR 1020257041229A KR 20257041229 A KR20257041229 A KR 20257041229A KR 20260008798 A KR20260008798 A KR 20260008798A
Authority
KR
South Korea
Prior art keywords
formulation
glp
analogue
buffer
concentration
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
Application number
KR1020257041229A
Other languages
English (en)
Korean (ko)
Inventor
리자 이헴
클러스 밀란더
이바 혼 몰러
Original Assignee
질랜드 파마 에이/에스
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by 질랜드 파마 에이/에스 filed Critical 질랜드 파마 에이/에스
Publication of KR20260008798A publication Critical patent/KR20260008798A/ko
Pending legal-status Critical Current

Links

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
    • A61K9/08—Solutions
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/16—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
    • 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
    • A61K47/16—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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012—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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
KR1020257041229A 2018-09-28 2019-09-27 글루카곤-유사 펩타이드 2 (glp-2) 유사체의 제형 Pending KR20260008798A (ko)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP18197755.4 2018-09-28
EP18197755.4A EP3628683A1 (en) 2018-09-28 2018-09-28 Formulations of glucagon-like-peptide-2 (glp-2) analogues
KR1020217010775A KR20210069056A (ko) 2018-09-28 2019-09-27 글루카곤-유사 펩타이드 2 (glp-2) 유사체의 제형
PCT/EP2019/076305 WO2020065064A1 (en) 2018-09-28 2019-09-27 Formulations of glucagon-like-peptide-2 (glp-2) analogues

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020217010775A Division KR20210069056A (ko) 2018-09-28 2019-09-27 글루카곤-유사 펩타이드 2 (glp-2) 유사체의 제형

Publications (1)

Publication Number Publication Date
KR20260008798A true KR20260008798A (ko) 2026-01-16

Family

ID=63794308

Family Applications (2)

Application Number Title Priority Date Filing Date
KR1020257041229A Pending KR20260008798A (ko) 2018-09-28 2019-09-27 글루카곤-유사 펩타이드 2 (glp-2) 유사체의 제형
KR1020217010775A Ceased KR20210069056A (ko) 2018-09-28 2019-09-27 글루카곤-유사 펩타이드 2 (glp-2) 유사체의 제형

Family Applications After (1)

Application Number Title Priority Date Filing Date
KR1020217010775A Ceased KR20210069056A (ko) 2018-09-28 2019-09-27 글루카곤-유사 펩타이드 2 (glp-2) 유사체의 제형

Country Status (14)

Country Link
US (2) US20220265551A1 (https=)
EP (2) EP3628683A1 (https=)
JP (2) JP7566730B2 (https=)
KR (2) KR20260008798A (https=)
CN (3) CN112771073B (https=)
AU (1) AU2019348538B2 (https=)
BR (1) BR112021005858A2 (https=)
CA (1) CA3114330A1 (https=)
CL (1) CL2021000678A1 (https=)
IL (1) IL281362B1 (https=)
MX (2) MX2021003271A (https=)
NZ (1) NZ775113A (https=)
SG (1) SG11202102383VA (https=)
WO (1) WO2020065064A1 (https=)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL299864B2 (en) 2017-06-16 2024-06-01 Zealand Pharma As Dosage regimes for the administration of glucagon-like-peptide-2 (glp-2) analogues
MX2022014671A (es) * 2020-05-22 2023-02-13 Hanmi Pharm Ind Co Ltd Formulacion liquida de conjugado de glp-2 de accion prolongada.
MX2023006901A (es) * 2020-12-16 2023-06-26 Zealand Pharma As Uso de analogos de glp-2 en pacientes con insuficiencia renal.
RS67423B1 (sr) * 2021-09-10 2025-12-31 Zealand Pharma As Postupak za formulisanje sastava koji sadrže analoge glukagonu sličnog peptida-2 (glp-2)
IL313732A (en) 2021-12-23 2024-08-01 Zealand Pharma As Processes for synthesizing glucagon-like-peptide 2 (glp-2) analogues
KR20250075601A (ko) 2022-09-30 2025-05-28 질랜드 파마 에이/에스 글루카곤-유사-펩타이드-2(glp-2) 유사체 및 단장 증후군(sbs) 치료를 위한 이의 의학적 용도
US20240415933A1 (en) * 2022-10-03 2024-12-19 Orbicular Pharmaceutical Technologies Private Limited Stable injectable compositions of glp-2 peptide
IL322328A (en) 2023-01-27 2025-09-01 Zealand Pharma As Glucagon-like peptide-2 (GLP-2) analogs and their medical uses for the treatment of short bowel syndrome (SBS)
TW202535919A (zh) 2023-12-28 2025-09-16 丹麥商西蘭製藥公司 類升糖素肽2(glp-2)類似物之調配物及其用途

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HU225496B1 (en) * 1993-04-07 2007-01-29 Scios Inc Pharmaceutical compositions of prolonged delivery, containing peptides
US5789379A (en) 1995-04-14 1998-08-04 Allelix Biopharmaceutical Inc. Glucagon-like peptide-2 analogs
US6184201B1 (en) 1995-04-14 2001-02-06 Nps Allelix Corp. Intestinotrophic glucagon-like peptide-2 analogs
EP1231219B1 (en) 1996-04-12 2010-08-25 1149336 Ontario Inc. GLucagon-like peptide-2 analogs
EP1076066A1 (en) 1999-07-12 2001-02-14 Zealand Pharmaceuticals A/S Peptides for lowering blood glucose levels
AU2020501A (en) 1999-12-08 2001-06-18 1149336 Ontario Inc. Chemotherapy treatment
GB9930882D0 (en) 1999-12-30 2000-02-23 Nps Allelix Corp GLP-2 formulations
DK1360202T3 (da) 2001-02-16 2008-09-22 Conjuchem Biotechnologies Inc Langvarigt glucagon-lignende peptid 2 (GLP-2) til behandling af gastrointestinale sygdomme og lidelser
ES2336826T3 (es) * 2005-05-03 2010-04-16 Novetide, Ltd. Procedimientos para la produccion de un peptido que presenta una amida c-terminal.
UA95235C2 (en) * 2005-05-04 2011-07-25 Зииланд Фарма А/С Glucagon-like-peptide-2 (glp-2) analogues
CN101341254A (zh) * 2005-12-24 2009-01-07 蒂加斯克乳制品研究中心 反-10，顺-12十八碳二烯酸的生产方法
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KR20130115086A (ko) * 2010-05-17 2013-10-21 세빅스 인코포레이티드 페길화된 c-펩티드
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Also Published As

Publication number Publication date
NZ775113A (en) 2026-01-30
CA3114330A1 (en) 2020-04-02
JP7738136B2 (ja) 2025-09-11
JP2022502432A (ja) 2022-01-11
CN118267455A (zh) 2024-07-02
CN120204366A (zh) 2025-06-27
KR20210069056A (ko) 2021-06-10
WO2020065064A1 (en) 2020-04-02
CN112771073B (zh) 2025-07-01
MX2021003271A (es) 2021-05-12
MX2026000859A (es) 2026-03-02
CN112771073A (zh) 2021-05-07
JP7566730B2 (ja) 2024-10-15
EP3856766A1 (en) 2021-08-04
JP2024156754A (ja) 2024-11-06
AU2019348538A1 (en) 2021-05-20
BR112021005858A2 (pt) 2021-07-27
SG11202102383VA (en) 2021-04-29
US20240065978A1 (en) 2024-02-29
EP3628683A1 (en) 2020-04-01
IL281362A (en) 2021-04-29
US20220265551A1 (en) 2022-08-25
IL281362B1 (en) 2026-03-01
AU2019348538B2 (en) 2025-04-03
CL2021000678A1 (es) 2021-08-06

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