Expert opinion on extrusion-based pharmaceutical 3D printing from the European Society of Hospital Pharmaceutical...

Three-dimensional (3D) printing technologies have been applied to manufacture a variety of medicinal products. This emerging technology holds significant potential in pharmaceutical applications, offering innovative solutions for both patients and pharmacies. In this paper, we describe the application of 3D printing in the hospital pharmacy setting. To describe the current and future role of 3D printing in hospital pharmacies, we start by discussing the relevant legislation of the three key European regulatory bodies: the European Medicines Agency (EMA, EU), the Swiss Agency for Therapeutic Products (Swissmedic, Switzerland), and the Medicines and Healthcare Products Regulatory Agency (MHRA, UK). Furthermore, we discuss critical elements of the printing process, such as quality assurance aspects of 3D printed tablets, focusing on quality management systems, process validation, and in-process controls. Additionally, we introduce three extrusion-based 3D printing techniques applicable in a clinical setting: fused deposition modelling (FDM), semi-solid extrusion (SSE), and direct powder extrusion (DPE). The different printing materials used for each technique are described, and examples of related GMP-compliant printers are given. We also address quality control measures and propose specifications for the final printed products. The information on the regulatory frameworks, quality assurance, printing techniques, and quality control is combined to develop a practical example of how extrusion-based 3D printing could be implemented in hospital pharmacy practice.