TCH-042 Stability Study of Ganciclovir in 0.9% Sodium Chloride in Different Types of Containers: Optimization of Resources

Background Ganciclovir is approved for the treatment of cytomegalovirus infections in patients with complications and for its prevention in recipients of solid organ transplants. This drug must be diluted by a hospital pharmacist. To our knowledge, there are no data about ganciclovir stability in two kinds of containers: polyolefin and polyethylene. Purpose To demonstrate the stability of ganciclovir sodium in 0.9% sodium chloride in two different types of containers: polyethylene [Ecoflac] and polyolefin [Viaflo]. It is very important to attribute a suitable expiry for this drug, prepared for infected hospital patients, in order to organise the work better and optimise the use of time and resources. Materials and Methods Twelve admixtures were prepared, six for every concentration (4.55 and 0.8 mg/mL), of ganciclovir sodium in 0.9% sodium chloride, stored at room temperature, at 4°C and −20°C (in darkness) in two type of containers, polyethylene and polyolefin. The admixtures were evaluated for up to 21 days at the three temperature conditions. To cheque the concentrations a UPLC-PDA method was developed. Results The method developed showed no interference peaks, and was reproducible and linear. There was no significant loss of ganciclovir during the study period. The drug at the concentrations considered showed no more than 5% of degradation during the analysis period in all the storage conditions. Moreover, there were no appreciable pH changes, and no evidence of visual incompatibility. Conclusions Ganciclovir sodium 4.55 mg/mL and 0.8 mg/mL in 0.9% sodium chloride in two different kind of bags (Viaflo and Ecoflac 100 mL) was visually and chemically stable for at least three weeks when stored at room temperature, 4°C and −20°C. No conflict of interest.