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Published on: March 11, 2017
Stability of meropenem in polyvinyl chloride bags and an elastomeric infusion device
Douglas L Smith1, Stephen M Bauer, David P Nicolau
1Department of Pharmacy Practice, Bernard J. Dunn School of Pharmacy, Winchester, VA 22601, USA. dsmit3@su.edu
Purpose:
The stability of meropenem in i.v. solutions stored in polyvinyl chloride (PVC) bags and an elastomeric infusion device at concentrations commonly used in home care was studied.
Methods:
Vials of meropenem were reconstituted with sterile water for injection and mixed with 0.9% sodium chloride injection (NS) to yield concentrations of 4, 10, and 20 mg/mL. Six replicate solutions were prepared in PVC containers and six in the Homepump ECLIPSE elastomeric infusion device. All solutions were stored at an average temperature of 5 degrees C and sampled immediately after preparation and at intervals up to 120 hours (five days); the 4-mg/mL solution was also sampled at 144 and 168 hours (seven days). Samples were assayed for meropenem concentration by stability-indicating high-performance liquid chromatography.
Results:
All solutions of meropenem retained over 90% of the initial drug concentration at five days. The 4-mg/mL solutions retained over 93% of the initial concentration at seven days. The rate of meropenem decay did not differ significantly between PVC and elastomeric infusion containers for the 4- and 20-mg/mL solutions; however, there was a difference for the 10-mg/mL solutions.
Conclusion:
Meropenem 4 mg/mL in NS was stable for at least seven days in PVC bags and elastomeric infusion containers when stored at 5 degrees C, and meropenem 10 and 20 mg/mL in NS was stable for at least five days in both containers at 5 degrees C.
Insights
Meropenem is stable for up to seven days in intravenous solutions stored at 5°C in both polyvinyl chloride (PVC) bags and elastomeric infusion devices. This stability supports its use in home care settings.
Area of Science:
- Pharmaceutical Science
- Drug Stability
- Intravenous Infusion Therapy
Background:
- Meropenem is a broad-spectrum antibiotic commonly administered intravenously.
- Home infusion therapy requires stable drug formulations in various storage containers.
- Understanding meropenem stability in polyvinyl chloride (PVC) bags and elastomeric infusion devices is crucial for patient care.
Purpose of the Study:
- To evaluate the stability of meropenem in 0.9% sodium chloride injection (NS) at concentrations used in home care.
- To compare meropenem stability in PVC bags versus an elastomeric infusion device.
- To determine the maximum storage duration for meropenem solutions under specific conditions.
Main Methods:
- Meropenem solutions (4, 10, and 20 mg/mL in NS) were prepared and stored in PVC bags and an elastomeric infusion device at 5°C.
- Samples were analyzed immediately and up to 168 hours using stability-indicating high-performance liquid chromatography (HPLC).
- Drug concentrations were measured to assess meropenem degradation over time.
Main Results:
- All meropenem solutions maintained over 90% of initial concentration at five days.
- The 4-mg/mL solution retained over 93% concentration at seven days.
- No significant difference in meropenem decay was observed between PVC and elastomeric containers for 4- and 20-mg/mL solutions, but a difference was noted for the 10-mg/mL solution.
Conclusions:
- Meropenem 4 mg/mL in NS is stable for at least seven days in both PVC bags and elastomeric infusion containers at 5°C.
- Meropenem 10 and 20 mg/mL in NS are stable for at least five days in both container types at 5°C.
- These findings support the safe use of meropenem in home care settings with appropriate storage.
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