FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to a hydrogel composition. A sterile hydrogel composition for use as a soft tissue filler contains cross-linked hyaluronan, where the amount of extractable hyaluronan having a molecular weight of less than 200 kDa is less than 15 wt.% relative to the total amount of hyaluronan, where the cross-linked hyaluronan has the structure HA-L-HA, where each HA group is hyaluronan or a salt thereof and L is a linker, and this linker is covalently linked to each HA group by replacing one OH moiety in the repeated unit, and L is derived from an LH2molecule, the cross-linked hyaluronan is the oxidation product of a thiol-modified hyaluronan, where the thiol-modified hyaluronan is modified with a molecule having a thiol group that forms intramolecular and intermolecular disulfide bonds upon oxidation, and the cross-linked hyaluronan is contained in an amount from 0.1 to 5 wt.% relative to the weight of the composition. A method of filling soft tissues is also disclosed.
EFFECT: group of inventions provides increased resistance to decomposition of formulations during storage.
13 cl, 3 tbl, 9 ex
Authors
Dates
2023-10-18—Published
2019-06-14—Filed