静电干粉沉积技术在药物洗脱支架涂层中的应用。
The application of electrostatic dry powder deposition technology to coat drug-eluting stents.
机构信息
University of Greenwich, School of Science, Medway Campus, Central Avenue, Chatham Maritime, Kent, ME4 4 TB, UK.
出版信息
Pharm Res. 2010 Jan;27(1):72-81. doi: 10.1007/s11095-009-0008-y. Epub 2009 Nov 14.
PURPOSE
A novel methodology has been introduced to effectively coat intravascular stents with sirolimus-loaded polymeric microparticles.
METHODS
Dry powders of the microparticulate formulation, consisting of non-erodible polymers, were produced by a supercritical, aerosol, solvent extraction system (ASES). A design of experiment (DOE) approach was conducted on the independent variables, such as organic/CO(2) phase volume ratio, polymer weight and stirring-rate, while regression analysis was utilized to interpret the influence of all operational parameters on the dependent variable of particle size. The dry powders, so formed, entered an electric field created by corona charging and were sprayed on the earthed metal stent. Furthermore, the thermal stability of sirolimus was investigated to define the optimum conditions for fusion to the metal surfaces.
RESULTS
The electrostatic dry powder deposition technology (EDPDT) was used on the metal strut followed by fusion to produce uniform, reproducible and accurate coatings. The coated stents exhibited sustained release profiles over 25 days, similar to commercial products. EDPDT-coated stents displayed significant reduced platelet adhesion.
CONCLUSIONS
EDPDT appeared to be a robust accurate and reproducible technology to coat eluting stents.
目的
介绍了一种新的方法，可有效地将载有西罗莫司的聚合物微粒包被到血管内支架上。
方法
通过超临界、气溶胶、溶剂萃取系统（ASES）制备由不可侵蚀聚合物组成的微粒制剂的干粉。在独立变量（如有机/CO2 相体积比、聚合物重量和搅拌速度）上进行了实验设计（DOE）方法，同时利用回归分析来解释所有操作参数对粒径这一因变量的影响。如此形成的干粉进入由电晕充电产生的电场，并喷涂到接地的金属支架上。此外，还研究了西罗莫司的热稳定性，以确定与金属表面融合的最佳条件。
结果
静电干粉沉积技术（EDPDT）用于金属支柱上，然后进行融合，以产生均匀、可重复和精确的涂层。涂层支架在 25 天内表现出持续释放的特性，类似于商业产品。EDPDT 涂层支架显示出明显减少的血小板黏附。
结论
EDPDT 似乎是一种强大、准确和可重复的包被洗脱支架的技术。
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