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.
Introduction
Additive manufacturing, or three-dimensional (3D) printing as it is commonly known, has developed at an impressive pace in recent years, revolutionizing the prototyping and manufacturing processes across many industries including sectors such as automotive, aerospace, and medicine (1–4).
In the pharmaceutical field, 3D printing could allow novel drug delivery systems to be manufactured with unprecedented complexity and precision, achieving detailed spatial composition and controllable release patterns not feasible (or difficult to achieve) with conventional formulation techniques (5–7).
The speed and flexibility of 3D printing also propel health care closer toward the goal of personalized medicine, enabling the on-demand, on-site manufacturing of customizable products to fit patient-specific needs (8, 9). Most advances made in this direction have so far concerned simple oral dosage forms (that is, tablets), where single or combinations of multiple drugs were incorporated and spatial and temporal control over drug release were demonstrated through adjustments in polymer content (10, 11), geometry (12), compartmentation (13, 14), or infill pattern (15, 16).
Read more: 3D printing of a wearable personalized oral delivery device
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