Analysis of weight uniformity, content uniformity and 30-day stability in halves and quarters of routinely prescribed cardiovascular medications

Objectives

Congenital and acquired cardiac disorders are frequently diagnosed in small breed dogs and cats. In order to appropriately dose cardiovascular drugs for small patients, fractions of commercially available tablets must be prescribed. The aims of this study were to evaluate weight and content uniformity and 30-day chemical stability in halves and quarters of 11 drug formulations commonly prescribed to treat cardiovascular disorders in small breed dogs and cats.

Animals, materials and methods

Fifteen tablets from 11 drug formulations were obtained within the same lot. Tablets were split by a single operator using a commercially available pill splitter. Whole tablets, halves and quarters were weighed and stored in plastic containers. High-pressure liquid chromatography or liquid chromatography with mass spectrometry were utilized to determine drug content and repeated 30 days later to estimate chemical stability.

Results

Statistically significant weight variability, content non-uniformity and chemical degradation were found for some formulations. Digoxin showed a significant degradation that should be considered in clinical practice.

Conclusions

It appears that pill splitting is overall a relatively reliable practice; however tablets should not be split ahead of time but only immediately prior to intended usage.