Drug Stability Research Group, CHU UCL Namur, Yvoir, Belgium.
Drug Stability Research Group and Department of Pharmacy, CHU UCL Namur, Yvoir, Belgium.
Int J Pharm Compd. 2021 Nov-Dec;25(6):446-462.
The objective of this review was to collect information and results about the method of the microwave freeze-thaw treatment of injectable drugs and whether the method can support the development of Centralized Intravenous Admixtures Services. A systematic review of the scientific literature about injectable drug stability studies was performed. The data are presented in a table, which describes the name of the drug, producer, final concentration, temperature and time of freezing storage, type of microwave oven, thawing power, method of dosage, and the results after treatment or final long-term storage at 5°C ± 3°C. From 1980 to 2021, 60 drugs were studied by the microwave freeze-thaw treatment, and the results were presented in 49 publications. Forty papers were presented by 8 teams (2 to 18 by team). The temperatures of freezing storage varied from -70°C to -10°C, the time storage from 4 hours to 12 months, and the thaw from low to full power. Drug concentrations were mainly determined by high-performance liquid chromatography. Most of the 59 drugs were stable during and after treatment. Only three teams tested the long-term stability after the microwave freeze-thaw treatment, the first for ganciclovir after 7 days, the second for ceftizoxime after 30 days, and the third for 20 drugs after 11 to 70 days. This review can help Centralized Intravenous Additive Services take charge of the productions of ready-to-use injectable drugs.
本次综述的目的是收集关于可注射药物微波冻融处理方法的信息和结果,以及该方法是否能够支持集中静脉药物调配服务的发展。对可注射药物稳定性研究的科学文献进行了系统评价。数据以表格形式呈现,描述了药物名称、生产商、最终浓度、冷冻储存温度和时间、微波炉类型、解冻功率、剂量方法以及处理或最终在 5°C±3°C 下长期储存后的结果。从 1980 年到 2021 年,有 60 种药物通过微波冻融处理进行了研究,结果在 49 篇出版物中呈现。40 篇论文由 8 个团队提交(每个团队 2 至 18 篇)。冷冻储存温度从-70°C 到-10°C 不等,储存时间从 4 小时到 12 个月,解冻功率从低到全。药物浓度主要通过高效液相色谱法确定。在处理过程中和处理后,59 种药物中的大多数都稳定。只有三个团队测试了微波冻融处理后的长期稳定性,第一个是更昔洛韦处理 7 天后,第二个是头孢唑肟处理 30 天后,第三个是 20 种药物处理 11 至 70 天后。本次综述可以帮助集中静脉药物调配服务部门负责即配型可注射药物的生产。