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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glp
buffer
concentration
acetate
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JP2022502432A (ja
JPWO2020065064A5 (enExample
Inventor
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, 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)
  • 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)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Dermatology (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)
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)

Application Number Title Priority Date Filing Date
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

Publications (3)

Publication Number Publication Date
JP2022502432A JP2022502432A (ja) 2022-01-11
JPWO2020065064A5 JPWO2020065064A5 (enExample) 2022-09-13
JP7566730B2 true JP7566730B2 (ja) 2024-10-15

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JP2021517294A Active JP7566730B2 (ja) 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
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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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

Country Status (13)

Country Link
US (2) US20220265551A1 (enExample)
EP (2) EP3628683A1 (enExample)
JP (2) JP7566730B2 (enExample)
KR (1) KR20210069056A (enExample)
CN (3) CN112771073B (enExample)
AU (1) AU2019348538B2 (enExample)
BR (1) BR112021005858A2 (enExample)
CA (1) CA3114330A1 (enExample)
CL (1) CL2021000678A1 (enExample)
IL (1) IL281362A (enExample)
MX (1) MX2021003271A (enExample)
SG (1) SG11202102383VA (enExample)
WO (1) WO2020065064A1 (enExample)

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ES2894629T3 (es) 2017-06-16 2022-02-15 Zealand Pharma As Pautas posológicas para la administración de análogos del péptido 2 similar al glucagón (GLP-2)
CA3179472A1 (en) * 2020-05-22 2021-11-25 Sung Hee Hong Liquid formulation of long-acting conjugate of glp-2
WO2022129142A1 (en) * 2020-12-16 2022-06-23 Zealand Pharma A/S Use of glp-2 analogues in patients with renal insufficiency
CA3231402A1 (en) * 2021-09-10 2023-03-16 Eva Horn Moller 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
IL319890A (en) 2022-09-30 2025-05-01 Zealand Pharma As Glucagon-like peptide-2 (GLP-2) analogs and their medical uses for the treatment of short bowel syndrome (SBS)
WO2024075135A1 (en) * 2022-10-03 2024-04-11 Orbicular Pharmaceutical Technologies Private Limited "stable injectable compositions of glp-2 peptide"
AU2024212236A1 (en) 2023-01-27 2025-08-28 Zealand Pharma A/S Glucagon-like-peptide-2 (glp-2) analogues 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

Citations (1)

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JP2008539713A (ja) 2005-05-04 2008-11-20 ジーランド ファーマ アクティーゼルスカブ グルカゴン様ペプチド−２（ｇｌｐ−２）アナログ

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US6184201B1 (en) 1995-04-14 2001-02-06 Nps Allelix Corp. Intestinotrophic glucagon-like peptide-2 analogs
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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
US7112567B2 (en) 2001-02-16 2006-09-26 Conjuchem Inc. Long lasting glucagon-like peptide 2 (glp-2) for the treatment of gastrointestinal diseases and disorders
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US20090028832A1 (en) * 2006-08-10 2009-01-29 Chung Leland F Compositions and methods for targeted tumor therapy
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Also Published As

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

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