CN118267455A - 胰高血糖素样肽2（glp-2）类似物的制剂 - Google Patents

胰高血糖素样肽2（glp-2）类似物的制剂 Download PDF

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Publication number
CN118267455A
CN118267455A CN202410277209.6A CN202410277209A CN118267455A CN 118267455 A CN118267455 A CN 118267455A CN 202410277209 A CN202410277209 A CN 202410277209A CN 118267455 A CN118267455 A CN 118267455A
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CN
China
Prior art keywords
formulation
glp
buffer
concentration
analog
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Pending
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CN202410277209.6A
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English (en)
Chinese (zh)
Inventor
利塞·吉姆
克拉斯·梅兰德
埃娃·霍恩·默勒
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Zealand Pharma AS
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Zealand Pharma AS
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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)
CN202410277209.6A 2018-09-28 2019-09-27 胰高血糖素样肽2（glp-2）类似物的制剂 Pending CN118267455A (zh)

Applications Claiming Priority (4)

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
CN201980063594.1A CN112771073B (zh) 2018-09-28 2019-09-27 胰高血糖素样肽2(glp-2)类似物的制剂

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201980063594.1A Division CN112771073B (zh) 2018-09-28 2019-09-27 胰高血糖素样肽2(glp-2)类似物的制剂

Publications (1)

Publication Number Publication Date
CN118267455A true CN118267455A (zh) 2024-07-02

Family

ID=63794308

Family Applications (3)

Application Number Title Priority Date Filing Date
CN202410277209.6A Pending CN118267455A (zh) 2018-09-28 2019-09-27 胰高血糖素样肽2（glp-2）类似物的制剂
CN202510255078.6A Pending CN120204366A (zh) 2018-09-28 2019-09-27 胰高血糖素样肽2（glp-2）类似物的制剂
CN201980063594.1A Active CN112771073B (zh) 2018-09-28 2019-09-27 胰高血糖素样肽2(glp-2)类似物的制剂

Family Applications After (2)

Application Number Title Priority Date Filing Date
CN202510255078.6A Pending CN120204366A (zh) 2018-09-28 2019-09-27 胰高血糖素样肽2（glp-2）类似物的制剂
CN201980063594.1A Active CN112771073B (zh) 2018-09-28 2019-09-27 胰高血糖素样肽2(glp-2)类似物的制剂

Country Status (13)

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)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
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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NZ250844A (en) * 1993-04-07 1996-03-26 Pfizer Treatment of non-insulin dependant diabetes with peptides; composition
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
EP2275438A1 (en) 1996-04-12 2011-01-19 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
WO2001041779A2 (en) 1999-12-08 2001-06-14 1149336 Ontario Inc. Combined use of glp-2 receptor agonist and chemotherapeutic agent in 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
EP2119724A1 (en) * 2005-05-03 2009-11-18 Novetide Ltd. Solid-phase process foor the preparation of goserelin
DE602006020123D1 (de) * 2005-05-04 2011-03-31 Zealand Pharma As Glucagon-like-peptide-2- (glp-2-) analoga
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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JP2013533217A (ja) * 2010-05-17 2013-08-22 セビックス・インコーポレイテッド Ｐｅｇ化ｃ−ペプチド
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Also Published As

Publication number Publication date
JP7566730B2 (ja) 2024-10-15
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
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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