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Immediate-release granule formulation of hydrocortisone, Alkindi®, for treatment of paediatric adrenal insufficiency
John Porter1, Mike Withe1, Richard J Ross2
1a Diurnal Ltd , Cardiff , UK.
Insights
Alkindi, a new hydrocortisone formulation, offers accurate dosing for paediatric adrenal insufficiency. This novel preparation addresses challenges with compounded medications, improving treatment for children.
Area of Science:
- Paediatric Endocrinology
- Pharmacology
- Drug Formulation
Background:
- Paediatric adrenal insufficiency treatment is complicated by the absence of suitable pediatric glucocorticoid formulations.
- Current therapies often rely on compounded hydrocortisone, leading to inconsistent dosing and practical difficulties for caregivers.
Purpose of the Study:
- To introduce Alkindi, a novel hydrocortisone formulation designed for paediatric adrenal insufficiency.
- To highlight the drawbacks of existing treatments and present the clinical trial data for Alkindi.
Main Methods:
- Review of current therapy drawbacks and formulation challenges.
- Presentation of the clinical trial program for Alkindi, including bioequivalence and tolerability studies.
Main Results:
- Alkindi provides accurate, age-appropriate hydrocortisone doses (0.5-5.0 mg) in a multiparticulate, taste-masked formulation.
- Clinical trials showed Alkindi achieved cortisol levels similar to healthy children, was well-tolerated, and preferred by parents over current treatments.
- Alkindi demonstrated bioequivalence to existing hydrocortisone preparations.
Conclusions:
- Alkindi offers a licensed, reliable therapeutic option for paediatric adrenal insufficiency, overcoming limitations of compounded hydrocortisone.
- The formulation is suitable for neonates, infants, and young children, allowing flexible administration (oral or mixed with food).
- Alkindi ensures accurate dosing, improving treatment adherence and outcomes for children with adrenal insufficiency.
Introduction:
Treatment of paediatric patients with adrenal insufficiency is challenging due to the lack of appropriate glucocorticoid preparations for children, and the use of either pharmacy- or parent-compounded hydrocortisone tablets. Alkindi (hydrocortisone granules in capsules for opening) is a new therapeutic option for paediatric adrenal insufficiency. Areas Covered: Drawbacks of current therapy and formulation and clinical trial programme for Alkindi. Expert Commentary: Compounding hydrocortisone has multiple issues including inconsistent dosing with under and over treatment and practical problems for parents who compound the drug themselves or travel long distances to a compounding pharmacy and the cost of compounding by the pharmacy. Alkindi® is a novel paediatric formulation of immediate release hydrocortisone licensed for use in paediatric adrenal insufficiency. Alkindi® is formulated to address the needs of neonates, infants and young children, being available at appropriate paediatric doses of 0.5, 1.0, 2.0 and 5.0 mg, is multiparticulate, allowing either direct oral dosing or dosing mixed with food, is taste masked to obscure the bitter taste of hydrocortisone and is bioequivalent to current hydrocortisone preparations. Clinical trials in young children with adrenal insufficiency demonstrated cortisol levels after dosing similar to those seen in healthy children and the drug was well tolerated and favoured over current therapy by parents. Alkindi® will provide a licenced treatment option for accurate dosing in children with adrenal insufficiency where compounded adult tablets of hydrocortisone are unsuitable.
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