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Potency and stability of compounded formulations of chlorambucil, melphalan and cyclophosphamide

Published Web Location

https://doi.org/10.1111/vco.12301
Abstract

Background

Oral chemotherapy agents are frequently compounded in veterinary medicine however, the potency of some formulations have been shown to vary from that of Food and Drug Administration (FDA)-approved products.

Aims

The objective of this study was to evaluate the potency and stability of three compounded oral chemotherapeutics commonly prescribed to be administered over time.

Materials & methods

Compounded chlorambucil 1 mg, cyclophosphamide 5 mg and melphalan 1 mg were obtained and for potency tested upon receipt and 6 weeks later.

Results

Potency ranged from 71 to 104% for chlorambucil and 58 to 109% for melphalan; 1/4 and 2/4 samples were <90% of labelled strength at baseline and 6 weeks, respectively, for both drugs. Potency of cyclophosphamide ranged from 92 to 107% with all samples +/-10% of labelled strength at all time points.

Discussion/conclusion

These results demonstrate variability of compounded chemotherapy products, and highlight the need to consider both potency and stability when prescribing orally compounded chemotherapy.

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