(496a) 3D Printing: A New Era of Precise Manufacturing of Individually Developed Pharmaceuticals

Zidan, A., U.S. Food and Drug Administration
Alayoubi, A., U.S. Food and Drug Administration
Asfari, S., U.S. Food and Drug Administration
Yazdanpanah, N., U.S. Food and Drug Administration
O'Connor, T., U.S. Food and Drug Administration
Ashraf, M., Office of Testing and Research, U.S. Food and Drug Administration
Cruz, C. N., U.S. Food and Drug Administration
The growing demand for customized medicines increases the impact of 3D printing as one of the emerging technologies for precise manufacturing of individually developed dosage forms. In all 3D printing technologies, large number of materials, geometrical and process factors affect the quality of these computationally designed dosage forms and safety of their use. In addition, for printing an identical dosage form, the quality may vary when built using different 3D printers, even when the same model of the printer, printing parameters, process steps, and raw materials are used. Therefore, knowledge of how the variability of each input parameter and processing step affects the final finished product is critical to ensuring its quality. There is no specific guidance concerning the design, manufacturing process and quality testing considerations for 3D printed solid dosage forms. This presentation will then highlight some of specific methodologies and control strategies considerations over the material, geometrical and process parameters for 3D printing of solid dosage forms. A case study of employing 3D pneumatic assisted microextrusion based 3D printing to manufacture modified release tablets and polypills will be presented. considerations for process validation will be also discussed so that quality for all printlets is maintained when built in a single cycle, between cycles, and by different printers. The issue of identifying and linking the critical factors to the critical quality attributes of the printlets will be also highlighted with an emphasis on the regulatory considerations involved.