Comparison of Polysorbate 80 Hydrolysis and Oxidation on the Aggregation of a Monoclonal Antibody

Larson, Nicholas R.; Wei, Yangjie; Prajapati, Indira; Chakraborty, Aishik; Peters, Björn-Hendrik; Kalonia, Cavan; Hudak, Suzanne; Choudhary, Sureshkumar; Esfandiary, Reza; Dhar, Prajna; Schöneich, Christian; Middaugh, C. Russell

doi:10.1016/j.xphs.2019.10.069

Cited by 72 publications

(61 citation statements)

References 22 publications

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“…This observation is consistent with previous findings that monoester components of PS80 were hydrolyzed favorably. 13,17,18 The pattern of enzyme-mediated PS hydrolysis, however, was reported to be dependent on the type of enzyme, the order of esters (mono-, di-, or triester), the identity of hydrophilic head group, and the fatty acid ester tail. 27 Enzymatic hydrolysis has been identified as a primary degradation pathway in high protein concentration drug products.…”

Section: Hydrolysis Degradation Of Ps80 Of Different Grades and In A Mab Drug Productmentioning

confidence: 99%

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Characterization of Polysorbate 80 by Liquid Chromatography-Mass Spectrometry to Understand Its Susceptibility to Degradation and Its Oxidative Degradation Pathway

Liu

Jin

Menon

et al. 2022

Journal of Pharmaceutical Sciences

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Section: Hydrolysis Degradation Of Ps80 Of Different Grades and In A Mab Drug Productmentioning

confidence: 99%

“…15,16 However, the oxidized PS80 was found to not only maintain its CMC properties and protective effect against mAb aggregation, but also show an increase in its surface activity. 17 Therefore, the impact of polysorbate degradation via auto-oxidation may be protein specific or buffer dependent and needs to be examined carefully.…”

Section: Introductionmentioning

confidence: 99%

Characterization of Polysorbate 80 by Liquid Chromatography-Mass Spectrometry to Understand Its Susceptibility to Degradation and Its Oxidative Degradation Pathway

Liu

Jin

Menon

et al. 2022

Journal of Pharmaceutical Sciences

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“…As an example, the moiety started to degrade after the elimination step of its physically adsorbed water, but it was not fully degraded, therefore it continued to decompose again in the second step until the complete degradation process had occurred [ 17 ]. Figure 4 C is the thermogram for T80 surfactant, showing two thermal events—a thermal loss at 121 and 406 °C with a value of 2.4 and 94.8%—which correspond to the attached water removal and polyoxyethylene (POE) chains, respectively [ 18 ].…”

Section: Resultsmentioning

confidence: 99%

Hexaconazole-Micelle Nanodelivery System Prepared Using Different Surfactants for Ganoderma Antifungal Application

et al. 2021

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Reports on fungicide-based agronanochemicals in combating disastrous basal stem rot disease in the oil palm industry are scant. Herein, we describe the potential of fungicide nanodelivery agents based on hexaconazole-micelle systems produced using three different surfactants; sodium dodecylbenze sulfonate (SDBS), sodium dodecyl sulfate (SDS) and Tween 80 (T80). The resulting nanodelivery systems were characterized and the results supported the encapsulation of the fungicide into the micelles of the surfactants. We have investigated in detail the size-dependent effects of the as-synthesized micelles towards the inhibition growth of Ganoderma Boninense fungi. All the nanodelivery systems indicate that their size decreased as the surfactant concentration was increased, and it directly affects the fungal inhibition. It was also found that Tween 80, a non-ionic surfactant gave the lowest effective concentration, the EC50 value of 2, on the pathogenic fungus Ganoderma boninense compared to the other anionic surfactants; SDBS and SDS. This study opens up a new generation of agronanofungicide of better efficacy for Ganoderma disease treatment.

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“…In [28], two pathways of the degradation inside the body are discussed: enzymatic hydrolysis and oxidation, which are exemplified by nonionic surfactant polysorbate 80 bearing ester groups. It was reported that enzymatic hydrolysis of polysorbate 80 can be achieved by esterases and lipases at ng/mL concentrations and phospholipase B at 200 ppm.…”

Section: Nanocontainers Based On Biodegradable Surfactantsmentioning

confidence: 99%

Self-Assembling Drug Formulations with Tunable Permeability and Biodegradability

et al. 2021

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This review focuses on key topics in the field of drug delivery related to the design of nanocarriers answering the biomedicine criteria, including biocompatibility, biodegradability, low toxicity, and the ability to overcome biological barriers. For these reasons, much attention is paid to the amphiphile-based carriers composed of natural building blocks, lipids, and their structural analogues and synthetic surfactants that are capable of self-assembly with the formation of a variety of supramolecular aggregates. The latter are dynamic structures that can be used as nanocontainers for hydrophobic drugs to increase their solubility and bioavailability. In this section, biodegradable cationic surfactants bearing cleavable fragments are discussed, with ester- and carbamate-containing analogs, as well as amino acid derivatives received special attention. Drug delivery through the biological barriers is a challenging task, which is highlighted by the example of transdermal method of drug administration. In this paper, nonionic surfactants are primarily discussed, including their application for the fabrication of nanocarriers, their surfactant-skin interactions, the mechanisms of modulating their permeability, and the factors controlling drug encapsulation, release, and targeted delivery. Different types of nanocarriers are covered, including niosomes, transfersomes, invasomes and chitosomes, with their morphological specificity, beneficial characteristics and limitations discussed.

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Comparison of Polysorbate 80 Hydrolysis and Oxidation on the Aggregation of a Monoclonal Antibody

Cited by 72 publications

References 22 publications

Characterization of Polysorbate 80 by Liquid Chromatography-Mass Spectrometry to Understand Its Susceptibility to Degradation and Its Oxidative Degradation Pathway

Characterization of Polysorbate 80 by Liquid Chromatography-Mass Spectrometry to Understand Its Susceptibility to Degradation and Its Oxidative Degradation Pathway

Hexaconazole-Micelle Nanodelivery System Prepared Using Different Surfactants for Ganoderma Antifungal Application

Self-Assembling Drug Formulations with Tunable Permeability and Biodegradability

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