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Stability of trisodium citrate and gentamicin solution for catheter locks after storage in plastic syringes at room
Dennis Cote1, Charmaine E Lok, Marisa Battistella
1, BSc(Pharm), MSc, PhD, is an Instructor with the Faculty of Pharmacy, University of Manitoba, Winnipeg, Manitoba.
Insights
A stable gentamicin-citrate catheter lock solution can be prepared in advance for hemodialysis patients. This advance preparation of the antibiotic and anticoagulant lock solution helps prevent catheter-related infections and maintain catheter patency.
Area of Science:
- Pharmacology
- Infectious Diseases
- Nephrology
Background:
- Catheter-related infections pose significant risks for hemodialysis patients relying on central venous catheters.
- Catheter lock solutions, often containing anticoagulants, are crucial for maintaining catheter patency between treatments.
- Antibiotic-infused lock solutions show promise in reducing infection rates and managing colonized catheters, potentially avoiding catheter replacement.
Purpose of the Study:
- To assess the stability and potency of an extemporaneously prepared gentamicin-citrate catheter lock solution over time.
- To determine if this combined solution allows for advance preparation, simplifying clinical workflows.
Main Methods:
- Aseptic preparation of three catheter lock solutions: gentamicin alone, citrate alone, and a combination of gentamicin and citrate.
- Packaging of solutions in polyethylene syringes and storage at room temperature.
- Analysis of samples using validated high-performance liquid chromatography at 112-day intervals.
Main Results:
- No degradation was observed in any of the three lock solutions over the 112-day study period.
- The combined gentamicin (2.5 mg/mL) and sodium citrate (40 mg/mL) solution maintained consistent concentrations of both agents.
- Over 98% of gentamicin and 99% of citrate remained in the combined solution at day 112, indicating excellent stability.
Conclusions:
- Extemporaneously compounded gentamicin-citrate catheter lock solutions are stable for advance preparation.
- This stable formulation supports clinical use, offering a reliable method for pharmacies to prepare solutions ahead of time.
- The findings facilitate the use of a stable gentamicin-citrate lock solution, enhancing patient care in hemodialysis.
Background:
Catheter-related infections are a major problem for hemodialysis patients with central venous catheters for vascular access. Catheter lock solutions containing an anticoagulant are used to maintain the patency of the catheter between hemodialysis sessions. There is evidence that the use of lock solutions containing an antibiotic is associated with lower rates of infection but also that these solutions can kill microbes in colonized catheters and thus avoid the risks and costs associated with replacing the catheter.
Objective:
This stability study was conducted to determine whether an extemporaneously prepared gentamicin-citrate catheter lock solution would retain its potency over time, thus allowing for advance preparation of the solution.
Methods:
Catheter lock solutions containing gentamicin alone, citrate alone, and the combination of gentamicin and citrate were prepared aseptically and packaged in polyethylene syringes. The syringes were stored at room temperature. At timed intervals over 112 days, samples were withdrawn for analysis by means of validated high-performance liquid chromatography.
Results:
None of the 3 lock solutions showed any evidence of degradation during the 112-day observation period. In the formulation containing both gentamicin 2.5 mg/mL and sodium citrate 40 mg/mL (4%), there was no change in the concentration of either gentamicin (p = 0.34) or citrate (p = 0.55). Linear regression analysis of the concentration-time data for the combined formulation showed that 99.97% of the labelled amount of gentamicin and 101.30% of the labelled amount of citrate remained at day 112. The lower limit of the 95% confidence intervals indicated that more than 98.17% of the gentamicin and more than 99.57% of the citrate remained on day 112.
Conclusion:
The results of this study will allow pharmacies to extemporaneously compound the combined gentamicin-citrate catheter lock solution in advance of use. The method described here will yield a stable product for use in clinical applications.
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