Absorption and tolerability of taste-masked hydrocortisone granules in neonates, infants and children under 6 years of age with adrenal insufficiency
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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 <6 years (n = 12); Cohort 2, infants aged 28 days to <2 years (n = 6); Cohort 3, neonates aged 1 to <28 days (n = 6). Methods Fasted children were given a single dose of Infacort ® as dry granules administered directly from a capsule or spoon followed by a drink. The primary end‐point was the maximum serum cortisol concentration up to 240 minutes after Infacort ® administration. Secondary end‐points were palatability and adverse events ( AE s). Results All children showed an increase in cortisol above baseline after Infacort ® ( P < .0001), with geometric mean ± SD cortisol concentration at 60 minutes of 575.8 ± 299.5 nmol L −1 . There was no failure in administration of Infacort ® , and 95.5% of parents/carers preferred Infacort ® to their child's current medication. In 7 children who completed the palatability questionnaire, 80% of responses were very good or neutral, and 20% were adverse. No serious or severe treatment‐emergent AE s were reported. Conclusions Infacort ® is well tolerated, easy to administer to neonates, infants and children and shows good absorption, with cortisol levels at 60 minutes after administration similar to physiological cortisol levels in healthy children.
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The granulated HC formulation offers small dosages of 0.5, 1, 2, and 5 mg, which can prove useful in children taking small quantities of HC.
“This formulation offers small dosages of 0.5, 1, 2, and 5 mg, which can prove useful in children taking small quantities of HC (41).”
From X-linked adrenoleukodystrophy and primary adrenal insufficiency (2023) · cites this paper as [41]
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Self-citation
- Authors
- Neumann, U., Whitaker, M. J., Wiegand, S., Krude, H., Porter, J., Davies, M., Digweed, D., Voet, B., Ross, R. J., & Blankenstein, O.
- Affiliations
- Charité – Universitätsmedizin Berlin (DE)
- Diurnal (United Kingdom) (GB)
- University of Sheffield (GB)
- Corresponding author
- Blankenstein, Oliver
- ORCID
- Venue
- Clinical Endocrinology
- Publisher
- Wiley
- Published
- 2017-09-07
- Volume
- 88
- Issue
- 1
- Pages
- 21-29
- ISSN
- 0300-0664 (ISSN-L)
- 1365-2265
- OpenAlex
- W2748713881
- Cited by
- 64
- References
- 26
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 11 · 2023: 7 · 2022: 6 · 2021: 8 · 2020: 5 · 2019: 10 · 2018: 8 · 2017: 2
- FWCI
- 5.40
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Endocrinology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Keywords
- cortisol, taste masking, adrenal insufficiency, pediatric adrenal insufficiency, drug absorption, serum cortisol, palatability, tolerability, neonates, infants, children
- MeSH terms
- Adrenal Insufficiency, Age Factors, Child, Preschool, Humans, Hydrocortisone, Infant, Infant, Newborn, Parents, Surveys and Questionnaires, Taste
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