Problems in the evaluation of polyvinylpyrrolidone (PVP) elution from polysulfone membrane dialyzers sterilized by gamma-ray irradiation

Murakami, Jun; Kaneko, Itaru; Naoki, Katsuhiko; Mineshima, Michio; Akiba, Takashi

doi:10.1186/s41100-016-0047-x

Cited by 8 publications

(16 citation statements)

References 4 publications

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“…Therefore, different approaches are available to stabilize PVP on the membrane. First, PVP may be stabilized by antioxidants, such as with α‐tocopherol, which was previously shown to reduce the amount of eluted PVP 35 . A PVP stabilization by α‐tocopherol was implemented in the FX CorAL dialyzer, which had non‐detectable PVP elution in the present study.…”

Section: Discussionmentioning

confidence: 88%

“…First, PVP may be stabilized by antioxidants, such as with α-tocopherol, which was previously shown to reduce the amount of eluted PVP. 35 A PVP stabilization by α-tocopherol was implemented in the FX CorAL dialyzer, which had non-detectable PVP elution in the present study. Moreover, PVP stabilization may vary between dialyzers sterilized with different approaches.…”

Section: Discussionmentioning

confidence: 99%

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Polyvinylpyrrolidone in hemodialysis membranes: Impact on platelet loss during hemodialysis

Zawada

Melchior

Erlenkötter

et al. 2021

Hemodialysis International

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Introduction: Hydrophilic modification with polyvinylpyrrolidone (PVP) increases the biocompatibility profile of synthetic dialysis membranes. However, PVP may be eluted into the patient's blood, which has been discussed as a possible cause for adverse reactions rarely occurring with synthetic membranes. We investigated the content of PVP and its elution from the blood-side surface from commercially available dialyzers, including the novel FX CorAL, with PVP-enriched and α-tocopherol-stabilized membrane, and link the results to the level of platelet loss during dialysis as a maker of biocompatibility. Methods: Six synthetic, PVP containing, dialyzers (FX CorAL, FX CorDiax [Fresenius Medical Care]; Polyflux, THERANOVA [Baxter]; ELISIO [Nipro]; xevonta [B. Braun]) were investigated in the present study. The content of PVP on blood-side surface was determined with X-ray photoelectron spectroscopy (XPS). The amount of elutable PVP was measured photometrically after 5 h recirculation. The level of platelet loss was evaluated in an ex vivo recirculation model with human blood. Findings: Highest PVP content on the blood-side surface was found for the polysulfone-based FX CorAL (26.3%), while the polyethersulfone-based THERANOVA (15.6%) had the lowest PVP content. Elution of PVP was highest for the autoclave steam-sterilized THERANOVA (9.1 mg/1.6 m 2 dialyzer) and Polyflux (9.0 mg/1.6 m 2 dialyzer), while the lowest PVP elution was found for the INLINE steam sterilized FX CorAL and FX CorDiax (<0.5 mg/1.6 m 2 dialyzer, for both). Highest platelet loss was found for xevonta (+164.4% compared to the reference) and the lowest for the FX CorAL (À225.2%) among the polysulfone-based dialyzers; among the polyethersulfone-based dialyzers, THERANOVA (+95.5%) had the highest and ELISIO (À52.1%) the lowest platelet loss. Discussion: Polyvinylpyrrolidone content and elution differ between commercially available dialyzers and were found to be linked to the membrane material and sterilization method. The amount of non-eluted PVP on the blood-side surface may be an important determinant for the biocompatibility of dialyzers.

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Section: Discussionmentioning

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Polyvinylpyrrolidone in hemodialysis membranes: Impact on platelet loss during hemodialysis

Zawada

Melchior

Erlenkötter

et al. 2021

Hemodialysis International

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“…For protons of pyrrolidone group in NVP, the main chain methine (H 6 ) and methylene protons (H 5 ) are assigned around 3.6-4.01 ppm and 1.5-1.88 ppm, respectively. The side chain methylene protons are assigned in the range 3.0-3.42 ppm (H 7 ), 2.13-2.5 ppm (H 9 ), and 1.8-2.1 ppm (H 8 ) [45,46]. Signals located at 0.88, 1.25, 1.43 and 2.37 ppm are assigned to the aliphatic protons of the DDT fragment, linked to the chain end of the oligomer, H 1 , H 2 , H 3 and H 4 respectively [47].…”

Section: Synthesis and Characterization Of Ddt-pnvpmentioning

confidence: 99%

Electrochemical Sensor Based on Thioether Oligomer Poly(N‐vinylpyrrolidone)‐modified Gold Electrode for Bisphenol A Detection

et al. 2019

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Presently, bisphenol A (BPA) has been added to the list of substances of very high concern as endocrine disruptors. According to the literature, exposure to bisphenol A even at low doses may result in adverse health effects. In this study, electrochemical sensor of Bisphenol A based on thioether DDT‐Poly(N‐vinylpyrrolidone) oligomer has been developed. The thioether oligomer, which is capable of recognizing BPA, was prepared and used for gold electrode modification. The characterization of the modified gold electrode and the synthesized thioether oligomer were carried out by cyclic voltammetry (CV), electrochemical impedance spectroscopy (EIS), atomic force microscopy (AFM), Fourier‐transform infrared spectroscopy (FTIR), proton nuclear magnetic resonance spectroscopy (1H NMR) and Size exclusion chromatography (SEC). Obtained results indicate that the modified electrode shows good electrochemical activity, good sensitivity and reproducibility for BPA detection. It exhibited a good linear relationship ranging from 1 to 20 pg/mL, and the detection limit was found to be 1.9 pg/mL at S/N=3. Several interfering species such as hydroquinone, phenol and resorcinol were used and their behaviors on the modified gold electrode were investigated.

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“…3,10 Cross-linking can decrease the mobility of PVP, 5,16,17 whereas degradation can increase PVP elution. 10…”

mentioning

confidence: 99%

“…3,10 Cross-linking can decrease the mobility of PVP, 5,16,17 whereas degradation can increase PVP elution. 10 In most cases, a potassium triiodide reagent 18,19 -sometimes called the Müller method-is used to quantify the amount of eluted PVP by PVP-iodine-complex formation in dialyzer elution studies. 1,3,4 In these investigations, different commercially available dialyzers were investigated.…”

mentioning

confidence: 99%

Comparative Study on Elution of Polyvinylpyrrolidone on Dialyzers Using Ultraviolet Analysis and Iodine Method

2022

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It is known that poly(arylethersulfone)-based dialyzers can elute poly(N-vinyl-2-pyrrolidone) (PVP). With regard to chronic renal replacement therapy, this is a burden for the patient, because PVP is deposited in different organs and cannot be degraded or released from there; so elutable PVP has to be minimized. Usually, the iodine method is used for quantification of extractable PVP. To overcome the chain length dependency of this method, we used an ultraviolet method that is independent from the PVP chain lengths; so the absolute amount of eluted PVP can be quantified. The current study shows the amount of eluted PVP on differently sterilized low flux dialyzers (1.6 m2, similar storage time, n = 12)—PS160 (Allmed, Egypt), F7HPS (Fresenius Medical Care, Germany), F16 (Wego, China), and B-16P (Bain, China). Using the ultraviolet method, the irradiated filters show a sum total of approximately 9 mg more eluted PVP compared with the steam-sterilized ones, whereas the iodine method shows a value about three times lower between different types of sterilization. The boundary conditions during the radiation sterilization could lead to PVP degradation instead of cross-linking. The resulting shorter PVP chains can be more easily rinsed out and can falsely decrease the calculated eluted PVP amount by using the iodine complexation method.

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Problems in the evaluation of polyvinylpyrrolidone (PVP) elution from polysulfone membrane dialyzers sterilized by gamma-ray irradiation

Cited by 8 publications

References 4 publications

Polyvinylpyrrolidone in hemodialysis membranes: Impact on platelet loss during hemodialysis

Polyvinylpyrrolidone in hemodialysis membranes: Impact on platelet loss during hemodialysis

Electrochemical Sensor Based on Thioether Oligomer Poly(N‐vinylpyrrolidone)‐modified Gold Electrode for Bisphenol A Detection

Comparative Study on Elution of Polyvinylpyrrolidone on Dialyzers Using Ultraviolet Analysis and Iodine Method

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