The field of pharmaceuticals has welcomed many new innovations since 3D printing entered the picture, and one important application to take note of is drug delivery. We’ve seen capsules, micro-rockets, and even microneedles used to transport and administer drugs, but now a team of researchers from ETH Zürich in Switzerland have published research on using 3D printed mouthguards as personalized oral drug delivery devices.
While the flexibility and speed of the technology has made it possible to 3D print pills, and even vaccines, the team believes that 3D printing can take this even further, and be used to create personalized devices with sustained drug release capabilities that are wearable or implantable.
According to the paper, “A primary reason for the gap between prototyping and application is that, although ample progress has been made in 3D printing technologies, the materials and standardized procedures remain generally inadequate from a pharmaceutical perspective, hampering the development of consistent, scalable, 3D-printed drug-eluting devices.”
Mouthguards are typically used to protect athletes’ teeth in sporting events, as well as for dental alignment purposes. But due to the ability of 3D printing to exploit and customize the shape of mouthguards, the ETH Zürich research team chose it as a proof-of-concept oral delivery device for their study.
The researchers published a paper on their work, titled “3D printing of a wearable personalized oral delivery device: A first-in-human study,” in the journal Science Advances; co-authors include Kun Liang, Simone Carmone, Davide Brambilla, and Jean-Christophe Leroux, all from the university’s Institute of Pharmaceutical Sciences (IPW) in the Department of Chemistry and Applied Biosciences.
The abstract reads, “Despite the burgeoning interest in three-dimensional (3D) printing for the manufacture of customizable oral dosage formulations, a U.S. Food and Drug Administration–approved tablet notwithstanding, the full potential of 3D printing in pharmaceutical sciences has not been realized. In particular, 3D-printed drug-eluting devices offer the possibility for personalization in terms of shape, size, and architecture, but their clinical applications have remained relatively unexplored. We used 3D printing to manufacture a tailored oral drug delivery device with customizable design and tunable release rates in the form of a mouthguard and, subsequently, evaluated the performance of this system in the native setting in a first-in-human study. Our proof-of-concept work demonstrates the immense potential of 3D printing as a platform for the development and translation of next-generation drug delivery devices for personalized therapy.”
The mouthguards, which were set up to deliver a pre-loaded compound, were 3D printed out of PLA and PVA materials on a Leapfrog Xeed 3D printer, using dental impressions from intraoral scans. Clobetasol propionate (CBS), an anti-inflammatory corticosteroid, was used as the model drug, because of its effectiveness in reducing oral inflammation; for the human release study, this was replaced with food-grade flavor vanillic acid (VA).
Different blends of the PLA and PVA were subjected to either CBS or VA in order to manufacture filaments as 3D printing feedstocks that had tunable release kinetics. An in vitro dissolution assay was used to evaluate the drug release kinetics of the 3D printed mouthguards over two weeks. For the clinical trial, six volunteers wore each of the three different types of mouthguards for two continuous hours a day over three consecutive days, with a week break between each test.
From the intraoral scan to the 3D printing and finally wearing the customized mouthguard, the entire workflow took less than two hours.
“This work demonstrates a 3D-printed tailored sustained delivery device in human that allows for full customizability in terms of tunable release and design, marking an important step in bridging the gap between modeling and clinical application of 3D-printed drug delivery devices,” the paper reads.
The researchers believe that their approach could be used to 3D print other personalized drug delivery devices on-demand, which could significantly lower the waiting time for patients…because who wants to spend more time sitting in the doctor’s office?
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