Crystalline paclitaxel coated DES with bioactive protective layer development

Drug eluting stents (DES) based on polymeric-carriers currently lead the market, however, reports on clinical complications encourage the development of safer and more effective DES. We recently reported on carrier-free DES based on rapamycin crystalline coating as a potential therapeutic solution. Here, we report for the first time surface crystallization of paclitaxel (PT) onto metallic stents. The physicochemical principles of crystallization and key process parameters were extensively studied for fabrication of controllable and homogeneous crystalline coatings on stent scaffolds. Stents loaded with nearly 100 μg PT were chosen as a potential therapeutic device with a multilayer coating of 4–7 μm thickness. In vitro PT release from these coated stents shows constant release for at least 28 days with 10% cumulatively released. The effect of fast dissolving top coating on the physical stability of the coated stent was determined. The top coating enhances the mechanical stability of the crystalline coating during deployment and expansion simulations. Also, incorporating PT in the protective top coating for developing bioactive top coating for multilayer controlled release purpose was intensively studied. This process has wide applications that can be further implemented for other drugs for effective local drug delivery from implantable medical devices.