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      Edge Effect in Hot Embossing and its Influence on Global Pattern Replication of Polymer-Based Microneedles

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          Abstract

          Hot embossing was used to fabricate a microneedle array on poly(methyl methacrylate) (PMMA) substrates. Both experimental and numerical researches were carried out to investigate the whole formation process. The results showed that the edge effect would significantly influence the replication rate of final products. An optimization design of convex flow barrier was proposed to improve the replication efficiency and structure uniformity. Furthermore, optimum parameters of the flow barrier were found to be 2 mm in length and 0.2 mm in height. Reasonable high molding temperature and force were conducive to reduce the filling time and increase the average height of microneedles.

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          Most cited references 35

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          Microneedles for drug and vaccine delivery.

          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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            Microneedles for transdermal drug delivery.

            The success of transdermal drug delivery has been severely limited by the inability of most drugs to enter the skin at therapeutically useful rates. Recently, the use of micron-scale needles in increasing skin permeability has been proposed and shown to dramatically increase transdermal delivery, especially for macromolecules. Using the tools of the microelectronics industry, microneedles have been fabricated with a range of sizes, shapes and materials. Most drug delivery studies have emphasized solid microneedles, which have been shown to increase skin permeability to a broad range of molecules and nanoparticles in vitro. In vivo studies have demonstrated delivery of oligonucleotides, reduction of blood glucose level by insulin, and induction of immune responses from protein and DNA vaccines. For these studies, needle arrays have been used to pierce holes into skin to increase transport by diffusion or iontophoresis or as drug carriers that release drug into the skin from a microneedle surface coating. Hollow microneedles have also been developed and shown to microinject insulin to diabetic rats. To address practical applications of microneedles, the ratio of microneedle fracture force to skin insertion force (i.e. margin of safety) was found to be optimal for needles with small tip radius and large wall thickness. Microneedles inserted into the skin of human subjects were reported as painless. Together, these results suggest that microneedles represent a promising technology to deliver therapeutic compounds into the skin for a range of possible applications.
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              Dissolving microneedles for transdermal drug delivery.

              Microfabrication technology has been adapted to produce micron-scale needles as a safer and painless alternative to hypodermic needle injection, especially for protein biotherapeutics and vaccines. This study presents a design that encapsulates molecules within microneedles that dissolve within the skin for bolus or sustained delivery and leave behind no biohazardous sharp medical waste. A fabrication process was developed based on casting a viscous aqueous solution during centrifugation to fill a micro-fabricated mold with biocompatible carboxymethylcellulose or amylopectin formulations. This process encapsulated sulforhodamine B, bovine serum albumin, and lysozyme; lysozyme was shown to retain full enzymatic activity after encapsulation and to remain 96% active after storage for 2 months at room temperature. Microneedles were also shown to be strong enough to insert into cadaver skin and then to dissolve within minutes. Bolus delivery was achieved by encapsulating molecules just within microneedle shafts. For the first time, sustained delivery over hours to days was achieved by encapsulating molecules within the microneedle backing, which served as a controlled release reservoir that delivered molecules by a combination of swelling the backing with interstitial fluid drawn out of the skin and molecule diffusion into the skin via channels formed by dissolved microneedles. We conclude that dissolving microneedles can be designed to gently encapsulate molecules, insert into skin, and enable bolus or sustained release delivery.
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                Author and article information

                Journal
                ipp
                International Polymer Processing
                Carl Hanser Verlag
                0930-777X
                2195-8602
                29 April 2019
                : 34
                : 2
                : 231-238
                Affiliations
                1 College of Mechanical and Electrical Engineering, Beijing University of Chemical Technology, Beijing, PRC
                2 State Key Laboratory of Organic-Inorganic Composites, Beijing, PRC
                Author notes
                [* ] Correspondence address, Mail address: Jingyao Sun, College of Mechanical and Electrical Engineering, Beijing University of Chemical Technology, No. 15 Beisanhuan East Road, Chaoyang District, Beijing, 100029, PRC, E-mail: sunjingyao5566@ 123456sina.com
                Article
                IPP3726
                10.3139/217.3726
                © 2019, Carl Hanser Verlag, Munich
                Page count
                References: 36, Pages: 8
                Product
                Self URI (journal page): http://www.hanser-elibrary.com/loi/ipp
                Categories
                Regular Contributed Articles

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