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1. WO2020007852 - A RECONSTITUTABLE TEVERELIX-TFA COMPOSITION

Publication Number WO/2020/007852
Publication Date 09.01.2020
International Application No. PCT/EP2019/067718
International Filing Date 02.07.2019
Chapter 2 Demand Filed 28.04.2020
IPC
A61K 38/09 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
08Peptides having 5 to 11 amino acids
09Luteinising hormone-releasing hormone ; Related peptides
A61K 9/19 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
19lyophilised
A61K 31/185 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
F26B 5/06 2006.1
FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
26DRYING
BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
5Drying solid materials or objects by processes not involving the application of heat
04by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
06the process involving freezing
CPC
A61K 31/185
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
A61K 38/09
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
08Peptides having 5 to 11 amino acids
09Luteinising hormone-releasing hormone [LHRH] ; , i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
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 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
A61K 9/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
A61K 9/19
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
19lyophilised ; , i.e. freeze-dried, solutions or dispersions
Applicants
  • ANTEV LIMITED [GB]/[GB]
Inventors
  • LARSEN, Finn
  • BOUTIGNON, François
  • POLAND, Guy
Agents
  • HOLME PATENT A/S
Priority Data
18181931.905.07.2018EP
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) A RECONSTITUTABLE TEVERELIX-TFA COMPOSITION
(FR) COMPOSITION DE TEVERELIX-TFA RECONSTITUABLE
Abstract
(EN) The present invention relates to a reconstitutable teverelix-TFA composition having a predefined molar ratio of teverelix to trifluoroacetate which is below the molar ratio required for microcrystal formation. Said composition remains stable during storage e.g. at a temperature around 2-8°C. Upon reconstitution a fixed amount of trifluoroacetate can be added to said composition thereby effectively and simply achieving an exact and desired molar ratio in order to obtain a fluid, milky microcrystalline aqueous teverelix-TFA suspension.
(FR) La présente invention concerne une composition de teverelix-TFA reconstituable, dont le rapport molaire prédéfini du teverelix au trifluoroacétate est inférieur au rapport molaire nécessaire à la formation de microcristaux. Ladite composition reste stable pendant le stockage, par exemple à une température comprise entre 2 et 8 °C environ. Lors de la reconstitution, une quantité fixe de trifluoroacétate peut être ajoutée à ladite composition, permettant ainsi d'obtenir, de façon efficace et simple, un rapport molaire exact et souhaité afin d'obtenir une suspension aqueuse microcristalline de teverelix-TFA fluide et laiteuse.
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