(56d) Before You Click “Print”: Regulatory Considerations for 3D Printed Oral Drug Products

Zidan, A., U.S. Food and Drug Administration
Alayoubi, A., U.S. Food and Drug Administration
Cruz, C. N., U.S. Food and Drug Administration
Coburn, J., FDA
Ashraf, M., Office of Testing and Research, U.S. Food and Drug Administration
Additive manufacturing/3D printing of oral drug products and medical devices has become more attractive to shift the manufacturing strategies to support individualized medicines of the future. The US Food and Drug Administration (FDA) is charged with protecting and promoting the public health by ensuring these products are safe and effective. To that end, FDA’s recent approval of a 3D-printed drug product in August 2015 (SPRITAM®) introduced a new chapter in pharmaceutical manufacturing for solid oral dosage form. Although the first approved 3D-printed drug product is a solid oral immediate release product, the majority of 3D printing research for oral delivery has been focused on controlled release, targeting and precise delivery for extremely low dose drugs. Various principles of 3D printing of oral drug products could support production of complex and personalized medicines on demand. However, standardization of some aspects of the 3D printed dosage form and associated manufacturing process may be required to achieve this objective. In this presentation, technical and regulatory considerations for development and control of 3D printed oral products will be discussed for various 3D printing technologies.


This presentation reflects the views of the presenter and should not be construed to represent FDA’s views or policies.