Quantitative spatial distribution of sirolimus and polymers in drug-eluting stents using confocal Raman microscopy
Quantitative spatial distribution of sirolimus and polymers in drug-eluting stents using confocal Raman microscopy
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DOI：
10.1002/jbm.a.31535
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发表时间：
2008-04-01
影响因子：
4.9
通讯作者：
Maryanoff, C. A.
中科院分区：
文献类型：
--
作者：
Balss, K. M.;LIanos, G.;Maryanoff, C. A.
拉曼光谱用于区分 CYPHER (R) 西罗莫司洗脱冠状动脉支架中的每种成分。然后，使用为每种成分确定的独特光谱特征来开发三个单独的校准曲线，以描述药物聚合物涂层支架上发现的固相分布。校准曲线是通过分析喷涂在支架和平面基底上的 16 种独特药物聚合物涂层配方的共焦拉曼光谱深度剖面而获得的。西罗莫司模型在药物的 0 至 100 wt% 范围内呈线性。聚(乙烯-共-乙酸乙烯酯)[PEVA]和聚(甲基丙烯酸正丁酯)[PBMA]的各个聚合物校准曲线从重量％到100％也是线性的。校准曲线在三个独立的药物聚合物涂层支架上进行测试。西罗莫司校准预测药物含量在实验室测定值的1wt％以内。聚合物校准预测含量在配方溶液含量的 7 wt% 范围内。五种配方的衰减全反射傅里叶变换红外 (ATR-FTIR) 光谱证实了对西罗莫司和聚合物含量变化的线性响应。 (c) 2007 年 Wiley 期刊公司。
Raman spectroscopy was used to differentiate each component found in the CYPHER (R) Sirolimus-eluting Coronary Stent. The unique spectral features identified for each component were then used to develop three separate calibration curves to describe the solid phase distribution found on drug-polymer coated stents. The calibration curves were obtained by analyzing confocal Raman spectral depth profiles from a set of 16 unique formulations of drug-polymer coatings sprayed onto stents and planar substrates. The sirolimus model was linear from 0 to 100 wt % of drug. The individual polymer calibration curves for poly(ethylene-co-vinyl acetate) [PEVA] and poly(n-butyl methacrylate) [PBMA] were also linear from to 100 wt %. The calibration curves were tested on three independent drug-polymer coated stents. The sirolimus calibration predicted the drug content within I wt % of the laboratory assay value. The polymer calibrations predicted the content within 7 wt % of the formulation solution content. Attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectra from five formulations confirmed a linear response to changes in sirolimus and polymer content. (c) 2007 Wiley Periodicals, Inc.