Zulu Jenipher None, Katebe Reuben None, Ramli Martalena None, Sakala Rita None, Mwape Elias None, Chipasha Ernest None, Hang'ombe Bernard Mudenda
Pharmacy/School of Health Sciences, Levy Mwanawasa Medical University, Zambia.
Department of Technology and Science, Ministry of Higher Education, Lusaka, Zambia.
World J Nucl Med. 2024 Jul 4;23(4):264-269. doi: 10.1055/s-0044-1788278. eCollection 2024 Dec.
The primary aim was to evaluate the prolonged quality characteristics of methyl diphosphonate (MDP) aliquots during ambient storage over a specified duration. This study further investigated potential additives that could enhance the stability of MDP aliquots stored under such conditions. This was a laboratory-based experimental study conducted at the University Teaching Adult Hospital in Lusaka, Zambia. A total of 36 MDP aliquots stored at ambient conditions and 4 MDP aliquots stored at conventional refrigerated frozen conditions were labeled with technitium-99m ( Tc) and tested for radiochemical purity (RCP) and other quality characteristics. A comparative analysis of the stability and quality of MDP aliquots from the two cohorts was then conducted. Stata 14 was used to analyze the data on the RCP of all MDP aliquots. The RCP of ambient stored MDP aliquots was found to be ranging from 98 to 99%, while that for frozen and refrigerated ones ranged from 99 to 100%. There was also a 1% increase in RCP for both cohorts with argon gas purging (98 and 99%, respectively). The RCP of MDP aliquots from both cohorts was much higher than the required minimum of 90% implying that there was no significant association of their stability and quality with the mode of storage. However, purging with argon gas seemed to increase the stability further in both streams. The study findings show potential for application in resource-constrained environments and centers, especially in developing countries, where challenges to maintain the cold storage chain of these important radiopharmaceuticals are likely to be encountered due to power outages.
主要目的是评估甲基二膦酸盐(MDP)等分试样在规定时长的常温储存期间的长期质量特性。本研究进一步调查了在这种条件下储存时可增强MDP等分试样稳定性的潜在添加剂。 这是一项在赞比亚卢萨卡大学教学成人医院开展的基于实验室的实验研究。总共36份在常温条件下储存的MDP等分试样以及4份在传统冷藏冷冻条件下储存的MDP等分试样用锝-99m(Tc)进行标记,并测试其放射化学纯度(RCP)及其他质量特性。然后对两个队列的MDP等分试样的稳定性和质量进行了比较分析。 使用Stata 14分析所有MDP等分试样的RCP数据。 发现常温储存的MDP等分试样的RCP范围为98%至99%,而冷冻和冷藏的MDP等分试样的RCP范围为99%至100%。对于两个队列,用氩气吹扫后RCP也都提高了1%(分别为98%和99%)。 两个队列的MDP等分试样的RCP均远高于要求的最低90%,这意味着其稳定性和质量与储存方式没有显著关联。然而,用氩气吹扫似乎在两个批次中都进一步提高了稳定性。研究结果表明在资源有限的环境和中心,特别是在发展中国家有应用潜力,因为在这些国家可能会因停电而遇到维持这些重要放射性药物冷链的挑战。