Hydrocortisone granules in capsules for opening (Alkindi) as replacement therapy in pediatric patients with adrenal insufficiency

Abstract

Introduction: Treatment of pediatric adrenal insufficiency (AI) has been challenging due to a lack of dose and age appropriate hydrocortisone preparations for children. Hydrocortisone granules in capsules for opening (Alkindi) is the only licensed replacement therapy specifically designed for use in pediatric adrenal insufficiency. Areas Covered: The high unmet need of the pediatric AI patient population for a licensed, doseappropriate hydrocortisone formulation and the development and approval of hydrocortisone granules in capsules for opening for pediatric AI. Expert opinion: To date, treatment of children with AI has relied on parents or pharmacists crushing tablets of hydrocortisone. Pediatric patients have suffered from over-and under-treatment with poor health outcomes. Hydrocortisone granules in capsules for opening provides accurate, age-appropriate dosing, allowing appropriate dose titration for the growing child. The granule-based formulation is taste masked to hide the bitterness of hydrocortisone, and in clinical trials was well tolerated and easily administered to children. The granules can be administered either directly to the mouth or sprinkled onto soft food or yogurt. Hydrocortisone granules in capsules for opening provides the first licensed treatment option specifically designed for pediatric patients with AI.

Alkindi Sprinkle for Pediatric Patients With Primary Adrenocortical Insufficiency: A Narrative Review

“…Alkindi was developed to help prevent inaccurate dosing in pediatric patients and stop adverse outcomes associated with incorrect doses that extend beyond childhood [ 23 ]. Alkindi Sprinkles are hydrocortisone granules that come in an openable cap, allowing precise dosages for pediatric patients [ 24 ]. Alkindi is available in flexible hydrocortisone dosages of 0.5 mg, 1 mg, 2 mg, and 5 mg, with its smaller dosage making it more appropriate for pediatric patients.…”

“…This also allows for appropriate dose titration as the child grows. The maximum diameter of the granules is 0.8 mm, significantly smaller than the FDA’s guidance to industry on sprinkle formulation limits of 2.5 mm [ 24 ]. The small granule size decreases the risk of choking and allows easy swallowing of the granules by neonates [ 24 ].…”

“…The maximum diameter of the granules is 0.8 mm, significantly smaller than the FDA’s guidance to industry on sprinkle formulation limits of 2.5 mm [ 24 ]. The small granule size decreases the risk of choking and allows easy swallowing of the granules by neonates [ 24 ]. Each granule has an inert cellulose capsule core, is sprayed with hydrocortisone, and is sealed with a taste masking coat that makes the granules less bitter.…”

“…Each granule has an inert cellulose capsule core, is sprayed with hydrocortisone, and is sealed with a taste masking coat that makes the granules less bitter. They are then contained within a size 00el transparent capsule that is meant to be opened to pour the granules out [ 24 ]. The clear capsule opens to allow for all granules in the capsule to be taken directly into the mouth or sprinkled onto soft food or yogurt [ 24 ].…”

“…They are then contained within a size 00el transparent capsule that is meant to be opened to pour the granules out [ 24 ]. The clear capsule opens to allow for all granules in the capsule to be taken directly into the mouth or sprinkled onto soft food or yogurt [ 24 ].…”