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Stability of Commonly Used Antibiotic Solutions in an Elastomeric Infusion Device

机译:弹性输注设备中常用抗生素溶液的稳定性

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Background: The Accufuser silicone-based elastomeric infusion device has recently been approved for die Canadian market.Objective: To evaluate die stability of 5 antibiotics (cefazolin, ceftazidime, ceftriaxone, clindamycin, and vancomycin) in either 5% dextrose in water (D5W) or 0.9% sodium chloride in water (NS) after storage in Accufuser disposable silicone balloon infusers.Methods: The study drugs were reconstituted, according to the manufacturers' directions, in polyvinyl chloride minibags with either D5W or NS, at 2 different concentrations. The resulting solutions were transferred to disposable silicone balloon infusers for storage at 4degC or at room temperature (23degC). The concentration of each drug in each solution was determined by validated stability-indicating liquid chromatographic methods after storage for 14 to 31 days.Results: Solutions of ceftriaxone in either diluent retained more than 95.2% of the initial concentration for 2 days at room temperature and more than 91.6% of the initial concentration for 14 days at 4degC. Solutions of cefazolin in D5W or NS retained more than 90% of the initial concentration for at least 3 days at room temperature and for at least 26 days at 4degC. Solutions of ceftazidime in D5W or NS retained more than 90% of the initial concentration for only 1 day when stored at room temperature and for at least 4 days at 4degC. Solutions of clindamycin or vancomycin in D5W or NS retained 90% of the initial concentration for at least 7.5 days at room temperature and at least 90% of the initial concentration for at least 27.8 days at 4degC.Conclusions: Previously reported expiration dates for solutions stored in elastomeric infusion devices were not based on 95% confidence intervals and were often longer than expiration dates determined from the studies reported here, which are based on 95% confidence intervals. Comparison of the observed concentrations remaining between previously published studies and the studies reported here indicates that the Accufuser elastomeric infusion device did not adversely affect the stability of these drugs.
机译:背景:基于Accufuser有机硅的弹性体输注设备最近已获准进入加拿大市场目的:评估在5%葡萄糖水溶液(D5W)中的5种抗生素(头孢唑啉,头孢他啶,头孢曲松,克林霉素和万古霉素)的模头稳定性方法:将研究药物根据制造商的指示,在装有D5W或NS的聚氯乙烯微型袋中以2种不同浓度重新配制。将所得溶液转移至一次性有机硅球囊浸泡器中,以在4℃或室温(23℃)下储存。储存14至31天后,通过验证的稳定性指示液相色谱法确定每种溶液中每种药物的浓度。结果:两种溶液中头孢曲松的溶液在室温下保留2天的初始浓度均超过初始浓度的95.2%。在4℃下放置14天,超过初始浓度的91.6%。头孢唑林在D5W或NS中的溶液在室温下至少保留3天,在4℃保留至少26天,保持超过初始浓度的90%。头孢他啶在D5W或NS中的溶液在室温下保存仅1天,在4℃下至少保存4天,保留超过初始浓度的90%。 D5W或NS中的克林霉素或万古霉素溶液在室温下至少7.5天保持初始浓度的90%,在4°C下至少27.8天保持初始浓度的90%。结论:先前报告的储存溶液的失效日期弹性体输注设备中的“有效期”并非基于95%的置信区间,并且通常比根据此处报告的研究(基于95%的置信区间)确定的失效日期更长。比较先前发表的研究与此处报道的研究之间剩余的观察到的浓度,结果表明Accufuser弹性体输注设备不会对这些药物的稳定性产生不利影响。

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