Hecq Jean-Daniel, Lewis Andrew L, Vanbeckbergen Danielle, Athanosopoulos Alexandre, Galanti Laurence, Jamart Jacques, Czuczman Peter, Chung Ting
Pharmacy Department, CHU Mont-Godinne, Yvoir & Drug Stability Research Group, Brussels, Belgium.
J Oncol Pharm Pract. 2013 Mar;19(1):65-74. doi: 10.1177/1078155212452765. Epub 2012 Jul 16.
Evaluation of doxorubicin stability over time when stored into the DC Bead embolic agent, in various containers, which are used for the delivery of the doxorubicin-loaded beads to the patients for up to 14 days under refrigerated conditions.
The doxorubicin was loaded through the ionic exchange mechanism into the calibrated polyvinyl alcohol-based hydrogel beads (DC Bead), with the loading process carried out either in the original DC Bead glass vials or within a polypropylene plastic syringe. The loaded samples were eluted at given time points and the extracted doxorubicin was analysed by high-performance liquid chromatography for concentration and chromatographic area response purity.
The variance on the doxorubicin concentration of the samples stored in the syringes under refrigerated conditions was less than 10% over the 14 days period. The chromatographic purity of doxorubicin eluted from the DC Bead in their primary glass vial packaging was measured at 99.7%. The dissolution test showed that the elution rate and amount recovered from samples stored in vials were statistically similar between Day 0 and Day 14. The chromatographic purity of the doxorubicin loaded into DC Bead in presence of non-ionic contrast medium was >99.0% for 7 days under refrigerated conditions.
Doxorubicin-loaded DC Bead® are shown to have adequate physicochemical stability over a period of 14 days when stored in syringes or vials under refrigerated conditions for up to 14 days. The admixtures of doxorubicin-loaded beads with contrast medium are stable for up to 7 days under refrigerated conditions.
评估阿霉素在储存于DC Bead栓塞剂中时，在不同容器内随时间的稳定性。这些容器用于将载有阿霉素的微球输送给患者，并在冷藏条件下保存长达14天。
通过离子交换机制将阿霉素加载到校准的聚乙烯醇基水凝胶微球（DC Bead）中，加载过程在原始的DC Bead玻璃瓶或聚丙烯塑料注射器中进行。在给定时间点对加载后的样品进行洗脱，并通过高效液相色谱法分析提取的阿霉素的浓度和色谱面积响应纯度。
在冷藏条件下储存在注射器中的样品，其阿霉素浓度在14天内的变化小于10%。从DC Bead的原始玻璃瓶包装中洗脱的阿霉素的色谱纯度经测定为99.7%。溶出试验表明，在第0天和第14天之间，从小瓶中储存的样品中回收的洗脱速率和量在统计学上相似。在非离子型造影剂存在的情况下，加载到DC Bead中的阿霉素在冷藏条件下7天内的色谱纯度>99.0%。
当在冷藏条件下储存在注射器或小瓶中长达14天时，载有阿霉素的DC Bead®显示在14天内具有足够的物理化学稳定性。载有阿霉素的微球与造影剂的混合物在冷藏条件下长达7天是稳定的。
