The in vitro and in vivo handling and performance characteristics of a small caliber radiopaque embolic microsphere, 40–90 μm DC Bead LUMI™ (LUMI40‐90), were studied. Microsphere drug loading and elution and effects on size, suspension, and microcatheter delivery were evaluated using established in vitro methodologies. In vivo evaluations of vascular penetration (rabbit renal artery embolization), long‐term biocompatibility and X‐ray imaging properties, pharmacokinetics and local tissue effects of both doxorubicin (Dox) and irinotecan (Iri) loaded microspheres (swine hepatic artery embolization) were conducted. Compared to 70–150 μm DC Bead LUMI (LUMI70‐150), LUMI40‐90 averaged 70 μm versus 100 μm, which was unchanged upon drug loading. Handling, suspension, and microsphere delivery studies were successfully performed. Dox loading was faster (20 min) and Iri equivalent (<10 min) while drug elution rates were similar. Contrast suspension times were longer with no delivery complications. Vascular penetration was statistically greater (rabbit) with no unexpected adverse safety findings (swine). Microspheres ± drug were visible under X‐ray imaging (CT) at 90 days. Peak plasma drug levels and area under the curve were greater for LUMI40‐90 compared to LUMI70‐150 but comparable to 70–150 μm DC BeadM1™ (DC70‐150). Local tissue effects showed extensive hepatic necrosis for Dox, whereas Iri displayed lower toxicity with more pronounced lobar fibrosis. LUMI40‐90 remains suspended for longer and have greater vessel penetration compared to the other DC Bead LUMI sizes and are similarly highly biocompatible with long‐term visibility under X‐ray imaging. Drug loading is equivalent or faster with pharmacokinetics similar to DC70‐150 for both Dox and Iri.

中文翻译：

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新型小口径不透射线栓塞微球的处理和性能特征。

研究了小口径不透射线栓塞微球 40-90 μm DC Bead LUMI™ (LUMI40-90) 的体外和体内处理和性能特征。使用已建立的体外方法评估微球载药和洗脱以及对大小、悬浮液和微导管递送的影响。进行了血管渗透（兔肾动脉栓塞）、长期生物相容性和 X 射线成像特性、药代动力学和阿霉素（Dox）和伊立替康（Iri）负载微球（猪肝动脉栓塞）的局部组织效应的体内评价. 与 70-150 μm DC Bead LUMI (LUMI70-150) 相比，LUMI40-90 平均为 70 μm，而 100 μm 在载药时没有变化。成功地进行了处理、悬浮和微球递送研究。Dox 加载更快（20 分钟）和 Iri 等效（<10 分钟），而药物洗脱速率相似。造影剂暂停时间更长，没有分娩并发症。血管渗透在统计学上更大（兔），没有意外的不良安全发现（猪）。在 90 天时，在 X 射线成像 (CT) 下可以看到微球 ± 药物。与 LUMI70-150 相比，LUMI40-90 的峰值血浆药物水平和曲线下面积更大，但与 70-150 μm DC BeadM1™ (DC70-150) 相当。局部组织效应显示 Dox 出现广泛的肝坏死，而 Iri 显示出较低的毒性和更明显的肺叶纤维化。与其他 DC Bead LUMI 尺寸相比，LUMI40-90 的悬浮时间更长，血管穿透能力更强，并且在 X 射线成像下具有同样的高度生物相容性和长期可见性。