Pharmacokinetics of adrenaline autoinjectors
Pharmacokinetics of adrenaline autoinjectors
Anaphylaxis is a medical emergency with adrenaline acknowledged as the first line therapy. It is therefore important that patients have access to self-injectable adrenaline in the community. Manufacturers have been requested by European Medicine Regulators to generate pharmacokinetic data for these autoinjector devices. For the first time, these data provide an insight into how individual devices work in different populations, and how they compare. We undertook a thorough literature search and also accessed grey literature, using searches of medicine regulators' websites and freedom of information requests. The data demonstrate that it takes at least 5-10 minutes to achieve early peak plasma concentration for most devices. The specific autoinjector device seems to be the most important determinant of pharmacokinetics, with different devices giving rise to different plasma adrenaline profiles. Needle length does not seem to be the most important factor; rather, the force and speed of injection (which varies from one device to another) is likely to be of greater importance. In general, peak plasma adrenaline concentration is lower and time-to-peak concentration longer with increased skin-to-muscle depth. However, it is difficult to draw conclusions with the current available data, due to a lack of head-to-head comparisons, small numbers of study participants, and the failure to acknowledge the biphasic nature of intramuscular adrenaline absorption for analysis purposes.
anaphylaxis, autoinjectors, pharmacokinetics
18-28
Turner, Paul J
22cee218-a226-4300-aad1-b9a77ca65915
Muraro, Antonella
c554bef5-502b-4540-a6f0-a3f7c37f0075
Roberts, Graham
ea00db4e-84e7-4b39-8273-9b71dbd7e2f3
January 2022
Turner, Paul J
22cee218-a226-4300-aad1-b9a77ca65915
Muraro, Antonella
c554bef5-502b-4540-a6f0-a3f7c37f0075
Roberts, Graham
ea00db4e-84e7-4b39-8273-9b71dbd7e2f3
Turner, Paul J, Muraro, Antonella and Roberts, Graham
(2022)
Pharmacokinetics of adrenaline autoinjectors.
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 52 (1), .
(doi:10.1111/cea.14055).
Abstract
Anaphylaxis is a medical emergency with adrenaline acknowledged as the first line therapy. It is therefore important that patients have access to self-injectable adrenaline in the community. Manufacturers have been requested by European Medicine Regulators to generate pharmacokinetic data for these autoinjector devices. For the first time, these data provide an insight into how individual devices work in different populations, and how they compare. We undertook a thorough literature search and also accessed grey literature, using searches of medicine regulators' websites and freedom of information requests. The data demonstrate that it takes at least 5-10 minutes to achieve early peak plasma concentration for most devices. The specific autoinjector device seems to be the most important determinant of pharmacokinetics, with different devices giving rise to different plasma adrenaline profiles. Needle length does not seem to be the most important factor; rather, the force and speed of injection (which varies from one device to another) is likely to be of greater importance. In general, peak plasma adrenaline concentration is lower and time-to-peak concentration longer with increased skin-to-muscle depth. However, it is difficult to draw conclusions with the current available data, due to a lack of head-to-head comparisons, small numbers of study participants, and the failure to acknowledge the biphasic nature of intramuscular adrenaline absorption for analysis purposes.
Text
Clin Experimental Allergy - 2021 - Turner - Pharmacokinetics of adrenaline autoinjectors
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More information
Accepted/In Press date: 13 November 2021
e-pub ahead of print date: 16 November 2021
Published date: January 2022
Additional Information:
Funding Information:
Dr Turner has received grants from Medical Research Council and NIHR/Imperial Biomedical Research Centre during the conduct of the study; personal fees and non‐financial support from Allergenis, plus grants from UK Medical Research Council, grants and personal fees from UK Food Standards Agency, personal fees and non‐financial support from Aimmune Therapeutics, grants from Jon Moulton Charity Trust, personal fees from Aquestive all outside the submitted work. Dr Muraro is a co‐author on the Epipen company PK study. Professor Roberts was editor in Chief Clinical & Experimental Allergy until December 2020 and has attended a Mylan advisory board; all remunerations from these activities paid to his University.
Funding Information:
This research was part-funded through a UK Medical Research Council Clinician Scientist award to PJT (reference MR/K010468/1). Professor Roberts is supported by NIHR Southampton Biomedical Research Centre.
Funding Information:
This research was part‐funded through a UK Medical Research Council Clinician Scientist award to PJT (reference MR/K010468/1). Professor Roberts is supported by NIHR Southampton Biomedical Research Centre.
Publisher Copyright:
wileyonlinelibrary.com/journal/cea
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
Keywords:
anaphylaxis, autoinjectors, pharmacokinetics
Identifiers
Local EPrints ID: 452797
URI: http://eprints.soton.ac.uk/id/eprint/452797
ISSN: 0954-7894
PURE UUID: 95bb8416-cab1-435e-91ee-bc50f6ca2547
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Date deposited: 20 Dec 2021 17:51
Last modified: 17 Mar 2024 03:02
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Author:
Paul J Turner
Author:
Antonella Muraro
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