5PSQ-205 Manipulating tablets containing poorly soluble prednisolone to obtain paediatric doses

Background and importance Manipulation of tablets is often necessary to achieve an appropriate dose in the paediatric ward.1 However, previous studies have shown a difference in dose accuracy obtained on manipulation for different tablets, in particular for the slightly soluble drug substance aspirin.2 Prednisolone is a very slightly soluble drug substance, and prednisolone tablets are frequently manipulated in paediatric care. Aim and objectives To investigate the dose accuracy and dose precision attained after manipulation of a commercially available prednisolone tablet, and to compare the results with those previously found for aspirin, a drug substance where solubility may similarly be challenging. Material and methods Prednisolone tablets: Prednisolon Alternova 5 mg, Alternova A/S. Instrument: UHPLC-system from Shimadzu Corp (Nexera, with prominence DAD detector). Analytical column: ACE Excel 2 μm C18-AR, 2.1 × 100 mm (Advanced Chromatography Technologies Ltd). The analytical method was validated for linearity, precision and specificity. Dosing accuracy study: six tablets were dissolved in 10 mL water. After 4 min of intermittent stirring, samples of 1 mL, a 10th of the tablet, were withdrawn. Dosing accuracy was recorded and compared with previous findings for aspirin. Results After manipulation of Prednisolon Alternova 5 mg tablets, 92.2% (85.3–95.1%) of the intended dose was retrieved. Conclusion and relevance After manipulation by dispersion and dose extraction, the prednisolone tablets were found to give doses within the limits of tablet fractions according to the European Pharmacopeia (85–115%). In contrast, conventional tablets containing aspirin (Aspirin ‘Bayer’ 500 mg), a slightly soluble drug substance, has previously been shown to have never exceeded 55% of the intended dose when a 10th of the tablet was extracted.2 This shows that knowledge about solubility is not always sufficient for estimating the suitability for manipulation of tablets. References and/or acknowledgements Bjerknes K, Boyum S, Kristensen S, et al. Manipulating tablets and capsules given to hospitalised children in Norway is common practice. Acta Paediatr 2017;106:503–8. Brustugun J, Notaker N, Paetz LH, et al. Adjusting the dose in paediatric care: Dispersing four different aspirin tablets and taking a proportion. Eur J Hosp Pharm 2019. https://doi.org/10.1136/ejhpharm-2019-001903 Conflict of interest No conflict of interest