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Pharmaceutics
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Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement,...
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Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 2nd Edition

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Clinical Pharmaceutics".

Deadline for manuscript submissions: closed (31 March 2024) | Viewed by 15307

Special Issue Editors

Dr. Andrzej Czyrski

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Guest Editor
Department of Physical Pharmacy and Pharmacokinetics, Poznań University of Medical Sciences, Rokietnicka 3 Street, 60-806 Poznań, Poland
Interests: therapeutic drug monitoring; drug analysis; pharmacokinetics; optimization of analytical procedure; drug-drug interactions
Special Issues, Collections and Topics in MDPI journals
Dr. Joanna Sobiak

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Guest Editor
Department of Physical Pharmacy and Pharmacokinetics, Poznań University of Medical Sciences, Rokietnicka 3 Street, 60-806 Poznań, Poland
Interests: therapeutic drug monitoring; immunosuppression; pediatrics; HPLC; pharmacokinetics; pharmacodynamics
Special Issues, Collections and Topics in MDPI journals
Dr. Matylda Resztak

E-Mail Website
Guest Editor
Department of Physical Pharmacy and Pharmacokinetics, Poznań University of Medical Sciences, Rokietnicka 3 Street, 60-806 Poznań, Poland
Interests: therapeutic drug monitoring; drug analysis; pharmacokinetics
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Responses to therapy may vary between patients. Therapeutic drug monitoring is helpful in order to deal with this phenomenon. This Special Issue is targeted towards authors whose work focuses on therapeutic drug monitoring. We invite the submission of manuscripts concerning observed drug–drug interactions based on the effects of drug concentrations on biological matrices, as well as their pharmacokinetic impacts. Original papers concerning new drugs for which therapeutic drug monitoring may be beneficial are also welcome, as are those focused on new approaches for therapeutic drug monitoring. Interactions in the pharmacokinetic phase may also be observed in animal models; however, they must be relevant to the human body. In this context, papers concerning pharmacokinetic interactions in both human and animal models will be welcome. This Special Issue will include original and review articles.

Dr. Andrzej Czyrski
Dr. Joanna Sobiak
Dr. Matylda Resztak
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • drug–drug interactions
  • pharmacokinetics
  • therapeutic drug monitoring

Related Special Issue

Published Papers (7 papers)

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Research

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10 pages, 1583 KiB  
Article
Towards Precision Medicine in Clinical Practice: Alinity C vs. UHPLC-MS/MS in Plasma Aripiprazole Determination
by Francisco José Toja-Camba, Enrique Bandín-Vilar, Gonzalo Hermelo-Vidal, Carolina Feitosa-Medeiros, Antonio Cañizo-Outeiriño, Ana Castro-Balado, Iria Varela-Rey, Irene Zarra-Ferro, Anxo Fernández-Ferreiro and Cristina Mondelo-García
Pharmaceutics 2024, 16(1), 104; https://doi.org/10.3390/pharmaceutics16010104 - 12 Jan 2024
Viewed by 819
Abstract
Therapeutic drug monitoring improves the benefit–risk balance of antipsychotic therapy. Ultra-high-performance liquid chromatography–tandem mass spectrometry (UHPLC-MS/MS) is considered the gold-standard method for measuring plasma drug concentrations; however, the Alinity C system has emerged as a promising alternative. This is the first study aimed [...] Read more.
Therapeutic drug monitoring improves the benefit–risk balance of antipsychotic therapy. Ultra-high-performance liquid chromatography–tandem mass spectrometry (UHPLC-MS/MS) is considered the gold-standard method for measuring plasma drug concentrations; however, the Alinity C system has emerged as a promising alternative. This is the first study aimed at comparing UHPLC-MS/MS versus Alinity C in measuring plasma concentrations of aripiprazole and dehydroaripiprazole. A total of 86 plasma samples were analyzed. The active moiety of aripiprazole was measured in 60 samples using both systems and 26 samples were analyzed twice using Alinity C with an intermediate period of 6 months to assess its reproducibility. Spearman’s correlation revealed a good association between the two assays (rs = 0.96) and no significance differences were found by McNemar’s test when classifying samples between infra-, supra- and therapeutic ranges. Passing–Bablock regression showed a good correlation among methods (rs = 0.93) and a slope of 1.12 indicating a slight tendency of Alinity C to measure higher values than UHPLC-MS/MS. In addition, a good intra-method correlation across the two sequential analyses with Alinity C was obtained (rs = 0.99). Nonetheless, clinical decisions could be different in 15% of the cases depending on the chosen method. No differences were found in active moiety determination by Alinity C depending on the concentration of aripiprazole and dehydroaripiprazole of the samples. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 2nd Edition)
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18 pages, 6822 KiB  
Article
The Chemometric Evaluation of the Factors Influencing Cloud Point Extraction for Fluoroquinolones
by Aleksandra Michałowska, Olga Kupczyk and Andrzej Czyrski
Pharmaceutics 2023, 15(6), 1774; https://doi.org/10.3390/pharmaceutics15061774 - 20 Jun 2023
Cited by 2 | Viewed by 786
Abstract
This study aimed to analyze the factors that impact the cloud point extraction of ciprofloxacin, levofloxacin, and moxifloxacin. The following independent variables were analyzed: Triton X-114 concentration, NaCl concentration, pH, and incubation temperature. The dependent variable studied was recovery. A central composite design [...] Read more.
This study aimed to analyze the factors that impact the cloud point extraction of ciprofloxacin, levofloxacin, and moxifloxacin. The following independent variables were analyzed: Triton X-114 concentration, NaCl concentration, pH, and incubation temperature. The dependent variable studied was recovery. A central composite design model was used. The applied quantitation method was HPLC. The method was validated for linearity, precision, and accuracy. The results underwent ANOVA® analysis. The polynomial equations were generated for each analyte. The response surface methodology graphs visualized them. The analysis showed that the factor most affecting the recovery of levofloxacin is the concentration of Triton X-114, while the recovery of ciprofloxacin and moxifloxacin is most affected by pH value. However, the concentration of Triton X-114 also plays an important role. The optimization resulted in the following recoveries: for ciprofloxacin, 60%; for levofloxacin, 75%; and for moxifloxacin, 84%, which are identical to those estimated with regression equations—59%, 74% and 81% for ciprofloxacin, levofloxacin, and moxifloxacin, respectively. The research confirms the validity of using the model to analyze factors affecting the recovery of the analyzed compounds. The model allows for a thorough analysis of variables and their optimization. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 2nd Edition)
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16 pages, 3462 KiB  
Article
The Effect of Voriconazole on Tacrolimus in Kidney Transplantation Recipients: A Real-World Study
by Yi-Chang Zhao, Chen-Lin Xiao, Jing-Jing Hou, Jia-Kai Li, Bi-Kui Zhang, Xu-Biao Xie, Chun-Hua Fang, Feng-Hua Peng, Indy Sandaradura and Miao Yan
Pharmaceutics 2022, 14(12), 2739; https://doi.org/10.3390/pharmaceutics14122739 - 07 Dec 2022
Cited by 3 | Viewed by 1681
Abstract
Tacrolimus is an immunosuppressant with a narrow therapeutic window. Tacrolimus exposure increased significantly during voriconazole co-therapy. The magnitude of this interaction is highly variable, but it is hard to predict quantitatively. We conducted a study on 91 kidney transplantation recipients with voriconazole co-therapy. [...] Read more.
Tacrolimus is an immunosuppressant with a narrow therapeutic window. Tacrolimus exposure increased significantly during voriconazole co-therapy. The magnitude of this interaction is highly variable, but it is hard to predict quantitatively. We conducted a study on 91 kidney transplantation recipients with voriconazole co-therapy. Furthermore, 1701 tacrolimus concentration data were collected. Standard concentration adjusted by tacrolimus daily dose (C/D) and weight-adjusted standard concentration (CDW) increased to 6 times higher during voriconazole co-therapy. C/D and CDW increased with voriconazole concentration. Patients with the genotype of CYP3A5 *3/*3 and CYP2C19 *2/*2 or *2/*3 were more variable at the same voriconazole concentration level. The final prediction model could explain 54.27% of the variation in C/D and 51.11% of the variation in CDW. In conclusion, voriconazole was the main factor causing C/D and CDW variation, and the effect intensity should be quantitative by its concentration. Kidney transplant recipients with CYP3A5 genotype of *3/*3 and CYP2C19 genotype of *2/*2 and *2/*3 should be given more attention during voriconazole co-therapy. The prediction model established in this study may help to reduce the occurrence of rejection. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 2nd Edition)
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10 pages, 1942 KiB  
Article
Therapeutic Drug Monitoring of Quinidine in Pediatric Patients with KCNT1 Genetic Variants
by Alessandro Ferretti, Raffaele Simeoli, Sara Cairoli, Nicola Pietrafusa, Marina Trivisano, Carlo Dionisi Vici, Nicola Specchio and Bianca Maria Goffredo
Pharmaceutics 2022, 14(10), 2230; https://doi.org/10.3390/pharmaceutics14102230 - 19 Oct 2022
Cited by 2 | Viewed by 1556
Abstract
Quinidine (QND) is an old antimalarial drug that was used in the early 20th century as an antiarrhythmic agent. Currently, QND is receiving attention for its use in epilepsy of infancy with migrating focal seizures (EIMFS) due to potassium sodium-activated channel subfamily T [...] Read more.
Quinidine (QND) is an old antimalarial drug that was used in the early 20th century as an antiarrhythmic agent. Currently, QND is receiving attention for its use in epilepsy of infancy with migrating focal seizures (EIMFS) due to potassium sodium-activated channel subfamily T member 1 (KCNT1) genetic variants. Here, we report the application of Therapeutic Drug Monitoring (TDM) in pediatric patients carrying KCNT1 genetic variants and orally treated with QND for developmental and epileptic encephalopathies (DEE). We measured plasma levels of QND and its metabolite hydroquinidine (H-QND) by using a validated method based on liquid chromatography coupled with mass spectrometry (LC-MS/MS). Three pediatric patients (median age 4.125 years, IQR 2.375–4.125) received increasing doses of QND. Cardiac toxicity was monitored at every dose change. Reduction in seizure frequency ranged from 50 to 90%. Our results show that QND is a promising drug for pediatric patients with DEE due to KCNT1 genetic variants. Although QND blood levels were significantly lower than the therapeutic range as an anti-arrhythmic drug, patients showed a significant improvement in seizure burden. These data underlie the utility of TDM for QND not only to monitor its toxic effects but also to evaluate possible drug–drug interactions. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 2nd Edition)
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12 pages, 1326 KiB  
Article
Monitoring of Ex Vivo Cyclosporin a Activity in Healthy Volunteers Using T Cell Function Assays in Relation to Whole Blood and Cellular Pharmacokinetics
by Aliede E. in ’t Veld, Manon A. A. Jansen, Bertine W. Huisman, Mascha Schoonakker, Marieke L. de Kam, Dirk Jan A. R. Moes, Mariëtte I. E. van Poelgeest, Jacobus Burggraaf and Matthijs Moerland
Pharmaceutics 2022, 14(9), 1958; https://doi.org/10.3390/pharmaceutics14091958 - 16 Sep 2022
Cited by 2 | Viewed by 1464
Abstract
Therapeutic drug monitoring (TDM) of calcineurin inhibitors (i.e., tacrolimus and cyclosporin A) is standard of care after solid organ transplantation. Although the incidence of acute rejection has strongly decreased, there are still many patients who experience severe side effects or rejection after long-term [...] Read more.
Therapeutic drug monitoring (TDM) of calcineurin inhibitors (i.e., tacrolimus and cyclosporin A) is standard of care after solid organ transplantation. Although the incidence of acute rejection has strongly decreased, there are still many patients who experience severe side effects or rejection after long-term treatment. In this healthy volunteer study we therefore aimed to identify biomarkers to move from a pharmacokinetic-based towards a pharmacodynamic-based monitoring approach for calcineurin inhibitor treatment. Healthy volunteers received a single dose of cyclosporine A (CsA) or placebo, after which whole blood samples were stimulated to measure ex vivo T cell functionality, including proliferation, cytokine production, and activation marker expression. The highest whole blood concentration of CsA was found at 2 h post-dose, which resulted in a strong inhibition of interferon gamma (IFNy) and interleukin-2 (IL-2) production and expression of CD154 and CD71 on T cells. Moreover, the in vitro effect of CsA was studied by incubation of pre-dose whole blood samples with a concentration range of CsA. The average in vitro and ex vivo CsA activity overlapped, making the in vitro dose–effect relationship an interesting method for prediction of post-dose drug effect. The clinical relevance of the results is to be explored in transplantation patients on calcineurin inhibitor treatment. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 2nd Edition)
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15 pages, 1947 KiB  
Article
Simultaneous LC-ESI-MS/MS Quantification of Levosimendan and Its Metabolites for Therapeutic Drug Monitoring of Cardiac Surgery Patients
by Hannah Kipka, Roland Tomasi, Max Hübner, Uwe Liebchen, Christian Hagl, Klaus T. Wanner, Hanna Mannell and Georg Höfner
Pharmaceutics 2022, 14(7), 1454; https://doi.org/10.3390/pharmaceutics14071454 - 12 Jul 2022
Cited by 1 | Viewed by 1544
Abstract
Levosimendan is used in severe chronic cardiac insufficiency, also within the peri-operative setting. Real-life pharmacokinetic data in surgical patients is lacking, making therapeutic drug monitoring (TDM) of levosimendan, its pharmacologically active metabolite OR-1896, and its intermediate OR-1855 important. A simultaneous highly sensitive quantification [...] Read more.
Levosimendan is used in severe chronic cardiac insufficiency, also within the peri-operative setting. Real-life pharmacokinetic data in surgical patients is lacking, making therapeutic drug monitoring (TDM) of levosimendan, its pharmacologically active metabolite OR-1896, and its intermediate OR-1855 important. A simultaneous highly sensitive quantification of levosimendan and its metabolites in small-volume samples has not yet been described. Here, levosimendan (LLOQ 0.450 nM), OR-1896, and OR-1855 (LLOQ both 1.0 nM) were successfully quantified by LC-ESI-MS/MS after liquid-liquid extraction in 300 µL of blood. A short C8 column under reversed-phase conditions enabled simultaneous and fast quantification of levosimendan in the negative and the metabolites in the positive ionization mode in a single run within 2 min. Interestingly and unexpectedly, constitutional isomers of levosimendan metabolites with identical mass transitions and similar retention times were observed in surgical patients’ samples, which we identified as the metamizole metabolites 4-aminoantipyrine and 4-acetamidoantipyrine. A longer C8 column and a modified mobile phase enabled selective quantification of all analytes in a single run within 7 min. We developed, validated, and applied highly sensitive LC-ESI-MS/MS methods for simultaneous quantification of levosimendan and its metabolites, enabling efficient TDM of cardiac surgery patients even with additional metamizole administration. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 2nd Edition)
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Review

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13 pages, 316 KiB  
Review
Controversial Interactions of Tacrolimus with Dietary Supplements, Herbs and Food
by Miłosz Miedziaszczyk, Aleksander Bajon, Ewelina Jakielska, Marta Primke, Jędrzej Sikora, Dagmara Skowrońska and Ilona Idasiak-Piechocka
Pharmaceutics 2022, 14(10), 2154; https://doi.org/10.3390/pharmaceutics14102154 - 10 Oct 2022
Cited by 5 | Viewed by 6669
Abstract
Tacrolimus is an immunosuppressive calcineurin inhibitor used to prevent rejection in allogeneic organ transplant recipients, such as kidney, liver, heart or lung. It is metabolized in the liver, involving the cytochrome P450 (CYP3A4) isoform CYP3A4, and is characterized by a narrow therapeutic window, [...] Read more.
Tacrolimus is an immunosuppressive calcineurin inhibitor used to prevent rejection in allogeneic organ transplant recipients, such as kidney, liver, heart or lung. It is metabolized in the liver, involving the cytochrome P450 (CYP3A4) isoform CYP3A4, and is characterized by a narrow therapeutic window, dose-dependent toxicity and high inter-individual and intra-individual variability. In view of the abovementioned facts, the aim of the study is to present selected interactions between tacrolimus and the commonly used dietary supplements, herbs and food. The review was based on the available scientific literature found in the PubMed, Scopus and Cochrane databases. An increase in the serum concentration of tacrolimus can be caused by CYP3A4 inhibitors, such as grapefruit, pomelo, clementine, pomegranate, ginger and turmeric, revealing the side effects of this drug, particularly nephrotoxicity. In contrast, CYP3A4 inducers, such as St. John’s Wort, may result in a lack of therapeutic effect by reducing the drug concentration. Additionally, the use of Panax ginseng, green tea, Schisandra sphenanthera and melatonin in patients receiving tacrolimus is highly controversial. Therefore, since alternative medicine constitutes an attractive treatment option for patients, modern healthcare should emphasize the potential interactions between herbal medicines and synthetic drugs. In fact, each drug or herbal supplement should be reported by the patient to the physician (concordance) if it is taken in the course of immunosuppressive therapy, since it may affect the pharmacokinetic and pharmacodynamic parameters of other preparations. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 2nd Edition)
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