A sequential temperature cycling study for the investigation of carboplatin infusion stability to facilitate 'dose-banding'

To determine the physical and chemical stability of carboplatin infusion for dosebanding, with cycling between refrigerated storage and room temperature in-use conditions.

A sequential study design was selected to closely simulate the temperatures and conditions experienced by drug infusions in pharmaceutical storage and in clinical use. Carboplatin infusions, 0.70 and 2.15 mg/mL, were stored refrigerated for up to 84 days, followed by incubation at 25degreesC for 24 h. The infusions were also returned to refrigerated storage for 3 and 7 days, to replicate a situation in which returned, unused infusions are kept for re-issuing. On pre-determined time-points, infusion chemical and physical stability were determined by HLPC, sub-visual particulate counts, pH-measurement, and weighing of infusions.

Light protected carboplatin infusions at both study concentrations were chemically and physically stable following refrigerated storage for 84 days, followed by a further 24 h under 'in-use' conditions at 25degreesC. Additionally, the infusions were stable following return to refrigerated storage again for at least 7 days.

This study has demonstrated extended stability of carboplatin infusions which enables batch-scale preparation of standard infusions for dose-banding schemes.