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      Microneedle-Assisted Transdermal Delivery of Etanercept for Rheumatoid Arthritis Treatment

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          Abstract

          Rheumatoid arthritis (RA) is a complicated autoimmune disease. The clinical applications of etanercept (EN), a TNF-α inhibitor, can efficiently halt the development of RA. EN is mainly administrated by subcutaneous injection, which may cause low compliance, side effects, and infection risk. In this study, a hyaluronic acid crosslinked microneedle system (MN) was constructed as the transdermal alternative to deliver EN. We describe the formulation, fabrication, characterization, and transdermal insertion study of MN. In vitro bioactivity of EN was conducted and analyzed by dynamic light scattering and circular dichroism spectrum. In vivo evaluation of MN was studied on adjuvant-induced arthritis mice. The MN possessed sufficient mechanical strength, good biocompatibility, little influence on the bioactivity of EN, and high anti-inflammatory efficacy. This work represents a successful example of delivering macromolecule therapeutic treatment by MN for RA treatment. The transdermal delivery of EN by MN offers a new treatment option for RA patients.

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          Microneedles for drug and vaccine delivery.

          Yeu-Chun Kim, Jung-Hwan Park, Mark Prausnitz (2012)
          Microneedles were first conceptualized for drug delivery many decades ago, but only became the subject of significant research starting in the mid-1990's when microfabrication technology enabled their manufacture as (i) solid microneedles for skin pretreatment to increase skin permeability, (ii) microneedles coated with drug that dissolves off in the skin, (iii) polymer microneedles that encapsulate drug and fully dissolve in the skin and (iv) hollow microneedles for drug infusion into the skin. As shown in more than 350 papers now published in the field, microneedles have been used to deliver a broad range of different low molecular weight drugs, biotherapeutics and vaccines, including published human studies with a number of small-molecule and protein drugs and vaccines. Influenza vaccination using a hollow microneedle is in widespread clinical use and a number of solid microneedle products are sold for cosmetic purposes. In addition to applications in the skin, microneedles have also been adapted for delivery of bioactives into the eye and into cells. Successful application of microneedles depends on device function that facilitates microneedle insertion and possible infusion into skin, skin recovery after microneedle removal, and drug stability during manufacturing, storage and delivery, and on patient outcomes, including lack of pain, skin irritation and skin infection, in addition to drug efficacy and safety. Building off a strong technology base and multiple demonstrations of successful drug delivery, microneedles are poised to advance further into clinical practice to enable better pharmaceutical therapies, vaccination and other applications. Copyright © 2012 Elsevier B.V. All rights reserved.
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            Hydrogels for protein delivery.

            Tina Vermonden, Roberta Censi, Wim E Hennink (2012)
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              Microneedle-array patches loaded with hypoxia-sensitive vesicles provide fast glucose-responsive insulin delivery.

              Jicheng Yu, Yuqi Zhang, Yanqi Ye … (2015)
              A glucose-responsive "closed-loop" insulin delivery system mimicking the function of pancreatic cells has tremendous potential to improve quality of life and health in diabetics. Here, we report a novel glucose-responsive insulin delivery device using a painless microneedle-array patch ("smart insulin patch") containing glucose-responsive vesicles (GRVs; with an average diameter of 118 nm), which are loaded with insulin and glucose oxidase (GOx) enzyme. The GRVs are self-assembled from hypoxia-sensitive hyaluronic acid (HS-HA) conjugated with 2-nitroimidazole (NI), a hydrophobic component that can be converted to hydrophilic 2-aminoimidazoles through bioreduction under hypoxic conditions. The local hypoxic microenvironment caused by the enzymatic oxidation of glucose in the hyperglycemic state promotes the reduction of HS-HA, which rapidly triggers the dissociation of vesicles and subsequent release of insulin. The smart insulin patch effectively regulated the blood glucose in a mouse model of chemically induced type 1 diabetes. The described work is the first demonstration, to our knowledge, of a synthetic glucose-responsive device using a hypoxia trigger for regulation of insulin release. The faster responsiveness of this approach holds promise in avoiding hyperglycemia and hypoglycemia if translated for human therapy.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Pharmaceutics
                Journal ID (iso-abbrev): Pharmaceutics
                Journal ID (publisher-id): pharmaceutics
                Title: Pharmaceutics
                Publisher: MDPI
                ISSN (Electronic): 1999-4923
                Publication date (Electronic): 15 May 2019
                Publication date Collection: May 2019
                Volume: 11
                Issue: 5
                Electronic Location Identifier: 235
                Affiliations
                [1 ]Department of Pharmaceutics, School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou 450001, China; justin1140@ 123456163.com (J.C.); nanzhang@ 123456zzu.edu.cn (N.Z.); wangziyia315@ 123456163.com (Z.W.); sujingjing0530@ 123456163.com (J.S.); jingyang0021@ 123456163.com (J.Y.); hanjiabing9283@ 123456163.com (J.H.)
                [2 ]Key Laboratory of Targeting Therapy and Diagnosis for Critical Diseases, Zhengzhou 450001, China
                [3 ]Key Laboratory of Advanced Pharmaceutical Technology, Ministry of Education of China, Zhengzhou 450001, China
                Author notes
                [* ]Correspondence: zhaoyx@ 123456zzu.edu.cn ; Tel.: +86-0371-6773-9165; Fax: +86-0371-6773-9546
                [†]

                These authors contributed equally to the work.

                Article
                Publisher ID: pharmaceutics-11-00235
                DOI: 10.3390/pharmaceutics11050235
                PMC ID: 6572071
                PubMed ID: 31096705
                SO-VID: a87868d8-5152-4bfe-b8c5-db4488757f9b
                Copyright © © 2019 by the authors.
                License:

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                Date received : 09 April 2019
                Date accepted : 13 May 2019
                Categories
                Subject: Article

                Keywords: microneedle,etanercept,rheumatoid arthritis,drug delivery,hyaluronic acid
                Data availability:
                Keywords: microneedle, etanercept, rheumatoid arthritis, drug delivery, hyaluronic acid

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