JP7566730B2 - グルカゴン様ペプチド－２（ｇｌｐ－２）類似体の製剤 - Google Patents

グルカゴン様ペプチド－２（ｇｌｐ－２）類似体の製剤 Download PDF

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JP7566730B2
JP7566730B2 JP2021517294A JP2021517294A JP7566730B2 JP 7566730 B2 JP7566730 B2 JP 7566730B2 JP 2021517294 A JP2021517294 A JP 2021517294A JP 2021517294 A JP2021517294 A JP 2021517294A JP 7566730 B2 JP7566730 B2 JP 7566730B2
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formulation
glp
buffer
concentration
acetate
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JP2022502432A5 (cg-RX-API-DMAC10.html
JP2022502432A (ja
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ギエーム，リセ
メランデル，セラエス
ムーレール，エバ・ホルン
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ジーランド・ファルマ・アー／エス
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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
    • 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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2021517294A 2018-09-28 2019-09-27 グルカゴン様ペプチド－２（ｇｌｐ－２）類似体の製剤 Active JP7566730B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024120747A JP7738136B2 (ja) 2018-09-28 2024-07-26 グルカゴン様ペプチド－２（ｇｌｐ－２）類似体の製剤

Applications Claiming Priority (3)

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

Related Child Applications (1)

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JP2024120747A Division JP7738136B2 (ja) 2018-09-28 2024-07-26 グルカゴン様ペプチド－２（ｇｌｐ－２）類似体の製剤

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JP2022502432A JP2022502432A (ja) 2022-01-11
JP2022502432A5 JP2022502432A5 (cg-RX-API-DMAC10.html) 2022-09-13
JP7566730B2 true JP7566730B2 (ja) 2024-10-15

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JP2024120747A Active JP7738136B2 (ja) 2018-09-28 2024-07-26 グルカゴン様ペプチド－２（ｇｌｐ－２）類似体の製剤

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Country Link
US (2) US20220265551A1 (cg-RX-API-DMAC10.html)
EP (2) EP3628683A1 (cg-RX-API-DMAC10.html)
JP (2) JP7566730B2 (cg-RX-API-DMAC10.html)
KR (2) KR20260008798A (cg-RX-API-DMAC10.html)
CN (3) CN118267455A (cg-RX-API-DMAC10.html)
AU (1) AU2019348538B2 (cg-RX-API-DMAC10.html)
BR (1) BR112021005858A2 (cg-RX-API-DMAC10.html)
CA (1) CA3114330A1 (cg-RX-API-DMAC10.html)
CL (1) CL2021000678A1 (cg-RX-API-DMAC10.html)
IL (1) IL281362B2 (cg-RX-API-DMAC10.html)
MX (2) MX2021003271A (cg-RX-API-DMAC10.html)
SG (1) SG11202102383VA (cg-RX-API-DMAC10.html)
WO (1) WO2020065064A1 (cg-RX-API-DMAC10.html)

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Publication number Priority date Publication date Assignee Title
IL271245B2 (en) 2017-06-16 2023-10-01 Zealand Pharma As Dosing regimen for administration of glucagon-like peptide analog (GLP-2) 2
IL298298A (en) * 2020-05-22 2023-01-01 Hanmi Pharm Ind Co Ltd A liquid formulation of a long-acting conjugate of glp–2
MX2023006901A (es) * 2020-12-16 2023-06-26 Zealand Pharma As Uso de analogos de glp-2 en pacientes con insuficiencia renal.
WO2023036862A1 (en) * 2021-09-10 2023-03-16 Zealand Pharma A/S Process for formulating compositions comprising glucagon-like-peptide-2 (glp-2) analogues
WO2023118416A1 (en) 2021-12-23 2023-06-29 Zealand Pharma A/S 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
WO2024075135A1 (en) * 2022-10-03 2024-04-11 Orbicular Pharmaceutical Technologies Private Limited "stable injectable compositions of glp-2 peptide"
TW202436330A (zh) 2023-01-27 2024-09-16 丹麥商西蘭製藥公司 類升糖素胜肽-2(glp-2)類似物及其用於治療短腸症候群(sbs)之醫藥用途
WO2025141129A1 (en) 2023-12-28 2025-07-03 Zealand Pharma A/S Formulations of glucagon-like-peptide 2 (glp-2) analogues and their uses

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Also Published As

Publication number Publication date
NZ775113A (en) 2026-01-30
EP3628683A1 (en) 2020-04-01
JP2024156754A (ja) 2024-11-06
EP3856766B1 (en) 2026-08-12
MX2021003271A (es) 2021-05-12
KR20260008798A (ko) 2026-01-16
WO2020065064A1 (en) 2020-04-02
BR112021005858A2 (pt) 2021-07-27
CA3114330A1 (en) 2020-04-02
CN112771073B (zh) 2025-07-01
CN112771073A (zh) 2021-05-07
CN118267455A (zh) 2024-07-02
US20240065978A1 (en) 2024-02-29
JP2022502432A (ja) 2022-01-11
CL2021000678A1 (es) 2021-08-06
EP3856766A1 (en) 2021-08-04
IL281362B2 (en) 2026-07-01
MX2026000859A (es) 2026-03-02
SG11202102383VA (en) 2021-04-29
JP7738136B2 (ja) 2025-09-11
CN120204366A (zh) 2025-06-27
AU2019348538A1 (en) 2021-05-20
US20220265551A1 (en) 2022-08-25
AU2019348538B2 (en) 2025-04-03
IL281362B1 (en) 2026-03-01
IL281362A (en) 2021-04-29
KR20210069056A (ko) 2021-06-10

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