Quantification of cabazitaxel in human plasma by liquid chromatography/triple-quadrupole mass spectrometry: A practical solution for non-specific binding

Bruijn, Peter de; Graan, Anne-Joy M. de; Nieuweboer, Annemieke J.M.; Mathijssen, Ron H.J.; Lam, Mei-Ho; Wit, Ronald de; Wiemer, Erik A.C.; Loos, Walter J.

doi:10.1016/j.jpba.2011.10.010

Cited by 34 publications

(27 citation statements)

References 12 publications

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“…To the best of our knowledge there are few published data on stability indicating HPLC methods for cabazitaxel containing medicinal products 8 9. Based on the findings of de Bruijn8 and other published data regarding stability testing of docetaxel10 and paclitaxel,11 a new HPLC method was developed and implemented.…”

Section: Discussionmentioning

confidence: 99%

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Physicochemical stability of cabazitaxel containing premix solution and diluted infusion solutions

2015

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ObjectivesThis study was conducted to investigate the extended physicochemical stability of cabazitaxel containing premix solution and diluted infusion solutions in either 0.9% sodium chloride (NaCl) or 5% glucose (G5) vehicle solution.MethodsA stability indicating, reverse phase, high performance liquid chromatography assay with ultraviolet detection was developed and validated. Premix solutions of cabazitaxel were prepared in the original vials. Infusion solutions were prepared in prefilled polypropylene/polyethylene (PP/PE) infusion bags (0.9% NaCl, G5) to achieve the recommended minimum and maximum cabazitaxel concentrations (0.1 mg/mL, 0.26 mg/mL). Test solutions were stored refrigerated (2–8°C) or at room temperature (25°C), protected from light. Samples were taken and assayed in triplicate over a 28 day storage period. Physical stability was determined by measuring the pH value and visual inspection whenever samples for quantitative analysis were taken.ResultsThe premix solution containing cabazitaxel was found to be physicochemically stable over a period of 28 days. Diluted cabazitaxel infusion solutions remained chemically stable over a period of 28 days. Particulate matter of cabazitaxel was recognised in some infusion solutions after 21 days of storage.ConclusionsCabazitaxel premix solutions and infusion solutions prepared with 0.9% NaCl or G5 vehicle solution in PP/PE bags are chemically stable over a storage period of 28 days, either refrigerated or stored at room temperature. However, unpredictable physical instability is to be regarded when expiration dates of diluted infusion solution are determined.

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Section: Discussionmentioning

confidence: 99%

“…Based on the findings of de Bruijn8 and other published data regarding stability testing of docetaxel10 and paclitaxel,11 a new HPLC method was developed and implemented. According to forced degradation experiments, peaks of cabazitaxel and degradation products are clearly separated and sharp.…”

Section: Discussionmentioning

confidence: 99%

Physicochemical stability of cabazitaxel containing premix solution and diluted infusion solutions

2015

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“…The timing of treatment administration and timing of sampling were precisely recorded for each patient. Total cabazitaxel concentrations in the plasma were determined using a validated liquid chromatography with tandem mass spectrometry method (LC–MS/MS) with a lower limit of quantification (LLOQ) of 1 ng/mL [22, 23]. In addition, blood samples were collected to determine the free, unbound fraction of cabazitaxel in all patients at Cycle 1 before start of infusion, 5 min before the end of infusion, and 3 and 24 h after end of infusion.…”

Section: Methodsmentioning

confidence: 99%

A phase I pharmacokinetic and safety study of cabazitaxel in adult cancer patients with normal and impaired renal function

Azaro

Rodón

Machiels

et al. 2016

Cancer Chemother Pharmacol

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PurposeLimited data are available on cabazitaxel pharmacokinetics in patients with renal impairment. This open-label, multicenter study assessed cabazitaxel in patients with advanced solid tumors and normal or impaired renal function.Methods Cohorts A (normal renal function: creatinine clearance [CrCL] >80 mL/min/1.73 m2), B (moderate renal impairment: CrCL 30 to <50 mL/min/1.73 m2) and C (severe impairment: CrCL <30 mL/min/1.73 m2) received cabazitaxel 25 mg/m2 (A, B) or 20 mg/m2 (C, could be escalated to 25 mg/m2), once every 3 weeks. Pharmacokinetic parameters and cabazitaxel unbound fraction (F U) were assessed using linear regression and mixed models. Geometric mean (GM) and GM ratios (GMRs) were determined using mean CrCL intervals (moderate and severe renal impairment: 40 and 15 mL/min/1.73 m2) versus a control (90 mL/min/1.73 m2).ResultsOverall, 25 patients received cabazitaxel (median cycles: 3 [range 1–20]; Cohort A: 5 [2–13]; Cohort B: 3 [1–15]; and Cohort C: 5 [1–20]), of which 24 were eligible for pharmacokinetic analysis (eight in each cohort). For moderate and severe renal impairment versus normal renal function, GMR estimates were: clearance normalized to body surface area (CL/BSA) 0.95 (90% CI 0.80–1.13) and 0.89 (0.61–1.32); area under the curve normalized to dose (AUC/dose) 1.06 (0.88–1.27) and 1.14 (0.76–1.71); and F U 0.99 (0.94–1.04) and 0.97 (0.87–1.09), respectively. Estimated slopes of linear regression of log parameters versus log CrCL (renal impairment) were: CL/BSA 0.06 (−0.15 to 0.28); AUC/dose −0.07 (−0.30 to 0.16); and F U 0.02 (−0.05 to 0.08). Cabazitaxel safety profile was consistent with previous reports.ConclusionsRenal impairment had no clinically meaningful effect on cabazitaxel pharmacokinetics.

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“…For quantification of docetaxel [83][84][85][86][87][88][89][90], docetaxel and its metabolites [91,92] (SupplemenTary Table 4), or docetaxel and other drugs [93][94][95] (Supplemen- Tary Table 5), fewer assays are published. A limited number of LC-MS/MS assays are developed for the quantification of the second-generation taxanes cabazitaxel [96,97], felotaxel [98,99] and larotaxel [100] and other taxane analogues (Sup-plemenTary Table 6) [101][102][103][104][105]. Usually, tandem quadrupole MS is performed, but assays using MS with a single quadrupole have also been developed for the quantification of paclitaxel and docetaxel [59,81].…”

Section: Lc-ms/msmentioning

confidence: 99%

Quantification of Taxanes in Biological Matrices: A Review of Bioanalytical Assays and Recommendations for Development of New Assays

et al. 2014

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Since the isolation of paclitaxel and its approval for the treatment of breast cancer, various taxanes and taxane formulations have been developed. To date, almost 100 bioanalytical assays have been published with the method development and optimization often extensively discussed by the authors. This Review presents an overview of assays published between January 1970 and September 2013 that described method development and validation of assays used to quantify taxanes in biological matrices such as plasma, urine, feces and tissue samples. For liquid chromatography assays, sample pretreatment, chromatographic separation and assay performance are compared. Since this Review discusses the limitations of previously developed liquid chromatography assays and gives recommendations for future assay development, it can be used as a reference for future development of liquid chromatography assays for the quantification of taxanes in various biological matrices to support preclinical and clinical studies.

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Quantification of cabazitaxel in human plasma by liquid chromatography/triple-quadrupole mass spectrometry: A practical solution for non-specific binding

Cited by 34 publications

References 12 publications

Physicochemical stability of cabazitaxel containing premix solution and diluted infusion solutions

Physicochemical stability of cabazitaxel containing premix solution and diluted infusion solutions

A phase I pharmacokinetic and safety study of cabazitaxel in adult cancer patients with normal and impaired renal function

Quantification of Taxanes in Biological Matrices: A Review of Bioanalytical Assays and Recommendations for Development of New Assays

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