Dataset Information

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

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 (Cmax) and area under the curve (AUC) for direct administration, sprinkles onto yogurt, and sprinkles onto soft food were: Cmax 428, 426, 427 nmol/L and AUC0-inf 859, 886, 844 h × nmol/L, and AUC0-t 853, 882, 838 h × nmol/L respectively. The 90% CI for the ratios of Cmax, AUC0-inf and AUC0-t for administration with soft food or yogurt to direct administration were well within the bioequivalent range, 80% to 125%. Median time to Cmax (Tmax) 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.

SUBMITTER: Daniel E

PROVIDER: S-EPMC6457279 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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

Daniel Eleni E Digweed Dena D Quirke Jo J Voet Bernard B Ross Richard J RJ Davies Madhu M

Journal of the Endocrine Society 20190227 5

<h4>Background</h4>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.<h4>Methods</h4>Randomized, 3-period crossover study in 18 dexamethasone-suppressed healthy men. In each period, the fasted participa ...[more]

PMID: 30993254

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Project description:In this study, to obtain a texture perception that is closer to the human sense, we designed eight bionic tongue indenters based on the law of the physiology of mandibular movements and tongue movements features, set up a bionic tongue distributed mechanical testing device, performed in vitro simulations to obtain the distributed mechanical information over the tongue surface, and preliminarily constructed a food fineness perception evaluation model. By capturing a large number of tongue movements during chewing, we analyzed and simulated four representative tongue movement states including the tiled state, sunken state, raised state, and overturned state of the tongue. By analyzing curvature parameters and the Gauss curvature of the tongue surface, we selected the regional circle of interest. With that, eight bionic tongue indenters with different curvatures over the tongue surface were designed. Together with an arrayed film pressure sensor, we set up a bionic tongue distributed mechanical testing device, which was used to do contact pressure experiments on three kinds of cookies-WZ Cookie, ZL Cookie and JSL Cookie-with different fineness texture characteristics. Based on the distributed mechanical information perceived by the surface of the bionic tongue indenter, we established a food fineness perception evaluation model by defining three indicators, including gradient, stress change rate and areal density. The correlation between the sensory assessment and model result was analyzed. The results showed that the average values of correlation coefficients among the three kinds of food with the eight bionic tongue indenters reached 0.887, 0.865, and 0.870, respectively, that is, a significant correlation was achieved. The results illustrate that the food fineness perception evaluation model is effective, and the bionic tongue distributed mechanical testing device has a good practical significance for obtaining food texture mouthfeel information.

Project description:BackgroundThere is growing interest to application of regenerative medicine approaches in otorhinolaryngological practice, especially in the framework of the therapy of vocal fold (VF) scar lesions. The used conservative and surgical methods, despite the achieved positive outcomes, are frequently unpredictable and do not result in the restoration of the VF's lamina propria's structure, which provides the mechanical properties necessary for vibration. In this connection, the aim of this study was to ascertain the safety and efficacy of a bioequivalent in the treatment of VF scars using a rabbit model of chronic damage.MethodsThe bioequivalent consisted of a hydrogel system based on a PEG-fibrin conjugate and human bone marrow-derived MSC. It was characterized and implanted heterotopically into rats and orthotopically into rabbits after VF scar excision.ResultsWe showed that the fabricated bioequivalent consisted of viable cells retaining their metabolic and proliferative activity. While being implanted heterotopically, it had induced the low inflammatory reaction in 7 days and was well tolerated. The orthotopic implantation showed that the gel application was characterized by a lower hemorrhage intensity (p = 0.03945). The intensity of stridor and respiratory rate between the groups in total and between separate groups had no statistically significant difference (p = 0.96 and p = 1; p = 0.9593 and p = 0.97…1, respectively). In 3 days post-implantation, MSC were detected only in the tissues closely surrounding the VF defect. The bioequivalent injection caused that the scar collagen fibers were packed looser and more frequently mutually parallel that is inherent in the native tissue (p = 0.018). In all experimental groups, the fibrous tissue's ingrowth in the adjacent exterior muscle tissue was observed; however, in Group 4 (PEG-Fibrin + MSC), it was much less pronounced than it was in Group 1 (normal saline) (p = 0.008). The difference between the thicknesses of the lamina propria in the control group and in Group 4 was not revealed to be statistically significant (p = 0.995). The Young's modulus of the VF after the bioequivalent implantation (1.15 ± 0.25 kPa) did not statistically significantly differ from the intact VF modulus (1.17 ± 0.45 kPa); therefore, the tissue properties in this group more closely resembled the intact VF.ConclusionsThe developed bioequivalent showed to be biocompatible and highly efficient in the restoration of VF's tissue.

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

Publications

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

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