Coating and Pharmacokinetic Evaluation of Air Spray
Coated Drug Coated Balloons
Mechanical Engineering Department, University of South Alabama, Mobile, AL 36688, USA; and
Clinical Research and Development, University of Colorado, Aurora, CO 80045, USA
(Received 27 November 2017; accepted 26 February 2018; published online 1 March 2018)
Associate Editors Baruch Barry Lieber and Ajit P. Yoganathan oversaw the review of this article.
Abstract—Drug coated balloons (DCB) are becoming the
standard-care treatment for peripheral arterial disease
(PAD). DCB use excipients to transfer and retain anti-
proliferative drugs, such as paclitaxel. Excipients thus play a
vital role in the design and function of DCB, however
methods to coat balloons with excipients and anti-prolifer-
ative drugs remain unknown. The goal of this study was to
thus develop an approach to coat and evaluate DCB for
various excipients. An air sprayer method was developed to
deposit paclitaxel and various excipients onto non-coated
commercially available angioplasty balloons. The coating of
the angioplasty balloons was evaluated for drug deposition
and coating efﬁciency using high performance liquid chro-
matography tandem mass spectrometry. Drug transfer and
retention of the coated angioplasty balloons into arterial
segments were evaluated ex vivo using harvested pig arteries
in a pulsatile ﬂow bioreactor. The air sprayer method
successfully delivered varying excipients including bovine
serum albumin (BSA), urea and iohexol. The air spray
method was conﬁgured to coat four angioplasty balloons
simultaneously with paclitaxel and iohexol with an average
paclitaxel load of 4.0 ± 0.70 lg/mm
. The intra-day (within)
and inter-day (between) coating precisions, deﬁned as relative
standard deviation (RSD), was 17.2 and 15.5%, respectively.
Ex vivo deployment of iohexol-paclitaxel DCB yielded an
arterial paclitaxel concentration of 123.4 ± 44.68 ng/mg
(n = 3) at 1 h, 126.7 ± 25.27 ng/mg (n = 3) at 1 day, and
12.9 ± 12.88 ng/mg (n = 3) at 7 days. This work provides
proof-of-concept of a quick, inexpensive approach to coat
commercially available angioplasty balloons with paclitaxel
and various excipients.
Keywords—Drug coated balloon, Coating, Pharmacokinet-
ics, Iohexol, Paclitaxel.
Peripheral arterial disease (PAD) aﬀects 8.5 million
Americans and costs the economy an estimated 4.37
Standard treatment of PAD has
traditionally included balloon angioplasty and stent-
ing, however, success of such devices is limited at best.
Balloon angioplasty results in high incidence of
restenosis post-treatment, up to 54%.
Stents are also limited by high rates of restenosis,
commonly as a result of stent fracture.
are accepted as the standard care treatment for coro-
nary artery disease, stents in the periphery are sub-
jected to biomechanical stresses such as ﬂexion and
extension/contraction which result in stent fracture.
Incidence of stent fracture varies greatly in the litera-
ture with fracture rates ranging from 2 to 65% in
Stent fracture in the superﬁcial
femoral artery can occur in up to 65% of cases
whereas, in the femoropopliteal segment, fracture
incidence is 24.5%.
Primary reasons for variability in
fracture rate are differences in biomechanical forces at
regions of stent placement,
multiple stent placement
and overlapping stents.
Long lesions requiring more
than one stent, such as those below-the-knee (BTK)
(mean lesion length 130–170 mm), are indicated with
balloon angioplasty with stenting as a bail-out strat-
Consequently, new technology, such as the
drug coated balloon (DCB), is seen as the next gener-
ation technology for treatment of PAD.
DCB employ an anti-proliferative drug coating,
typically paclitaxel, to combat restenosis. DCB act by
transferring drug from a coated angioplasty balloon to
the vessel lumen. DCB require a quick, 2-min transfer
of the drug load to the artery. With such a short time
to interact with the target lesion, excipients or drug
Address correspondence to Saami K. Yazdani, Mechanical
Engineering Department, University of South Alabama, Mobile,
AL 36688, USA. Electronic mail: firstname.lastname@example.org
Cardiovascular Engineering and Technology, Vol. 9, No. 2, June 2018 (
2018) pp. 240–250
2018 Biomedical Engineering Society