Development and Testing in Healthy Adults of Oral Hydrocortisone Granules With Taste Masking for the Treatment of Neonates and Infants With Adrenal Insufficiency

Background: Treatment of neonates and infants with adrenal insufficiency is unsatisfactory because unlicensed hydrocortisone formulations are used. Objectives: The objectives were to survey current hydrocortisone prescribing practice and develop a novel hydrocortisone formulation, Infacort. Methods: The use of hydrocortisone by European pediatric endocrinologists was surveyed. Based on this, an oral hydrocortisone granule formulation, Infacort, with taste masking was developed and evaluated in vitro and then in vivo in a phase I pharmacokinetic study. Results: The survey showed that pediatricians use a variety of unlicensed compounded adult medications at doses of between 0.5 and 5 mg. Infacort was formulated with a taste-masking layer stable for at least 5 minutes in aqueous media and was produced in unit doses of 0.5, 1, 2, and 5 mg. Infacort 10 mg is the bioequivalent of a 10-mg hydrocortisone tablet (mean area under the curve from zero to infinity [AUC0-inf] ratio, 101%; 90% confidence interval, 96–10...