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Physical compatibility and chemical stability of amphotericin B in combination with magnesium sulfate in 5% dextrose
1College of Pharmacy, University of New Mexico, Albuquerque 87131.
Abstract:
The physical compatibility and chemical stability of amphotericin B for injection USP (AB) admixed with magnesium sulfate injection USP (MS) in 5% dextrose injection USP (D5W) was evaluated. AB (final concentration of either 40 or 80 micrograms/mL of solution) and MS (final concentration of 0, 2, or 4 mg/mL of solution) were mixed in glass volumetric flasks containing D5W. AB concentration, as quantitated by high-performance liquid chromatography, and visible admixture clarity were monitored at zero, three, and six hours after combining with MS. At the three-hour observation, visible admixture clarity appeared to decrease in all multiple drug combinations and a clear supernatant began to develop as particulates settled to the bottom of the container. MS (final concentration of 4 or 8 mg/mL of solution) and AB (final concentration of 80 micrograms/mL of solution) were prepared in two separate intravenous polyvinyl chloride bags of D5W. The solutions were manually set to infuse via gravity for six hours and mix at the y-site of an intravenous administration set. Samples of the mixture were collected from the terminal end of a primary intravenous administration set at zero, two, four, and six hours after beginning the infusions. Each sample appeared visibly clear and maintained an AB concentration of at least 100 percent of the initial admixture concentration. MS and AB mixed in the same container appeared to be physically incompatible. The same admixture appeared to be physically compatible and chemically stable, in terms of AB, when infused as separate solutions mixed at a y-site of an intravenous administration set.
Insights
Amphotericin B (AB) mixed directly with magnesium sulfate (MS) in dextrose is physically incompatible. However, infusing AB and MS solutions separately through a y-site maintains AB stability and compatibility.
Area of Science:
- Pharmaceutical Sciences
- Clinical Pharmacy
- Drug Compatibility Studies
Background:
- Amphotericin B (AB) is a critical antifungal medication.
- Magnesium sulfate (MS) is often administered intravenously.
- Assessing the compatibility of co-administered drugs is essential for patient safety.
Purpose of the Study:
- To evaluate the physical compatibility and chemical stability of amphotericin B (AB) when mixed with magnesium sulfate (MS) in 5% dextrose injection (D5W).
- To determine the optimal administration method for co-infusion of AB and MS.
Main Methods:
- AB and MS were admixed in D5W at various concentrations in glass flasks and PVC bags.
- Visual clarity and AB concentration (using HPLC) were monitored over time.
- Simulated Y-site co-infusion was performed and samples analyzed.
Main Results:
- Direct admixture of AB and MS in D5W resulted in decreased clarity and particulate formation within 3 hours.
- When infused separately via a Y-site, the admixture remained visibly clear.
- Amphotericin B concentration remained stable (≥100% of initial) throughout the 6-hour Y-site infusion study.
Conclusions:
- Direct physical mixing of amphotericin B and magnesium sulfate in dextrose is not recommended due to incompatibility.
- Co-infusion of separate amphotericin B and magnesium sulfate solutions via a Y-site is a physically compatible and chemically stable method for administration.