CA3114330A1 - Formulations of glucagon-like-peptide-2 (glp-2) analogues - Google Patents

Formulations of glucagon-like-peptide-2 (glp-2) analogues Download PDF

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Publication number
CA3114330A1
CA3114330A1 CA3114330A CA3114330A CA3114330A1 CA 3114330 A1 CA3114330 A1 CA 3114330A1 CA 3114330 A CA3114330 A CA 3114330A CA 3114330 A CA3114330 A CA 3114330A CA 3114330 A1 CA3114330 A1 CA 3114330A1
Authority
CA
Canada
Prior art keywords
formulation
glp
buffer
analogue
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
CA3114330A
Other languages
English (en)
French (fr)
Inventor
Lise GIEHM
Claes MELANDER
Eva Horn Moller
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zealand Pharma AS
Original Assignee
Zealand Pharma AS
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 Zealand Pharma AS filed Critical Zealand Pharma AS
Publication of CA3114330A1 publication Critical patent/CA3114330A1/en
Pending legal-status Critical Current

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    • 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)
  • 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)
CA3114330A 2018-09-28 2019-09-27 Formulations of glucagon-like-peptide-2 (glp-2) analogues Pending CA3114330A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3114330A1 true CA3114330A1 (en) 2020-04-02

Family

ID=63794308

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3114330A Pending CA3114330A1 (en) 2018-09-28 2019-09-27 Formulations of glucagon-like-peptide-2 (glp-2) analogues

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

Family Cites Families (19)

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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
US20090028832A1 (en) * 2006-08-10 2009-01-29 Chung Leland F Compositions and methods for targeted tumor therapy
AU2007319066B2 (en) * 2006-11-08 2013-09-19 Zealand Pharma A/S Selective glucagon-like-peptide-2 (GLP-2) analogues
CN101668535B (zh) * 2006-12-29 2017-07-28 益普生制药股份有限公司 Glp‑1药物组合物
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
FR2994390B1 (fr) * 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
US9636407B2 (en) * 2012-11-20 2017-05-02 Fresenius Kabi Usa, Llc Caspofungin acetate formulations
ES2964713T3 (es) * 2014-10-23 2024-04-09 Amgen Inc Reducción de la viscosidad de formulaciones farmacéuticas
SMT202500120T1 (it) * 2016-11-21 2025-05-12 Amylyx Pharmaceuticals Inc Formulazioni tamponate di esendina (9-39)

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
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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