Evaluation of compounded aqueous milbemycin oxime: issues with formulation potency and reproducibility

The Journal of Small Animal Practice
Z N CochraneJ F Hans Coetzee

Abstract

To determine the potency and reproducibility of milbemycin oxime when compounded as an aqueous suspension (20 mg/mL). Preparation choice reflected current prescribing practices. Samples were acquired by prescription from two national veterinary compounding pharmacies at three time points. Two different storage conditions were evaluated and sampled at four time points from the order date (day 7, 14, 21 and 28). Milbemycin oxime recovery was performed by solid-phase extraction and concentration strength measured via high-performance liquid chromatography. The average concentration on day 7 for Pharmacy A samples was 16.29 mg/mL [confidence interval (CI): 15.66 to 16.92] with a coefficient of variation (CV) = 11%, while for Pharmacy B it was 20.46 mg/mL (CI: 19.83 to 21.08) with CV = 22%. The mean decrease in concentration over 28 days for Pharmacy A was 22% (CI: 9% to 34%) while Pharmacy B was 18% (CI: 2% to 35%). The compounded milbemycin oxime suspensions evaluated in this study deviated by more than 10% from their labelled strength in five of the six lots. Clinical efficacy of compounded milbemycin oxime suspensions remains unknown and the use of these products should be discouraged at this time.

References

Oct 1, 1996·Journal of Veterinary Pharmacology and Therapeutics·Q A McKellar, H A Benchaoui
Sep 21, 2006·The Veterinary Clinics of North America. Small Animal Practice·Dawn Merton Boothe
Dec 21, 2006·Advances in Pharmacology·Werner Sieghart
Oct 17, 2008·Veterinary Parasitology·Katrina L Mealey
Mar 3, 2012·The Veterinary Clinics of North America. Small Animal Practice·Valentina M Merola, Paul A Eubig
May 23, 2012·Journal of the American Animal Hospital Association·Audrey K CookSusan L Longhofer
Sep 14, 2012·Veterinary Dermatology·Meghan E UmsteadDonna Angarano
Jun 4, 2013·Journal of the American Veterinary Medical Association·Mark G PapichLisa A Fortier

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