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      Hydrocortisone Granules Are Bioequivalent When Sprinkled Onto Food or Given Directly on the Tongue

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          Abstract

          Background

          Immediate-release hydrocortisone granules in capsules for opening in pediatric-appropriate doses have recently been licensed for children with adrenal insufficiency. This study evaluated the bioavailability of hydrocortisone granules administered as sprinkles onto soft food and yogurt compared with direct administration to the back of the tongue.

          Methods

          Randomized, 3-period crossover study in 18 dexamethasone-suppressed healthy men. In each period, the fasted participants received 5 mg hydrocortisone granules either directly to the back of the tongue or sprinkled onto soft food (applesauce), or yogurt, followed by 240 mL of water. Serum cortisol was measured by liquid chromatography tandem mass spectometry.

          Results

          The cortisol geometric mean maximum concentration (C max) and area under the curve (AUC) for direct administration, sprinkles onto yogurt, and sprinkles onto soft food were: C max 428, 426, 427 nmol/L and AUC 0-inf 859, 886, 844 h × nmol/L, and AUC 0-t 853, 882, 838 h × nmol/L respectively. The 90% CI for the ratios of C max, AUC 0-inf and AUC 0-t for administration with soft food or yogurt to direct administration were well within the bioequivalent range, 80% to 125%. Median time to Cmax (T max) was similar between methods of administration: 0.63 hours administered directly, 0.75 hours on soft food and 0.75 hours on yogurt. No adverse events occurred during the study.

          Conclusions

          Hydrocortisone granules administered as sprinkles onto soft food or yogurt but not mixed with these foods are bioequivalent to those administered directly to the back of the tongue. Carers, parents, or patients may choose to administer hydrocortisone granules either directly or sprinkled onto soft food or yogurt.

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          Most cited references 26

          • Record: found
          • Abstract: not found
          • Article: not found

          Consensus statement on 21-hydroxylase deficiency from the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology.

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            • Record: found
            • Abstract: not found
            • Article: not found

            Viability of yoghurt and probiotic bacteria in yoghurts made from commercial starter cultures

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              • Record: found
              • Abstract: not found
              • Article: not found

              Survival of Lactobacillus acidophilus and Bifidobacterium animalis ssp. lactis in stirred fruit yogurts

                Bookmark

                Author and article information

                Contributors
                Journal
                J Endocr Soc
                J Endocr Soc
                jes
                Journal of the Endocrine Society
                Endocrine Society (Washington, DC )
                2472-1972
                01 May 2019
                27 February 2019
                : 3
                : 5
                : 847-856
                Affiliations
                [1 ]Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, United Kingdom
                [2 ]Diurnal Ltd, Cardiff Medicentre, Cardiff, United Kingdom
                Author notes
                Correspondence:  Richard J. Ross, MD, The University of Sheffield, Room EU14 Floor E, The Medical School, Beech Hill Road, Sheffield S10 2RX, United Kingdom. E-mail: r.j.ross@ 123456sheffield.ac.uk .
                Article
                js_201800380
                10.1210/js.2018-00380
                6457279
                Copyright © 2019 Endocrine Society

                This article has been published under the terms of the Creative Commons Attribution Non-Commercial, No-Derivatives License (CC BY-NC-ND; https://creativecommons.org/licenses/by-nc-nd/4.0/).

                Page count
                Pages: 10
                Product
                Funding
                Funded by: Diurnal Ltd
                Categories
                Clinical Research Articles
                Adrenal

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