Compounded trilostane capsules (15 mg, 45 mg, or 100 mg) were purchased from eight pharmacies and assayed for content and dissolution characteristics. Capsules made in-house containing either inert material or 15 mg of the licensed product and proprietary capsules (30 mg and 60 mg) served as controls. Findings were compared with regulatory specifications for the licensed product. Altogether, 96 batches of compounded trilostane and 16 control batches underwent analysis. In total, 36 of 96 (38%) compounded batches were below the acceptance criteria for content. The average percentage label claim (% LC) for each batch ranged from 39% to 152.6% (mean, 97.0%). The range of average % LC for the controls was 96.1–99.6% (mean, 97.7%). The variance in content of the purchased compounded products was substantially greater than for the controls (234.65 versus 1.27; P<0.0001). All control batches exceeded the acceptance criteria for dissolution, but 19 of 96 batches (20%) of purchased compounded products did not. Mean percent dissolution for the purchased compounded products was lower than for controls (75.96% versus 85.12%; P=0.013). These findings indicate that trilostane content of compounded capsules may vary from the prescribed strength, and dissolution characteristics may not match those of the licensed product. The use of compounded trilostane products may therefore negatively impact the management of dogs with hyperadrenocorticism.
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July/August 2012
Original Studies|
July 01 2012
Pharmaceutical Evaluation of Compounded Trilostane Products
Audrey K. Cook, BVM&S;
Department of Small Animal Clinical Sciences (A.C.) and Veterinary Medical Teaching Hospital (C.N.), College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX; and Dechra Ltd., Overland Park, KS (S.L.).
Correspondence: [email protected] (A.C.)
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Cornelia D. Nieuwoudt, PharmD;
Cornelia D. Nieuwoudt, PharmD
Department of Small Animal Clinical Sciences (A.C.) and Veterinary Medical Teaching Hospital (C.N.), College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX; and Dechra Ltd., Overland Park, KS (S.L.).
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Susan L. Longhofer, MS, DVM
Susan L. Longhofer, MS, DVM
Department of Small Animal Clinical Sciences (A.C.) and Veterinary Medical Teaching Hospital (C.N.), College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX; and Dechra Ltd., Overland Park, KS (S.L.).
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J Am Anim Hosp Assoc (2012) 48 (4): 228–233.
Citation
Audrey K. Cook, Cornelia D. Nieuwoudt, Susan L. Longhofer; Pharmaceutical Evaluation of Compounded Trilostane Products. J Am Anim Hosp Assoc 1 July 2012; 48 (4): 228–233. doi: https://doi.org/10.5326/JAAHA-MS-5763
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