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      The comparison of biodistribution of glutathione PEGylated nanoliposomal doxorubicin formulations prepared by pre‐insertion and post‐insertion methods for brain delivery in normal mice

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          Abstract

          Several obstacles limit the efficacy of brain tumour treatment, most notably the blood‐brain barrier (BBB), which prevents the brain uptake of the majority of accessible medicines due to tight junctions. The presence of glutathione (GSH) receptors on the BBB surface has been demonstrated in numerous papers; consequently, products containing glutathione as a targeting ligand coupled with nanoliposomes are used to enhance drug delivery across the BBB. Here, the 5% pre‐inserted PEG2000‐GSH PEGylated liposomal doxorubicin was conducted according to 2B3‐101 being tested in clinical trials. In addition, PEGylated nanoliposomal doxorubicin connected to the spacer‐GSH targeting ligand (GSGGCE) and the PEG3400 was conducted using post‐insertion method. Next, in vivo biodistribution of the produced formulations was tested on healthy mice to see if GSGGCE, as the targeted ligand, could cross the BBB compared to 5% pre‐inserted PEG2000‐GSH and Caelyx ®. Compared to the pre‐inserted formulation and Caelyx ®, the post‐inserted formulations' concentration was lower in the heart and higher in brain tissues, resulting in boosting the brain concentration of accumulated doxorubicin with fewer possible side effects, including cardiotoxicity. In comparison to the pre‐insertion procedure, the post‐insertion method is easier, faster, and more cost‐effective. Moreover, employing PEG3400 and the post‐insertion approach in the PEG3400‐GSGGCE liposomal formulations was found to be effective in crossing the BBB.

          Abstract

          The 5% pre‐inserted PEG2000‐GSH PEGylated liposomal doxorubicin and PEGylated nanoliposomal doxorubicin connected to the spacer‐GSH targeting ligand (GSGGCE) and the PEG3400 was conducted using post‐insertion method. Next, biodistribution of the produced formulations was tested on healthy mice. Compared to the pre‐inserted formulation and Caelyx ®, the post‐inserted formulations' concentration was lower in the heart and higher in brain tissues, resulting in boosting the brain concentration of accumulated doxorubicin with fewer possible side effects.

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          Cancer Statistics, 2021

          Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths in the United States and compiles the most recent data on population-based cancer occurrence. Incidence data (through 2017) were collected by the Surveillance, Epidemiology, and End Results Program; the National Program of Cancer Registries; and the North American Association of Central Cancer Registries. Mortality data (through 2018) were collected by the National Center for Health Statistics. In 2021, 1,898,160 new cancer cases and 608,570 cancer deaths are projected to occur in the United States. After increasing for most of the 20th century, the cancer death rate has fallen continuously from its peak in 1991 through 2018, for a total decline of 31%, because of reductions in smoking and improvements in early detection and treatment. This translates to 3.2 million fewer cancer deaths than would have occurred if peak rates had persisted. Long-term declines in mortality for the 4 leading cancers have halted for prostate cancer and slowed for breast and colorectal cancers, but accelerated for lung cancer, which accounted for almost one-half of the total mortality decline from 2014 to 2018. The pace of the annual decline in lung cancer mortality doubled from 3.1% during 2009 through 2013 to 5.5% during 2014 through 2018 in men, from 1.8% to 4.4% in women, and from 2.4% to 5% overall. This trend coincides with steady declines in incidence (2.2%-2.3%) but rapid gains in survival specifically for nonsmall cell lung cancer (NSCLC). For example, NSCLC 2-year relative survival increased from 34% for persons diagnosed during 2009 through 2010 to 42% during 2015 through 2016, including absolute increases of 5% to 6% for every stage of diagnosis; survival for small cell lung cancer remained at 14% to 15%. Improved treatment accelerated progress against lung cancer and drove a record drop in overall cancer mortality, despite slowing momentum for other common cancers.
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            Impact of Particle Size and Polydispersity Index on the Clinical Applications of Lipidic Nanocarrier Systems

            Lipid-based drug delivery systems, or lipidic carriers, are being extensively employed to enhance the bioavailability of poorly-soluble drugs. They have the ability to incorporate both lipophilic and hydrophilic molecules and protecting them against degradation in vitro and in vivo. There is a number of physical attributes of lipid-based nanocarriers that determine their safety, stability, efficacy, as well as their in vitro and in vivo behaviour. These include average particle size/diameter and the polydispersity index (PDI), which is an indication of their quality with respect to the size distribution. The suitability of nanocarrier formulations for a particular route of drug administration depends on their average diameter, PDI and size stability, among other parameters. Controlling and validating these parameters are of key importance for the effective clinical applications of nanocarrier formulations. This review highlights the significance of size and PDI in the successful design, formulation and development of nanosystems for pharmaceutical, nutraceutical and other applications. Liposomes, nanoliposomes, vesicular phospholipid gels, solid lipid nanoparticles, transfersomes and tocosomes are presented as frequently-used lipidic drug carriers. The advantages and limitations of a range of available analytical techniques used to characterize lipidic nanocarrier formulations are also covered.
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              To exploit the tumor microenvironment: Since the EPR effect fails in the clinic, what is the future of nanomedicine?

              F Danhier (2016)
              Tumor targeting by nanomedicine-based therapeutics has emerged as a promising approach to overcome the lack of specificity of conventional chemotherapeutic agents and to provide clinicians the ability to overcome shortcomings of current cancer treatment. The major underlying mechanism of the design of nanomedicines was the Enhanced Permeability and Retention (EPR) effect, considered as the "royal gate" in the drug delivery field. However, after the publication of thousands of research papers, the verdict has been handed down: the EPR effect works in rodents but not in humans! Thus the basic rationale of the design and development of nanomedicines in cancer therapy is failing making it necessary to stop claiming efficacy gains via the EPR effect, while tumor targeting cannot be proved in the clinic. It is probably time to dethrone the EPR effect and to ask the question: what is the future of nanomedicines without the EPR effect? The aim of this review is to provide a general overview on (i) the current state of the EPR effect, (ii) the future of nanomedicine and (iii) the strategies of modulation of the tumor microenvironment to improve the delivery of nanomedicine.
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                Author and article information

                Contributors
                Jafarimr@mums.ac.ir
                Moosavianka@mums.ac.ir
                Journal
                IET Nanobiotechnol
                IET Nanobiotechnol
                10.1049/(ISSN)1751-875X
                NBT2
                IET Nanobiotechnology
                John Wiley and Sons Inc. (Hoboken )
                1751-8741
                1751-875X
                03 January 2023
                April 2023
                : 17
                : 2 ( doiID: 10.1049/nbt2.v17.2 )
                : 112-124
                Affiliations
                [ 1 ] Department of Pharmaceutical Nanotechnology School of Pharmacy Mashhad University of Medical Sciences Mashhad Iran
                [ 2 ] Nanotechnology Research Center Pharmaceutical Technology Institute Mashhad University of Medical Sciences Mashhad Iran
                [ 3 ] Nanotechnology Research Center Student Research Committee Faculty of Pharmacy Mashhad University of Medical Sciences Mashhad Iran
                Author notes
                [*] [* ] Correspondence

                Mahmoud Reza Jaafari and Seyedeh Alia Moosavian, Nanotechnology Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad 91775‐1365, Iran.

                Email: Jafarimr@ 123456mums.ac.ir and Moosavianka@ 123456mums.ac.ir

                Author information
                https://orcid.org/0000-0003-1648-6431
                Article
                NBT212111
                10.1049/nbt2.12111
                10116028
                36594666
                4a10f93c-c9fe-4390-8881-5ac965aee526
                © 2023 The Authors. IET Nanobiotechnology published by John Wiley & Sons Ltd on behalf of The Institution of Engineering and Technology.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 December 2022
                : 24 August 2022
                : 15 December 2022
                Page count
                Figures: 7, Tables: 1, Pages: 13, Words: 7941
                Funding
                Funded by: Mashhad University of Medical Sciences , doi 10.13039/501100004748;
                Award ID: 960833
                Categories
                Original Research
                Original Research
                Custom metadata
                2.0
                April 2023
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.2.7 mode:remove_FC converted:20.04.2023

                brain,drug delivery systems,nanomedicine,nanoparticles
                brain, drug delivery systems, nanomedicine, nanoparticles

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