Evaluation of a novel micro-sampling device, Mitra (TM), in comparison to dried blood spots, for analysis of praziquantel in Schistosoma haematobium-infected children in rural Cote d'Ivoire

摘要

Pharmacokinetic (PK) studies with paediatric populations are increasing in importance for drug development. However, conventional PK sampling methods are characterised by invasiveness and low patient adherence, unsuitable for use with sensitive population, such as children. Mitra (TM) is a novel volumetric absorptive micro-sampling device, which offers an alternative to the dried blood spotting (DBS) technique, a current popular sampling technique within PK studies. We tested Mitra (TM) for the first time in the framework of a randomised controlled trial in rural Cote d'Ivoire. Thirty-five school-aged children, infected with Schistosoma haematobium, were sampled with both DBS and Mitra (TM), at 10 time points after treatment with praziquantel (PZQ). An extraction method for PZQ from Mitra (TM) was developed, optimised and validated. Analytes, namely R- and S-praziquantel (R-/SPZQ) and the main human metabolite, R-trans-4-OH-praziquantel, were measured using liquid chromatography-tandem mass spectrometry and the results were compared with Bland-Altman analysis to determine agreement between matrices. PK parameters, such as maximal plasma concentration and area under the concentration-time curve, were estimated using non-compartmental analysis.