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• W2052153490 abstract "To the Editor: Sufentanil, an opioid analgesic and an analogue of fentanyl, is used for the induction and maintenance of anesthesia and for postoperative analgesia.1.Monk J.P Beresford R Ward A Sufentanil. A review of its pharmacological properties and therapeutic use.Drugs. 1998; 36: 286-313Crossref Scopus (94) Google Scholar It also can be used for intraspinal administration. In the latter approach, it can be combined with local anesthetics, such as levobupivacaine, the S(-)-enantiomer of the long-acting local anesthetic bupivacaine. This enantiomer is less cardiotoxic than the racemic bupivacaine.2.McClellan K.J Spenser C.M Levobupivacaine. Drugs. 1998; 56: 355-362Crossref Scopus (62) Google Scholar Advance preparation of a solution could be useful to improve security, time management, and quickness of drug delivery to the hospital floor prior to administration.3.Galanti L.M Hecq J.D Vanbeckbergen D et al.Long-term stability of cefuroxime and cefazolin sodium in intravenous solutions.J Clin Pharm Ther. 1996; 21: 185-189Crossref PubMed Scopus (26) Google Scholar, 4.Galanti L.M Hecq J.D Vanbeckbergen D et al.Long-term stability of vancomycin hydrochloride in intravenous solutions.J Clin Pharm Ther. 1997; 22: 353-356Crossref PubMed Scopus (11) Google Scholar, 5.Galanti L.M Hecq J.D Vanbeckbergen D Jamart J Assessment of the stability of teicoplanin in intravenous infusions.Int J Pharmaceutical Compounding. 2001; 5: 397-400PubMed Google Scholar Although the stability of mixtures of sufentanil and bupivacaine has been studied,6.Brouwers J.R.B.J van Doorne H Meevis R.F Boersma F.P Stability of sufentanil citrate and sufentanil citrate/bupivacaine mixture in portable infusion pump reservoirs.EHP. 1995; 1: 12-14Google Scholar, 7.Farhang-Asnefi S Barra J Callaert S et al.Compatibilité et stabilité du mélange bupivacaine-sufentanil en poche.J Pharm Clin. 2000; 19: 248-251Google Scholar, 8.Roos P.J Glerum J.H Meilink J.W Zwang L Effect of pH on absorption of sufentanil citrate in a portable pump reservoir during storage and administration under simulated epidural conditions.Pharm World Science. 1993; 15: 139-144Crossref PubMed Scopus (9) Google Scholar, 9.Roos P.J Glerum J.H Schroeders M.J.H Effect of glucose 5% solution and bupivacaine hydrochloride on absorption of sufentanil citrate in a portable pump reservoir during storage and simulated infusion by an epidural catheter.Pharm World Science. 1993; 15: 269-275Crossref PubMed Scopus (16) Google Scholar few data are available about mixtures of sufentanil and levobupivacaine. The aim of this study was to investigate how storage at 4°C may affect the stability of such a mixture in polyvinyl chloride (PVC) bags. Commercially available ampoules of 75 μg sufentanil citrate (Sufenta Forte, Janssen-Cilag, Beerse, Belgium) and levobupivacaine 7.5 mg (Chirocaine, Ottignies, Belgium) mixed together in a laminar-airflow hood were added to 500 mL Viaflex bags containing 0.9% sodium hydrochloride (Baxter, Lessines, Belgium) to produce solutions containing approximately 500 μg of sufentanil and 625 mg of levobupivacaine. Commercially available ampoules of 7.5 μg sufentanil citrate and levobupivacaine were used for extemporaneous preparation of one level the standard solution (0.2 mg/mL). A modular high-performance liquid chromatographic system (Waters Associates, Milford, Massachusetts, USA) consisting of a W600 pump, a W717 autosampler, an ultraviolet detector DAD 996, and a data acquisition and processing module (Millenium 32 Chromatograph Manager) was used. Other equipment included a Lichrosorb (Varian, Middelburg, The Netherlands) precolumn (10 × 2 mm, ref CP28141) and column (100 × 3 mm, 7μ, ref CP28296). The mobile phase contained 18% (v/v) acetonitrile (REF 9017, Baker, The Netherlands) in tetrabutyl ammonium hydrogen sulfate (TBAHS) buffer 0.03 M pH 3.00 ± 0.05 (Sigma, USA). All solvents were prepared from HPLC-grade solvents and purified water (Milli-Q, Millipore, Brussels, Belgium). The flow rate was 0.6 mL/min and the HPLC system was operated at 30°C. The wavelength was set at 235 nm for sufentanil and 260 nm for levobupivacaine. The within-day and between-day reproducibility was 3.3% and 2.2% for sufentanil citrate and 0.6% and 0.8% for levobupivacaine, respectively. Sufentanil and levobupivacaine concentrations followed a linear relationship (r ≥ 0.99) in the range of 0.24 μg/mL to 5 μg/mL sufentanil and 0.125 mg/mL to 2.5 mg/mL levobupivacaine. The sufentanil–levobupivacaine mixture degraded by heating at 100°C for 15, 30, and 60 minutes under initial (pH 4.86), acidic (pH 0.87, HCl), and basic (pH 12.0, NaOH) conditions was assayed to confirm separation of the parent molecule from its degradation products. In all conditions, the decomposition products peaks were resolved from the peak corresponding to the intact drug. The pH of solutions was measured with a glass electrode pH meter (pH meter Inolab, WTW, Weilheim, Germany). Five PVC bags of solution containing 500 μg of sufentanil and 625 mg of levobupivacaine hydrochloride per 500 mL of 0.9% sodium chloride solution were prepared, agitated, and stored for 2 months at 4°C. Immediately after preparation of bags (Day 0), and after 1, 2, 3, 4, 6, 7, 10, 11, 14, 16, 17, 21, 23, 28, 35, 43, 42, 44, 49, 51, 56, and 58 days of storage, 2 mL of solution were withdrawn from each bag by means of a 2 mL polypropylene plastic syringe (Terumo, Haasrode, Belgium) and were placed in glass containers. The admixture was visually inspected and the pH measured. The concentration of the two drugs was determined in triplicate on each bag. A 10 μL quantity for sufentanil and 50 μL quantity for levobupivacaine of the assay solution, as well as standard solution, were injected into the chromatograph. Results were automatically calculated by interpolation of a single-level calibration curve (linear through zero) performed with Millenium software; a least squares fit of response (peak high) versus standard concentration was used in the calculations. Data are expressed as the mean ± SD. Drug concentration and pH were followed as a function of time. The drug solutions were considered stable as long as the 95% lower confidence limit of the estimated regression line of the concentration-time profile remained above 90% of the initial concentration as recommended by the U.S. Food and Drug Administration.10.Guideline for submitting documentation for the stability of human drugs and biologics. Food and Drug Administration, Rockville, MD1987www.fda.gov/cder/guidance/cmc2.pdfGoogle Scholar No color change or precipitation was observed in the analgesic admixture during the long-term storage at 4°C. Using chromatographic conditions described above, the retention time was approximately 4 min for sufentanil and 1.9 min for levobupivacaine. Statistical analysis demonstrated a significant modification (P < 0.001) in the pH values of solutions under storage (Figure 1). However, the slight pH decrease did not affect chromatographic parameters and remained in acceptable range for perfusion. The initial concentration of the admixture and the changes that took place over subsequent days under storage are shown in Table 1. Statistical analysis showed a significant decrease in levobupivacaine concentration (P<0.001) but no significant modification in sufentanil concentration (P = 0.362) under storage. The lower 95% confidence limit of the estimated common regression line remained above the 90% of the initial concentration at least until day 58.Table 1Stability of Sufentanil Citrate and Levobupivacaine Hydrochloride in 500 mL 0.9% Sodium Chloride PVC BagsConcentrationInitial Concentration (100%)Sufentanil Citrate (1μg/mL) 1.046 ± 0.018 (μg/mL)Levobupivacaine HCl (1.25 mg/mL) 1.215 ± 0.007 (mg/mL)Storage Time at 4°C (days)Percentage of Initial Concentration (%)95% Lower Confidence LimitPercentage of Initial Concentration (%)95% Lower Confidence Limit1100.799.499.399.0298.597.499.299.03100.099.199.299.0497.997.5--6--99.298.9798.397.899.198.910--99.198.911--99.098.914--99.098.81699.298.398.998.81799.698.6--2197.997.298.898.72398.097.598.898.62898.997.698.798.53597.596.798.598.342--98.498.14498.897.9--49--98.297.95199.598.798.297.956--98.197.75899.698.898.097.7 Open table in a new tab In conclusion, sufentanil citrate (500 μg) with levobupivacaine hydrochloride (625 mg) in 0.9% sodium chloride injection 500 mL in PVC infusion bags may be prepared in advance by a centralized intravenous admixture service and stored for 58 days at 4°C without major changes affecting concentration." @default.
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• W2052153490 title "Long-term stability of sufentanil citrate with levobupivacaine hydrochloride in 0.9% sodium chloride infusion PVC bags at 4° C" @default.
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