Related Experiment Videos
Stability of mitomycin admixtures
Abstract:
The stability of mitomycin in admixtures for continuous intravenous infusion was studied. Mitomycin was reconstituted and diluted to 50 micrograms/mL in polyvinyl chloride minibags containing 5% dextrose injection 50 mL or 0.9% sodium chloride injection 50 mL. Additional mitomycin admixtures were reconstituted with a buffer solution containing monobasic and dibasic sodium phosphate; these were diluted with 5% dextrose injection only. Admixtures were stored at room temperature (27-30 degrees C) and refrigerated temperature (5 degrees C) for 120 days. Mitomycin concentrations in each admixture were tested by high-performance liquid chromatography (HPLC) immediately after admixture and at intervals during storage. Ultraviolet spectra were determined at the same time as HPLC analysis, and the admixtures were visually inspected and tested for pH. Mitomycin concentrations decreased rapidly in the unbuffered admixtures; after 12 hours at room temperature, less than 26% of the drug remained in the dextrose admixture. When the unbuffered admixtures were refrigerated for 12 hours, the mitomycin concentrations decreased 10% in the sodium chloride admixtures and 33% in the dextrose admixtures; after 24 hours, the percentages of drug loss were 23% and 42%, respectively. Mitomycin concentrations in the buffered admixtures showed no substantial decrease during 120 days at 5 degrees C. At room temperature, concentrations decreased 10% after 15 days. When the admixture is buffered to a pH of approximately 7.8, mitomycin is stable in 5% dextrose injection for up to 15 days at room temperature and at least 120 days at 5 degrees C. Unbuffered mitomycin admixtures should not be stored or administered by prolonged i.v. infusion.
Insights
Mitomycin stability for intravenous infusion is enhanced by buffering. Buffered mitomycin in dextrose solution remains stable for 15 days at room temperature and 120 days refrigerated, unlike unbuffered solutions.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability Studies
- Intravenous Infusion Formulations
Background:
- Continuous intravenous infusion requires stable drug formulations.
- Mitomycin stability in common intravenous admixtures is not well-established.
- Understanding mitomycin stability is crucial for safe and effective administration.
Purpose of the Study:
- To evaluate the stability of mitomycin in admixtures for continuous intravenous infusion.
- To determine the impact of buffering and storage conditions on mitomycin stability.
- To provide guidelines for the preparation and storage of mitomycin infusions.
Main Methods:
- Mitomycin was reconstituted and diluted in 5% dextrose or 0.9% sodium chloride injections.
- Admixtures were prepared with or without a phosphate buffer solution.
- Stability was assessed by HPLC, UV spectroscopy, visual inspection, and pH testing under various storage conditions (room temperature and refrigeration) for up to 120 days.
Main Results:
- Unbuffered mitomycin admixtures showed rapid degradation, with less than 26% remaining after 12 hours at room temperature in dextrose.
- Refrigeration slowed degradation of unbuffered admixtures, but significant loss was still observed within 24 hours.
- Buffered mitomycin admixtures demonstrated excellent stability, with minimal degradation (<10%) over 120 days at 5°C and up to 15 days at room temperature (27-30°C).
Conclusions:
- Buffering mitomycin to a pH of approximately 7.8 significantly enhances its stability in 5% dextrose injection.
- Buffered mitomycin admixtures are suitable for prolonged storage and administration via continuous intravenous infusion.
- Unbuffered mitomycin admixtures are unstable and should not be used for prolonged infusions.