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1. WO2020065063 - FORMULATIONS OF GLUCAGON-LIKE-PEPTIDE-2 (GLP-2) ANALOGUES

Publication Number WO/2020/065063
Publication Date 02.04.2020
International Application No. PCT/EP2019/076304
International Filing Date 27.09.2019
IPC
C07K 14/605 2006.01
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
14Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
435from animals; from humans
575Hormones
605Glucagons
A61K 38/26 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
26Glucagons
A61K 38/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
CPC
A61K 38/26
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
26Glucagons
A61K 47/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
A61K 47/12
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
12Carboxylic acids; Salts or anhydrides thereof
A61K 47/183
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
16containing nitrogen, ; e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
183Amino acids, e.g. glycine, EDTA or aspartame
A61K 47/26
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 9/0019
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
Applicants
  • ZEALAND PHARMA A/S [DK]/[DK]
Inventors
  • PARSHAD, Henrik Rajesh Kumar
  • GIEHM, Lise
  • MELANDER, Claes
Agents
  • MEWBURN ELLIS LLP
Priority Data
18197750.528.09.2018EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) FORMULATIONS OF GLUCAGON-LIKE-PEPTIDE-2 (GLP-2) ANALOGUES
(FR) FORMULATIONS D'ANALOGUES DU PEPTIDE-2 DE TYPE GLUCAGON (GLP-2)
Abstract
(EN)
Liquid formulations of GLP-2 analogues are described that make it possible to include a preservative while allowing the formulation to be stabilised for long term storage as liquids and/or as multi-dose liquid formulations. The development of these formulations is base on the finding that that reducing the pH of the formulation to below 7.0, e.g. to a pH between about pH 5.0 and about 6.8, was able to offset the effect that the addition of a preservative such as meta-cresol has on the physical stability of the formulation. Additionally, the addition of an excipient such as propylene glycol was shown to be able to offset the effect that the addition of a preservative, such as meta-cresol, has on the physical stability of the formulation. This opens up the possibility of being able to deliver the GLP-2 analogues as multi-dose formulations, for example allowing the use of the formulations in a drug delivery device.
(FR)
L'invention concerne des formulations liquides d'analogues de GLP-2 qui permettent d'inclure un conservateur tout en permettant à la formulation d'être stabilisée en vue d'un stockage à long terme sous forme de liquides et/ou en tant que formulations liquides à doses multiples. Le développement de ces formulations est basé sur la découverte selon laquelle réduire le pH de la formulation à moins de 7,0, par exemple à un pH entre environ 5,0 et environ 6,8, est capable de compenser l'effet que l'ajout d'un conservateur tel que le méta-crésol a sur la stabilité physique de la formulation. De plus, l'ajout d'un excipient tel que le propylène glycol a été démontré pour pouvoir compenser l'effet que l'ajout d'un conservateur, tel que le méta-crésol, a sur la stabilité physique de la formulation. Ceci ouvre la possibilité de pouvoir administrer des analogues de GLP-2 en tant que formulations à doses multiples, par exemple la possibilité d'utiliser les formulations dans un dispositif d'administration de médicament.
Also published as
Latest bibliographic data on file with the International Bureau