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Formulation of Nanoparticle-Eluting Stents by a Cationic Electrodeposition Coating Technology

Efficient Nano-Drug Delivery via Bioabsorbable Polymeric Nanoparticle-Eluting Stents in Porcine Coronary Arteries

Kaku Nakano, PhD^_*, Kensuke Egashira, MD, PhD^_*,_*, Seigo Masuda, MD^_*, Kouta Funakoshi, MD^_*, Gang Zhao, MD, PhD, Satoshi Kimura, MD, Tetsuya Matoba, MD, PhD^_*, Katsuo Sueishi, MD, PhD, Yasuhisa Endo, PhD^¶, Yoshiaki Kawashima, PhD^||, Kaori Hara, PhD^#, Hiroyuki Tsujimoto, PhD^#, Ryuji Tominaga, MD, PhD, Kenji Sunagawa, MD, PhD^_*

^_* Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Department of Cardiovascular Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Department of Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Department of Cardiovascular Medicine, 6th People's Hospital, Shanghai Jiaotong University, Shanghai, China
^|| School of Pharmaceutical Science, Aichi Gakuin University, Aichi, Japan
^¶ Division of Applied Biology, Kyoto Institute of Technology, Kyoto, Japan
^# Hosokawa Powder Technology Research Institute, Osaka, Japan

^_* Reprint requests and correspondence: Dr. Kensuke Egashira, Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyushu University, 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan (Email: egashira{at}cardiol.med.kyushu-u.ac.jp).

Objectives: The objective of this study was to formulate a nanoparticle (NP)-eluting drug delivery stent system by a cationic electrodeposition coating technology.

Background: Nanoparticle-mediated drug delivery systems (DDS) are poised to transform the development of innovative therapeutic devices. Therefore, we hypothesized that a bioabsorbable polymeric NP-eluting stent provides an efficient DDS that shows better and more prolonged delivery compared with dip-coating stent.

Methods: We prepared cationic NP encapsulated with a fluorescence marker (FITC) by emulsion solvent diffusion method, succeeded to formulate an NP-eluting stent with a novel cation electrodeposition coating technology, and compared the in vitro and in vivo characteristics of the FITC-loaded NP-eluting stent with dip-coated FITC-eluting stent and bare metal stent.

Results: The NP was taken up stably and efficiently by cultured vascular smooth muscle cells in vitro. In a porcine coronary artery model in vivo, substantial FITC fluorescence was observed in neointimal and medial layers of the stented segments that had received the FITC-NP-eluting stent until 4 weeks. In contrast, no substantial FITC fluorescence was observed in the segments from the polymer-based FITC-eluting stent or from bare metal stent. The magnitudes of stent-induced injury, inflammation, endothelial recovery, and neointima formation were comparable between bare metal stent and NP-eluting stent groups.

Conclusions: Therefore, this NP-eluting stent is an efficient NP-mediated DDS that holds as an innovative platform for the delivery of less invasive nano-devices targeting cardiovascular disease.

Key Words: drug delivery system • nanotechnology • restenosis • smooth muscle cells • stents

Abbreviations and Acronyms   DDS = drug delivery system   DES = drug-eluting stent(s)   FITC = fluorescein isothiocyanate   NP = nanoparticle(s)   PLGA = poly (DL-lactide-co-glycolide)   VSMC = vascular smooth muscle cell