In vitro particulate and in vivo drug retention study of a novel polyethylene oxide formulation for drug-coated balloons

Abstract

The amorphous PAT in the PEO balloon provided comparable drug tissue retention levels to those of the commercially available DCB and fewer particulates. Thus prepared PEO balloon proved to be safe and effective in the preclinical experimental setting. The clinical outcomes of these findings need further investigation.

Development of an automated micropipette coating method for drug‐coated balloons

“…The PAT powder demonstrated an endothermic peak at 221°C, indicating a crystalline nature for the PAT powder. Importantly, this peak does not exist for Balloons 4, 11, 16, or 22, indicating that PAT is in the amorphous form in the balloon coatings (Figure 8a) as previously reported (Anderson et al, ; Anderson et al, ).…”

Development of drug-coated balloon for the treatment of multiple peripheral artery segments

“…7 The PEO-based DCB has been shown to be safe and effective through minimal particulates shed and therapeutic amounts of drug retained in the tissues at day 30, respectively. 8 This demonstrates its potential as an alternative to the currently available DCBs to treat a single lesion.…”

“…The methods of the model are provided in our previous study. 8 The particulates were imaged using an Olympus SZX10 stereo microscope equipped with Olympus DP22 camera (Olympus America, Center Valley, Pa), and the number of particulates and average size of the particulates were quantitatively analyzed (>100 mm) using ImageJ software (National Institutes of Health, Bethesda, Md). For proper visualization, the white particulates were artificially colored green.…”

“…The in vivo animal operations were carried out as previously described (Supplementary Methods, online only). 8 Treatment of porcine arteries using MR-TMD-DCB. The pretreatment of the arteries was performed as previously described.…”

“…We previously developed a single-release Tailored Medical Devices DCB (SR-TMD-DCB) and compared the drug retention in the tissue with a commercially available DCB until day 30. 8 In this study, we have developed multiplerelease Tailored Medical Devices DCBs (MR-TMD-DCBs) for the treatment of two arterial segments. The DCB coating was carefully formulated, and a suitable multilayer dip coating approach was used to obtain the MR-TMD-DCB with the desirable controlled drug release properties.…”