INJECTABLE SOLUTION WITH A PH OF 7 COMPRISING AT LEAST ONE BASAL INSULIN WITH A PI OF BETWEEN 5.8 AND 8.5 AND A CO-POLYAMINOACID BEARING CARBOXYLATE CHARGES AND HYDROPHOBIC RADICALS
CHAN, YOU-PING,NOEL, ROMAIN,GEISSLER, ALEXANDRE,ROGER, WALTER,CHARVET, RICHARD,LAURENT, NICOLAS
申请号：
CA3084689
公开号：
CA3084689A1
申请日:
2018.12.07
申请国别(地区):
CA
年份:
2019
代理人:
摘要：
The invention relates to a composition in the form of an injectable aqueous solution, the pH of which is between 6.0 and 8.0, comprising at least: - a basal insulin whose isoelectric point pl is between 5.8 and 8.5； - A co-polyamino acid consisting of glutamic or aspartic units as defined in the claims. In one embodiment, the composition according to the invention is characterized in that the co-polyamino acid carrying carboxylate charges and at least one hydrophobic radical -Hy is chosen from the co-polyamino acids of formula (XXXb) in which: D independently represents either a -CH2 - group (aspartic unit) or a -CH2-CH2 group - (glutamic unit)； X represents a cationic entity chosen from the group comprising alkaline cations； Rb and Rb ′, identical or different, are either a hydrophobic radical -Hy, or a radical chosen from the group consisting of an H, a linear C2 to C10 acyl group, a branched C3 to C10 acyl group, a benzyl, a terminal "amino acid" unit and a pyroglutamate, at least one of Rb and R'b is a hydrophobic radical -Hy； Q and Hy have the meanings given above； n + m represents the degree of polymerization DP of the co-polyamino acid, that is to say the average number of monomeric units per chain of co-polyamino acid and 5 = :； n + m = :； 250.L'invention se rapporte à une compositon 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 pl est compris entre 5,8 et 8,5； - un co-polyaminoacide constitué d'unités glutamiques ou aspartiques tel que défini dans les revendications. Dans un mode de réalisation, la composition selon l'invention est caractérisée en ce que le co-polyaminoacide porteur de charges carboxylates et d'au moins un radical hydrophobe -Hy est choisi parmi les co-polyaminoacides de formule (XXXb) dans laquelle: D représente, indépendamment, soit un groupe -CH2 - (unité aspartique) soit un groupe -CH2-CH2 - (unité glutamique)； X représente
