Whitaker, M.J., Huatan, H. and Ross, R.J. orcid.org/0000-0001-9222-9678 (2023) Chronotherapy based on modified-release hydrocortisone to restore the physiological cortisol diurnal rhythm. DRUG DELIVERY AND TRANSLATIONAL RESEARCH, 13 (1). pp. 1-8. ISSN 2190-393X
Abstract
In this inspirational note, we describe the development of an endocrine chronotherapy to restore the physiological rhythm of the essential adrenal stress hormone, cortisol. The challenges included demonstrating the circadian rhythm of the drug target, creating a drug formulation that replicated that rhythm and then proving benefit in clinical trials. The physiological cortisol circadian rhythm is well defined with cortisol levels high on waking and low on going to sleep. We experimented with different formulation technologies including modified-release tablets and multi-particulates to replicate the cortisol rhythm where absent through disease. We describe the development of Efmody®, a modified-release formulation of hydrocortisone, which replicates the cortisol diurnal rhythm and improves the disease control of congenital adrenal hyperplasia, the commonest hereditary form of adrenal insufficiency. This program shows it is possible, through modified-release technology, to treat chronic endocrine diseases with physiological replacement to preserve health for life.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2022 The Authors. This is an Open Access article distributed under the terms of the Creative Commons Attribution Licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
Keywords: | Chronotherapy; Circadian; Cortisol; Hydrocortisone; Efmody; Hormone; Multi-particulate |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Sheffield Teaching Hospitals |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 23 Dec 2022 15:24 |
Last Modified: | 23 Dec 2022 15:24 |
Status: | Published |
Refereed: | Yes |
Identification Number: | 10.1007/s13346-022-01183-w |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:194456 |