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US 8,986,609 B2Granted
Sterilization of biodegradable hydrogels
AssigneeAscendis Pharma A/S
InventorsHarald Rau, Tobias Voigt, Ulrich Hersel
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Abstract
The present invention relates to a terminal sterilization process for biodegradable PEG-based insoluble hydrogels using irradiation. The presence of a protective solvent ensures that the hydrogel remains intact with functionally preserved three-dimensional and physicochemical properties.
Claims16
A method for sterilizing a biodegradable poly(ethylene glycol) based insoluble hydrogel comprising backbone moieties which are interconnected by hydrolytically degradable bonds, the method comprising the steps of:
- (a) providing the hydrogel;
- (b) solvating the hydrogel in a protective solvent, or in a mixture of the protective solvent with another protective solvent, or in an aqueous solution thereof;
- and
- (c) subjecting the solvated hydrogel, in the presence of the protective solvent, to gamma radiation;
- wherein the protective solvent comprises at least one component selected from the group consisting of NMP, DMA, DME and DMI;
- and
- wherein the protective solvent optionally contains one or more protecting agents.
4 more elements
Dependencies are inferred from the claim text.