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      mPEG-PLA and PLA-PEG-PLA nanoparticles as new carriers for delivery of recombinant human Growth Hormone (rhGH)

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          Abstract

          mPEG-PLA and PLA-PEG-PLA copolymeric nanoparticles with three different PLA to PEG ratios are synthesized and used for encapsulation of recombinant human Growth hormone (rhGH). The structure and composition of the synthesized copolymers were analyzed by 1H NMR and GPC techniques. Moreover, morphology, encapsulation efficiency (EE), cytotoxicity, release profile and stability of the encapsulated rhGH were measured. Structural analysis of the prepared copolymers showed that they were successfully synthesized with approximately expected molecular weight and relatively low size distribution. It was also revealed that by increasing amounts of PLA/PEG ratio, EE content and size of nanoparticles were increased. Release profile evaluation of rhGH from both formulations indicated that copolymeric nanoparticles of Di-B2 and Tri-B2 exhibited the best results among the synthesized nanospheres, by having initial burst release of 17.5% and 28% and then slow and constant release of rhGH up to 65% and 77% of the encapsulated drug, respectively. Furthermore, results of HPLC, SDS-PAGE and CD analyses showed stability of rhGH during encapsulation and release from nanoparticles. Finally, the results showed that these two formulations provided safe and efficient sustained release of rhGH for more than a month and they have the potential to do further studies under in vivo conditions.

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          Methoxy poly(ethylene glycol)-poly(lactide) (MPEG-PLA) nanoparticles for controlled delivery of anticancer drugs.

          S Feng, Yuancai Dong (2004)
          Methoxy poly(ethylene glycol)-poly(lactide) copolymer (MPEG-PLA) was synthesized and used to make nanoparticles by the nanoprecipitation method for clinical administration of antineoplastic drugs. Paclitaxel was used as a prototype drug due to its excellent efficacy and commercially great success. The size and size distribution, surface morphology, surface charge and surface chemistry of the paclitaxel-loaded nanoparticles were then investigated by laser light scattering, atomic force microscopy, zeta-potential analyzer and X-ray photoelectron spectroscopy (XPS). The drug encapsulation efficiency (EE) and in vitro release profile were measured by high-performance liquid chromatography. The effects of various formulation parameters were evaluated. The prepared nanoparticles were found of spherical shape with size less than 100 nm. Zeta potential measurement and XPS analysis demonstrated the presence of PEG layer on the particle surface. Viscosity of the organic phase was found to be one of the main process factors for the size determination. The EE was found to be greatly influenced by the drug loading. The drug release pattern was biphasic with a fast release rate followed by a slow one. The particle suspension exhibited good steric stability in vitro. Such a nanoparticle formulation of paclitaxel can be expected to have long-circulating effects in circulation.
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            Issues in long-term protein delivery using biodegradable microparticles.

            Mingli Ye, Sungwon Kim, Kinam Park (2010)
            Recently, a variety of bioactive protein drugs have been available in large quantities as a result of advances in biotechnology. Such availability has prompted development of long-term protein delivery systems. Biodegradable microparticulate systems have been used widely for controlled release of protein drugs for days and months. The most widely used biodegradable polymer has been poly(d,l-lactic-co-glycolic acid) (PLGA). Protein-containing microparticles are usually prepared by the water/oil/water (W/O/W) double emulsion method, and variations of this method, such as solid/oil/water (S/O/W) and water/oil/oil (W/O/O), have also been used. Other methods of preparation include spray drying, ultrasonic atomization, and electrospray methods. The important factors in developing biodegradable microparticles for protein drug delivery are protein release profile (including burst release, duration of release, and extent of release), microparticle size, protein loading, encapsulation efficiency, and bioactivity of the released protein. Many studies used albumin as a model protein, and thus, the bioactivity of the release protein has not been examined. Other studies which utilized enzymes, insulin, erythropoietin, and growth factors have suggested that the right formulation to preserve bioactivity of the loaded protein drug during the processing and storage steps is important. The protein release profiles from various microparticle formulations can be classified into four distinct categories (Types A, B, C, and D). The categories are based on the magnitude of burst release, the extent of protein release, and the protein release kinetics followed by the burst release. The protein loading (i.e., the total amount of protein loaded divided by the total weight of microparticles) in various microparticles is 6.7+/-4.6%, and it ranges from 0.5% to 20.0%. Development of clinically successful long-term protein delivery systems based on biodegradable microparticles requires improvement in the drug loading efficiency, control of the initial burst release, and the ability to control the protein release kinetics. Copyright 2010 Elsevier B.V. All rights reserved.
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              Oral delivery of macromolecular drugs: Where we are after almost 100years of attempts.

              Elena Moroz, Simon Matoori, Jean-Christophe Leroux (2016)
              Since the first attempt to administer insulin orally in humans more than 90years ago, the oral delivery of macromolecular drugs (>1000g/mol) has been rather disappointing. Although several clinical pilot studies have demonstrated that the oral absorption of macromolecules is possible, the bioavailability remains generally low and variable. This article reviews the formulations and biopharmaceutical aspects of orally administered biomacromolecules on the market and in clinical development for local and systemic delivery. The most successful approaches for systemic delivery often involve a combination of enteric coating, protease inhibitors and permeation enhancers in relatively high amounts. However, some of these excipients have induced local or systemic adverse reactions in preclinical and clinical studies, and long-term studies are often missing. Therefore, strategies aimed at increasing the oral absorption of macromolecular drugs should carefully take into account the benefit-risk ratio. In the absence of specific uptake pathways, small and potent peptides that are resistant to degradation and that present a large therapeutic window certainly represent the best candidates for systemic absorption. While we acknowledge the need for systemically delivering biomacromolecules, it is our opinion that the oral delivery to local gastrointestinal targets is currently more promising because of their accessibility and the lacking requirement for intestinal permeability enhancement.
              Article 0 comments Cited 71 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Saman Hosseinkhani: saman_h@modares.ac.ir
                Journal
                Journal ID (nlm-ta): Sci Rep
                Journal ID (iso-abbrev): Sci Rep
                Title: Scientific Reports
                Publisher: Nature Publishing Group UK (London )
                ISSN (Electronic): 2045-2322
                Publication date (Electronic): 29 June 2018
                Publication date PMC-release: 29 June 2018
                Publication date Collection: 2018
                Volume: 8
                Electronic Location Identifier: 9854
                Affiliations
                [1 ]ISNI 0000 0001 1781 3962, GRID grid.412266.5, Department of Nanobiotechnology, Faculty of Biological Sciences, , Tarbiat Modares University, ; Tehran, 14115–175 Iran
                [2 ]ISNI 0000 0001 1781 3962, GRID grid.412266.5, Polymer Engineering Department, Faculty of Chemical Engineering, , Tarbiat Modares University, ; Tehran, 14115–114 Iran
                [3 ]ISNI 0000 0001 1781 3962, GRID grid.412266.5, Department of Biochemistry, Faculty of Biological Sciences, , Tarbiat Modares University, ; Tehran, 14115–175 Iran
                [4 ]ISNI 0000 0001 1016 0356, GRID grid.419412.b, Processing Department, , Iran Polymer and Petrochemical Institute, ; Tehran, 14965–115 Iran
                [5 ]ISNI 0000 0001 1781 3962, GRID grid.412266.5, Faculty of Interdisciplinary Science and Technology, , Tarbiat Modares University, ; Tehran, 14115–336 Iran
                Author information
                http://orcid.org/0000-0002-1712-2149
                Article
                Publisher ID: 28092
                DOI: 10.1038/s41598-018-28092-8
                PMC ID: 6026132
                PubMed ID: 29959339
                SO-VID: 77aa4be8-7f39-4cc2-b7cf-05694db0c95c
                Copyright © © The Author(s) 2018
                License:

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

                History
                Date received : 16 March 2018
                Date accepted : 13 June 2018
                Categories
                Subject: Article
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                issue-copyright-statement © The Author(s) 2018

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