Development and validation of an HPLC-MS/MS method for the quantification of the anti-leishmanial drug miltefosine in human skin tissue

Roseboom, Ignace C.; Thijssen, Bram; Rosing, Hilde; Alves, Fabiana; Mondal, Dinesh; Teunissen, Marcel B. M.; Beijnen, Jos H.; Dorlo, Thomas P. C.

doi:10.1016/j.jpba.2021.114402

Cited by 12 publications

(18 citation statements)

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“…These PK studies improved formulation strategies for amphotericin B and improved therapeutic dosing regimens for all antileishmanial drugs by characterizing exposure and exposure‐response relationships of the treatments. There is an increased interest to involve target‐site PK data coupled to classical blood matrices to gain more information on exposure‐response relationships and distribution of drugs to their respective site of target (Rizk et al, 2017; Roseboom, Rosing, et al, 2020; Roseboom, Thijssen, Rosing, Alves, Mondal, et al, 2022; Xue et al, 2012). Considering future target‐site antileishmanial PK studies, the development and validation of bioanalytical methods for the quantification of antileishmanial drugs in human skin tissue (CL and PKDL), spleen, liver, and bone marrow (VL) and PBMCs (leishmaniasis in general) will gain prominence.…”

Section: Discussionmentioning

confidence: 99%

“…Considering future target‐site antileishmanial PK studies, the development and validation of bioanalytical methods for the quantification of antileishmanial drugs in human skin tissue (CL and PKDL), spleen, liver, and bone marrow (VL) and PBMCs (leishmaniasis in general) will gain prominence. Quantification in skin tissue was to date published only for amphotericin B (Roseboom, Thijssen, Rosing, Alves, Sundar, et al, 2022), miltefosine (Roseboom, Thijssen, Rosing, Alves, Mondal, et al, 2022), and pentavalent antimonials (da Justa Neves et al, 2009) and is expected to contribute to future antileishmanial target‐site PK studies in CL and PKDL patients. Quantification in liver was described for pentavalent antimonials (Lyon et al, 2002; Patriarca et al, 1999).…”

Section: Discussionmentioning

confidence: 99%

“…Intracellular Leishmania parasites reside and survive in macrophages; therefore, quantifying miltefosine intracellularly directly provides the exposure in concentration of Leishmania to miltefosine (Kip et al, 2015). The validated calibration model ranges of the bioanalytical methods for miltefosine were 300–2500 ng/ml (Lemke & Kayser, 2006), 2.5–400 ng/ml (Jaiswal et al, 2016), 4–1000 ng/ml (Roseboom, Thijssen, Rosing, Alves, Mondal, et al, 2022), and 4–2000 ng/ml (Dorlo, Hillebrand, et al, 2008; Kip et al, 2015, 2016, 2017; Roy et al, 2015). The range of 2.5–400 ng/ml was the most sensitive bioanalytical assay for miltefosine using MS/MS, although showing a low sample preparation volume of 50 μl (Jaiswal et al, 2016).…”

Section: Bioanalytical Methodsmentioning

confidence: 99%

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Bioanalytical methods for pharmacokinetic studies of antileishmanial drugs

Roseboom

Rosing

Beijnen

et al. 2022

Biomedical Chromatography

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Bioanalytical method development and validation for the quantification of antileishmanial drugs are pivotal to support clinical trials and provide the data necessary to conduct pharmacokinetic (PK) analysis. This review provides a comprehensive overview of published validated bioanalytical assays for the quantification of antileishmanial drugs amphotericin B, miltefosine, paromomycin, pentamidine, and pentavalent antimonials in human matrices. The applicability of the assays for leishmaniasis clinical trials as well as their relevance to PK studies with emphasis on the choice of matrix, calibration range, sample volume, sample preparation, choice of internal standards, separation, and detection was discussed for each antileishmanial drug. Given that no published bioanalytical methods included multiple antileishmanial drugs in a single assay although antileishmanial shortened combination regimens currently were under investigation, it was recommended to combine various drugs in a single bioanalytical method. Furthermore, bioanalytical method development regarding target site matrix as well as applying microsampling strategies was recommended to optimize future clinical PK studies in leishmaniasis.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Bioanalytical Methodsmentioning

confidence: 99%

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Bioanalytical methods for pharmacokinetic studies of antileishmanial drugs

Roseboom

Rosing

Beijnen

et al. 2022

Biomedical Chromatography

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“…Nowadays, and transversal to several fields of science-including medicine, chemistry, pharmacy, and other related fields, high resolution chromatographic techniques (HRCT) and mass spectrometry (MS), has evolved as one of the most valuable analytical tools available to modern scientists allowing a deep and comprehensive knowledge on structural elucidation of unknown substances [133], quality control of drugs [134], clinical [135], environmental [136], food control [137], and forensic analytes [138], providing qualitative as well as quantitative information for a broad variety of compound classes. Other applications include inorganic chemical analysis, geochronology [139], reaction kinetics [140], determination of thermodynamic parameters and ion-molecule reactions [141].…”

Section: Advanced Mass Spectrometry and Chromatographymentioning

confidence: 99%

Seafood Processing, Preservation, and Analytical Techniques in the Age of Industry 4.0

Hassoun¹,

Siddiqui

Smaoui

et al. 2022

Applied Sciences

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Fish and other seafood products are essential dietary components that are highly appreciated and consumed worldwide. However, the high perishability of these products has driven the development of a wide range of processing, preservation, and analytical techniques. This development has been accelerated in recent years with the advent of the fourth industrial revolution (Industry 4.0) technologies, digitally transforming almost every industry, including the food and seafood industry. The purpose of this review paper is to provide an updated overview of recent thermal and nonthermal processing and preservation technologies, as well as advanced analytical techniques used in the seafood industry. A special focus will be given to the role of different Industry 4.0 technologies to achieve smart seafood manufacturing, with high automation and digitalization. The literature discussed in this work showed that emerging technologies (e.g., ohmic heating, pulsed electric field, high pressure processing, nanotechnology, advanced mass spectrometry and spectroscopic techniques, and hyperspectral imaging sensors) are key elements in industrial revolutions not only in the seafood industry but also in all food industry sectors. More research is still needed to explore how to harness the Industry 4.0 innovations in order to achieve a green transition toward more profitable and sustainable food production systems.

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“…They showed that there is a considerable difference in the proteome profiles of drug sensitive and drug resistance groups, therefore highlighting the possibilities of the development of therapeutic antileishmanials [ 88 ]. Roseboom and his co-workers showed that HPLC-MS/MS could be successfully used for the quantification of the anti-leishmanial drug miltefosine in human skin tissue for its potential efficacy [ 89 ]. Nevertheless, the pharmacokinetic studies, which are key to the later development and validation of drugs, have also been conducted for leishmaniasis [ 90 ].…”

Section: Advanced Proteomics Approaches In Leishmaniasis Drug Discoverymentioning

confidence: 99%

Omics Approaches in Drug Development against Leishmaniasis: Current Scenario and Future Prospects

Rabaan

Bakhrebah

Mohapatra³

et al. 2022

Pathogens

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Leishmaniasis is a zoonotic disease transmitted in humans by the bite of Leishmania-infected phlebotomine sandflies. Each year approximately 58,500 cases of leishmaniasis are diagnosed across the globe, with a mortality rate of nearly seven percent. There are over 20 parasitic strains of Leishmania which are known to cause distinct types of leishmaniasis and pose an endemic threat to humans worldwide. Therefore, it is crucial to develop potential medications and vaccines to combat leishmaniasis. However, the task of developing therapeutic solutions is challenging due to Leishmania's digenetic lifecycle. The challenge is further intensified by cases of resistance against the available drugs. Owing to these challenges, the conventional drug development regimen is further limited by target discovery and ligand suitability for the targets. On the other hand, as an added advantage, the emergence of omics-based tools, such as high-end proteomics, transcriptomics and genomics, has hastened the pace of target discovery and target-based drug development. It is now becoming apparent that multi-omics convergence and an inter-connected systems approach is less time-consuming and more cost-effective for any drug-development process. This comprehensive review is an attempt to summarize the current knowledge on the muti-omics approach in drug development against leishmaniasis. In particular, it elaborates the potential target identification from secreted proteins in various stages of Leishmania infection and also illustrates the convergence of transcriptomic and genomic data towards the collective goal of drug discovery. This review also provides an understanding of the potential parasite’s drug targets and drug resistance characteristics of the parasite, which can be used in designing effective and specific therapeutics.

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Development and validation of an HPLC-MS/MS method for the quantification of the anti-leishmanial drug miltefosine in human skin tissue

Cited by 12 publications

References 18 publications

Bioanalytical methods for pharmacokinetic studies of antileishmanial drugs

Bioanalytical methods for pharmacokinetic studies of antileishmanial drugs

Seafood Processing, Preservation, and Analytical Techniques in the Age of Industry 4.0

Omics Approaches in Drug Development against Leishmaniasis: Current Scenario and Future Prospects

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