Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Abstract

Polyvinylpyrrolidone (PVP) is a conventionally applied hydrophilic lubricious coating on catheter-based cardiovascular devices, used in order to ease movement through the vasculature. Its use as drug reservoir and transfer agent on drug-coated balloons (DCB) is therefore extremely promising with regard to the simplification of its approval as a medical device. Here, we developed a PVP-based coating for DCB, containing paclitaxel (PTX) as a model drug, and studied the impact of crosslinking via UV radiation on drug stability, wash off, and transfer during simulated use in an in vitro vessel model. We showed that crosslinking was essential for coating stability and needed to be performed prior to PTX incorporation due to decreased drug bioavailability as a result of photodecomposition and/or involvement in vinylic polymerization with PVP under UV radiation. Moreover, the crosslinking time needed to be carefully controlled. While short radiation times did not provide enough coating stability, associated with high wash off rates during DCB insertion, long radiation times lowered drug transfer efficiency upon balloon expansion. A ten minutes radiation of PVP, however, combined a minimized drug wash off rate of 34% with an OPEN ACCESSCoatings 2013, 3 254 efficient drug transfer of 49%, underlining the high potential of photochemically crosslinked PVP as a coating matrix for DCB.

Correlating Coating Characteristics with the Performance of Drug-Coated Balloons – A Comparative In Vitro Investigation of Own Established Hydrogel- and Ionic Liquid-Based Coating Matrices

“…In this regard, we developed and established three different matrices for DCB based on (i) the ionic liquid (IL) cetylpyridinium salicylate (Cetpyrsal) [ 12 ], (ii) the natural and body-own hydrogel hyaluronic acid (HA) [ 13 ] and (iii) the synthetic but pharmaceutically often applied hydrogel polyvinylpyrrolidone (PVP) [ 14 ] in previous studies. We considered IL as attractive matrix for DCB, because important physical, chemical and biological properties are tunable [ 15 ] by combination of various e.g.…”

“…In our first in vitro studies, the IL- and both hydrogel-based coatings evidenced good performance with regard to drug loss and transfer. For example, we determined drug wash-off rates of 28% for the Cetpyrsal/PTX, < 5% for the HA/PTX and 34% for the PVP/PTX coating and drug transfer rates of 40%, 50% and 49%, respectively [ 12 ] [ 13 ] [ 14 ]. Although values are not comparable as different in vitro models were used for their determination, we like to conclude from these data that the application of either IL or hydrogels approved as promising matrices for DCB at first sight.…”

Polymers in Cardiology

“…From this it follows that polymers intended as scaffold materials degrade in a moderate period of 6-9 months to 2 years and the degradation products are biocompatible and do not induce undesired inflammation reactions [15]. On the other hand, due to the fact that PTX-coated balloons using low-molecular excipients showed a clear inferiority regarding their deliverability in comparison to uncoated balloon catheters [16], it can be supposed that also hydrophilic polymers, such as poly(vinylpyrrolidone) (PVP) or hyaluronic acid (HA), with high swelling and lubricious properties will be of great interest in the future also in this field [17,18]. Another cardiovascular intervention, where polymeric implant materials could be used with increasing scope, is the transcatheter aortic valve implantation or replacement (TAVI or TAVR) usually performed in an interdisciplinary team of cardiologists and heart surgeons.…”

“…In this regards, we investigated the use of the body-own and hence highly biocompatible biopolymer HA [18] and the pharmaceutically well-established synthetic polymer PVP [17] as drug reservoir and transfer agent for DCB. In both Fig.…”

Marine Antifouling Surface Coatings Using Tannic Acid and Poly(N‐vinylpyrrolidone)

“…Zhang et al synthesized polysulfobetaine‐coated surfaces on which ultralow marine fouling occurs using surface‐initiated polymerization . In addition to the abovementioned polymers, poly( N ‐vinylpyrrolidone) (PVP) has attracted interest as a coating material due to its good antifouling properties and biocompatibility and has been approved by the Food and Drug Administration . However, marine antifouling applications of PVP have not been investigated, because of the lack of a versatile coating method, which is in critical need of being developed.…”