Department of Clinical Pharmacy and Pharmacology, Graduate School of Medical and Dental Sciences, Kagoshima University, Japan.
Am J Health Syst Pharm. 2012 Sep 1;69(17):1509-12. doi: 10.2146/ajhp100116.
The stability of prepared infusions of the tumor necrosis factor (TNF)-α agent infliximab after storage for up to two weeks was investigated.
To determine the feasibility of liberalized expiration dating of infliximab (current recommendations call for the infusion of prepared doses within three hours), the stability of diluted infliximab stored in polyvinyl chloride (PVC) bags at 4 °C for up to 14 days was evaluated. A known quantity of TNF-α was combined with infliximab test samples in PVC bags for one hour; immediately after the reaction period and after 7 and 14 days of storage, the residual amount of TNF-α (an indirect measure of the drug's biological activity) was analyzed via a validated enzyme-linked immunosorbent assay (ELISA).
The mean ± S.D. amount of TNF-α consumed by infliximab was calculated to be 24.5 ± 5.6 pg/mL at baseline, 29.0 ± 4.4 pg/mL at 7 days, and 24.8 ± 17.3 pg/mL at 14 days. At all evaluated time points, ELISA results indicated that 19-24% of the original TNF-α had been consumed by infliximab (mean ± S.D. consumption: 19.6% ± 4.5% at baseline, 23.2% ± 3.5% at 7 days, and 19.8% ± 13.8% at 14 days).
Infliximab, when prepared at a concentration of 400 μg/mL in 0.9% sodium chloride injection, incurred no loss of biological activity when stored for up to 14 days at 4 °C in PVC bags. Changing infliximab preparation practices may improve clinic efficiency by reducing patient dissatisfaction with long wait times for infusions and avoiding costly waste.
研究储存长达两周的肿瘤坏死因子（TNF）-α 制剂英夫利昔单抗（infliximab）制备后的稳定性。
为了确定放宽英夫利昔单抗（目前的建议要求在制备剂量的 3 小时内输注）的过期日期的可行性，评估了在 4°C 下储存长达 14 天的聚氯乙烯（PVC）袋中稀释的英夫利昔单抗的稳定性。将已知量的 TNF-α 与 PVC 袋中的英夫利昔单抗测试样品混合 1 小时；在反应期结束后立即以及储存 7 天和 14 天后，通过验证的酶联免疫吸附测定（ELISA）分析残留的 TNF-α 量（药物生物活性的间接测量）。
计算出英夫利昔单抗消耗的 TNF-α 平均±标准偏差量为基础时的 24.5±5.6pg/mL，7 天时的 29.0±4.4pg/mL，14 天时的 24.8±17.3pg/mL。在所有评估的时间点，ELISA 结果表明，英夫利昔单抗消耗了 19-24%的原始 TNF-α（平均±标准偏差消耗：基础时的 19.6%±4.5%，7 天时的 23.2%±3.5%，14 天时的 19.8%±13.8%）。
当在 0.9%氯化钠注射液中以 400μg/mL 的浓度制备英夫利昔单抗时，在 PVC 袋中在 4°C 下储存长达 14 天不会导致其丧失生物活性。改变英夫利昔单抗的制备方法可以通过减少患者对输注等待时间过长的不满并避免昂贵的浪费，从而提高临床效率。
