Publication: Bioequivalence study of lumefantrine rectal enema and the commercially available generic oral suspension. A pilot study
Authors
Mhango, E. K. G. ; Marín, P. ; Escudero, E. ; Yuste Pérez, María Teresa ; Eiriksson, F. F. ; Snorradottir, B. S. ; Sveinbjornsson, B. R. ; Gizurarson, S.
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Publisher
Society of Pharmaceutical Sciences and Research (SPSR)
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DOI
https://doi.org/10.13040/IJPSR.0975-8232.15(5).1391-99
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info:eu-repo/semantics/article
Description
© 2024 The authors
This document is the published version of a published work that appeared in final form in International Journal of Pharmaceutical Sciences and Research (IJPSR. .
This document is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0
To access the final edited and published work see:
https://doi.org/10.13040/IJPSR.0975-8232.15(5).1391-99
Abstract
Children under five years of age, with severe or cerebral malaria,
cannot consume oral medication especially if they are vomiting or are
unconscious. In such situations they are given an injectable drug until they can
tolerate oral medication. The situation is bad in Sub-Saharan Africa, especially
in rural areas as children are sometimes referred to the closest referral health
care facility for proper management. The aim of this study was therefore to
conduct a pilot study to estimate the bioavailability of lumefantrine (LF) when
administered as a rectal enema, and compare it with a commercially available
oral suspension, in rabbits. The study was conducted on six healthy rabbits in an
open randomized, crossover three sequence, single dose study, where each rabbit
received rectal and oral formulations. The oral formulation was administered
under fed and fasted conditions. A two-week washout period was allowed
between the experiments. LF was quantified in rabbit plasma using
ultraperformance liquid chromatography tandem mass spectrometry (UPLC
MS/MS). Results showed that the relative bioavailability of rectal LF was about
four times higher than oral. The observed data suggest that a significant
adjustment in the dose will be required when LF is administered via the rectal
route. The data provide important information for the next step in finding a
method to provide a rescue treatment for children with severe or cerebral
malaria.
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Citation
International Journal of Pharmaceutical Sciences and Research, 2024; Vol. 15(5): 1391-1399.
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