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      Formulation development of itraconazole PEGylated nano-lipid carriers for pulmonary aspergillosis using hot-melt extrusion technology

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          Abstract

          Pulmonary delivery is a promising alternative for the oral treatment of pulmonary aspergillosis. This study aimed to develop continuous and scalable itraconazole PEGylated nano-lipid carriers (ITZ-PEG-NLC) for inhalation delivery. The feasibility of preparing NLCs utilizing hot-melt extrusion (HME) coupled with probe sonication was investigated. The process parameters for HME and sonication were varied to optimize the formulation. ITZ-PEG-NLC (particle size, 101.20 ± 1.69 nm; polydispersity index, 0.26 ± 0.01) was successfully formulated. The drug entrapment efficiency of ITZ-PEG-NLC was 97.28 ± 0.50%. Transmission electron microscopy was used to characterize the shape of the particles. The developed formulations were evaluated for their aerodynamic properties for pulmonary delivery. The lung deposition of ITZ-PEG-NLC was determined using an Anderson Cascade Impactor and Philips Respironics Sami the Seal Nebulizer Compressor. In vitro cytotoxicity studies were performed using A549 cells. A burst-release pattern was observed in ITZ-PEG-NLC with a drug release of 41.74 ± 1.49% in 60 min. The in vitro aerosolization of the ITZ-PEG-NLC formulation showed a mass median aerodynamic diameter of 3.51 ± 0.28 μm and a geometric standard deviation of 2.44 ± 0.49. These findings indicate that HME technology could be used for the production of continuous scalable ITZ-PEG-NLC.

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          PEGylation as a strategy for improving nanoparticle-based drug and gene delivery.

          Jung Suk, Qingguo Xu, Namho Kim … (2016)
          Coating the surface of nanoparticles with polyethylene glycol (PEG), or "PEGylation", is a commonly used approach for improving the efficiency of drug and gene delivery to target cells and tissues. Building from the success of PEGylating proteins to improve systemic circulation time and decrease immunogenicity, the impact of PEG coatings on the fate of systemically administered nanoparticle formulations has, and continues to be, widely studied. PEG coatings on nanoparticles shield the surface from aggregation, opsonization, and phagocytosis, prolonging systemic circulation time. Here, we briefly describe the history of the development of PEGylated nanoparticle formulations for systemic administration, including how factors such as PEG molecular weight, PEG surface density, nanoparticle core properties, and repeated administration impact circulation time. A less frequently discussed topic, we then describe how PEG coatings on nanoparticles have also been utilized for overcoming various biological barriers to efficient drug and gene delivery associated with other modes of administration, ranging from gastrointestinal to ocular. Finally, we describe both methods for PEGylating nanoparticles and methods for characterizing PEG surface density, a key factor in the effectiveness of the PEG surface coating for improving drug and gene delivery.
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            Mucus-penetrating nanoparticles for drug and gene delivery to mucosal tissues.

            Samuel Lai, Ying-Ying Wang, Justin Hanes (2009)
            Mucus is a viscoelastic and adhesive gel that protects the lung airways, gastrointestinal (GI) tract, vagina, eye and other mucosal surfaces. Most foreign particulates, including conventional particle-based drug delivery systems, are efficiently trapped in human mucus layers by steric obstruction and/or adhesion. Trapped particles are typically removed from the mucosal tissue within seconds to a few hours depending on anatomical location, thereby strongly limiting the duration of sustained drug delivery locally. A number of debilitating diseases could be treated more effectively and with fewer side effects if drugs and genes could be more efficiently delivered to the underlying mucosal tissues in a controlled manner. This review first describes the tenacious mucus barrier properties that have precluded the efficient penetration of therapeutic particles. It then reviews the design and development of new mucus-penetrating particles that may avoid rapid mucus clearance mechanisms, and thereby provide targeted or sustained drug delivery for localized therapies in mucosal tissues.
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              Nanostructured lipid matrices for improved microencapsulation of drugs.

              R.H Müller, M. Radtke, S.A. Wissing (2002)
              At the beginning of the nineties solid lipid nanoparticles (SLN) have been introduced as a novel nanoparticulate delivery system produced from solid lipids. Potential problems associated with SLN such as limited drug loading capacity, adjustment of drug release profile and potential drug expulsion during storage are avoided or minimised by the new generation, the nanostructured lipid carriers (NLC). NLC are produced by mixing solid lipids with spatially incompatible lipids leading to special structures of the lipid matrix, i.e. three types of NLC: (I) the imperfect structured type, (II) the structureless type and (III) the multiple type. A special preparation process-applicable to NLC but also SLN-allows the production of highly concentrated particle dispersions (>30-95%). Potential applications as drug delivery system are described.
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                Author and article information

                Contributors
                Michael Repka
                Journal
                Journal ID (nlm-ta): Int J Pharm X
                Journal ID (iso-abbrev): Int J Pharm X
                Title: International Journal of Pharmaceutics: X
                Publisher: Elsevier
                ISSN (Electronic): 2590-1567
                Publication date PMC-release: 03 March 2021
                Publication date Collection: December 2021
                Publication date (Electronic): 03 March 2021
                Volume: 3
                Electronic Location Identifier: 100074
                Affiliations
                [a ]Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, MS 38677, USA
                [b ]Pii Center for Pharmaceutical Technology, University of Mississippi, University, MS 38677, USA
                [c ]Department of Pharmaceutics, College of Pharmacy, University of Hail, Hail 81442, Saudi Arabia
                [d ]College of Pharmacy, The University of Texas at Austin, TX 78712, USA
                Author notes
                [* ]Corresponding author at: Department of Pharmaceutics and Drug Delivery, Pii Center for Pharmaceutical Technology, School of Pharmacy, University of Mississippi, University, MS 38677, USA. marepka@ 123456olemiss.edu
                Article
                Publisher Item ID: S2590-1567(21)00003-7 Publisher ID: 100074
                DOI: 10.1016/j.ijpx.2021.100074
                PMC ID: 7973123
                PubMed ID: 33748741
                SO-VID: a3a72376-81a4-4dde-a1a2-3ea4e7add39c
                Copyright © © 2021 The Author(s)
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 26 February 2021
                Date accepted : 27 February 2021
                Categories
                Subject: Research Paper

                Keywords: itraconazole,pegylation,hot-melt extrusion,pulmonary drug delivery,inhalation,nanostructured lipid carriers
                Data availability:
                Keywords: itraconazole, pegylation, hot-melt extrusion, pulmonary drug delivery, inhalation, nanostructured lipid carriers

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