3D-Printed Oral Dosage Forms: Mechanical Properties, Computational Approaches and Applications

Abstract

The aim of this review is to present the factors influencing the mechanical properties of 3D-printed oral dosage forms. It also explores how it is possible to use specific excipients and printing parameters to maintain the structural integrity of printed drug products while meeting the needs of patients. Three-dimensional (3D) printing is an emerging manufacturing technology that is gaining acceptance in the pharmaceutical industry to overcome traditional mass production and move toward personalized pharmacotherapy. After continuous research over the last thirty years, 3D printing now offers numerous opportunities to personalize oral dosage forms in terms of size, shape, release profile, or dose modification. However, there is still a long way to go before 3D printing is integrated into clinical practice. 3D printing techniques follow a different process than traditional oral dosage from manufacturing methods. Currently, there are no specific guidelines for the hardness and friability of 3D printed solid oral dosage forms. Therefore, new regulatory frameworks for 3D-printed oral dosage forms should be established to ensure that they meet all appropriate quality standards. The evaluation of mechanical properties of solid dosage forms is an integral part of quality control, as tablets must withstand mechanical stresses during manufacturing processes, transportation, and drug distribution as well as rough handling by the end user. Until now, this has been achieved through extensive pre- and post-processing testing, which is often time-consuming. However, computational methods combined with 3D printing technology can open up a new avenue for the design and construction of 3D tablets, enabling the fabrication of structures with complex microstructures and desired mechanical properties. In this context, the emerging role of computational methods and artificial intelligence techniques is highlighted.

3D printed, personalized sustained release cortisol for patients with adrenal insufficiency

“…HME-FDM printed tablets have different physical properties compared to compressed tablets which may indicate that current guidelines on tablet friability may not be suitable for 3D printed tablets, in general HME-FDM tablets do not tend to be abrasive (Quodbach et al, 2022). The results for tablet hardness (Table 6) suggest that tablet mechanical strength is comparable to other HME-FDM based tablets (Karalia et al, 2021;Brambilla et al, 2021). The observed breaking force of 35.5 N may be an underestimation as tablets were intact after hardness testing (Fig.…”

The Advent of a New Era in Digital Healthcare: A Role for 3D Printing Technologies in Drug Manufacturing?

“…The need for novel non-destructive techniques and process analytical technologies (PAT) to confirm the safety and quality of the medication without tampering the sample is essential [ 15 , 55 ]. Although 3D printing of medicines can be realized through a one-step procedure [ 60 , 61 ], most technologies still require post-printing processing (e.g., drying, cooling, UV curing) to enhance the product’s mechanical stability [ 62 ]. However, this extra step might lead to further quality control issues, as it places the stability of the active pharmaceutical ingredients at risk [ 61 ] and it may affect the drug release performance [ 63 ].…”

Coupling of Fused Deposition Modeling and Inkjet Printing to Produce Drug Loaded 3D Printed Tablets

“…In the past, FDM was applied for non-pharmaceutical purposes. Nowadays, there are several pharmaceutical grade polymers used in FDM technology such as ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl methyl cellulose acetate succinate, ethylated acrylate copolymer, polyethylene glycol, polyethylene oxide, polylactic acid, PVA, and polyvinyl pyrrolidone [17][18][19][20][21].…”