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New Formulation of Hydrocortisone May Soon Be Available for Children

Granules offer more precise dosing for pediatric population

In the Pipeline - A PPM Brief

Pediatric formulation of hydrocortisone is not yet FDA-approved in the United States. Current treatment of hydrocortisone doses for children requires pharmacists to compound the medication, or a parent/caregiver to break up an adult-dose tablet. Both methods have led to errors in specification, with error reports of up to 20% by pharmacies and up to 50% by caregivers, according to research1 presented earlier this month at ENDO 2018: The Endocrine Society Annual Meeting.

Hydrocortisone granules, however, may offer improved dosing precision when taken by mouth or sprinkled on food for pediatric patients, according to lead study author Eleni Daniel, MSc, of the University of Sheffield in the United Kingdom. A hydrocortisone capsule that can be broken open offers pediatric doses of 0.5 mg, 1 mg, 2 mg, and 5 mg. Daniel noted that this immediate-release, taste-masked formulation may be beneficial in that it can be continuously measured, adjusted, and optimized for balance in the pediatric population.

One such granulized product from Diurnal, in Cardiff, Wales, is an immediate-release hydrocortisone preparation specifically designed for children under six years of age. Called Infacort, the product was well-tolerated and absorbed in a study2 published earlier this year in which healthy physiologic cortisol levels were achieved by 60 minutes after administration. Under the brand name Alkindi, Infacort was recently granted3 a pediatric marketing authorization in Europe for the treatment of adrenal insufficiency in children, and was previously granted4 orphan drug designation by the FDA in the United States.

The research presented at ENDO included a study of Infacort’s effect in adults. In a randomized, crossover trial, bioequivalence was demonstrated for drug delivery directly into the mouth or sprinkled on soft food in 18 dexamethasone-suppressed healthy men. The participants received Infacort 5 mg either directly applied to the back of the tongue or sprinkled onto 5 mL of applesauce or yogurt. Bioequivalence was confirmed after maximum cortisol concentrations and area under the curve fell within the 90% confidence interval of 80% to 120% for direct administration (median time to maximum cortisol concentration = 0.63 hours) compared with the two soft food doses (median time to maximum cortisol concentration = 0.75 hours).1

Session moderator Gail K Adler, MD, associate professor of medicine at Brigham and Women’s Hospital in Boston, noted that while future research should test the delivery methods in children, she hypothesized that the same results would be found. The formulation may hold promise for children suffering from conditions beyond Infacort’s indication (adrenal insufficiency), such as certain types of inflammation and pain.

Last updated on: June 15, 2020
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