Long-Term Physicochemical Stability of a Morphine-Ketamine Admixture in Polypropylene Syringes at Room Temperature.

Q4 Medicine
Luigi Devis, Marie-Lise Colsoul, Benoît Bihin, Jacques Jamart, Laura Soumoy, Louise Lombet, Jean-Daniel Hecq, Laurence Galanti, Mélanie Closset, Emilie Catry
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引用次数: 0

Abstract

Background: In advance preparation of solutions containing morphine and ketamine can reduce the risk of error, lower costs, and reduce nursing workload, thereby improving the quality of care. However, data on the stability of morphine hydrochloride and ketamine hydrochloride admixture in polypropylene syringes stored at room temperature are lacking.

Objective: To assess the physical and chemical stability of a morphine hydrochloride (2.0 mg/mL) and ketamine hydrochloride (3.3 mg/mL) admixture in polypropylene syringes, stored at room temperature and protected from light, for up to 49 days.

Methods: Five syringes containing the admixture were prepared under aseptic conditions and analyzed periodically over 49 days. Physical stability was assessed visually, microscopically, and through turbidity measurements. Chemical stability was evaluated using ultra-high-performance liquid chromatography (UHPLC).

Results: No visual precipitation, color change, or significant turbidity increase was observed. The pH remained stable. UHPLC analysis showed that both morphine and ketamine concentrations remained above 90% of initial values at day 49.

Conclusion: The admixture of morphine hydrochloride (2.0 mg/mL) and ketamine hydrochloride (3.3 mg/mL) is physically and chemically stable for at least 49 days in polypropylene syringes stored at room temperature and protected from light. This allows for the in advance preparation of the admixture by centralized intravenous admixture services, improving efficiency and potentially reducing errors.

室温下聚丙烯注射器中吗啡-氯胺酮混合物的长期物理化学稳定性。
背景:预先配制含有吗啡和氯胺酮的溶液可以减少差错风险,降低成本,减少护理工作量,从而提高护理质量。然而,关于盐酸吗啡和盐酸氯胺酮混合物在聚丙烯注射器中室温保存稳定性的数据缺乏。目的:评价盐酸吗啡(2.0 mg/mL)和盐酸氯胺酮(3.3 mg/mL)在聚丙烯注射器中避光常温保存49天的理化稳定性。方法:在无菌条件下制备5支含该制剂的注射器,定期分析49 d。物理稳定性通过目视、显微镜和浊度测量进行评估。采用超高效液相色谱法(UHPLC)评价其化学稳定性。结果:未见明显的沉淀、颜色变化或明显的浊度增加。pH值保持稳定。UHPLC分析显示,第49天吗啡和氯胺酮浓度均保持在初始值的90%以上。结论:盐酸吗啡(2.0 mg/mL)与盐酸氯胺酮(3.3 mg/mL)在聚丙烯注射器中室温避光保存49 d以上,物理化学性质稳定。这允许通过集中的静脉注射外加剂服务预先制备外加剂,提高效率并潜在地减少错误。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
0.40
自引率
0.00%
发文量
62
期刊介绍: The International Journal of Pharmaceutical Compounding (IJPC) is a bi-monthly, scientific and professional journal emphasizing quality pharmaceutical compounding. IJPC is the only publication that covers pharmaceutical compounding topics relevant and necessary to empower pharmacists to meet the needs of today"s patients. No other publication features hands-on, how-to compounding techniques or the information that contemporary pharmacists need to provide individualized care.
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