Hydrocortisone granules are bioequivalent when sprinkled onto food or given directly on the tongue

Background Immediate-release hydrocortisone granules in capsules for opening in paediatric appropriate doses have recently been licensed for children with adrenal insufficiency. This study evaluated the bioavailability of hydrocortisone granules administered as sprinkles onto soft food and yoghurt compared to direct administration to the back of the tongue.

Methods Randomised, three-period crossover study in 18 dexamethasone-suppressed healthy men. In each period the fasted participants received hydrocortisone granules 5mg either directly to the back of the tongue, or sprinkled onto soft food (applesauce), or yoghurt, followed by 240mL of water. Serum cortisol was measured by LC-MS/MS.

Results The cortisol geometric mean Cmax and AUC for direct administration, sprinkles onto yoghurt, and sprinkles onto soft food were: Cmax 428, 426, 427 nmol/L & AUC0-inf 859, 886, 844 h*nmol/L, & AUC0-t 853, 882, 838 h*nmol/L respectively. The 90% confidence intervals (CI) for the ratios of Cmax, AUC0-inf & AUC0-t for administration with soft food or yoghurt to direct administration were well within the bioequivalent range, 80-125%. Median Tmax was similar between methods of administration: 0.63h administered directly, 0.75h on soft food and 0.75h on yoghurt. No adverse events occurred during the study.

Conclusions Hydrocortisone granules administered as sprinkles onto soft food or yoghurt but not mixed with are bioequivalent to those administered directly to the back of the tongue. Carers, parents or patients may choose to administer hydrocortisone granules either directly or sprinkled onto soft food or yoghurt.