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      Immunogenicity of Polyethylene Glycol Based Nanomedicines: Mechanisms, Clinical Implications and Systematic Approach

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          Abstract

          PEGylation technique is currently considered the gold standard approach to provide a long and safe circulation of drugs. Although this is the accepted dogma, various clinical reports and animal studies show the occurrence of immunogenic responses against polyethylene glycol (PEG) after systemic injection. These side effects, associated with complement activation and/or anti‐PEG antibody production, result in hypersensitivity reactions and lack of therapeutic efficacy of the drug during clinical protocols. Furthermore, different healthy patients show the presence of anti‐PEG antibodies in their blood stream, even though they have not received PEGylated drugs. The aim of this review is to discuss the main mechanisms based on PEG immunogenicity and its clinical implications and report the most promising approaches to reduce these unexpected side effects.

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          Doxil®--the first FDA-approved nano-drug: lessons learned.

          Yechezkel Barenholz (2012)
          Doxil®, the first FDA-approved nano-drug (1995), is based on three unrelated principles: (i) prolonged drug circulation time and avoidance of the RES due to the use of PEGylated nano-liposomes; (ii) high and stable remote loading of doxorubicin driven by a transmembrane ammonium sulfate gradient, which also allows for drug release at the tumor; and (iii) having the liposome lipid bilayer in a "liquid ordered" phase composed of the high-T(m) (53 °C) phosphatidylcholine, and cholesterol. Due to the EPR effect, Doxil is "passively targeted" to tumors and its doxorubicin is released and becomes available to tumor cells by as yet unknown means. This review summarizes historical and scientific perspectives of Doxil development and lessons learned from its development and 20 years of its use. It demonstrates the obligatory need for applying an understanding of the cross talk between physicochemical, nano-technological, and biological principles. However, in spite of the large reward, ~2 years after Doxil-related patents expired, there is still no FDA-approved generic "Doxil" available. Copyright © 2012 Elsevier B.V. All rights reserved.
          Article 0 comments Cited 771 times – based on 0 reviews     Review now
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            Erythrocyte membrane-camouflaged polymeric nanoparticles as a biomimetic delivery platform.

            Che-Ming J Hu, Li Zhang, Santosh Aryal … (2011)
            Efforts to extend nanoparticle residence time in vivo have inspired many strategies in particle surface modifications to bypass macrophage uptake and systemic clearance. Here we report a top-down biomimetic approach in particle functionalization by coating biodegradable polymeric nanoparticles with natural erythrocyte membranes, including both membrane lipids and associated membrane proteins for long-circulating cargo delivery. The structure, size and surface zeta potential, and protein contents of the erythrocyte membrane-coated nanoparticles were verified using transmission electron microscopy, dynamic light scattering, and gel electrophoresis, respectively. Mice injections with fluorophore-loaded nanoparticles revealed superior circulation half-life by the erythrocyte-mimicking nanoparticles as compared to control particles coated with the state-of-the-art synthetic stealth materials. Biodistribution study revealed significant particle retention in the blood 72 h following the particle injection. The translocation of natural cellular membranes, their associated proteins, and the corresponding functionalities to the surface of synthetic particles represents a unique approach in nanoparticle functionalization.
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              Poly(ethylene glycol) in drug delivery: pros and cons as well as potential alternatives.

              Katrin Knop, Richard Hoogenboom, Dagmar Fischer … (2010)
              Poly(ethylene glycol) (PEG) is the most used polymer and also the gold standard for stealth polymers in the emerging field of polymer-based drug delivery. The properties that account for the overwhelming use of PEG in biomedical applications are outlined in this Review. The first approved PEGylated products have already been on the market for 20 years. A vast amount of clinical experience has since been gained with this polymer--not only benefits, but possible side effects and complications have also been found. The areas that might need consideration and more intensive and careful examination can be divided into the following categories: hypersensitivity, unexpected changes in pharmacokinetic behavior, toxic side products, and an antagonism arising from the easy degradation of the polymer under mechanical stress as a result of its ether structure and its non-biodegradability, as well as the resulting possible accumulation in the body. These possible side effects will be discussed in this Review and alternative polymers will be evaluated.
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                Author and article information

                Contributors
                Hélder A. Santos: (View ORCID Profile)
                Journal
                Title: Advanced Therapeutics
                Abbreviated Title: Advanced Therapeutics
                Publisher: Wiley
                ISSN (Print): 2366-3987
                ISSN (Electronic): 2366-3987
                Publication date Created: March 2020
                Publication date (Electronic): February 13 2020
                Publication date (Print): March 2020
                Volume: 3
                Issue: 3
                Affiliations
                [1 ] Department of Health Sciences University of Catanzaro “Magna Græcia” Campus Universitario “S. Venuta”, Viale Europa I‐88100 Catanzaro Italy
                [2 ] Department of Pharmacy University of Chieti‐Pescara “G. d'Annunzio” Via dei Vestini 31 I‐66100 Chieti Italy
                [3 ] Department of Drug Chemistry and Technology University of Rome “Sapienza” 00185 Rome Italy
                [4 ] Drug Research Program, Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy; and Helsinki Institute of Life Science (HiLIFE) University of Helsinki FI‐00014 Helsinki Finland
                Article
                DOI: 10.1002/adtp.201900170
                SO-VID: 48a6129b-579f-4f5f-9204-0c3a00052ae8
                Copyright © © 2020
                License:

                http://onlinelibrary.wiley.com/termsAndConditions#vor

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