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1. WO2020115334 - METHOD FOR PREPARING A STABLE COMPOSITION IN THE FORM OF AN INJECTABLE AQUEOUS SOLUTION

Publication Number WO/2020/115334
Publication Date 11.06.2020
International Application No. PCT/EP2019/084294
International Filing Date 09.12.2019
IPC
A61K 38/28 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
28Insulins
A61K 47/34 2017.01
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
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 9/08 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
CPC
A61K 38/28
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
28Insulins
A61K 47/34
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
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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 9/08
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
Applicants
  • ADOCIA [FR]/[FR]
Inventors
  • DI LORENZO, Fany
Agents
  • TRIPOZ, Inès
Priority Data
16/213,96307.12.2018US
FR190613607.06.2019FR
Publication Language French (FR)
Filing Language French (FR)
Designated States
Title
(EN) METHOD FOR PREPARING A STABLE COMPOSITION IN THE FORM OF AN INJECTABLE AQUEOUS SOLUTION
(FR) PROCEDE DE PREPARATION D'UNE COMPOSITION STABLE SOUS FORME D'UNE SOLUTION AQUEUSE INJECTABLE
Abstract
(EN)
The invention concerns a method for preparing a composition in the form of an injectable aqueous solution, the pH of which is between 6.0 and 8.0, comprising at least one basal insulin for which the isoelectric point (pi) is between 5.8 and 8.5 and a co-polyaminoacid bearing carboxylate charges and hydrophobic radicals enabling the fast solubilisation of the at least one basal insulin and the at least one co-polyaminoacid when compared with a method used in the prior art.
(FR)
L'invention concerne un procédé de préparation d'une composition sous forme d'une solution aqueuse injectable, dont le pH est compris entre 6, 0 et 8,0, comprenant au moins une insuline basale dont le point isoélectrique (pi) est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes permettant la solubilisation rapide de ladite au moins une insuline basale et dudit au moins un copolyaminoacide en comparaison à un procédé utilisé dans l'art antérieur.
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