Comparative Life Cycle Assessment and Pharmaceutical Validations of Directly Compressed versus Additively Manufactured Tablets

Abstract

Selective laser sintering (SLS)-mediated additive manufacturing (AM) technology is increasingly being used for manufacturing pharmaceutical solid oral dosage forms (SODFs) due to its advantages over other AM and conventional manufacturing (CM) methods. Direct compression (DC) has a competitive edge in CM due to ease of manufacturing, while both DC and SLS-mediated AM processes share similarities in manufacturing steps and usage of fewer excipients. There is a need for a comparative evaluation of the pharmaceutical performance of the prepared DC and SLS-mediated SODFs and the environmental impacts of both DC and SLS-mediated AM processes, which has yet to be addressed. The cradle-to-gate approach was used for the life cycle assessment (LCA) of manufactured tablets, using both processes. Laboratory-scale data was generated using wet laboratory-scale experiments, literature, and LCA software with data extrapolation using the unitary method. In addition to that, the pharmaceutical performance of manufactured tablets using both processes was thoroughly assessed. The study found that DC has less environmental impact than SLS-mediated AM, with electricity consumption and waste generation being critical factors. The results may vary if SLS electricity and material utilization are reduced, resulting in less energy consumption and material requirements. In addition to that, in terms of physicochemical characterizations, both DC and SLS-mediated sintered tablets showed indistinguishable results. Furthermore, the drug contents of DC and SLS-mediated sintered tablets were determined to be 90.06 ± 5.96 and 94.29 ± 6.29%, with approximately 87 and 100% drug release after 12 h, respectively. The study concluded that, despite their environmental impact, SLS-mediated sintered tablets demonstrated pharmaceutical performance identical to that of DC tablets.