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
Inventor
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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (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)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (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)
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
BR112019026711A2 (pt) 2017-06-16 2020-06-30 Zealand Pharma A/S regimes de dosagem para a administração de análogos de peptídeo semelhante a glucagon- 2 (glp-2)
EP4154869A4 (en) * 2020-05-22 2025-01-22 Hanmi Pharm. Co., Ltd. Liquid formulation of 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.
AU2022341538A1 (en) * 2021-09-10 2024-04-11 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
EP4572783A1 (en) 2022-09-30 2025-06-25 Zealand Pharma A/S Glucagon-like-peptide-2 (glp-2) analogues 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"
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)
WO2025141129A1 (en) 2023-12-28 2025-07-03 Zealand Pharma A/S Formulations of glucagon-like-peptide 2 (glp-2) analogues and their uses

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
DE60142885D1 (de) 1996-04-12 2010-10-07 Ontario Inc 1149336 Dem Glukagon ähnliches Peptid-2
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
ATE396202T1 (de) 2001-02-16 2008-06-15 Conjuchem Biotechnologies Inc Lang wirkendes glucagon-ähnliches peptid-2 für die behandlung von gastrointestinalen krankheiten und störungen
EP2119724A1 (en) * 2005-05-03 2009-11-18 Novetide Ltd. Solid-phase process foor the preparation of goserelin
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
WO2008082656A1 (en) * 2006-12-29 2008-07-10 Ipsen Pharma S.A.S. Glp-1 pharmaceutical compositions
CA2798518A1 (en) * 2010-05-17 2011-11-24 Cebix, Inc. Pegylated c-peptide
FR2994390B1 (fr) * 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
PT2922530T (pt) * 2012-11-20 2016-12-22 Fresenius Kabi Usa Llc Formulações de acetato de caspofungina
AU2015335743B2 (en) * 2014-10-23 2020-12-24 Amgen Inc. Reducing viscosity of pharmaceutical formulations
EP4591853A1 (en) * 2016-11-21 2025-07-30 Amylyx Pharmaceuticals, Inc. Buffered formulations of exendin (9-39)

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US20220265551A1 (en) 2022-08-25
CN118267455A (zh) 2024-07-02
EP3856766A1 (en) 2021-08-04
IL281362B1 (en) 2026-03-01
MX2026000859A (es) 2026-03-02
NZ775113A (en) 2026-01-30
MX2021003271A (es) 2021-05-12
JP2022502432A (ja) 2022-01-11
CA3114330A1 (en) 2020-04-02
EP3628683A1 (en) 2020-04-01
KR20260008798A (ko) 2026-01-16
JP7738136B2 (ja) 2025-09-11
JP2024156754A (ja) 2024-11-06
US20240065978A1 (en) 2024-02-29
BR112021005858A2 (pt) 2021-07-27
IL281362A (en) 2021-04-29
CL2021000678A1 (es) 2021-08-06
SG11202102383VA (en) 2021-04-29
CN120204366A (zh) 2025-06-27
CN112771073B (zh) 2025-07-01
WO2020065064A1 (en) 2020-04-02
KR20210069056A (ko) 2021-06-10
AU2019348538A1 (en) 2021-05-20
JP7566730B2 (ja) 2024-10-15
CN112771073A (zh) 2021-05-07

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