In Vitro Dissolution Testing of Drug-Eluting Stents

Anne      Seidlitz; Stefan      Nagel; Beatrice      Semmling; Katrin      Sternberg; Heyo      K. Kroemer; Werner      Weitschies

Abstract

Drug-eluting stents (DES) have revolutionized the treatment of coronary artery blockage by tremendously reducing the rate of in-stent restenosis and the necessity of repeat revascularization compared to bare-metal stents. They are also gaining increasing importance in other medical fields such as the treatment of certain localized tumors and in glaucoma therapy. DES generally contain most potent drugs, e.g. immunosuppressants or cytostatics, which are supposed to be released in a well controlled manner over time spans which are chosen according to disease progression. Typically, this means that fairly small amounts of drug are released over long periods of time. Therefore, quantification of in vivo plasma levels is often not feasible. Due to this limitation and the fact that tissue levels cannot be determined in humans, in vitro dissolution testing is one of the most powerful tools to gain insight into the release behaviour of DES. This article focuses on the methods for in vitro dissolution testing of DES which are available up to date and highlights the specific characteristics of drug release from stents arising from the composition and the in vivo localization of the dosage form.

Keywords: Biorelevant dissolution, drug-eluting stent, flow-through cell, in vitro dissolution, reciprocating holder, vesselsimulating flow-through cell

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