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Urinary excretion studies of meldonium after multidose parenteral application

Authorized Users Only
2018
Authors
Forsdahl, Guro
Jančić-Stojanović, Biljana
Anđelković, Marija
Dikić, Nenad
Geisendorfer, Tomas
Jeitler, Veronika
Gmeiner, Gunter
Article (Published version)
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Abstract
Meldonium is a drug exhibiting cardioprotective and anti-ischemic effects. Due to its potential performance-enhancing benefit in sports, meldonium was added to the World Anti-Doping Agency list of prohibited substances in 2016. Since then, a high number of adverse analytical findings reported on meldonium has questioned meldonium's detection time in urine. Hence, the objective of the current study was to characterize the pharmacokinetic urinary excretion pattern of meldonium when administered as multiple intravenous injections. Three injections of 250 mg meldonium were given over a time period of five days to six healthy volunteers and urine samples were collected for eight months after the last injection of the drug. For the quantification of meldonium in urine, a liquid chromatography-tandem mass spectrometry method was fully validated according to the World Anti-Doping Agency guidelines in terms of specificity, matrix interferences, intra- and inter-day precision, accuracy, carry-ov...er, robustness, linearity, limit of detection, and limit of quantification. The assay was successfully applied to the pharmacokinetic study. A three-compartment model was found to best describe the pharmacokinetics of meldonium with average alpha, beta, and gamma half-lives of 1.4 h, 9.4 h, and 655 h, respectively. The detection time in urine varied between 94 and 162 days.

Keywords:
Meldonium / Pharmacokinetics / Urinary excretion / Doping analysis
Source:
Journal of Pharmaceutical and Biomedical Analysis, 2018, 161, 289-295
Publisher:
  • Elsevier Science BV, Amsterdam
Projects:
  • Austrian Ministry of Defence and Sports

DOI: 10.1016/j.jpba.2018.08.053

ISSN: 0731-7085

PubMed: 30189410

WoS: 000447682300031

Scopus: 2-s2.0-85052653931
[ Google Scholar ]
2
1
URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/3044
Collections
  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy
TY  - JOUR
AU  - Forsdahl, Guro
AU  - Jančić-Stojanović, Biljana
AU  - Anđelković, Marija
AU  - Dikić, Nenad
AU  - Geisendorfer, Tomas
AU  - Jeitler, Veronika
AU  - Gmeiner, Gunter
PY  - 2018
UR  - http://farfar.pharmacy.bg.ac.rs/handle/123456789/3044
AB  - Meldonium is a drug exhibiting cardioprotective and anti-ischemic effects. Due to its potential performance-enhancing benefit in sports, meldonium was added to the World Anti-Doping Agency list of prohibited substances in 2016. Since then, a high number of adverse analytical findings reported on meldonium has questioned meldonium's detection time in urine. Hence, the objective of the current study was to characterize the pharmacokinetic urinary excretion pattern of meldonium when administered as multiple intravenous injections. Three injections of 250 mg meldonium were given over a time period of five days to six healthy volunteers and urine samples were collected for eight months after the last injection of the drug. For the quantification of meldonium in urine, a liquid chromatography-tandem mass spectrometry method was fully validated according to the World Anti-Doping Agency guidelines in terms of specificity, matrix interferences, intra- and inter-day precision, accuracy, carry-over, robustness, linearity, limit of detection, and limit of quantification. The assay was successfully applied to the pharmacokinetic study. A three-compartment model was found to best describe the pharmacokinetics of meldonium with average alpha, beta, and gamma half-lives of 1.4 h, 9.4 h, and 655 h, respectively. The detection time in urine varied between 94 and 162 days.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Urinary excretion studies of meldonium after multidose parenteral application
VL  - 161
SP  - 289
EP  - 295
DO  - 10.1016/j.jpba.2018.08.053
ER  - 
@article{
author = "Forsdahl, Guro and Jančić-Stojanović, Biljana and Anđelković, Marija and Dikić, Nenad and Geisendorfer, Tomas and Jeitler, Veronika and Gmeiner, Gunter",
year = "2018",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/3044",
abstract = "Meldonium is a drug exhibiting cardioprotective and anti-ischemic effects. Due to its potential performance-enhancing benefit in sports, meldonium was added to the World Anti-Doping Agency list of prohibited substances in 2016. Since then, a high number of adverse analytical findings reported on meldonium has questioned meldonium's detection time in urine. Hence, the objective of the current study was to characterize the pharmacokinetic urinary excretion pattern of meldonium when administered as multiple intravenous injections. Three injections of 250 mg meldonium were given over a time period of five days to six healthy volunteers and urine samples were collected for eight months after the last injection of the drug. For the quantification of meldonium in urine, a liquid chromatography-tandem mass spectrometry method was fully validated according to the World Anti-Doping Agency guidelines in terms of specificity, matrix interferences, intra- and inter-day precision, accuracy, carry-over, robustness, linearity, limit of detection, and limit of quantification. The assay was successfully applied to the pharmacokinetic study. A three-compartment model was found to best describe the pharmacokinetics of meldonium with average alpha, beta, and gamma half-lives of 1.4 h, 9.4 h, and 655 h, respectively. The detection time in urine varied between 94 and 162 days.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Urinary excretion studies of meldonium after multidose parenteral application",
volume = "161",
pages = "289-295",
doi = "10.1016/j.jpba.2018.08.053"
}
Forsdahl G, Jančić-Stojanović B, Anđelković M, Dikić N, Geisendorfer T, Jeitler V, Gmeiner G. Urinary excretion studies of meldonium after multidose parenteral application. Journal of Pharmaceutical and Biomedical Analysis. 2018;161:289-295
Forsdahl, G., Jančić-Stojanović, B., Anđelković, M., Dikić, N., Geisendorfer, T., Jeitler, V.,& Gmeiner, G. (2018). Urinary excretion studies of meldonium after multidose parenteral application.
Journal of Pharmaceutical and Biomedical AnalysisElsevier Science BV, Amsterdam., 161, 289-295.
https://doi.org/10.1016/j.jpba.2018.08.053
Forsdahl Guro, Jančić-Stojanović Biljana, Anđelković Marija, Dikić Nenad, Geisendorfer Tomas, Jeitler Veronika, Gmeiner Gunter, "Urinary excretion studies of meldonium after multidose parenteral application" 161 (2018):289-295,
https://doi.org/10.1016/j.jpba.2018.08.053 .

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