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Non-invasive therapeutic drug monitoring: LC-MS validation for lamotrigine quantification in dried blood spot and oral fluid/saliva

M. Pelcová, V. Ďurčová, P. Šmak, O. Strýček, M. Štolcová, O. Peš, Z. Glatz, P. Šištík, J. Juřica

. 2025 ; 262 (-) : 116877. [pub] 20250411

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu časopisecké články, validační studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc25015104

Epilepsy, affecting over 50 million people globally, presents a significant neurological challenge. Effective prevention of epileptic seizures relies on proper administration and monitoring of Anti-Seizure Medication (ASMs). Therapeutic Drug Monitoring (TDM) ensures optimal dosage adjustment, minimizing adverse effects and potential drug interactions. While traditional venous blood collection for TDM may be stressful, emerging alternative sampling methods, particularly Dried Blood Spot (DBS) or oral fluid offer less invasive way of sampling. This study aimed to develop and validate an analytical method for the determination of lamotrigine in such alternative samples. The sample, either DBS or oral fluid, was subjected to extraction, evaporation, and reconstitution in 15 % acetonitrile containing 0.1 % formic acid. A Kinetex C18 Polar column was used for liquid chromatographic separation and MS in ESI+ mode was used for detection and quantitation of lamotrigine using an isotopically labelled internal standard according to EMA guidelines. The calibration range of the developed method enables the determination of lamotrigine in the concentration range of 1-30 μg/mL in DBS and 0.5-20 μg/mL in oral fluid. Oral fluid and DBS samples from patients treated with lamotrigine analysed by the developed method were compared to plasma concentrations measured by the hospital's accredited laboratory. Preliminary results indicate a promising potential for these alternative matrices in clinical TDM applications. By offering a less invasive sampling approach, this method improves the accessibility and safety of pharmacotherapy for epilepsy patients. The results of this study lay the foundation for further clinical applications by implementing alternative matrix TDM, which may significantly advance personalized care in epilepsy management.

Citace poskytuje Crossref.org

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$a Epilepsy, affecting over 50 million people globally, presents a significant neurological challenge. Effective prevention of epileptic seizures relies on proper administration and monitoring of Anti-Seizure Medication (ASMs). Therapeutic Drug Monitoring (TDM) ensures optimal dosage adjustment, minimizing adverse effects and potential drug interactions. While traditional venous blood collection for TDM may be stressful, emerging alternative sampling methods, particularly Dried Blood Spot (DBS) or oral fluid offer less invasive way of sampling. This study aimed to develop and validate an analytical method for the determination of lamotrigine in such alternative samples. The sample, either DBS or oral fluid, was subjected to extraction, evaporation, and reconstitution in 15 % acetonitrile containing 0.1 % formic acid. A Kinetex C18 Polar column was used for liquid chromatographic separation and MS in ESI+ mode was used for detection and quantitation of lamotrigine using an isotopically labelled internal standard according to EMA guidelines. The calibration range of the developed method enables the determination of lamotrigine in the concentration range of 1-30 μg/mL in DBS and 0.5-20 μg/mL in oral fluid. Oral fluid and DBS samples from patients treated with lamotrigine analysed by the developed method were compared to plasma concentrations measured by the hospital's accredited laboratory. Preliminary results indicate a promising potential for these alternative matrices in clinical TDM applications. By offering a less invasive sampling approach, this method improves the accessibility and safety of pharmacotherapy for epilepsy patients. The results of this study lay the foundation for further clinical applications by implementing alternative matrix TDM, which may significantly advance personalized care in epilepsy management.
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$a Ďurčová, Viktória $u Department of Biochemistry, Faculty of Science, Masaryk University, Kamenice 5, Brno 62500, Czech Republic
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$a Šmak, Pavel $u Department of Biochemistry, Faculty of Medicine, Masaryk University, Kamenice 5, Brno 62500, Czech Republic
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$a Strýček, Ondřej $u Brno Epilepsy Center, First Department of Neurology, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Member of ERN-EpiCARE, Pekařská 53, Brno 602 00, Czech Republic
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$a Štolcová, Miriam $u Department of Biochemistry, Faculty of Science, Masaryk University, Kamenice 5, Brno 62500, Czech Republic
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$a Peš, Ondřej $u Department of Biochemistry, Faculty of Medicine, Masaryk University, Kamenice 5, Brno 62500, Czech Republic
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$a Glatz, Zdeněk $u Department of Biochemistry, Faculty of Science, Masaryk University, Kamenice 5, Brno 62500, Czech Republic
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$a Šištík, Pavel $u Department of Clinical Pharmacology, Institute of Laboratory Medicine, University, Hospital Ostrava, 17. listopadu 1790, Ostrava 708 52, Czech Republic
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$a Juřica, Jan $u Department of Pharmacology, Faculty of Medicine and Department of Pharmacology and Toxicology, Faculty of Pharmacy, Masaryk University, Kamenice 5, Brno 62500, Czech Republic; Pharmacy at Masaryk Memorial Cancer Institute, Žlutý kopec 7, Brno 60200, Czech Republic. Electronic address: jurica@med.muni.cz
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