Keratose as a Novel Drug Carrier for Drug Coated Balloons

Drug coated balloons (DCB) represent a novel approach to develop a superior intervention for the treatment of peripheral artery disease (PAD). Currently, DCB are coated with anti-proliferative drugs which combat neointimal hyperplasia reducing the occurrence of restenosis. The common anti-proliferative drug is paclitaxel, which when coated alone has very poor retention rates due to its diffusion from the treated artery following deployment. Excipients have marginally improved paclitaxel retention however retention rates are still less than 10% 24-hours post-treatment. Keratose, an extracted form of keratin derived from human hair, is a potential option for an excipient due to its intrinsic scaffolding characteristics and biocompatibility. Keratose hydrogels support tunable release of various drugs and factors as a function of keratose concentration. Therefore, the goal of this project is to evaluate the ability of keratose to act as an excipient of paclitaxel in DCB. Briefly, various paclitaxel-containing keratose hydrogels were formed. Keratose degradation and paclitaxel release were quantified up to 45 days by spectrophotometry and HPLC-MS/MS respectively. To confirm the ability of keratose to form a DCB, keratose hydrogels were coated on angioplasty balloons using a dipping technique. The keratose DCB was sectioned and coating thickness was quantified by light microscopy. Results demonstrated that paclitaxel-keratose hydrogels degraded and released paclitaxel as a function of keratose concentration. The keratose DCB displayed uniform coating circumferentially with coating thicknesses ranging from 5-20 microns. These studies highlight the potential of a new biomaterial that can provide a safe and controllable drug release profile for treatment of PAD.