Nanoparticles eluting stents for coronary intervention: Formulation, characterization and in vitro evaluation.

Coronary artery disease (CAD) is currently a leading cause of death worldwide. In the history of percutaneous coronary intervention for the treatment of CAD, a drug-eluting stent (DES) is recognized as a revolutionary technology that has the unique ability to significantly reduce restenosis and provide both mechanical and biological solutions simultaneously to the target lesion. The aim of the research work was to design and fabricate DES coated with a nanoparticulate drug formulation. Sirolimus, an inhibitor of the smooth muscle cell (SMC) proliferation and migration, was encapsulated in polymeric nanoparticles. The nanoparticle formulation was characterized for various physicochemical parameters. Cell viability and cell uptake studies were performed using human coronary artery smooth muscle cells (HCASMCs). The developed nanoparticle formulation showed enhanced efficacy compared to plain drug solution and exhibited time-dependent uptake into the HCASMCs. The developed nanoparticle formulation was coated on the FlexinniumTM ultra-thin cobalt-chromium alloy coronary stent platform. The nanoparticle coated stents were characterized for morphology and residual solvent analysis. In-vitro drug release was also evaluated. Ex-vivo arterial permeation was carried out to evaluate the nanoparticle uptake from the surface of the stents. The characterization studies together corroborated that the developed nanoparticle coated stent can be a promising replacement of the current drug-eluting stents.