86282-96-4Relevant articles and documents
PH 7 INJECTABLE SOLUTION COMPRISING AT LEAST ONE BASAL INSULIN OF WHICH THE PI IS FROM 5.8 TO 8.5 AND A CO-POLYAMINO ACID BEARING CARBOXYLATE CHARGES AND HYDROPHOBIC RADICALS AND A LIMITED AMOUNT OF M-CRESOL
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Paragraph 000699, (2020/07/04)
The invention relates to physically stable compositions in the form of an injectable aqueous solution, the pH of which is from 6.0 to 8.0, comprising at least: a) a basal insulin whose isoelectric point (pI) is from 5.8 to 8.5, b) m-cresol in a concentration lower than or equal to 30 mM (0 a co-polyamino acid bearing carboxylate charges and at least one Formula X hydrophobic radical.
INJECTABLE SOLUTION AT PH 7 COMPRISING AT LEAST ONE BASAL INSULIN WHEREIN THE PI IS COMPRISED FORM 5.8 TO 8.5 AND A CO-POLYAMINO ACID BEARING CARBOXYLATE CHARGES AND HYDROPHOBIC RADICALS
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Paragraph 1004; 1005; 1006; 1007, (2019/09/20)
In one embodiment, the composition according to the invention is characterized in that the co-polyamino acid bearing carboxylate charges and at least one hydrophobic radical -Hy is chosen among the co-polyamino acids according to formula XXXb hereinafter: wherein, D represents, independently, either a group —CH2— (aspartic acid) or a group —CH2—CH2— (glutamic acid),X represents a cationic entity chosen in the group comprising alkali cations,Rb and Rb′, identical or different, are either a hydrophobic radical -Hy, or a radical chosen in the group consisting of an H, a C2 to C10 linear acyl group, a C3 to C10 branched 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 are as defined above.n+m represents the degree of polymerization DP of the co-polyamino acid, namely the mean number of monomeric units per co-polyamino acid chain and 5≤n+m≤250.
Compositions in the form of an injectable aqueous solution comprising human glucagon and a co-polyamino acid
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Paragraph 0537-0539; 0667-0670; 0799-0802, (2018/01/09)
An injectable aqueous solution, the pH of which is from 6.0 to 8.0, having at least: a) human glucagon, and b) a co-polyamino acid bearing carboxylate charges and hydrophobic radicals Hy. In an embodiment, the compositions have, in addition, a gastrointestinal hormone.