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JAC Advance Access published online on September 19, 2007
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkm355
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© The Author 2007. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Pharmacokinetics of two paediatric artesunate–mefloquine drug formulations in the treatment of uncomplicated falciparum malaria in Gabon

Michael Ramharter1,2,3,*, Florian M. Kurth1, Sabine Bélard1, Marielle K. Bouyou-Akotet4, Modeste Mabika Mamfoumbi4, Selidji T. Agnandji1,2, Michel A. Missinou1,2, Ayola A. Adegnika1,2, Saadou Issifou1,2, Nathalie Cambon5, János L. Heidecker5, Maryvonne Kombila4 and Peter G. Kremsner1,2

1 Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon 2 Institute for Tropical Medicine, Department for Parasitology, University of Tübingen, Tübingen, Germany 3 Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria 4 Département de Parasitologie-Mycologie et Médecine Tropicale, Faculté de Médecine, Université des Sciences de la Santé, Libreville, Gabon 5 Pharmaceutical Research Development and Manufacture, Mepha Ltd, Aesch, Switzerland

Received 3 June 2007; returned 28 July 2007; revised 5 August 2007; accepted 20 August 2007

* Corresponding author. Tel: +43-1-40400-4440; Fax: +43-1-40400-4418; E-mail: michael.ramharter{at}meduniwien.ac.at

Objectives: Paediatric drug formulations of artemisinin combination therapies and pharmacokinetic data supporting their use in African children are urgently needed for the effective treatment of young children suffering from falciparum malaria in sub-Saharan Africa.

Patients and methods: In this study, the pharmacokinetic characteristics of a novel paediatric granule formulation of artesunate–mefloquine therapy were evaluated in comparison to the standard tablet formulation in the treatment of uncomplicated malaria in paediatric patients. Twenty-four patients were assigned to treatment according to body weight with either a fixed-dose paediatric granule co-formulation (10–20 kg body weight) or a free-dose co-blister tablet formulation of artesunate–mefloquine (>20–40 kg body weight).

Results: Median values for Cmax (861 and 930 ng/mL), Tmax (1.5 and 1.5 h) and AUC0–t (2050 and 2470 ng·h/mL) were comparable for dihydroartemisinin in the two groups. Exploratory analysis of mefloquine plasma levels revealed a trend towards higher concentrations in the younger age group during the absorption phase (2550 and 1815 ng/mL, 54 h after initiation of treatment, respectively). Median mefloquine concentrations at day 28 were 197 and 343 ng/mL, respectively.

Conclusions: The pharmacokinetic characteristics of the two paediatric dosage forms, i.e. the novel fixed-dose co-formulation and the standard co-blister of artesunate–mefloquine show comparable results in the two treatment groups. The novel fixed-dose paediatric formulation is an interesting option for outpatient treatment of uncomplicated malaria in African children.

Key Words: malaria , Plasmodium falciparum , PK , Africa


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