An overview of 3D printing techniques, capabilities, and challenges.
By Ashley Johnson, Ph.D., Merck & Co., Inc.; Akm Khairuzzaman, Ph.D.,* Food and Drug Administration; Suniket Fulzele, Ph.D., Teva Pharmaceutical Industries Ltd.; Adam Procopio, Ph.D., Merck & Co., Inc.; Yash Kapoor, Ph.D., Merck & Co., Inc.; Derrick Smith, Ph.D., Merck & Co., Inc.
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 In 2016, FDA released draft guidance for submission of medical devices fabricated by 3DP.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. Here, we compare 3DP with traditional methods of manufacturing tablets. We also provide an outlook on the future of 3DP within the pharmaceutical industry, including a discussion of regulatory opportunities and hurdles.