Sarakbi Iman, Thiesen Judith, Krämer Irene
Department of Pharmacy, University Medical Center Mainz, Johannes Gutenberg-University, Mainz, Germany.
Eur J Hosp Pharm. 2016 Jan;23(1):38-43. doi: 10.1136/ejhpharm-2015-000668. Epub 2015 Aug 11.
Irinotecan-loaded microspheres are used for simultaneous embolisation and chemotherapy of liver metastases of colorectal carcinoma. The aim of the study was to evaluate the compatibility of recently introduced DC Bead (bead size 70-150 µm) loaded with irinotecan after admixture with different types and volumes of non-ionic contrast media over a maximum period of 24 h and storage at room temperature.
Test suspensions were prepared by loading 2 mL DC Bead with 100 mg irinotecan within 2 h. The loading efficiency was determined by measuring the concentrations of irinotecan in the excess solutions via a reversed phase high pressure liquid chromatography (RP-HPLC) assay with ultraviolet detection. The compatibility of irinotecan-loaded DC Bead with different types and volumes of contrast media was studied by mixing 2 mL loaded bead slurry each with up to four different volumes (5, 10, 20, 30 mL) of seven different contrast media. Samples were withdrawn after 30 min, 1, 2, 4, 8 and 24 h. Admixtures were stored light protected at room temperature over the observation period. The concentrations of eluted irinotecan were measured in triplicate samples using the RP-HPLC assay.
Mixing of irinotecan loaded beads with non-ionic contrast media decreased the irinotecan loading efficiency between minimum 2.5% and maximum 17% over the observation period of 24 h. The rate and amount of irinotecan eluted from the beads varied relying on the type and volume of contrast medium admixed. However, no further elution or degradation was observed after the rapid release during the first 8 h.
Because of the rapid and extensive release of irinotecan, it is not recommendable to prepare admixtures of irinotecan-loaded DC Bead with contrast media in centralised cytotoxic preparation units in advance. Admixture should be performed with the smallest possible amount by the radiologists immediately prior to the delivery procedure.
载有伊立替康的微球用于结直肠癌肝转移的同步栓塞和化疗。本研究的目的是评估最近引入的载有伊立替康的DC Bead（珠粒大小70 - 150 µm）在与不同类型和体积的非离子型造影剂混合后，在最长24小时内并在室温下储存时的兼容性。
通过在2小时内将100 mg伊立替康加载到2 mL DC Bead中来制备测试悬浮液。通过使用带有紫外检测的反相高压液相色谱（RP - HPLC）测定法测量过量溶液中伊立替康的浓度来确定加载效率。通过将2 mL加载珠粒浆液分别与七种不同造影剂的多达四种不同体积（5、10、20、30 mL）混合，研究载有伊立替康的DC Bead与不同类型和体积造影剂的兼容性。在30分钟、1、2、4、8和24小时后取出样品。在观察期内，混合物在室温下避光储存。使用RP - HPLC测定法对一式三份的样品测量洗脱的伊立替康的浓度。
在24小时的观察期内，载有伊立替康的珠粒与非离子型造影剂混合使伊立替康加载效率降低了至少2.5%至最多17%。从珠粒中洗脱的伊立替康的速率和量因混合的造影剂的类型和体积而异。然而，在最初8小时的快速释放后未观察到进一步洗脱或降解。
由于伊立替康的快速和大量释放，不建议在集中细胞毒性制剂单位预先制备载有伊立替康的DC Bead与造影剂的混合物。造影剂混合应由放射科医生在给药程序即将进行之前以尽可能小的量进行。
