用于输送液体或固体蛋白质配方的注射器件
Daniel A Bernards1, Chu Jian Ma2, Youning Zhang2
1University of California, San Francisco, Department of Bioengineering and Therapeutic Sciences, San Francisco, California 94143, United States.
ACS materials Au
|December 13, 2023
概括
这项研究介绍了用于持续蛋白质治疗的新型微型设备,其释放时间超过400天. 该技术在包括眼内注射在内的最小侵入性应用中证明了安全性和有效性.
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
- 眼科医生 眼科 眼科
背景情况:
- 持续提供蛋白质治疗药物是各种解剖学部位的重大挑战.
- 微型设备为蛋白质配方的最小侵入性管理提供了一个有希望的解决方案.
- 开发配方独立的制造技术是广泛适用的关键.
研究的目的:
- 开发和描述用于持续蛋白质治疗释放的微型管状装置.
- 评估这些设备的负载能力,释放动力学和体内安全性.
主要方法:
- 使用浸造工艺制造微小尺度 (壁厚低至30微米) 管状装置.
- 开发用于将固体或液体蛋白质配方装入与22度针相容的设备的技术.
- 一种模型蛋白的体外释放研究,证明持续释放超过400天.
- 在子模型中进行体内内注射,以评估眼睛的安全性和耐受性.
主要成果:
- 可靠的生产管状设备,可控制墙壁厚度和圆柱形状.
- 成功地将蛋白质配方装入适合小型应用的设备 (直径约300微米).
- 从固体装载设备中持续释放超过400天的模型蛋白质.
- 在子模型中证明了眼睛的安全性,在静脉内注射后,没有显著的炎症.
结论:
- 开发的浸造技术使微型设备的制造成为可能,用于持续的蛋白质输送.
- 这些设备可以有效地加载蛋白质配方,并提供长期释放.
- 该技术显示出对最小侵入性治疗应用的希望,特别是在眼科中,具有可接受的眼部安全性.
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