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

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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.

Original languageEnglish (US)
Pages (from-to)1558-1563
Number of pages6
JournalVeterinary and Comparative Oncology
Volume15
Issue number4
DOIs
StatePublished - Dec 1 2017

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Chlorambucil
cyclophosphamide
Melphalan
Cyclophosphamide
drug therapy
Drug Therapy
mouth
Veterinary Medicine
United States Food and Drug Administration
veterinary medicine
sampling
drugs
Pharmaceutical Preparations
methodology

Keywords

  • canine
  • chemotherapy
  • feline
  • oncology
  • veterinary

ASJC Scopus subject areas

  • veterinary(all)

Cite this

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title = "Potency and stability of compounded formulations of chlorambucil, melphalan and cyclophosphamide",
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.",
keywords = "canine, chemotherapy, feline, oncology, veterinary",
author = "Burton, {Jenna H} and Knych, {Heather K} and Stanley, {Scott D} and Rebhun, {Robert B}",
year = "2017",
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language = "English (US)",
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TY - JOUR

T1 - Potency and stability of compounded formulations of chlorambucil, melphalan and cyclophosphamide

AU - Burton, Jenna H

AU - Knych, Heather K

AU - Stanley, Scott D

AU - Rebhun, Robert B

PY - 2017/12/1

Y1 - 2017/12/1

N2 - 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.

AB - 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.

KW - canine

KW - chemotherapy

KW - feline

KW - oncology

KW - veterinary

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DO - 10.1111/vco.12301

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JO - Veterinary and Comparative Oncology

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SN - 1476-5829

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