Stability of doripenem in polyvinyl chloride bags and elastomeric pumps

Abstract

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.

Stability of doripenem in reconstituted solution – thermal and oxidative decomposition kinetics and degradation products by LC–MS

“…In the drug formulation, doripenem has been estimated by instrumental techniques such as HPLC, UPLC, UV and derivative spectrophotometry and capillary electrophoresis (Cielecka‐Piontek & Jelinska, ; Mantovani et al, ; Paliosa, Garcia, Schapoval, Mendez, & Steppe, ; Reddy et al, ), all assays being developed through experimental protocols applied to analytical validation and investigating the stability‐indicating profile. Concerning stability, some studies have investigated the chemical decomposition of doripenem in reconstituted samples (Crandon, Sutherland, & Nicolau, ; Psathas, Kuzmission, Ikeda, & Yasuo, ; Reddy et al, ). Psathas et al () studied doripenem stability after reconstitution testing of different solutions such as 0.9% sodium chloride and 5% dextrose, at room temperature and under refrigerated conditions.…”

Systematic review of stability data pertaining to selected antibiotics used for extended infusions in outpatient parenteral antimicrobial therapy (OPAT) at standard room temperature and in warmer climates

“…Results in table 3 show stability data for carbapenems do not meet our three criteria. Stability up to 12–16 hours was demonstrated, with two studies showing stability of doripenem for 24 hours 31 32. However, neither study reported sequential data after refrigeration and are therefore not useful in the OPAT setting.…”

Microwave freeze-thaw technique of injectable drugs. A review from 1980 to 2014

“…MFTT was not applied. Contrariwise, Doripenem [70], ertapenem [71] and meropenem [72] (carbapenems, J01DH) do not support freezing. Imipenem was not tested but meet probably the same characteristics.…”