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头孢洛林在弹性输液装置中的物理和化学稳定性。

Physical and chemical stability of ceftaroline in an elastomeric infusion device.

作者信息

Al Madfai Farah, Zaidi Syed Tabish R, Ming Long Chiau, Wanandy Troy, Patel Rahul P

机构信息

Division of Pharmacy, School of Medicine, University of Tasmania, Hobart, Australia.

School of Pharmacy, KPJ Healthcare University College, Nilai, Malaysia.

出版信息

Eur J Hosp Pharm. 2018 Oct;25(e2):e115-e119. doi: 10.1136/ejhpharm-2017-001221. Epub 2017 Jul 24.

Abstract

BACKGROUND

Severe infections such as endocarditis and osteomyelitis require long-term treatment with parenteral antibiotics and hence prolonged hospitalisation. Continuous infusion of ceftaroline through elastomeric devices can facilitate early hospital discharge by managing parenteral antibiotics in patient's home. Therefore, the purpose of this study was to investigate the stability of ceftaroline in a commonly used elastomeric device.

METHOD

A total of 24 elastomeric devices were prepared, and six elastomeric devices containing 6mg/mL of ceftaroline (three in each type of diluents) were stored at one of the following conditions: 4°C for 6 days, 25°C for 24hours, 30°C for 24hours or 35°C for 24hours. An aliquot was withdrawn before storage and at different time points. Chemical stability was measured using a stability indicating high-performance liquid chromatography, and physical stability was assessed as change in pH, colour and particle content.

RESULTS

Ceftaroline, when admixed with both diluents, was stable for 144, 24 and 12hours at 4°C, 25°C and 30°C, respectively. At 35°C, ceftaroline admixed with normal saline (NS) and glucose 5% was stable for 12hours and for 6hours, respectively. No evidence of particle formation, colour change or pH change was observed throughout the study period.

CONCLUSIONS

Our findings support 12 or 24hours continuous elastomeric infusion of ceftaroline-NS admixture, and bulk preparation of elastomeric pumps containing ceftaroline solution in advance. This would facilitate early hospital discharge of patients eligible for the elastomeric-based home therapy and avoid the need for patient's caregivers travelling to the hospital on a daily basis.

摘要

背景

诸如心内膜炎和骨髓炎等严重感染需要长期使用胃肠外抗生素治疗,因此住院时间延长。通过弹性装置持续输注头孢洛林,可通过在患者家中管理胃肠外抗生素来促进早期出院。因此,本研究的目的是调查头孢洛林在常用弹性装置中的稳定性。

方法

共制备24个弹性装置,将6个含有6mg/mL头孢洛林的弹性装置(每种稀释剂各3个)储存在以下条件之一:4°C下保存6天、25°C下保存24小时、30°C下保存24小时或35°C下保存24小时。在储存前和不同时间点取出一份样品。使用稳定性指示高效液相色谱法测量化学稳定性,并通过pH值、颜色和颗粒含量的变化评估物理稳定性。

结果

头孢洛林与两种稀释剂混合后,在4°C、25°C和30°C下分别稳定144小时、24小时和12小时。在35°C下,与生理盐水(NS)和5%葡萄糖混合的头孢洛林分别稳定12小时和6小时。在整个研究期间未观察到颗粒形成、颜色变化或pH值变化的迹象。

结论

我们的研究结果支持对头孢洛林-NS混合物进行12或24小时的弹性装置持续输注,并预先批量制备含有头孢洛林溶液的弹性泵。这将有助于符合弹性装置家庭治疗条件的患者早期出院,并避免患者护理人员每天前往医院的需要。

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