Long-Term Stability of Trimix: A Three-Drug Injection Used to Treat Erectile Dysfunction.
Author(s): Trissel Lawrence A, Zhang Yanping
Issue: May/Jun 2004 - Andropause
View All Articles in Issue
Page(s): 231-235
Download in electronic PDF format for $75
Abstract: A three-drug injection mixture of alprostadil 12.5 µg/mL, papaverine hydrochloride 4.5 mg/mL and phentolamine mesylate 0.125 mg/mL in bacteriostatic 0.9% sodium chloride injection was evaluated for stability at 23°C, 4°C, -20°C and -70°C. The injection remained clear and colorless in all samples throughout the study. Chemical stability testing was performed using stability-indicating high-performance liquid chromatographic analysis. Alprostadil was the least stable of the drug components at room temperature and under refrigeration. About 8% alprostadil loss occurred in five days at room temperature; under refrigeration losses of about 6% and 11% occurred after 1 and 2 months, respectively. Frozen at -20°C and -70°C, less than 5% loss of any of the drug components occurred in 6 months.
A beyond-use date of 6 months when stored frozen at -20°C and 1 month when stored refrigerated at 4°C is appropriate for batches of the injection that have passed sterility testing. Room temperature exposure should be limited, and the vial should be returned to refrigeration as soon as possible.Related Keywords: Erectile dysfunction, Trimix, alprostadil, papaverine hydrochloride, phentolamine mesylate, prostaglandin
Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS