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Spore exines increase vitamin D clinical bioavailability by mucoadhesion and bile triggered release. [Dataset]

Contributors

Albert Diego-Taboada
Data Collector

Thozhukat Sathyapalan
Data Collector

Fraser Courts
Data Collector

Mark Lorch
Data Collector

Farooq Almutairi
Data Collector

Benjamin P. Burke
Data Collector

Kate Harris
Data Collector

Martin Kruusm�gi
Data Collector

Thomas Walther
Data Collector

Jonathan Booth
Data Collector

Andrew N. Boa
Data Collector

Stephen J. Archibald
Data Collector

Colin Thompson
Data Collector

Stephen L. Atkin
Data Collector

Grahame Mackenzie
Data Collector

Abstract

Sporopollenin exine capsules (SpECs) are microcapsules derived from the outer shells (exines) of plant spore and pollen grains. This work reports the first clinical study on healthy volunteers to show enhanced bioavailability of vitamin D encapsulated in SpECs from Lycopodium clavatum L. spore grains vs vitamin D alone, and the first evidence (in vitro, ex vivo and in vivo) of mechanisms to account for the enhancement and release of the active in the small intestine. Evidence for mucoadhesion of the SpECs contributing to the mechanism of the enhancement is based on: (i) release profile over time of vitamin D in a double-blind crossover human study, showing significant release in the small intestine; (ii) in vivo particle-counting data in rats, showing preferred retention of SpECs vs synthetic beads; (iii) ex vivo 99mTc labelling and counting data using rat small intestine sections, showing preferred retention of SpECs vs synthetic beads; (iv) in vitro mucoadhesion data. Triggered release by bile in the small intestine was shown in vitro using solid state NMR and HPLC. The accompanying file contains supplementary material available at https://doi.org/10.1016/j.jconrel.2022.08.017.

Citation

DIEGO-TABOADA, A., SATHYAPALAN, T., COURTS, F., LORCH, M., ALMUTAIRI, F., BURKE, B.P., HARRIS, K., KRUUSMÄGI, M., WALTHER, T., BOOTH, J., BOA, A.N., ARCHIBALD, S.J., THOMPSON, C., ATKIN, S.L. and MACKENZIE, G. 2022. Spore exines increase vitamin D clinical bioavailability by mucoadhesion and bile triggered release. [Dataset] Journal of controlled release [online], 350, pages 244-255. Available from: https://www.sciencedirect.com/science/article/pii/S0168365922005211?via%3Dihub#s0180

Acceptance Date Aug 10, 2022
Online Publication Date Aug 24, 2022
Publication Date Oct 31, 2022
Deposit Date Aug 26, 2022
Publicly Available Date Mar 29, 2024
Publisher Elsevier
DOI https://doi.org/10.1016/j.jconrel.2022.08.017
Keywords Sporopollenin microcapsules; Spore exines; Mucoadhesion; Bile; Vitamin D; Drug delivery systems
Public URL https://rgu-repository.worktribe.com/output/1740888
Related Public URLs https://rgu-repository.worktribe.com/output/1734907
Type of Data DOCX file of supplementary information.
Collection Date Aug 10, 2022
Collection Method Blood samples were withdrawn after fasting (time 0), then at 15, 30, 45, 60, 120, 180 and 240 minutes after taking the supplement. Serum was separated in a refrigerated centrifuge and stored at −80 °C until batch analysis was done. 25OHD was analysed using tandem mass spectrometry, the current gold standard in clinical practice for measurement of 25OHD, with a coefficient of variation of 5%. Area under the curve (AUC0-4h) was used to determine the bioavailability of 25OH vitamin D2 from the two different ergocalciferol preparations. The mean AUC for 25OHD was calculated using the linear trapezoid method, baseline levels were normalised to 0 (Tables S3 a-b). Since the number of subjects was small, potentially jeopardising the strong assumption of normality a non-parametric statistical test, the Wilcoxon signed rank test, was used to compare the 25OHD from two different supplements using SPSS software version 15. Data were recorded as median (interquartile range).

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