An Overview of In Vitro Drug Release Methods for Drug-Eluting Stents

Abstract

The drug release profile of drug-eluting stents (DESs) is affected by a number of factors, including the formulation, design, and physicochemical properties of the utilized material. DES has been around for twenty years and despite its widespread clinical use, and efficacy in lowering the rate of target lesion restenosis, it still requires additional development to reduce side effects and provide long-term clinical stability. Unfortunately, for analyzing these implants, there is still no globally accepted in vitro test method. This is owing to the stent’s complexity as well as the dynamic arterial compartments of the blood and vascular wall. The former is the source of numerous biological, chemical, and physical mechanisms that are more commonly observed in tissue, lumen, and DES. As a result, universalizing bio-relevant apparatus, suitable for liberation testing of such complex implants is difficult. This article aims to provide a comprehensive review of the methods used for in vitro release testing of DESs. Aspects related to the correlation of the release profiles in the cases of in vitro and in vivo are also addressed.