AU2019348538B2 - 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
AU2019348538B2
AU2019348538B2 AU2019348538A AU2019348538A AU2019348538B2 AU 2019348538 B2 AU2019348538 B2 AU 2019348538B2 AU 2019348538 A AU2019348538 A AU 2019348538A AU 2019348538 A AU2019348538 A AU 2019348538A AU 2019348538 B2 AU2019348538 B2 AU 2019348538B2
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formulation
buffer
glp
analogue
concentration
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AU2019348538A1 (en
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Lise GIEHM
Claes MELANDER
Eva Horn MØLLER
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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)
  • 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)
AU2019348538A 2018-09-28 2019-09-27 Formulations of glucagon-like-peptide-2 (GLP-2) analogues Active AU2019348538B2 (en)

Applications Claiming Priority (3)

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
PCT/EP2019/076305 WO2020065064A1 (en) 2018-09-28 2019-09-27 Formulations of glucagon-like-peptide-2 (glp-2) analogues

Publications (2)

Publication Number Publication Date
AU2019348538A1 AU2019348538A1 (en) 2021-05-20
AU2019348538B2 true AU2019348538B2 (en) 2025-04-03

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AU2019348538A Active AU2019348538B2 (en) 2018-09-28 2019-09-27 Formulations of glucagon-like-peptide-2 (GLP-2) analogues

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=)

Families Citing this family (9)

* 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

Citations (3)

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WO2001049314A2 (en) * 1999-12-30 2001-07-12 Nps Allelix Corp. Glp-2 formulations
WO2006117565A2 (en) * 2005-05-04 2006-11-09 Zealand Pharma A/S Glucagon-like-peptide-2 (glp-2) analogues
WO2008056155A1 (en) * 2006-11-08 2008-05-15 Zealand Pharma A/S Selective glucagon-like-peptide-2 (glp-2) analogues

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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
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WO2001049314A2 (en) * 1999-12-30 2001-07-12 Nps Allelix Corp. Glp-2 formulations
WO2006117565A2 (en) * 2005-05-04 2006-11-09 Zealand Pharma A/S Glucagon-like-peptide-2 (glp-2) analogues
WO2008056155A1 (en) * 2006-11-08 2008-05-15 Zealand Pharma A/S Selective glucagon-like-peptide-2 (glp-2) analogues

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
KR20260008798A (ko) 2026-01-16
CL2021000678A1 (es) 2021-08-06

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