By: Ashley Johnson
Recently, there has been increasing interest in using 3D printing (3DP) to manufacture drug products. Notably, in 2015, the Food and Drug Administration (FDA) approved the first 3D printed tablet, Aprecia Pharmaceutical’s Spritam for the treatment of epileptic seizures. Spritam is fabricated using the company’s ZipDose 3DP technology, which creates porous tablets that dissolve almost instantaneously in the mouth. In 2016, FDA released draft guidance for submission of medical devices fabricated by 3DP. In addition to these regulatory advancements, 3DP of pharmaceuticals has generated significant academic and industrial interest due to its ability to produce complex geometries and customizable material properties.
In the March AAPS Newsmagazine cover article 3D Printing in Drug Product Development, we compare 3DP (including 3DP by photopolymerizaton, thermal processes, binder jetting, and paste extrusion) with traditional methods of manufacturing tablets. As compared to traditional powder compaction techniques, which require bulky production lines and large economies of scale, additive manufacturing is an agile technique. It enables tablets to be computationally designed and rapidly prototyped; a larger tablet design space is also available due to enhanced control over geometry and material characteristics, including multi-component designs.
We also provide an outlook on the future of 3DP within the pharmaceutical industry, including a discussion of regulatory opportunities and hurdles. Like any other conventional pharmaceutical manufacturing, the risk and potential control strategies for 3DP depend on the type of printing method; its size, speed, and quality; and the material used for formulation. Incorporating process controls to ensure that 3D printers reliably produce safe medicines will be essential. Methods for safety testing personalized products printed at point of care need to be developed. Despite these and several other challenges, 3DP has definitely presented itself to create unique opportunities to develop complex, personalized, and on-demand products.
*Disclaimer: This article reflects the views of the author and should not be construed to represent FDA’s views or policies.
Ashley Johnson is a senior scientist at Merck & Co., Inc. in West Point, Pennsylvania. Her work focuses on the use of 3D printing in pharmaceutical manufacturing.