Abstract by Yingya Wang

Additive manufacturing, also known as three-dimensional (3D) printing, is a novel technology developed for the fabrication of objects since the 1980s. It has recently gained increasing attention in the pharmaceutical sector. Binder jetting 3D printing is a powder-based additive manufacturing method, which allows the freeform design of powder-based materials that are subsequently solidified by addition of binder. Technical challenges and limitations have been encountered in application of this approach, mainly due to the lack of fundamental understanding of the underpinning mechanisms related to the fabrication of solid products and the choice of printable pharmaceutical materials.

In this work, a thorough overview of binder jetting 3D printing technology in fabricating solid products for oral drug delivery was retrieved and based on this, critical material properties, process parameter selection, and manufacturing considerations were summarized. Based on a structured risk assessment, placebo and drug-loaded products with different primary powder compositions were fabricated, which met the requirements for the quality target product profile of a tablet analogue. A structured study was performed to determine factors including the selection of the composition and mass ratio of liquid to solid materials, and the process parameters related to printing (layer thickness and number of layers) that can impact critical quality attributes. Their influence on the binding mechanisms was investigated. An approach based on fluidized bed coating was further developed to modify lactose, the matrix material in primary powder, to achieve the optimal product hardness and disintegration behaviour.

In summary, this work presents an overview of the current stage of applying binder jetting 3D printing to fabricate pharmaceutical solid products. Additionally, this work highlights the importance of using systematic and quality-oriented product development strategies for understanding the underlying mechanisms affecting product performance to optimize material and process parameter selections.