(64k) Panel Discussion, Q&A

Additive manufacturing (AM), also referred to as 3D printing (3DP), is poised to bring about a revolution in the way drug products are designed, manufactured, and distributed to patients. This technology has gained significant academic acceptance as well as industrial interest and commercial implementation from the ability to create complex geometries along with customizable material properties. Here we demonstrate the use of two common desktop 3D printing approaches, Fused Deposition Modeling (FDM) and Stereolithography (SLA), to manufacture oral and non-oral dosage forms.

Using a re-engineered desktop FDM we succuessfully manufacture thin-walled capsules out of pharmaceutically acceptable materials and co-print with API containing formulations such as liquids, gels, pastes and powders. The main advantage to this approach is our ability to design and create custom API release profiles to test in a clinical setting. To date we have developed three distinct designs that provide unique and informative dissolution profiles: 1) osmotic-like zero-order releases using nondissolvable capsules with dissolvable capsule features, 2) controlled delay releases using variable thickness, and 3) pulsatile releases using pill-in-a-pill designs. Additionally, the agility in this approach potentially introduces a rapid on-site manufacturing for personalized dosing.

For non-oral applications, we demonstrate a simple, low cost, and commercially available method for fabricating microneedle arrays using a desktop SLA printer. The default settings of the printer introduce defects into the fabricated microneedles, but through proper optimization, using a combination of reducing layer height, employing a high quality antialiasing algorithm, and rescaling the input images enables the production of high fidelity microneedles. These microneedles demonstrate sharp tip radii with fabrication times less than one hour. Further, we demonstrate that the opimal microneedle design is accomplished through adjustments in the height, width, and spacing of these arrays. Microneedle masters produced using this technique is combined with standard micromolding approaches to fabricate microneedles from desired materials, such as water soluble or biodegradable polymers. We anticipate that this approach will lower the barrier to entry into the microneedle field for researchers with little background in microfabrication and provide an easy way to adjust key microneedle parameters, such as size, aspect ratio, and spacing tuned for the active ingredient and drug delivery rate.