<p style="text-align: justify">Fixed-dose combinations are the preferred approach to simplify the disease management for chronic diseases (e.g., HIV, asthma, diabetes, lipid regulation, hypertension) by reducing dosage intake and improving efficacy through the synergistic effect of active compound's mechanisms of action. Although there are multiple approaches for designing and manufacturing Fixed-Dose combinations, multilayer tablets are the preferred choice for administering incompatible pharmaceutical compounds in a single dosage due to the inherent flexibility in release profiles and dissolution modes that can be incorporated into the tablet layers. Nevertheless, there are still some drawbacks related to their optimal manufacturing and personalized medicine treatments. Pharmaceutical Additive Manufacturing technologies emerge as a promissory and effective solution to address some of the issues related to Polytherapies in chronic patients since it allows manufacturing advanced drug delivery systems and complex/sophisticated three-dimensional dosages in a single operation that achieve personalization in terms of release profiles and dosage strengths without further machine adjustments. Other advantages of additive manufacturing technology adoption in the pharmaceutical industry include patient-centric therapy/personalized medicine, on-demand manufacturing, and low capital/operation costs compared to traditional processes.<br>
However, widespread adoption of Additive Manufacturing technologies in the Pharmaceutical Industry remains to be seen. Despite a growing volume of research works attempt to develop AM processes for the fabrication of Fixed-Dose combination pharmaceutical products, a common framework for Conceptual design that simplify the product development process is needed. This work proposes a Conceptual Design Framework for Pharmaceutical Additive Manufacturing technologies by integrating functional analysis and solution principles from different pharmaceutical Additive Manufacturing research output into a single morphology matrix by following the design methodology proposed by Pahl and Beitz. While initially conceived as an Additive Manufacturing process classification tool, the morphology matrix can be used as a framework to support the divergent stage of the idea generation process in conceptual design stages. This work starts by presenting the Conceptual Design framework, including the functional structure for pharmaceutical Additive Manufacturing processes, solution principles identified in state of the art, and the morphological matrix that summarizes these findings. Then, the authors present a case study for the development of an Additive Manufacturing process for the fabrication of Fixed-Dose combination pharmaceutical products. The focus in this work is the design and analysis of a pharmaceutical flexible manufacturing process that does not limit a formulator scientist in his choice of release profile, size, and the number of pharmaceutical compounds, that allows the product to adapt to the need of patients incorporating multiple pharmaceutical compounds and different release profiles based on additive manufacturing.</p>

A Conceptual Design Framework for Pharmaceutical Additive Manufacturing Technologies: Fixed Dose Combinations Case Study

Paper Proceedings: https://asmedigitalcollection.asme.org/IMECE/IMECE2021/volume/85543

ASME 2021 International Mechanical Engineering Congress and Exposition (IMECE2021)

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