Sufentanil citrate is available as a 50-mcg/mL preservative-free solution in 1-, 2-, and 5-mL ampuls and vials.3967; 3968 Each mL of solution contains sufentanil citrate equivalent to 50 mcg of sufentanil base in water for injection.3967; 3968 Sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment.3968
pH
Trade Name(s)
Sufenta
Sufentanil citrate is administered by slow intravenous injection or intravenous infusion, or by epidural injection.3967
Intact containers should be stored at controlled room temperature and protected from light.3967 The manufacturer states vials should be retained in the carton until time of use.3968
pH Effects
Sufentanil citrate is hydrolyzed in acidic solutions. A 5-mcg/mL solution with a pH greater than 3 lost less than 1% in 48 weeks at 90°C. However, at a pH of less than 2, the drug loss was 14% at 60°C and 32% at 90°C in 48 weeks.1755
Freezing Solutions
Sufentanil citrate (Janssen) 5 mcg/mL in sodium chloride 0.9% became nonhomogeneous and difficult to restore to homogeneity when frozen at -20°C.1755
Syringes
Sufentanil citrate (Janssen) 2 mcg/mL in sodium chloride 0.9% was packaged in 50-mL polypropylene syringes (Omnifix, B. Braun) and stored at 21°C. Less than 10% sufentanil loss occurred in 24 hours.2201
Ambulatory Pumps
Sufentanil citrate 50 mcg/mL was evaluated in CADD-1 and CADD-PRIZM medication cassettes. About 4% drug loss occurred in 14 days at room and refrigeration temperatures.2717
Sorption
Sufentanil citrate (Janssen) demonstrated loss from solutions in concentrations from 1 to 20 mcg/mL due to sorption to polyvinyl chloride (PVC)/Kalex 3000 reservoirs for use with CADD pumps (Pharmacia Deltec) and administration tubing.790
Sufentanil citrate (Janssen) 2 mcg/mL in sodium chloride 0.9% was delivered from 50-mL polypropylene syringes (Omnifix, B. Braun) by a syringe pump (JMS-Syringe-Pump Model SP-100, Japan Medical Supply Company) through polyethylene extension sets (Original-Perfusor-Leitung, Type PE, B. Braun) or PVC extension sets (Original-Perfusor-Leitung, Type N, B. Braun), 0.2-µm epidural filters (Sterifix, B. Braun), and epidural catheters (Perifix, B. Braun) over 24 hours. The pump, syringes, and extension sets were kept at 21°C while the filters and epidural catheters were kept at 36°C. Running at 1 mL/hr, the delivered sufentanil concentration using PVC tubing was about 7 to 10% below the theoretical concentration throughout 24 hours. Using polyethylene tubing, losses were about 16% initially but the concentration returned to expected levels within 1 to 2 hours and remained stable throughout the 24-hour delivery.2201
Filtration
Sufentanil citrate (Janssen) 50 mcg/10 mL in sodium chloride 0.9% was evaluated for drug loss when administered through filters or epidural catheters; 2.5-g cellulose acetate/cellulose nitrate 0.2-µm filters (Millex, Millipore) were utilized. Approximately 20% of the sufentanil was lost to the void volume and/or adsorption. This loss should be considered when a new filter is used.1667
Sufentanil citrate (Janssen) 2 mcg/mL in sodium chloride 0.9% delivered at 1 mL/hr through 0.2-µm epidural filters (Sterifix, B. Braun) during the first hour was 83% of the theoretical concentration and remained at reduced concentrations of 85 to 89% of theoretical through at least 6 hours. By 24 hours the concentration was near 96% of theoretical. The authors attributed the lower concentrations to sorption of sufentanil onto the filter.2201
In addition, sufentanil citrate (Janssen) demonstrated varying amounts of loss from solutions in concentrations ranging from 1 to 20 mcg/mL due to sorption to several filters including Millex-OR, Minisart NML, Schleicher & Schuell FP 30/3, and Sterifix EF.790
Sufentanil citrate was found to undergo sorption to 0.22-µm polyamide epidural filters (Perifix, Braun Melsungen). Delivery of a 5-mcg/mL solution through the filter resulted in nearly total loss of the drug from the first mL. 3 mL had to be passed through the filter before the delivered drug concentration was near the original concentration.2545
For a list of references cited in the text of this monograph, search the monograph titled References.