Topete Ana, Pinto Carlos A, Barroso Helena, Saraiva Jorge A, Barahona Isabel, Saramago Benilde, Serro Ana Paula
Centro de Química Estrutural, Departamento de Engenharia Química, Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1049001 Lisboa, Portugal.
QOPNA & LAQV-REQUIMTE, Department of Chemistry, University of Aveiro, Aveiro 3810-193, Portugal.
ACS Biomater Sci Eng. 2020 Jul 13;6(7):4051-4061. doi: 10.1021/acsbiomaterials.0c00412. Epub 2020 Jun 17.
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.
灭菌是载药人工晶状体（IOL）制造过程中的关键步骤。商业IOL最常用的两种灭菌方法是蒸汽加热和伽马辐射。然而，当IOL载有药物时，这些方法的适用性必须受到质疑，因为灭菌可能会影响药物的活性和/或药物释放。最近，食品工业中越来越多地使用的高静水压（HHP）已被应用于医疗用凝胶的灭菌。这项工作的目的是评估HHP在用于生产IOL的商业丙烯酸材料灭菌中的性能，包括未载药和载药的情况。对空白样品以及载有抗生素和两种抗炎药的样品进行了测试，并将结果与传统灭菌方法得到的结果进行了比较。HHP不仅对高度污染的样品进行了灭菌，还提高了药物负载量，并且对水凝胶性能没有显著影响。伽马辐射会使溶液中的药物降解；因此，它仅适用于干燥样品的灭菌。蒸汽加热不影响释放曲线，但不能应用于对温度敏感的药物。我们得出结论，在载药IOL的灭菌中，HHP可能有利地替代蒸汽加热和伽马辐射。
