Drug-
coated balloons (DCBs) are used to treat various cardiovascular diseases. Currently available DCBs carry
drug on the
balloon surface either solely or using different carriers. Several studies have shown that a significant amount of
drug is lost in the blood stream during
balloon tracking to deliver only a sub-therapeutic level of
drug at the treatment site. This research is focused on developing paclitaxel (PAT) loaded polyethylene oxide (PEO) films (PAT–PEO) as a controlled
drug delivery carrier for DCBs. An array of PAT–PEO films were developed in this study to provide tailored release of >90% of
drug only at specific time intervals, which is the time frame required for carrying out
balloon-based therapy. The characterizations of PAT–PEO films using SEM, FTIR, and DSC showed that the films developed were homogenous and the PAT was molecularly dispersed in the PEO matrix. Mechanical tests showed that most PAT–PEO films developed were flexible and ductile, with yield and tensile strengths not affected after PAT incorporation. The viability, proliferation, morphology, and phenotype of smooth muscle cells (SMCs) interacted with control-PEO and PAT–PEO films were investigated. All control-PEO and PAT–PEO films showed a significant inhibitory effect on the growth of SMCs, with the degree of inhibition strongly dependent on the w/v% of the polymer used. The PAT–PEO coating was produced on the
balloons. The integrity of PAT–PEO coating was well maintained without any mechanical defects occurring during
balloon inflation or deflation. The
drug release studies showed that only 15% of the total PAT loaded was released from the
balloons within the initial 1 min (typical
balloon tracking time), whereas 80% of the PAT was released between 1 min and 4 min (typical
balloon treatment time). Thus, this study demonstrated the use of PEO as an alternate
drug delivery system for the
balloons.
Statement of Significance
Atherosclerosis is primarily responsible for cardiovascular diseases (CVDs) in millions of patients every year. Drug-coated balloons (DCBs) are commonly used to treat various CVDs. However, in several currently used DCBs, a significant amount of drug is lost in the blood stream during balloon tracking to deliver only a sub-therapeutic level of drug at the treatment site. In this study, paclitaxel containing polyethylene oxide (PEO) films were developed to provide unique advantages including drug release profiles specifically tailored for balloon-based therapy, homogeneous films with molecularly dispersed drug, flexible and ductile films, and exhibits significant inhibitory effect on smooth muscle cell growth. Thus, this study demonstrated the use of PEO as an alternate drug delivery platform for DCBs to improve its efficacy.
