Absorption and tolerability of taste‐masked hydrocortisone granules in neonates, infants and children under 6 years of age with adrenal insufficiency

Summary Objectives There is no licensed, dose‐appropriate formulation of hydrocortisone for children with adrenal insufficiency (AI) and patients rely on compounded adult medication. The aim of this study was to evaluate the absorption, palatability and safety of Infacort®, an immediate‐release, gra...

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Bibliographic Details
Published in:Clinical endocrinology (Oxford) 2018-01, Vol.88 (1), p.21-29
Main Authors: Neumann, Uta, Whitaker, Martin J., Wiegand, Susanna, Krude, Heiko, Porter, John, Davies, Madhu, Digweed, Dena, Voet, Bernard, Ross, Richard J., Blankenstein, Oliver
Format: Article
Language:English
Subjects:
Adrenal glands
adrenal insufficiency
Adrenal Insufficiency - drug therapy
Age Factors
Child, Preschool
Children
congenital adrenal hyperplasia
Hormones
Humans
Hydrocortisone
Hydrocortisone - administration & dosage
Hydrocortisone - blood
Hydrocortisone - therapeutic use
Infant
Infant, Newborn
Infants
Neonates
Newborn babies
oral hydrocortisone granules
Palatability
Parents - psychology
Satellites
Steroids
Surveys and Questionnaires
Taste
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Summary:Summary Objectives There is no licensed, dose‐appropriate formulation of hydrocortisone for children with adrenal insufficiency (AI) and patients rely on compounded adult medication. The aim of this study was to evaluate the absorption, palatability and safety of Infacort®, an immediate‐release, granule formulation of hydrocortisone with taste masking. Study design Single site with satellites attended by a “flying” doctor from investigator site. Open‐label, single‐dose study in three consecutive child cohorts (n = 24) with AI; Cohort 1, children aged 2 to
ISSN:0300-0664
1365-2265
DOI:10.1111/cen.13447