A sequential temperature cycling study for the investigation of carboplatin infusion stability to facilitate 'dose-banding'.
OBJECTIVE
To determine the physical and chemical stability of carboplatin infusion for dosebanding, with cycling between refrigerated storage and room temperature in-use conditions.


METHODS
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.


RESULTS
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.


CONCLUSIONS
This study has demonstrated extended stability of carboplatin infusions which enables batch-scale preparation of standard infusions for dose-banding schemes.
Kaestner
Sabine
S
Department of Pharmacy and Pharmacology, University of Bath, Bath BA2 7AY, UK.
Sewell
Graham
G
D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000737:chemistry; D016190:Carboplatin / Q000008:administration & dosage* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005947:Glucose / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D007262:Infusions, Intravenous; D008027:Light; D013696:Temperature
D000970:Antineoplastic Agents; D016190:Carboplatin; D005947:Glucose