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Background <p>Bivalirudin is the preferred anticoagulant for pediatric ventricular assist device (VAD) patients. The manufacturer only permits the diluted drug to be used for 24&#xa0;h once mixed with the sterile solutions. Most infants on VAD require much less than a single infusion bag in 24&#xa0;h and any remaining infusion at 24&#xa0;h must be discarded, resulting in increased medication waste and health care costs. The objective of this study was to examine the effect of storage containers and temperature on the stability and activity of intravenous (IV) bivalirudin solutions. </p> Results <p>Diluted bivalirudin (AngioMax®) IV solutions (1 and 5&#xa0;mg/mL in dextrose 5% in water) were prepared in bags and syringes and stored at room temperature and at 2–8&#xa0;°C. Bivalirudin concentrations were determined at different time points. Bivalirudin activity was determined by assessing its anticoagulating effect on human plasma via partial thromboplastin time (PTT) prolongation. Results suggest that a compounded bivalirudin infusion solution maintains its therapeutic activity and stability at room temperature for up to 48&#xa0;h.</p> Conclusions <p>Data suggest that bivalirudin solutions in dextrose 5% in water and protected from light are potentially stable at room temperature for up to 48&#xa0;h. Further studies are needed to confirm our study findings.</p>

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Extended stability of bivalirudin in intravenous solutions

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年7月7日

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  • Sherif Hanafy Mahmoud,
  • Forugh Sanaee,
  • Jenna Smith,
  • Lindsay Ryerson,
  • Mary Bauman,
  • Yvonne Rees,
  • Elona Turley,
  • Rashid Alobaidi,
  • Marcel Romanick,
  • Afsaneh Lavasanifar

摘要

Background

Bivalirudin is the preferred anticoagulant for pediatric ventricular assist device (VAD) patients. The manufacturer only permits the diluted drug to be used for 24 h once mixed with the sterile solutions. Most infants on VAD require much less than a single infusion bag in 24 h and any remaining infusion at 24 h must be discarded, resulting in increased medication waste and health care costs. The objective of this study was to examine the effect of storage containers and temperature on the stability and activity of intravenous (IV) bivalirudin solutions.

Results

Diluted bivalirudin (AngioMax®) IV solutions (1 and 5 mg/mL in dextrose 5% in water) were prepared in bags and syringes and stored at room temperature and at 2–8 °C. Bivalirudin concentrations were determined at different time points. Bivalirudin activity was determined by assessing its anticoagulating effect on human plasma via partial thromboplastin time (PTT) prolongation. Results suggest that a compounded bivalirudin infusion solution maintains its therapeutic activity and stability at room temperature for up to 48 h.

Conclusions

Data suggest that bivalirudin solutions in dextrose 5% in water and protected from light are potentially stable at room temperature for up to 48 h. Further studies are needed to confirm our study findings.