Stability of daptomycin in peritoneal dialysis solutions packaged in dual-compartment infusion bags

Abstract

BackgroundIntraperitoneal daptomycin is used for the treatment of peritoneal dialysis (PD)-associated peritonitis caused by vancomycin-resistant bacteria. This study investigated the stability of daptomycin in a pH-neutral PD solution.MethodsReconstituted solution of daptomycin was added to a total of nine PD bags to obtain a concentration of 20 mg/L and stored at 1 of 3 different temperatures: 4 or 25°C for up to 168 h or 37°C for up to 48 h. Stabilities were determined by visual inspection, pH measurement and high-performance liquid chromatography.ResultsDaptomycin retained more than 90% of its initial concentration for 120, 72 and 12 h at 4°C, 25°C and 37°C, respectively. No physical precipitation or pH change was observed during the study.ConclusionsDaptomycin in a pH-neutral PD solution is physically and chemically stable for 120 and 12 h at 4°C and 37°C, respectively.

Stability and compatibility of intraperitoneal antimicrobials in peritoneal dialysate solutions

“…Physical incompatibility was reported with anidulafungin in Extraneal and Dianeal 21 and with daptomycin in Balance solution. 23…”

“…In all studies except one, 25 the drug stability was assessed in a PD solution that was contained either in the polyvinyl chloride (PVC) or polyolefin bag. A stabilityindicating assay was utilised in 33% of the studies (n = 7), 12,13,19,23,28,29,31 and an antimicrobial activity assay was reported in 24% of the studies (n = 5). 15,20,22,26,27 Table 1 lists the stability data of b-lactam antimicrobial agents assessed as a single additive to various PD solutions.…”

“…12,14,20 Table 2 lists single non-b-lactam antimicrobial agents in various PD solutions. 11,13,14,16,18,[21][22][23][24][25][26][27][28] All included non-blactam agents were stable for 7-14 days if stored in a refrigerator except daptomycin which was stable for up to 1 day and 5 days in Physioneal and unmixed Balance solutions, respectively. 25 Except for ciprofloxacin in Physioneal 1.36%, all agents were stable for at least 6 h both at room and body temperature in all the solutions studied.…”

“…Physical incompatibility was reported with anidulafungin in Extraneal and Dianeal 21 and with daptomycin in Balance solution. 23 The stability data of antimicrobial combination agents or antimicrobial agents mixed with heparin are listed in Table 3. 11,14,16,19,[29][30][31] Drug combinations did not cause All studied PD solutions were contained in a polyvinyl chloride bag except Balance which is contained in a polyolefin bag.…”

“…Of note, seven studies in this review utilised stability-indicating analytical methods and conducted partial stress testing with extremes in pH, elevated temperatures and/or oxidation. 12,13,19,23,28,29,31 Forced degradation/stress testing is a labour and time-intensive procedure. However, the use of a stability-indicating analytical method is essential to accurately and selectively quantitate the intact drug from degradation products and other solution components and to establish the degradation pathways and profiles.…”