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Published on: March 3, 2023
Stability of meropenem in normal saline solution after storage at room temperature
Sutep Jaruratanasirikul1, Somchai Sriwiriyajan
1Department of Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand. jasutep@ratree.psu.ac.th
Abstract:
The bactericidal activity of meropenem is determined by the time that concentrations in tissue and serum are above the MIC for the pathogens during the dosing interval. Thus, the most effective mode of administering of meropenem is continuous infusion. However, the stability of meropenem reconstituted in solution is influenced by the storage temperature. Until now we have had no data to evaluate the stability of this drug during continuous infusion in a tropical country. The objective of this study was to provide such data. Meropenem 0.5 g and 100 ml normal saline solution were mixed together and stored at room temperature for 8 hours. Half of the solution was stored in a room with air conditioning at 20 degrees C and the other half of the solution was stored in a room without air conditioning at 32 degrees-37 degrees C. The concentrations of meropenem in the solution were measured at 0, 1, 2, 3, 4, 6 and 8 hours after the drug was reconstituted. Twelve lots of (0.5 g meropenem in normal saline) solution were evaluated in each temperature condition. The mean meropenem concentrations reconstituted in normal saline solution decreased 1.66%, 3.31% and 5.80% after 2, 4 and 8 hours storage at 20 degrees C, respectively. Drug concentrations decreased 3.14%, 5.86% and 11.85% after 2, 4 and 8 hours storage at 32 degrees-37 degrees C, respectively. Therefore, we conclude that this agent should not be administered by 8-hour continuous infusion at room temperature in a tropical country.
Insights
Continuous infusion of meropenem is effective, but stability is temperature-dependent. This study found meropenem degrades significantly faster at tropical room temperatures (32-37°C) over 8 hours, making it unsuitable for prolonged infusion in such climates.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Infectious Diseases
- Clinical Pharmacy
Background:
- Meropenem's bactericidal activity relies on maintaining serum and tissue concentrations above the Minimum Inhibitory Concentration (MIC) for pathogens.
- Continuous infusion is an optimal administration method for meropenem to ensure sustained therapeutic levels.
- The stability of reconstituted meropenem solutions is critical for effective continuous infusion, particularly concerning storage temperature.
Purpose of the Study:
- To evaluate the stability of meropenem solutions during 8-hour continuous infusion under tropical environmental conditions.
- To provide crucial data on meropenem stability in warm climates, previously lacking for this administration method.
Main Methods:
- Meropenem (0.5 g) was reconstituted in 100 ml of normal saline.
- Solutions were stored for 8 hours at two temperatures: 20°C (air-conditioned) and 32-37°C (room temperature).
- Meropenem concentrations were measured at intervals (0, 1, 2, 3, 4, 6, 8 hours) using 12 solution lots per condition.
Main Results:
- At 20°C, meropenem concentrations decreased by 1.66%, 3.31%, and 5.80% after 2, 4, and 8 hours, respectively.
- At 32-37°C, meropenem concentrations decreased more rapidly: 3.14%, 5.86%, and 11.85% after 2, 4, and 8 hours, respectively.
- Higher temperatures significantly accelerated the degradation of meropenem in solution.
Conclusions:
- Meropenem administered via 8-hour continuous infusion is not stable at typical tropical room temperatures (32-37°C).
- The observed degradation suggests that continuous infusion of meropenem for 8 hours at room temperature in tropical climates may lead to sub-therapeutic drug levels.
- Refrigerated storage or alternative administration methods should be considered for meropenem in tropical regions to ensure treatment efficacy.
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