Oritsegidenene Beji
Exploration of temperature and shelf-life dependency of the therapeutically available Insulin Detemir
Beji, Oritsegidenene; Gillis, Richard B.; Dinu, Vlad; Jiwani, Shahwar I.; Gyasi-Antwi, Philemon; Fisk, Ian D.; Meal, Andrew; Morgan, Paul S.; Harding, Stephen E.; Huang, Sha; Agugini, Giulia; Fedele, Federica; Adams, Gary G.
Authors
Richard B. Gillis
Vlad Dinu
SHAHWAR JIWANI SHAHWAR.JIWANI1@NOTTINGHAM.AC.UK
Post-Doctoral Research Fellow
Philemon Gyasi-Antwi
Professor IAN FISK IAN.FISK@NOTTINGHAM.AC.UK
Professor of Flavour Science
ANDY MEAL andy.meal@nottingham.ac.uk
Assistant Professor
Paul S. Morgan
STEPHEN HARDING STEVE.HARDING@NOTTINGHAM.AC.UK
Professor of Applied Biochemistry
Sha Huang
Giulia Agugini
Federica Fedele
Dr GARY ADAMS gary.adams@nottingham.ac.uk
Associate Professor
Contributors
Charlotte Moody
Other
Abstract
© 2020 Elsevier B.V. Purpose: Insulin, in typical use, undergoes multiple changes in temperature; from refrigerator, to room temperature, to body temperature. Although long-term storage temperature has been well-studied, the short term changes to insulin are yet to be determined. Insulin detemir (IDet) is a clinically available, slow-acting, synthetic analogue characterised by the conjugation of a C14 fatty acid. The function of this modification is to cause the insulin to form multi-hexameric species, thus retarding the pharmacokinetic rate of action. In this investigation, the temperature dependence properties of this synthetic analogue is probed, as well as expiration. Methods: Dynamic light scattering (DLS) and viscometry were employed to assess the effect of temperature upon IDet. Mass spectrometry was also used to probe the impact of shelf-life and the presence of certain excipients. Results: IDet was compared with eight other insulins, including human recombinant, three fast-acting analogues and two other slow-acting analogues. Of all nine insulins, IDet was the only analogue to show temperature dependent behaviour, between 20 °C and 37 °C, when probed with non-invasive backscatter dynamic light scattering. Upon further investigation, IDet observed significant changes in size related to temperature, direction of temperature (heated/cooled) and expiration with cross-correlation observed amongst all 4 parameters. Conclusions: These findings are critical to our understanding of the behaviour of this particular clinically relevant drug, as it will allow the development of future generations of peptide-based therapies with greater clinical efficacy.
Citation
Beji, O., Gillis, R. B., Dinu, V., Jiwani, S. I., Gyasi-Antwi, P., Fisk, I. D., …Adams, G. G. (2020). Exploration of temperature and shelf-life dependency of the therapeutically available Insulin Detemir. European Journal of Pharmaceutics and Biopharmaceutics, 152, 340-347. https://doi.org/10.1016/j.ejpb.2020.05.016
Journal Article Type | Article |
---|---|
Acceptance Date | May 17, 2020 |
Online Publication Date | May 21, 2020 |
Publication Date | Jul 1, 2020 |
Deposit Date | May 29, 2020 |
Publicly Available Date | Mar 29, 2024 |
Journal | European Journal of Pharmaceutics and Biopharmaceutics |
Print ISSN | 0939-6411 |
Electronic ISSN | 1873-3441 |
Publisher | Elsevier |
Peer Reviewed | Peer Reviewed |
Volume | 152 |
Pages | 340-347 |
DOI | https://doi.org/10.1016/j.ejpb.2020.05.016 |
Keywords | Biotechnology; Pharmaceutical Science; General Medicine |
Public URL | https://nottingham-repository.worktribe.com/output/4529760 |
Publisher URL | https://www.sciencedirect.com/science/article/pii/S0939641120301429 |
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