Comparative Stability and Quality Assessment of Powder-Liquid Double-Chamber Bag Versus Traditional Meropenem Infusions: Implications for Critical Care and Individualized Dosing.

Background

Maintaining therapeutic meropenem plasma concentrations requires prolonged infusion, but stability concerns exist between preparation and administration. This study compared the stability and operability of ready-to-use powder-liquid double-chamber bag (DCB) infusions versus traditional powder-for-injection (PFI) meropenem under clinical conditions.

Methods

Infusions at clinically relevant concentrations were stored at 2-8 °C, 25 ± 5 °C, and 40 ± 2 °C for 12 h. Stability assessments included appearance, pH, osmolality, insoluble particle count, meropenem content (HPLC), and impurity A level.

Results

DCBs demonstrated superior content uniformity, significantly fewer insoluble particles (p < 0.05), and greater operational simplicity compared to PFI. Refrigeration maintained meropenem content > 95% and effectively suppressed impurity formation for up to 12 h. However, at both room temperature and elevated temperature, impurity A exceeded pharmacopoeial limits within 2 h, particularly at higher concentrations. An innovative bedside solvent volume adjustment method enabled DCBs to deliver high-concentration infusions, facilitating individualized critical care dosing.

Conclusions

Compared with traditional powder injection formulations, the Meropenem powder-liquid dual-chamber bag offers more convenient operation under routine preparation conditions and poses a lower risk of contamination during the preparation process. Its stability is more sensitive to storage temperature, requiring strict adherence to refrigeration conditions. When stored under standardized conditions, the dual-chamber bag can better ensure drug efficacy stability and medication safety, making it particularly suitable for clinical emergency use and standardized workflow management.