Analytical methodologies for measuring colistin levels in pharmacokinetic studies

Zabidi, Mohd Shafie; Bakar, Ruzilawati Abu; Musa, Nurfadhlina; Yusuf, Wan Nazirah Wan

doi:10.1080/10826076.2020.1783291

Cited by 7 publications

(9 citation statements)

References 60 publications

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“…Another factor is the predominant use of colistin in the form of an antimicrobial inactive prodrug, which is characterized by heterogeneity of components in the individual products evolving over time [ 13 , 63 , 64 , 65 ], the interindividually different extent and rate of activation to colistin and different pharmacokinetics in general [ 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 ], but also the presence of spontaneous conversion to colistin ex vivo. Thus, the physicochemical properties of CMS and colistin become another source of uncertainty with a limited degree of possible extrapolation in several preclinical and clinical questions, such as the stability of infusion and nebulization solutions under different conditions, the stability of samples for TDM, the MIC determination of pathogens in the microbiology laboratory, analytical methods for quantifying CMS and colistin in a specific matrix, the nature of particles formed during nebulization, and the rate of nebulization [ 17 , 18 , 26 , 27 , 32 , 37 , 38 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 48 , 49 ].…”

Section: Discussionmentioning

confidence: 99%

“…The optimal analytical method should be fast, simple, accurate, and sufficiently sensitive. These conditions are currently best fulfilled by the liquid chromatography with mass detection (LC/MS), as evidenced by recently published methodologies [ 26 , 27 ]. The LC/MS provides high selectivity, sensitivity, does not require prior derivatization, and analyses are performed in minutes.…”

Section: Colistin Physicochemical Properties and Their Consequencesmentioning

confidence: 99%

“…For better spectrometer response, colistin is more often measured in the ESI positive mode with m / z [M + H] + , [M + 2H] 2+ and [M + 3H] 3+ , at m / z 1170, 586, 391 for colistin A and 1156, 579, 386 for colistin B. The most frequently mentioned product ion corresponds to values in the range m / z 100.9–101.4 [ 26 , 27 ]. The product ions and a summary of the selected methods are listed in Table 1 [ 17 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ].…”

Section: Colistin Physicochemical Properties and Their Consequencesmentioning

confidence: 99%

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Challenges of Colistin Use in ICU and Therapeutic Drug Monitoring: A Literature Review

et al. 2023

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The emerging resistance of Gram-negative bacteria is a growing problem worldwide. Together with the financial cost, limited efficacy, and local unavailability of newer antibiotics or their combinations, it has led to the reintroduction of colistin as a therapeutic alternative. Despite its protracted development and availability on the market, there is now a complex maze of questions surrounding colistin with a more or less straightforward relationship to its safety and efficacy. This review aims to offer a way to navigate this maze. We focus on summarizing the available literature regarding the use of colistin in critically ill patients, particularly on stability, pharmacokinetics, methods for determining plasma concentrations, and therapeutic drug monitoring benefits and limitations. Based on these data, we then highlight the main gaps in the available information and help define directions for future research on this drug. The first gap is the lack of data on the stability of intravenous and nebulization solutions at clinically relevant concentrations and under external conditions corresponding to clinical practice. Furthermore, pharmacokinetic-pharmacodynamic parameters should be validated using standardized dosing, including a loading dose. Based on the pharmacokinetic data obtained, a population model for critically ill patients should be developed. Finally, the interference of colistin with extracorporeal methods should be quantified.

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Section: Discussionmentioning

confidence: 99%

Section: Colistin Physicochemical Properties and Their Consequencesmentioning

confidence: 99%

Section: Colistin Physicochemical Properties and Their Consequencesmentioning

confidence: 99%

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Challenges of Colistin Use in ICU and Therapeutic Drug Monitoring: A Literature Review

et al. 2023

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“…However, recent developments in TDM for other antibiotics, such as Beta-lactams, quinolones, linezolid, or daptomycin, with their broader therapeutic indices, suggest a valid use for TDM in outcomes related to efficacy [26]. Regarding colistin, TDM includes microbiological bioassays [27,28], Fourier-transform infrared spectroscopy (FTIR) [29,30], high-resolution liquid chromatography (HPLC) [31,32], liquid chromatography-mass spectrometry (LC-MS) [33][34][35], and ultra-performance liquid chromatography-electrospray tandem mass spectrometry with electrospray ionization (UPLC-ESI-MS/MS) [36]. The HPLC technique has been widely used due to its robustness, sensitivity, and accuracy compared to other techniques, such as bioassays.…”

Section: Introductionmentioning

confidence: 99%

Estimation of the Difference in Colistin Plasma Levels in Critically Ill Patients with Favorable or Unfavorable Clinical Outcomes

et al. 2021

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In recent decades, antimicrobial resistance (AMR) has led to an increased use of therapeutic alternatives. Among these options, colistin continues to be an option for the treatment of multi-resistant (MDR) Gram-negative bacterial infections. However, due to its high toxicity (nephrotoxicity and neurotoxicity) and narrow therapeutic window, colistin treatment must be utilized carefully. Colistin-treated patients have been observed to have higher mortality due to inadequate therapeutic levels. The objective of this study was to estimate the difference in colistin plasma levels in critically ill patients, and its relationship to favorable or unfavorable clinical outcomes. This prospective observational study was conducted between September 2017 and June 2020 at the Universidad de La Sabana Clinic, in patients who had been treated with colistimethate sodium (CMS) for at least 72 h until day 7 of drug treatment in the critical care unit of a university hospital. There were no statistically significant differences in colistin levels between groups with favorable or unfavorable clinical outcomes (0.16 SD vs. 0.54 SD p-value = 0.167). There was higher mortality in patients with subtherapeutic levels (18% vs. 0%), and additionally, there was a greater rate of renal failure in the group with higher therapeutic levels (50% vs. 20.7%). Due to the loss of power of the study, we were unable to demonstrate a possible difference between colistin levels related to favorable or unfavorable clinical outcomes at day 7. However, we recommend further studies to evaluate the impact of measuring levels in terms of mortality and security.

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“…Several analytical methods have been developed for the measurement of CS and CMS levels in various biological materials, as CS assay is crucial for shedding light in its pharmacokinetics and dosage regimen in order to eliminate the drug toxicity [ 10 , 11 ]. Although some developed methods include high performance liquid chromatography (HPLC) coupled to fluorescence detector [ 12 , 13 , 14 ], the majority are based on hyphenated mass spectrometry (MS) techniques [ 15 , 16 , 17 , 18 ].…”

Section: Introductionmentioning

confidence: 99%

Colistimethate Acidic Hydrolysis Revisited: Arrhenius Equation Modeling Using UPLC-QToF MS

2021

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Colistimethate (CMS), the prodrug of polymyxin E (colistin), is an antibiotic widely used as a last-line therapy against multidrug resistant Gram-negative bacteria, but little is known about its pharmacokinetics as its administration has stopped as a result of high neuro- and nephro-toxicity. The measurement of CMS levels in patients’ biological fluids is of great importance in order to find the optimal dose regimen reducing the drug toxicity. Until now, CMS assay methods are based on the indirect determination after its hydrolysis to colistin (CS). Herein, the aim is to find the optimal conditions for the complete hydrolysis of CMS to CS. The reaction was studied at accelerated conditions: 40 °C, 50 °C, and 60 °C, and the results were evaluated by assessing the Arrhenius equation and computation employing the Tenua software. A validated analytical methodology based on ultra-performance liquid chromatography (UPLC) coupled to a hybrid quadrupole time of flight (QToF) instrument is developed for the simultaneous measurement of CMS and CS. The current methodology resulted in complete hydrolysis, in contrast with the previously reported one.

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Analytical methodologies for measuring colistin levels in pharmacokinetic studies

Cited by 7 publications

References 60 publications

Challenges of Colistin Use in ICU and Therapeutic Drug Monitoring: A Literature Review

Challenges of Colistin Use in ICU and Therapeutic Drug Monitoring: A Literature Review

Estimation of the Difference in Colistin Plasma Levels in Critically Ill Patients with Favorable or Unfavorable Clinical Outcomes

Colistimethate Acidic Hydrolysis Revisited: Arrhenius Equation Modeling Using UPLC-QToF MS

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