Key result
Cilostazol release from a reservoir-based stent was effectively modulated by drug-to-polymer ratio and an abluminal polymer barrier, with excellent correlation between in vitro and in vivo release.
A novel reservoir-based drug-eluting stent allows for controlled, directional release of cilostazol with predictable in vivo kinetics based on in vitro testing.
Supports preclinical validation of directional cilostazol stents; leaves open clinical translation in coronary disease.
Sustained release formulations of a potent antithrombotic drug, cilostazol, in poly-(lactic acid-co-glycolic acid) (PLGA) matrices were created for luminal release from a novel drug-eluting stent utilizing reservoirs (RES TECHNOLOGY™). The crystallinity of cilostazol and the morphology of the cilostazol/polymer matrix in the stent reservoirs were examined by cross-polarized optical microscopy and differential scanning calorimetry. An in vitro method was developed to study release kinetics of various cilostazol formulations and to examine correlation with in vivo release. Formulation parameters such as drug-to-polymer ratio and the use of a polymer barrier on the abluminal surface of the drug/polymer matrix were found to be effective in modulating drug release rate. Cilostazol/PLGA(75/25) in the weight ratio of 50/50 to 70/30 displayed first-order release kinetics for the majority of the drug load. Addition of an abluminal polymer barrier slowed cilostazol release rate when compared to the bidirectional reservoir design. Excellent correlation between cilostazol in vivo release profile from stents in a porcine coronary artery model and that measured in vitro in a modified USP-7 apparatus suggests that the in vitro release system is capable of predicting in vivo release of cilostazol from stent reservoirs.
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Parker et al. (2012) studied this question. Cilostazol in PLGA matrices from a reservoir-based stent vs. Bidirectional reservoir design was evaluated on Release kinetics and in vitro/in vivo correlation. Cilostazol release from a reservoir-based stent was effectively modulated by drug-to-polymer ratio and an abluminal polymer barrier, with excellent correlation between in vitro and in vivo release.
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