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Nanoparticle-eluting stents for coronary intervention: formulation, characterization, and in vitro evaluation
Ankit A Agrawal1, Ankur J Raval2, Shilpa M Velhal3
1Department of Pharmaceutical Sciences, Institute of Chemical Technology, N.P. Marg, Matunga, Mumbai, Maharashtra, India-400019.
Insights
Researchers developed a novel drug-eluting stent (DES) using sirolimus-loaded polymeric nanoparticles. This advanced stent technology shows promise for reducing restenosis in coronary artery disease treatment.
Area of Science:
- Biomedical Engineering
- Materials Science
- Pharmacology
Background:
- Coronary artery disease (CAD) remains a significant global health concern.
- Drug-eluting stents (DES) are crucial for percutaneous coronary intervention, reducing restenosis.
- Current DES technologies require further optimization for enhanced therapeutic delivery.
Purpose of the Study:
- To design and fabricate a novel DES coated with sirolimus-loaded polymeric nanoparticles (NPs).
- To evaluate the physicochemical properties, efficacy, and safety of the NP formulation and coated stent.
- To assess the potential of the developed NP-coated DES as an improved alternative to existing treatments.
Main Methods:
- Sirolimus was encapsulated into polymeric nanoparticles (NPs).
- NP formulation characterized for physicochemical properties; in vitro studies with human coronary artery smooth muscle cells (HCASMCs) for viability and uptake.
- NP formulation coated onto a cobalt-chromium stent platform; characterization included morphology, residual solvents, in vitro drug release, and ex vivo arterial permeation.
Main Results:
- The NP formulation demonstrated enhanced efficacy and time-dependent uptake in HCASMCs compared to plain sirolimus.
- Characterization of NP-coated stents confirmed suitable morphology and controlled drug release.
- Ex vivo studies indicated effective NP uptake from the stent surface.
Conclusions:
- The developed sirolimus-loaded NP formulation shows significant potential for enhancing DES performance.
- NP-coated DES offers a promising strategy to improve treatment outcomes for CAD by reducing restenosis.
- This novel NP-coated stent represents a potential advancement over current DES technologies.
Abstract:
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 (NPs). The NP 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 NP formulation showed enhanced efficacy compared to plain drug solution and exhibited time-dependent uptake into the HCASMCs. The developed NP formulation was coated on the Flexinnium™ ultra-thin cobalt-chromium alloy coronary stent platform. The NP-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 NP uptake from the surface of the stents. The characterization studies together corroborated that the developed NP coated stent can be a promising replacement of the current DESs.
