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

Department of Pharmacy and Pharmacology, University of Bath, Bath BA2 7AY, UK

Graham Sewell

Department of Pharmacy, Kingston University, Kingston-on-Thames, KT1 2EE, UK, G.J.Sewell{at}kingston.ac.uk, Plymouth Hospitals NHS Trust, Plymouth PL6 8DH, UK

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

Design. 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 258C 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 particulatecounts, 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 258C. Additionally, the infusions were stable following return to refrigerated storage again for at least 7 days.

Conclusion. This study has demonstrated extended stability of carboplatin infusions which enables batch-scale preparation of standard infusions for dose-J Oncol Pharm Practice (2007) 13: 119–126.

Key Words: carboplatin • dose-banding • sequential temperature • stability

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				S. Kaestner and G. Sewell Dose-banding of carboplatin: rationale and proposed banding scheme Journal of Oncology Pharmacy Practice, June 1, 2007; 13(2): 109 - 117. [Abstract] [PDF]