Method for assessing coating uniformity of angioplasty balloons coated with poly(lactic-co-glycolic acid) nanoparticles loaded with quercetin

Abstract

In this study, we aim to quantify coating uniformity and correlate fluorescence intensity to drug loading for drug-coated angioplasty balloons (DCB) coated with 5, 10, 15, or 20 layers of poly(lactic-co-glycolic acid) nanoparticles (NPs) entrapped with quercetin. Uniformity was quantified from histograms and horizontal line profiles of microscopic fluorescent images acquired with sample specific parameters, and cracks in the coating were measured and counted. The fluorescence of images acquired with global parameters was correlated with quercetin loading measured via gravimetric/HPLC analysis. More layers on DCBs may be associated with less uniform coatings, as indicated by differences in histogram standard deviations. The line profile percent deviation from average for each sample was <20%. Cracks were present on all balloons, but their length was not significantly different between samples. The 5-layer DCBs had the fewest cracks, whereas the 15-layer DCBs had the most cracks. A strong positive correlation (R = 0.896) was identified between fluorescence intensity and drug loading. A relationship between the number of layers and coating uniformity seems to exist, but further investigations are required for confirmation. Fluorescence intensity appears to strongly predict drug loading, demonstrating that fluorescent imaging may be a viable alternative to drug release studies.

Keywords:

• Nanoparticles
• drug-coated balloon
• fluorescence microscopy
• coating
• uniformity
• peripheral artery disease
• angioplasty

Authors’ contributions

CEA, DB, and TRD conceptualized the study. ADZ, CEA, DB, and KFH developed the methodology. CEA acquired the images for analysis, and ADZ processed the images and analyzed the data. TRD acquired funding, and DB, KFH, and TRD supervised the study. ADZ wrote the manuscript, and DB, KFH, and TRD edited the manuscript. All authors read and approved the final manuscript.

Disclosure statement

TRD has intellectual property related to the contents of the manuscript and is a co-founder of a biomedical company that develops angioplasty balloon coatings.

Data availability statement

The datasets supporting the conclusions of this article are included within the article and its additional files.

Additional information

Funding

This work was funded through a grant award from the National Institutes of Health [R41HL123334] and the Industrial Ties Research Subprogram of the Louisiana Board of Regents Support Fund. Partial support was provided from the USDA NIFA Hatch Program [LAB #94443]. This paper is published with the approval of the Director of the Louisiana Agricultural Experiment Station as manuscript #2023-232-38387.