High Hydrostatic Pressure as Sterilization Method for Drug-Loaded Intraocular Lenses,ACS Biomaterials Science & Engineering

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High Hydrostatic Pressure as Sterilization Method for Drug-Loaded Intraocular Lenses
ACS Biomaterials Science & Engineering ( IF 5.4 ) Pub Date : 2020-06-09 , DOI: 10.1021/acsbiomaterials.0c00412
Ana Topete ₁ , Carlos A. Pinto ₂ , Helena Barroso ₃ , Jorge A. Saraiva ₂ , Isabel Barahona ₃ , Benilde Saramago ₁ , Ana Paula Serro _{1,

3}

Affiliation

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.

中文翻译：

高静水压作为载药人工晶状体的灭菌方法

灭菌是制造装有药物的人工晶状体（IOL）的关键步骤。消毒工业IOL的两种最常用的方法是蒸汽加热和伽马辐射。但是，当将人工晶状体装满药物时，必须质疑这些方法的适当性，因为灭菌可能会影响药物的活性和/或药物的释放。近来，在食品工业中越来越多地使用的高静水压（HHP）已被用于医疗应用的凝胶灭菌中。这项工作的目的是评估HHP在用于生产和不装载药物的IOL的商业丙烯酸材料灭菌中的性能。对裸露的样品以及装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获得的结果进行比较。HHP不仅对高度污染的样品进行了灭菌处理，而且还增加了载药量，并没有显着影响水凝胶的性能。伽马射线使溶液中的药物降解；因此，仅适用于干样品灭菌。蒸汽热不会影响释放曲线，但不能应用于温度敏感的药物。我们得出的结论是，在载药的IOL灭菌中，HHP可能有利地替代了蒸汽热和伽马辐射。蒸汽热不会影响释放曲线，但不能应用于温度敏感的药物。我们得出的结论是，HHP可以在载药IOL的灭菌中有利地替代蒸汽热和伽马辐射。蒸汽热不会影响释放曲线，但不能应用于温度敏感的药物。我们得出的结论是，HHP可以在载药IOL的灭菌中有利地替代蒸汽热和伽马辐射。

更新日期：2020-07-13

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