What they did
Researchers evaluated 96 batches of compounded trilostane capsules in 15-, 45-, and 100-mg sizes purchased from eight different pharmacies. These were compared with 15-mg capsules made with the licensed product, capsules containing inert materials, and proprietary capsules in 30- and 60-mg sizes. All capsules were analyzed for content and dissolution characteristics and compared with the specifications for the licensed product.
What they found
There was a wide variability in drug content among the compounded trilostane batches—39% to 152.6% of label claim—compared with the variance for the controls, which was 96.1% to 99.6%. The average dissolution rate of the compounded batches was also lower than for the controls—76% vs. 85%, respectively.
The wide variability in content and the dissolution rates of compounded trilostane products may compromise effective management of patients being treated for hyperadrenocorticism. Patients may be overdosed or underdosed when these products are used, which may prompt owners to discontinue therapy and negatively impact patient care. If nonapproved capsule sizes are required, it is important clinicians be aware of the source of the trilostane being used.
Cook AK, Nieuwoudt CD, Longhofer SL. Pharmaceutical evaluation of compounded trilostane products. J Am Anim Hosp Assoc 2012;48(4):228-233.