Evaluation of lactose based 3D powder bed printed pharmaceutical drug product tablets

It is key to understand powder blend characteristics in relation to tablet characteristics when using pharmaceutical 3D printing, in order to obtain 3D powder bed printed tablets that comply with the pharmaceutical specifications. There is limited literature available on excipient selection for 3D printing, even though the only marketed 3D printed drug is prepared with powder bed printing. In this study, the impact of different particle size distributions of lactose-starch base formulations on key critical material attributes such as wettability, consolidation and flowability was studied. It was found that fewer fines in the particle size of the blend is beneficial for a fast penetration time of the ink (liquid) into the powder bed. The impact of varying the print settings or binder type on primary tablet properties such as hardness and dissolution was studied using formulations with Acetaminophen or Diclofenac Sodium. It was found that optimizing the base formulation and print settings have to be in conjunction as they are closely related. This study shows in detail how hydrophilic/hydrophobic API's can be successfully formulated into 3D printed tablets taking into account the formulation considerations as described. [Display omitted] •A lactose monohydrate binder blend is preferred for 3D powder bed printing.•Wettability is related to the particle size distribution of the blend.•A hydrophilic and hydrophobic API was successfully formulated into a printed tablet.•The impact of pre-blend/print settings on tablet hardness and dissolution was studied.•Optimizing the pre-blend and print settings have to be in conjunction for 3D printing.