+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Pharmaceutical evaluation of compounded trilostane products

Pharmaceutical evaluation of compounded trilostane products

Journal of the American Animal Hospital Association 48(4): 228-233

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.

Please choose payment method:

(PDF emailed within 0-6 h: $19.90)

Accession: 054953924

Download citation: RISBibTeXText

PMID: 22611212

DOI: 10.5326/JAAHA-MS-5763

Related references

Stability of compounded trilostane suspension in cod liver oil. Veterinary Journal 228: 15-17, 2018

Single-patient trials, extemporaneously compounded products and pharmaceutical care. International Journal of Pharmaceutical Compounding 7(6): 441-447, 2003

Comparison for pharmaceutical equivalence of FDA-approved products and compounded preparations of ketoprofen, amikacin, and boldenone. Proceedings of the 49th Annual Convention of the American Association of Equine Practitioners, New Orleans, Louisiana, USA, 21-25 November 2003: 238-242, 2003

Analysis of compounded pharmaceutical products to teach the importance of quality in an applied pharmaceutics laboratory course. American Journal of Pharmaceutical Education 78(3): 61, 2014

Pre-trilostane and three-hour post-trilostane cortisol to monitor trilostane therapy in dogs. Veterinary Record 179(23): 597, 2016

Requirements regarding compounded pharmaceutical preparation. Nederlands Tijdschrift Voor Geneeskunde 154: A2032, 2010

Compounded suppositories and pharmaceutical care. International Journal of Pharmaceutical Compounding 1(2): 93-99, 1997

A demographic and pharmaceutical study of compounded prescriptions. Journal of the American Pharmaceutical Association 11(6): 345-349, 1971

The inhibiting effect of trilostane on testosterone synthesis. Hormonal and morphologic alterations induced by subchronic trilostane treatment in rats and healthy volunteers. Arzneimittel-Forschung 33(5): 754-756, 1983

The inhibiting effect of trilostane on adrenal steroid synthesis hormonal and morphological alterations induced by subchronic trilostane treatment in normal rats. Research in Experimental Medicine 180(2): 193-200, 1982

Stability of hydroxyprogesterone caproate alone and in a compounded pharmaceutical product. American Journal of Health-System Pharmacy 71(13): 1120-1127, 2015

Synthesis 4 carbon 14 trilostane and 6 7 dideuterium trilostane. Journal of Labelled Compounds & Radiopharmaceuticals 27(1): 9-22, 1989

Stability Assessment of 10 Active Pharmaceutical Ingredients Compounded in SyrSpend SF. International Journal of Pharmaceutical Compounding 19(5): 420-427, 2016

Standardization proposal to pharmaceutical compounded forms elaboration - information system. Conference Proceedings 2010: 3911-3914, 2011

Raman Spectroscopy: A Sensitive and Specific Technique for Determining the Accuracy of Compounded Pharmaceutical Formulations. Journal of Pediatric Pharmacology and Therapeutics 21(5): 413-418, 2016