Kinet-Poleur Amélie, Colsoul Marie-Lise, Catry Emilie, Bihin Benoît P, Sneyers Barbara E, Hubert Justine, Jamart Jacques, Soumoy Laura, Galanti Laurence M, Hecq Jean-Daniel, Closset Mélanie
Department of Medical Laboratory, CHU UCL Namur, Yvoir, Belgium
Drug Stability Research Group, CHU UCL Namur, Yvoir, Belgium.
Eur J Hosp Pharm. 2025 Jun 24;32(4):376-380. doi: 10.1136/ejhpharm-2024-004227.
Esketamine (Vesierra) is a molecule, used alone or in combination, to induce and maintain general anaesthesia and to relieve pain in emergency medicine. The aim of this study is to evaluate the long-term physicochemical stability of a 1 mg/mL solution of esketamine diluted in 0.9% sodium chloride (NaCl) and stored in polypropylene syringes at 5±3°C during 65 days (64+1 day at 22±3°C) and 72 hours at 22±3°C (room temperature), in order to centralise preparation under aseptic conditions in hospital pharmacy.
Ten syringes were prepared under aseptic conditions. Five syringes were stored at 22±3°C for 3 days, and the five others were stored at 5±3°C for 64 days (+ 1 day at room temperature). The stability was periodically investigated. Particle appearance or colour changes were checked by visual inspection. A research of crystals was performed under the microscope. pH was followed to assess its stability. The turbidity of the solutions was estimated by a measure of optical densities at 350, 410 and 550 nm. The molecule concentrations were measured by ultra-high performance liquid chromatography (UHPLC) coupled with a photodiode array detection (PDA), using a newly developed method.
Based on microscopic examination, no crystals were observed, during the observation period. pH and absorbances at 350, 410 and 550 nm were also stable. Macroscopically, there was no change in colour and appearance of opacity, turbidity or precipitation. Statistical analysis indicates that 1 mg/mL esketamine solutions were chemically stable under these conditions, given that less than 5% of the solutions have lost more than 10% of their initial content during the study based on the prediction interval.
One mg/mL solutions of esketamine hydrochloride are physically and chemically stable after production, for at least 72 hours at 22±3°C and 64 days at 5±3°C (+ 1 day at room temperature).
艾氯胺酮（Vesierra）是一种分子，可单独使用或联合使用，用于诱导和维持全身麻醉以及在急诊医学中缓解疼痛。本研究的目的是评估在65天内（在22±3°C下64 + 1天）和在22±3°C（室温）下72小时，将1 mg/mL艾氯胺酮溶液稀释于0.9%氯化钠（NaCl）中并储存在聚丙烯注射器中，于5±3°C下的长期物理化学稳定性，以便在医院药房无菌条件下集中配制。
在无菌条件下制备10支注射器。5支注射器在22±3°C下储存3天，另外5支在5±3°C下储存64天（在室温下+ 1天）。定期研究稳定性。通过目视检查检查颗粒外观或颜色变化。在显微镜下进行晶体研究。跟踪pH以评估其稳定性。通过测量350、410和550 nm处的光密度来估计溶液的浊度。使用新开发的方法，通过超高效液相色谱（UHPLC）结合光电二极管阵列检测（PDA）测量分子浓度。
基于显微镜检查，在观察期内未观察到晶体。350、410和550 nm处的pH和吸光度也稳定。从宏观上看，颜色、不透明度、浊度或沉淀的外观没有变化。统计分析表明，根据预测区间，在这些条件下1 mg/mL艾氯胺酮溶液化学稳定，因为在研究期间少于5%的溶液损失了超过其初始含量的10%。
1 mg/mL盐酸艾氯胺酮溶液在生产后物理和化学稳定，在22±3°C下至少稳定72小时，在5±3°C下稳定64天（在室温下+ 1天）。
