Alkindi® (hydrocortisone granules in capsules for opening) is Diurnal’s first commercialised medicine and is indicated as replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to less than 18 years old)1. Alkindi was approved through the centralised paediatric use marketing authorisation (PUMA) route in the European Union in 2018. Prior to Alkindi, most treatment of paediatric adrenal insufficiency in the UK relied on parents preparing child-appropriate doses from adult hydrocortisone formulations, a practice which yields highly variable doses and can be stressful for parents and caregivers2,3.
Alkindi is an immediate-release hydrocortisone preparation that has been specifically designed to meet the dosing needs of paediatric patients with adrenal insufficiency for whom, prior to Alkindi, no licensed, child-friendly products were available. Alkindi is manufactured using commercially proven technology in four doses: 0.5mg, 1mg, 2mg and 5mg, in order to give maximum flexibility to clinicians in tailoring the treatment to the child. Taste-masking excipients that are acceptable for paediatric use eliminate the bitter taste of hydrocortisone, potentially increasing compliance. Alkindi has a shelf life exceeding two years which is significantly longer than that of existing unlicensed hydrocortisone products.
2. Watson C, Webb EA, Kerr S, Davies JH, Stirling H, Batchelor H. How close is the dose? Manipulation of 10mg hydrocortisone tablets to provide appropriate doses to children. Int J Pharm 2018; 545:57-63
3. Simpson A, Ross R, Porter J, Dixon S, Whitaker MJ, Hunter A. Adrenal Insufficiency in Young Children: A Mixed Methods Study of Parents' Experiences. J Genet Couns 2018; 27:1447-1458