Printing and Additive Manufacturing

Visualization of the 3D printed mold fi lling apparatus that would allow the extemporaneous production of tablets with a designed disintegration and drug release: (a) overview of all components: building base (purple), punches (yellow), and pistons (green and pink); (b) insertion of punches into the building base; (c) molds fi lled with the casting formulation;
(d) use of shorter pistons (green) to raise the punches which subsequently aid tablet removal; (e) and (f) use of longer pistons (purple) to remove punches
(doi: 10.1208/s12249-019-1341-z)


by Jukka Rantanen and Niklas Sandler

Additive manufacturing (AM) of pharmaceutical products is a potential game-changer for the whole pharmaceutical business area. This opens totally new possibilities for implementing innovative product design principles. For instance, the possibility to design the inner structure of a product gives unique opportunities to tailor-make the products size and shape, as well as inner structure of it and by this means control the drug release characteristics. This approach is paving the way towards patient-centered medication strategies and implementation of mass customization principles.

Many of the potential AM methods are naturally operating the continuous mode, which is underpinning the need for early implementation of quality by design (QbD) and process analytical technologies (PAT) principles. Additionally, AM methods are typically based on computer based design of the product geometry giving a unique possibility to early implementation of computational methods covering product design in a broader sense. Another important aspect is the materials science dimension; more fundamental work is needed to develop materials and analytical methods that can be utilized when implementing AM principles.

As a summary, the pharmaceutical area is still missing broadly accepted processing principles, key equipment, optimized excipients, computational methods, as well as quality control tools for additive manufacturing of innovative pharmaceuticals. This [AAPS PharmSciTech theme issue, Printing and Additive Manufacturing,] is collecting recent scientific development related to these aspects and by this means creating a scientific basis for innovative pharmaceutical products for the twenty-first century.

In this theme issue we have an excellent collection of cutting edge contributions from the field exemplifying the use of printing technologies in manufacturing of drug delivery systems. The journal articles include intriguing examples of the use of advanced materials in three-dimensional structures for tailoring release and dose adjustment for biologicals and small molecules.

We are delighted to see progress in the application of printing technologies. However, further development will be needed for the 3D technology to establish itself as a multipurpose tool for future treatments and delivery systems. Printing technologies will be able to become fabrication tools of the future if state-of-the-art printers are continuously developed, processing speeds are improved, and wider range of printable materials are developed to broaden the possibilities to create multifunctional drug delivery systems and medical devices of
the future.

CAD drawings of cylindrical tablets with a single infill density that serve as input templates for 3D printing (left). Detail of the FDM print-head used in this work (right).
(doi: 10.1208/s12249-018-1176-z)

It is probably fair to say that the development of printing processes in the pharmaceutical field has moved from its infancy to adolescence and the next decade will most likely show immense progress and activity within the field including the pharma industry, various start-ups, pharmacies, and hospitals, where point-of-care fabrication in hospitals can be reality and individualized treatments are made closer to the patient. Safe integration of these products into the health-related big data and Internet of Things (IoT) remains one of the future challenges. 

 

Table of Contents

1. 3D Printing of Metformin HCl PVA Tablets by Fused Deposition Modeling: Drug Loading, Tablet Design, and Dissolution Studies
2. The Use of 3D Printed Molds to Cast Tablets with a Designed Disintegration Profile
3. 3D-Printed Isoniazid Tablets for the Treatment and Prevention of Tuberculosis—Personalized Dosing and Drug Release
4. Manufacturing of Multi-drug Formulations with Customised Dose by Solvent Impregnation of Mesoporous Silica Tablets
5. 3D-Printed Network Structures as Controlled-Release Drug Delivery Systems: Dose Adjustment, API Release Analysis
   and Prediction
6. Industrial Development of a 3D-Printed Nutraceutical Delivery Platform in the Form of a Multicompartment HPC Capsule
7. Influence of Geometry on the Drug Release Profiles of Stereolithographic (SLA) 3D-Printed Tablets
8. Controlled Release of 5-Fluorouracil from Alginate Beads Encapsulated in 3D Printed pH-Responsive Solid Dosage Forms
9. The Effect of Inkjet Printing over Polymeric Films as Potential Buccal Biologics Delivery Systems
10. Pharmaceutical Additive Manufacturing: a Novel Tool for Complex and Personalized Drug Delivery Systems
11. Extrusion 3D Printing of Paracetamol Tablets from a Single Formulation with Tunable Release Profiles Through Control of Tablet Geometry
12. Virtual Prototyping and Parametric Design of 3D-Printed Tablets Based on the Solution of Inverse Problem

 

This editorial is reprinted from AAPS PharmSciTech (doi: 10.1208/s12249-019-1427-7).