High Hydrostatic Pressure as Sterilization Methodfor Drug-Loaded Intraocular Lenses
2020
Sterilization is
a key step in the manufacturing of drug-loaded
intraocular lenses (IOLs). Two of the most used methods to sterilize
commercial IOLs are steam heat and gamma radiation. However, when
the IOLs are loaded with drugs, the adequacy of those methods must
be questioned because sterilization may affect the activity of the
drugs and/or the drug release. Recently, high hydrostatic pressure
(HHP), which is increasingly used in the food industry, has been applied
in the sterilization of gels for medical applications. The objective
of this work was to assess the performance of HHP in the sterilization
of a commercial acrylic material used for the production of IOLs,
both without and with loaded drugs. Bare samples and samples loaded
with an antibiotic and two anti-inflammatories were tested, and the
results were compared to those obtained with conventional sterilization
methods. HHP not only sterilized highly contaminated samples but also
enhanced drug loading and did not affect significantly the hydrogel
properties. Gamma radiation degraded the drugs in solution; thus,
it is adequate only for dry sample sterilization. Steam heat did not
affect the release profiles but cannot be applied to temperature-sensitive
drugs. We concluded that HHP may advantageously substitute steam heat
and gamma radiation in the sterilization of drug-loaded IOLs.
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