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Pharmaceutical evaluation of compounded trilostane products
Audrey K Cook1, Cornelia D Nieuwoudt, Susan L Longhofer
1Department of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USA. akcook@cvm.tamu.edu
Compounded trilostane capsules frequently fail content and dissolution standards, potentially harming treatment for hyperadrenocorticism in dogs. This variability impacts therapeutic efficacy and patient outcomes.
Area of Science:
- Veterinary Pharmacology
- Pharmaceutical Sciences
- Companion Animal Medicine
Background:
- Trilostane is a critical medication for managing hyperadrenocorticism in dogs.
- Compounded medications offer flexibility but require rigorous quality control.
- Variability in compounded drug products can affect therapeutic outcomes.
Purpose of the Study:
- To evaluate the content and dissolution characteristics of compounded trilostane capsules.
- To compare compounded trilostane products against regulatory specifications and licensed products.
- To assess the potential impact of compounded trilostane variability on canine hyperadrenocorticism management.
Main Methods:
- Purchased compounded trilostane capsules (15 mg, 45 mg, 100 mg) from eight pharmacies.
- Assayed capsules for content (percentage label claim) and dissolution characteristics.
- Utilized in-house and proprietary capsules as controls; compared findings to regulatory specifications.
Main Results:
- 38% of compounded trilostane batches failed content acceptance criteria (range 39%-152.6% LC).
- Variance in content was significantly greater in compounded products versus controls (234.65 vs. 1.27).
- 20% of compounded batches failed dissolution criteria, with lower mean dissolution than controls (75.96% vs. 85.12%).
Conclusions:
- Compounded trilostane capsules exhibit significant variability in drug content and dissolution.
- These inconsistencies may compromise the effective management of canine hyperadrenocorticism.
- Careful consideration and quality assessment are needed when prescribing compounded trilostane.
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