Development of oral hydrocortisone granules with taste masking for the treatment of neonates and infants with adrenal insufficiency

Current treatment in Europe for adrenal insufficiency in neonates and infants is unsatisfactory as unlicensed adult dosage formulations are used. These are difficult to administer and may give rise to inconsistencies in dose as the content uniformity of the dosage form cannot be verified. As there is no licensed hydrocortisone formulation for children < 6 years hydrocortisone is often compounded by pharmacies using adult hydrocortisone tablets. In a recent study of compounded hydrocortisone up to 20% of the batches did not meet European Pharmacopeial accuracy and precision criteria (ECE 2014 Abstract #1278). This medication safety study investigated hydrocortisone individually and extemporaneously compounded for paediatric use in adrenally insufficient patients, meaning the current therapy is inadequate in up to every 5th child treated. Thus, there is a need for specifically designed and licensed hydrocortisone formulations for this vulnerable paediatric patient group especially neonates and infants.