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Volumetric absorptive microsampling (VAMS) as an alternative to conventional dried blood spots in the quantification of miltefosine in dried blood samples.
J Pharm Biomed Anal 2017; 135:160-166JP

Abstract

Miltefosine is an oral agent against the neglected tropical disease leishmaniasis, which is mostly endemic in resource-poor areas. Dried blood spot (DBS) sampling is an attractive alternative to plasma sampling for pharmacokinetic studies in these remote areas, but introduces additional variability in analyte quantification due to possible blood spot inhomogeneity and variability in blood spot volume and haematocrit values. Volumetric absorptive microsampling (VAMS) potentially overcomes a few of these issues as the VAMS device absorbs a fixed volume that is processed as a whole. We developed and validated an LC-MS/MS method for the quantification of miltefosine with this novel sampling technique with good performance in terms of linearity, selectivity, accuracy (bias within ±10.8%), precision (CV%≤11.9%), recovery, carry-over and matrix effect. VAMS samples were stable for at least one month at room temperature and 37°C. The impact of haematocrit on assay accuracy was reduced compared to conventional DBS sampling, but indicated a declining recovery with increased haematocrit due to haematocrit dependency in recovery from the sampling device. A clinical validation will be required to investigate whether VAMS is an appropriate and cost-effective alternative sampling method to conventional DBS sampling.

Authors+Show Affiliations

Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital/Slotervaart Hospital, P.O. Box 90440, 1006 BK, Amsterdam, The Netherlands; Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands. Electronic address: a.kip@nki.nl.Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital/Slotervaart Hospital, P.O. Box 90440, 1006 BK, Amsterdam, The Netherlands.Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital/Slotervaart Hospital, P.O. Box 90440, 1006 BK, Amsterdam, The Netherlands.Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands; Department of Clinical Pharmacology, Antoni van Leeuwenhoek Hospital/the Netherlands Cancer institute, P.O. Box 90203, 1006 BE, Amsterdam, The Netherlands.Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital/Slotervaart Hospital, P.O. Box 90440, 1006 BK, Amsterdam, The Netherlands; Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands; Department of Clinical Pharmacology, Antoni van Leeuwenhoek Hospital/the Netherlands Cancer institute, P.O. Box 90203, 1006 BE, Amsterdam, The Netherlands.Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands; Pharmacometrics Research Group, Department of Pharmaceutical Biosciences, Uppsala University, Box 570, 751 23 Uppsala, Sweden.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28033553

Citation

Kip, A E., et al. "Volumetric Absorptive Microsampling (VAMS) as an Alternative to Conventional Dried Blood Spots in the Quantification of Miltefosine in Dried Blood Samples." Journal of Pharmaceutical and Biomedical Analysis, vol. 135, 2017, pp. 160-166.
Kip AE, Kiers KC, Rosing H, et al. Volumetric absorptive microsampling (VAMS) as an alternative to conventional dried blood spots in the quantification of miltefosine in dried blood samples. J Pharm Biomed Anal. 2017;135:160-166.
Kip, A. E., Kiers, K. C., Rosing, H., Schellens, J. H. M., Beijnen, J. H., & Dorlo, T. P. C. (2017). Volumetric absorptive microsampling (VAMS) as an alternative to conventional dried blood spots in the quantification of miltefosine in dried blood samples. Journal of Pharmaceutical and Biomedical Analysis, 135, pp. 160-166. doi:10.1016/j.jpba.2016.12.012.
Kip AE, et al. Volumetric Absorptive Microsampling (VAMS) as an Alternative to Conventional Dried Blood Spots in the Quantification of Miltefosine in Dried Blood Samples. J Pharm Biomed Anal. 2017 Feb 20;135:160-166. PubMed PMID: 28033553.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Volumetric absorptive microsampling (VAMS) as an alternative to conventional dried blood spots in the quantification of miltefosine in dried blood samples. AU - Kip,A E, AU - Kiers,K C, AU - Rosing,H, AU - Schellens,J H M, AU - Beijnen,J H, AU - Dorlo,T P C, Y1 - 2016/12/09/ PY - 2016/09/15/received PY - 2016/11/29/revised PY - 2016/12/04/accepted PY - 2016/12/30/pubmed PY - 2017/5/26/medline PY - 2016/12/30/entrez KW - Bioanalysis KW - Dried blood KW - Hematocrit KW - LC–MS/MS KW - Miltefosine KW - Volumetric absorptive microsampling (VAMS) SP - 160 EP - 166 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 135 N2 - Miltefosine is an oral agent against the neglected tropical disease leishmaniasis, which is mostly endemic in resource-poor areas. Dried blood spot (DBS) sampling is an attractive alternative to plasma sampling for pharmacokinetic studies in these remote areas, but introduces additional variability in analyte quantification due to possible blood spot inhomogeneity and variability in blood spot volume and haematocrit values. Volumetric absorptive microsampling (VAMS) potentially overcomes a few of these issues as the VAMS device absorbs a fixed volume that is processed as a whole. We developed and validated an LC-MS/MS method for the quantification of miltefosine with this novel sampling technique with good performance in terms of linearity, selectivity, accuracy (bias within ±10.8%), precision (CV%≤11.9%), recovery, carry-over and matrix effect. VAMS samples were stable for at least one month at room temperature and 37°C. The impact of haematocrit on assay accuracy was reduced compared to conventional DBS sampling, but indicated a declining recovery with increased haematocrit due to haematocrit dependency in recovery from the sampling device. A clinical validation will be required to investigate whether VAMS is an appropriate and cost-effective alternative sampling method to conventional DBS sampling. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/28033553/Volumetric_absorptive_microsampling__VAMS__as_an_alternative_to_conventional_dried_blood_spots_in_the_quantification_of_miltefosine_in_dried_blood_samples_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(16)30491-5 DB - PRIME DP - Unbound Medicine ER -