3D Screen Printing Offers Unprecedented Anticounterfeiting Strategies for Oral Solid Dosage Forms Feasible for Large Scale Production.

A threat to human health in developed and, in particular, in developing countries, counterfeit medicines represent the largest identified fraud market worldwide. 3D screen printing (3DSP), an additive manufacturing technology that enables large-scale production, offers unique opportunities to combat counterfeit drugs. One such possibility is the generation of oral dosage forms with a distinct colored inner structure that becomes visible upon breakage and cannot be copied with conventional manufacturing methods. To illustrate this, we designed tablets containing a blue cross. Owing to paste properties and the limited dimensions of the cross, the production process was chosen to be continuous, involving two screen and paste changes. The two pastes (tablet body, cross) were identical except for the blue color of the latter. This ensured the build-up and mechanical stability of the resulting tablets in a mass production environment. The ensuing tablets were found to be uniform in weight and size and to comply with regulatory requirements for hardness, friability, and disintegration time (immediate release). Moreover, all tablets exhibited the covert anticounterfeit feature. The study delivers a proof-of-concept for incorporating complex structures into tablets using 3DSP and showcases the power of the technology offering new avenues for combating counterfeit drugs.

3D screen printing technology enables fabrication of oral drug dosage forms with freely tailorable release profiles.

3D printing offers new opportunities to customize oral dosage forms of pharmaceuticals for different patient populations, improving patient safety, care, and compliance. Although several notable 3D print technologies have been developed, such as inkjet printing, powder-based printing, selective laser sintering (SLS) printing, and fused deposition modelling (FDM), among others, their capacity is often limited by the number of printing heads. 3D screen-printing (3DSP) is based on a classic flatbed screen printing that is widely used in industrial applications for technical applications. 3DSP can build up thousands of units per screen simultaneously, enabling mass customization of pharmaceuticals. Here, we use 3DSP to investigate two novel paste formulations: immediate-release (IR) and extended-release (ER) using Paracetamol (acetaminophen) as the active pharmaceutical ingredient (API). Both disk-shaped and donut-shaped tablets were fabricated using one or both pastes to design drug delivery systems (DDS) with tailored API release profiles. The size and mass of the produced tablets demonstrated high uniformity. Characterization of the tablets physical properties, such as breaking force (25-39 N) and friability (0.002-0.237%), adhering to Ph. Eur (10th edition). Finally, drug release tests with a phosphate buffer at pH 5.8 showed Paracetamol release depended on the IR- and ER paste materials and their respective compartment size of the composite DDS, which can be readily varied using 3DSP. This work further demonstrates the potential of 3DSP to manufacture complex oral dosage forms exhibiting custom release functionalities for mass production.

3D screen printing - An innovative technology for large-scale manufacturing of pharmaceutical dosage forms.

Three-dimensional (3D) screen printing was used to fabricate oral dosage forms of different geometry and size. The paste required as starting material for the 3D screen printing process was designed for delayed release and contained the model drug paracetamol (acetaminophen). A prototype screen printing unit was used to fabricate different tablets in a single production process. The resulting tablets were produced with three different sizes and designed geometries (disk, donut, cuboid, oval and grid). Investigation of size and mass of the individual tablets demonstrated high uniformity within the various groups of tablets. Further characterization of their physical properties, such as breaking force and friability, yielded results comparing favorably to conventionally produced tablets. Finally, drug release tests in artificial gastric media showed paracetamol release to depend on the surface-area-to-volume ratio. In conclusion, the study shows the potential of 3D screen printing to fabricate more complex oral dosage forms in the setting of mass production with high reproducibility.