Background: Current standard treatment for adrenal insufficiency in neonates and infants is unsatisfactory as unlicensed adult dosage formulations are used. These are generally difficult to administer and may give rise to inconsistencies in dose as the content uniformity of the dosage form cannot be verified.
Methods: Infacort is a newly-developed immediate release formulation of hydrocortisone that is provided in appropriate unit dosage units (0.5, 1, 2, and 5 mg) in capsules containing multi-particulate granules. The granules are designed with a taste masking layer to permit compliant oral dosing. The objective of this study was to evaluate the pharmacokinetic performance of Infacort and its safety. Infacort exposure was compared to the adult immediate-release dosage form, hydrocortisone 10 mg tablets. This was a single centre, open-label, randomised crossover study in 16 dexamethasone suppressed healthy adults.
Results: Infacort and hydrocortisone at a dose of 10 mg are bioequivalent, as reflected by geometric LSmean 90% CI for ratios of Cmax, AUC0-t and AUC0-inf within 0.81.25. The majority of subjects described the Infacort as, not good or bad, for smell (81.387.5% of subjects), feel in the mouth (68.8% of subjects), and taste (68.881.3% of subjects).
|Infacort granules 10 mg geomean||Hydrocortisone tablets 10 mg geomean||Ratio infacort: hydrocortisone (90% CI)|
|Cmax (nmol/l)||566||598||95 (84 to 107)|
|AUC0-inf (h×nmol/l)||1602||1576||101 (96 to 107)|
|Tmax (h)||0.75||1.00||0.0 (−0.5 to 0.3)|
Conclusions: Infacort was safe, well tolerated and of neutral taste when administered as a single oral dose of 10 mg. Infacort granules and hydrocortisone tablets were bioequivalent with respect to Cmax, AUC, and tmax.