可降解的水凝微球用于药物输送:在体外性能和E-beam杀菌的影响
Laurent Bédouet1, Anne Beilvert1, Emeline Servais1
1Occlugel, 17 Bis, Avenue Des Andes, 91940, Les Ulis, France.
AAPS PharmSciTech
|June 4, 2025
概括
可降解微球 (DrugMic) 对持续的药物输送有希望. 电子光束灭菌会影响药物的稳定性,但调整加载方法可以保持药物的完整性和释放概况.
科学领域:
- 生物材料科学 生物材料科学
- 药物输送系统 药物输送系统
- 聚合物化学 聚合物化学
背景情况:
- 基于聚乙烯甘醇的水凝微球 (DrugMic) 正在研究药物输送.
- 电子射线灭菌是医疗器械灭菌的常见方法,但可能会影响药物的稳定性.
- 该研究重点关注电子射线灭菌对装入DrugMic.Mic.中的各种活性物质的影响.
研究的目的:
- 评估可降解的DrugMic.的体外药物递送性能.
- 评估电子射线灭菌对装载药物的稳定性的影响.
- 根据药物对辐射的稳定性来确定最佳的加载策略.
主要方法:
- 将药物加载到预制,可降解的微球上 (降解3天,1或2周).
- 药物载荷微球 (15或25kGy) 的E射线灭菌.
- 使用RP-HPLC进行体外药物释放研究和稳定性评估.
主要成果:
- 在不同的时间内,DrugMic成功地输送了尼胺酸,塔达拉菲尔,提科普拉宁,波利米辛B,布普伦诺芬和特拉沃普罗斯特.
- 布普伦诺芬和特拉沃普罗斯特在灭菌后显示显著的放射性溶解;聚米辛B降解.
- 尼弗酸,塔达拉菲尔和提科普拉宁的水平保持稳定. 随时加载可保护敏感药物的药物完整性和释放概况.
结论:
- 药物Mic是一个可持续药物释放的可行平台.
- 负载模式的适应对于管理药物稳定性对抗e-beam辐射至关重要.
- 在消毒的微球上随时加载敏感药物是防止降解的成功策略.
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