动态测试与静态测试以及在体内测试聚甲基-三甲碳酸-ε-caprolactone延迟释放植入物的机械性能
Norman L Ilich1, Siamak Saifzadeh2, Dietmar W Hutmacher3
1Australian Research Council Training Centre for Cell and Tissue Engineering Technologies, Queensland University of Technology, 1 George Street, Brisbane, QLD 4000, Australia; Centre for Materials Science, School of Chemistry & Physics, Faculty of Science, Queensland University of Technology (QUT), Brisbane, Queensland 4000, Australia.
概括
开发灵活植入物的动态体外测试是至关重要的. 循环柔性测试可以准确预测机械应力和药物释放,与静态方法不同,改善临床前翻译.
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
- 机械工程 机械工程
背景情况:
- 毫米尺寸的植入物提供精确的药物释放控制,但面临着制造方面的挑战.
- 皮下植入使大型植入物受到静态体外试验无法预测的机械应力.
- 目前的体外试验方法无法复制体内条件,阻碍了设备的开发,并导致临床前失败.
研究的目的:
- 为了制造柔性植入物,使用聚糖化物-co-trimethylene碳酸盐-co-ε-caprolactone).
- 评估小鼠体外降解和体内性能.
- 开发一个可扩展,高通量循环曲测试系统,以预测体内行为.
主要方法:
- 制造柔性多样化 (glycolide-co-trimethylene碳酸盐-co-ε-caprolactone) 植入物. 这种植入物可以在体内使用.
- 在静态条件下与脂蛋白脂酶进行体外降解研究.
- 开发和应用一个循环弹性测试系统.
- 在大鼠模型中进行皮下植入,以评估体内性能.
主要成果:
- 与静态条件相比,周期性曲负荷对机械性能产生了重大影响.
- 静态体外试验显示,在染料释放之前,存在60天的延迟时间.
- 柔性负荷导致20天的早期植入物骨折,与动物模型观察结果一致.
- 动态测试揭示了与体内机械应力相一致的早期骨折.
结论:
- 调整体外试验测试以适应特定的剂型和注射途径至关重要.
- 动态体外测试对于评估植入物活力和释放动力学至关重要.
- 实施循环柔性测试简化了设备评估,并增强了临床前翻译.
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