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Spray-coating process development, manufacture, quality assessment and drug release behavior of peripheral drug-eluting stents

Year: 2012
Type: article
Abstract: Manufacture of peripheral DES requires development of process technologies to accommodate their geometrical and biomechanical specifics.In this study, a spray-coating process for peripheral DES coatings was developed.Peripheralsize, self-expanding nickel titanium stents (7.0 x 40 mm) were coated with the biodegradable polymer poly(L-lactide) (PLLA) incorporated with the immunosuppressant sirolimus (SIR) in a ratio of 82.5/17.5 % w/w.Coating mass was 3400 µg.A parameter study was conducted to assess optimum coating parameters.The coated DES were evaluated for coating morphology, thickness, and integrity.Drug release behavior was assessed by HPLC.SEM evaluation confirmed a smooth, defect-free PLLA/SIR coating with complete strut coverage.A coating thickness of 5.5 ± 0.4 µm was determined by CLSM.SIR release was traced over up to 430 h, exhibiting an initial burst over 30 h, followed by a steady, retarded drug release.Altogether, the results indicate the technical feasibility of self-expanding, peripheral DES. Bare stent surface
Language: English
Subfield: Surgery
Field: Medicine
Open Access status: bronze
OpenAlex ID: W1980062719
FWCI: 0.973
Cites: 1
Cited by: 8
Related to: 10