Accuracy of tablet splitting for paediatric dosing: mass and content uniformity.

OBJECTIVES: To evaluate the accuracy of tablet splitting for paediatric dosing by assessing mass and content uniformity. METHODS: Whole, half, and quarter tablets of mercaptopurine, azathioprine, and spironolactone were prepared using a manual tablet splitter. Fragment mass and quarter-tablet drug content were assessed against European Pharmacopoeia criteria. KEY FINDINGS: Split fragments showed high variability (coefficient of variation 8.6%-23.3%). Most failed European Pharmacopoeia mass uniformity criteria. Content analysis revealed only 50%-70% of quarters complied with acceptance limits, with ranges of 52%-133% of claim. CONCLUSIONS: Tablet splitting introduces substantial dose variability undetectable by weighing alone. Where possible, low-strength tablets or alternative formulations should be preferred.