Carboplatin is available as a 10-mg/mL aqueous solution in 5-mL (50-mg), 15-mL (150-mg), 45-mL (450-mg), 60-mL (600-mg), and 100-mL (1-g) multidose vials.2939; 2940 In addition to water for injection, some products also contain mannitol 10 mg in each mL of solution.2939
pH
Carboplatin usually is administered by intravenous infusion over a period of 15 minutes or longer.2939; 2940 The drug also has been administered as a continuous intravenous infusion over 24 hours.2939; 2940 Manufacturers state that carboplatin solution may be diluted in dextrose 5% or sodium chloride 0.9% to a concentration as low as 0.5 mg/mL for administration.2939; 2940
Because of an interaction occurring between carboplatin and aluminum (resulting in precipitate formation and loss of drug potency), only administration equipment (e.g., needles, intravenous sets) that does not contain aluminum should be used for the preparation or administration of this drug.2939; 2940
Intact vials should be stored at controlled room temperature and protected from light.2939; 2940
Manufacturers state that reconstituted solutions are stable for 8 hours at room temperature (25°C).2939; 2940 Because no antibacterial preservative is present, the manufacturers recommend that carboplatin solutions for infusion be discarded 8 hours after dilution.2939; 2940 However, other information indicates that the drug may be stable for a much longer time. At a concentration of 15 mg/mL in sterile water for injection or at concentrations of 0.5 and 2 mg/mL in dextrose 5%, no decomposition occurred in 24 hours at 22 to 25°C.234
Formation of cisplatin in solutions of carboplatin 1 mg/mL in sodium chloride 0.9% at 25°C with exposure to fluorescent light was evaluated. Less than 0.1% of the carboplatin had converted to cisplatin in 2 hours, and 0.7% had converted in 24 hours.1695
Carboplatin 1 mg/mL in sterile water for injection was reported to exhibit less than 10% loss in 14 days at room temperature.1379
Carboplatin (Bristol-Myers Oncology) 1 mg/mL in sterile water for injection was stable in polyvinyl chloride (PVC) reservoirs (Parker Micropump) for 14 days at 4 and 37°C, exhibiting no loss.1696
Manufacturers state that carboplatin 10 mg/mL aqueous injection in multidose vials is stable for up to 14 days at 25°C, even with multiple needle entries.2939; 2940
pH Effects
The pH range of maximum stability has been reported to be pH 4 to 61919 or 6.5.1369 The degradation rate increases above pH 6.5.1369
Syringes
Carboplatin 10-mg/mL aqueous solution prefilled into plastic syringes exhibited no decomposition in 5 days at 4°C and only 3% loss in 24 hours at 37°C.1238
Carboplatin 10 mg/mL (Bristol-Myers Squibb) was repackaged into 30-mL polypropylene syringes for use in the Intelliject portable syringe pump. The carboplatin solution exhibited no visual changes, and no loss of carboplatin content was found when stored at 25°C for 8 days. No evidence of interaction between carboplatin and the syringe plastic was identified, and no impact on the functioning of the syringe pump was observed.2147
Sorption
Carboplatin (Ribosepharm) 0.72 mg/mL in dextrose 5% exhibited little or no loss due to sorption in polyethylene and PVC containers compared to glass containers over 72 hours at room and refrigeration temperatures.2420; 2430 Simulated infusion of carboplatin 10 mg/mL through a Silastic catheter over 24 hours at 37°C did not affect the delivered drug concentration.1238
For a list of references cited in the text of this monograph, search the monograph titled References.