Franceschi Loretta, Cojutti Piergiorgio, Baraldo Massimo, Pea Federico
Institute of Clinical Pharmacology, Azienda Ospedaliero-Universitaria Santa Maria della Misericordia; Department of Experimental and Clinical Medical Sciences, Medical School, University of Udine, Italy.
Ther Drug Monit. 2014 Oct;36(5):674-6. doi: 10.1097/FTD.0000000000000054.
Administration by continuous infusion may represent an effective tool for the treatment of multidrug-resistant gram-negative related infections with meropenem. Currently, no data on chemical stability of generic bioequivalent versions of meropenem over time are available. Triplicate samples of 5 mg/mL solutions of a generic meropenem formulation, Hospira, were evaluated for chemical stability at increasing temperatures (25°C, 30°C, 35°C, and 40°C) by means of a high-performance liquid chromatography technique over 4 separate days. Degradation of generic meropenem was both time and temperature dependent, and the aqueous solutions were stable for up to 8 hours in the temperature range between 25°C and 35°C, and for up to 5 hours at 40°C. Continuous infusion of generic meropenem Hospira may be applied in clinical settings with ambient temperature below 35°C, provided that the 5 mg/mL aqueous solution is reconstituted at most after 6-8 hours.
持续输注给药可能是美罗培南治疗多重耐药革兰氏阴性菌相关感染的一种有效手段。目前，尚无关于美罗培南通用生物等效剂型随时间变化的化学稳定性数据。采用高效液相色谱技术，在4个不同日期对Hospira公司生产的一种美罗培南通用制剂的5 mg/mL溶液的一式三份样品在升高温度（25°C、30°C、35°C和40°C）下进行化学稳定性评估。美罗培南通用制剂的降解既取决于时间也取决于温度，其水溶液在25°C至35°C的温度范围内最多可稳定8小时，在40°C时最多可稳定5小时。如果5 mg/mL的水溶液最多在6 - 8小时后重新配制，那么在环境温度低于35°C的临床环境中可以应用Hospira公司生产的美罗培南通用制剂进行持续输注。
