Protective Layer Development for Enhancing Stability and Drug-Delivery Capabilities of DES Surface-Crystallized Coatings

Carrier-free drug-eluting stents (DES)-based crystalline coatings are gaining prominence because of their function, skipping many limitations and clinical complications of the currently marketed DES. However, their usage has been humbled by inflexibility of the crystalline coating and limited mechanical and physical properties. This study reports for the first time the development of a protective top coating for enhancing the merits and delivery capabilities of the crystalline coating. Flexible and water-soluble polysaccharide top coating was developed and applied onto rapamycin (RM) crystalline carpet. The top coating prevented crystalline coating delamination during stent crimping and expansion without affecting its release profile. Crystalline coating strata and its interfaces with the metallic substrate and top coating were fully studied and characterized. The crystalline top-coated stents showed significant physical, mechanical, and chemical stability enhancement with similar to 2% RM degradation after 1 year under different storage conditions. Biocompatibility study of the top-coated stents implanted subcutaneously for 1 month into SD rats did not provoke any safety concerns. Incorporating RM into the top coating to develop a bioactive protective coating for multilayer release purposes was also investigated. The developed protective coating had wide applicability and may be further implemented for various drugs and implantable medical devices.