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

Abstract

The technological revolution has physically affected all manufacturing domains, at the gateway of the fourth industrial revolution. Three-dimensional (3D) printing has already shown its potential in this new reality, exhibiting remarkable applications in the production of drug delivery systems. As part of this concept, personalization of the dosage form by means of individualized drug dose or improved formulation functionalities has concentrated global research efforts. Beyond the manufacturing level, significant parameters must be considered to promote the real-time manufacturing of pharmaceutical products in distributed areas. The majority of current research activities is focused on formulating 3D-printed drug delivery systems while showcasing different scenarios of installing 3D printers in patients' houses, hospitals, and community pharmacies, as well as in pharmaceutical industries. Such research presents an array of parameters that must be considered to integrate 3D printing in a future healthcare system, with special focus on regulatory issues, drug shortages, quality assurance of the product, and acceptability of these scenarios by healthcare professionals and public parties. The objective of this review is to critically present the spectrum of possible scenarios of 3D printing implementation in future healthcare and to discuss the inevitable issues that must be addressed.

Keywords: 3D printing; Industry 4.0; digital healthcare; drug delivery systems; personalized medications; pharmaceutical product.

Figure 1

The need for personalization of pharmaceutical products and changes in product volume and va-riety due to product customization according to the needs of individual patients. This figure has been reproduced with permission from © 2021 Rydvikha Govender [6].

Figure 2

3D-printed solid dosage forms in various shapes (upper part) and 3D-printed polypills (lower part) [33].

Figure 3

3D-printed solid dosage forms for pediatric patients; gummy dosage forms (upper left) [41]; dosage forms shaped like candy (Starmix^®) (middle left) [42]; taste-masked chewable dosage forms in various shapes (lower left) [43]; soft chewable Lego ™-shaped dosage form (upper right) [44]; chocolate-based dosage forms in various shapes (lower right) [40].

Figure 4

3D-printed oral films (left) and tablet (right) containing Braille characters for identification of the dosage form by visually impaired patients. The respective diameters of the Braille patterns are 1.6 mm (A), 2 mm (B), and 1.5 mm (right) [51,52].

Figure 5

Two possible scenarios for the production of 3D-printed medicine: in the community pharmacy (left) or in the pharmaceutical industry (right). Both cases comprise an integral network between the proposed therapeutic plan, the design of a personalized dosage form, the utilization of the appropriate feedstock, and the production and final distribution of the medicinal product to the patient [55].

Figure 6

Example of a future scenario for automated digital design of customized medicinal products through an algorithm. The algorithm processes the appropriate input data, i.e., the suggested therapeutic plan and the available feedstock properties, and generates the optimal digital design of the medicinal product. Afterwards, the generated design can be loaded to the 3D printer by a medical doctor, a pharmacist, or a patient in order to proceed with manufacturing of a personalized dosage form [79].