Determination of feed forces to improve process understanding of Fused Deposition Modeling 3D printing and to ensure mass conformity of printed solid oral dosage forms

Fused Deposition Modeling is a suitable technique for the production of personalized solid oral dosage forms. For widespread application, it is necessary to be able to print a wide range of different formulations to address individual therapeutic needs. Due to the complexity of formulation composition (e.g., due to different compounds, excipients for enhancement of release and mechanical properties) and limited mechanical understanding, determination of suitable printing parameters is challenging. To address this challenge, we have developed a feed force tester using a Texture Analyser setup that mimics the actual printing process. Feed force data were compared to the mass of tablets printed from technical materials as well as pharmaceutical filaments containing ketoconazole at high drug loads of 20% and 40% and polyvinyl alcohol. By determining a feed force limit for the 3D printer from feed force data of several formulations printed, it was possible to specify the operable printing range, where printing is reproducible and printed mass corresponds the target mass. Based on these results, rational optimization of the printing process in terms of speed, time and temperature for different materials and formulations is possible.