PURPOSE: The stability of doripenem 500 and 1000 mg in polyvinyl chloride (PVC) bags and elastomeric pumps at various storage temperatures was evaluated. METHODS: Commercially available doripenem vials were reconstituted and mixed with either 0.9% sodium chloride injection or 5% dextrose injection to produce 100-mL solutions with concentrations of 5 and 10 mg/mL. Six replicate solutions in either PVC bags or elastomeric pumps were prepared. Bags were sampled immediately after preparation and stored at 25 degrees C, 4 degrees C, or -20 degrees C. Those stored at 25 degrees C were sampled for an additional 48 hours, and bags stored at 4 degrees C were sampled for 12 days. Bags frozen at -20 degrees C for 14-28 days were allowed to thaw at either 25 degrees C for 4-6 hours or 4 degrees C for 24 hours and sampled for an additional 48 hours. Solutions retaining > or =90% of the initial concentration were considered stable. RESULTS: At 25 degrees C, both concentrations were stable for 24 hours in 0.9% sodium chloride injection and for 16 hours in 5% dextrose injection. At 4 degrees C, 5-mg/mL solutions were stable for 10 days in both 0.9% sodium chloride injection and 5% dextrose injection, while 10-mg/mL solutions were stable for 10 days in 0.9% sodium chloride injection and 7 days in 5% dextrose injection. A white precipitate, which returned to solution by shaking, was noted after thawing the frozen containers. Whether thawed at 4 degrees C or 25 degrees C, both 5- and 10-mg/mL solutions were stable for 16 hours at 25 degrees C. CONCLUSION: Doripenem 5- and 10-mg/mL solutions were stable for 24 hours at 25 degrees C when diluted in 0.9% sodium chloride injection. When diluted in 5% dextrose injection, the stability of both concentrations of doripenem decreased to 16 hours at 25 degrees C. When stored at 4 degrees C, 5-mg/mL solutions in either 0.9% sodium chloride or 5% dextrose injection were stable for at least 10 days, and all solutions containing doripenem 10 mg/mL were stable for at least 7 days. Both concentrations of doripenem were stable for 16 hours when previously frozen and thawed at 25 degrees C and 4 degrees C. The rate of doripenem degradation was similar between PVC and elastomeric containers.
PURPOSE: The stability of doripenem 500 and 1000 mg in polyvinyl chloride (PVC) bags and elastomeric pumps at various storage temperatures was evaluated. METHODS: Commercially available doripenem vials were reconstituted and mixed with either 0.9% sodium chloride injection or 5% dextrose injection to produce 100-mL solutions with concentrations of 5 and 10 mg/mL. Six replicate solutions in either PVC bags or elastomeric pumps were prepared. Bags were sampled immediately after preparation and stored at 25 degrees C, 4 degrees C, or -20 degrees C. Those stored at 25 degrees C were sampled for an additional 48 hours, and bags stored at 4 degrees C were sampled for 12 days. Bags frozen at -20 degrees C for 14-28 days were allowed to thaw at either 25 degrees C for 4-6 hours or 4 degrees C for 24 hours and sampled for an additional 48 hours. Solutions retaining > or =90% of the initial concentration were considered stable. RESULTS: At 25 degrees C, both concentrations were stable for 24 hours in 0.9% sodium chloride injection and for 16 hours in 5% dextrose injection. At 4 degrees C, 5-mg/mL solutions were stable for 10 days in both 0.9% sodium chloride injection and 5% dextrose injection, while 10-mg/mL solutions were stable for 10 days in 0.9% sodium chloride injection and 7 days in 5% dextrose injection. A white precipitate, which returned to solution by shaking, was noted after thawing the frozen containers. Whether thawed at 4 degrees C or 25 degrees C, both 5- and 10-mg/mL solutions were stable for 16 hours at 25 degrees C. CONCLUSION:Doripenem 5- and 10-mg/mL solutions were stable for 24 hours at 25 degrees C when diluted in 0.9% sodium chloride injection. When diluted in 5% dextrose injection, the stability of both concentrations of doripenem decreased to 16 hours at 25 degrees C. When stored at 4 degrees C, 5-mg/mL solutions in either 0.9% sodium chloride or 5% dextrose injection were stable for at least 10 days, and all solutions containing doripenem 10 mg/mL were stable for at least 7 days. Both concentrations of doripenem were stable for 16 hours when previously frozen and thawed at 25 degrees C and 4 degrees C. The rate of doripenem degradation was similar between PVC and elastomeric containers.
Authors: Beatriz Fernández-Rubio; Paula Del Valle-Moreno; Laura Herrera-Hidalgo; Alicia Gutiérrez-Valencia; Rafael Luque-Márquez; Luis E López-Cortés; José María Gutiérrez-Urbón; Sonia Luque-Pardos; Aurora Fernández-Polo; María V Gil-Navarro Journal: Antibiotics (Basel) Date: 2021-12-30