Linked to EAHP Statements

Section 3 - Production and Compounding: Statements 3.3, 3.5
Section 6 - Education and Research: Statements 6.2, 6.3

ACPE UAN: 0475-0000-21-014-L07-P. A knowledge-based activity. 

Abstract

There is a need for tailoring medicines according to a patient's specific needs due to his/her genetic profile, phenotypic response, and pathophysiology. To enable the manufacturing of individualised oral medication in a scalable manner, new technologies such as multi-dimensional printing (3D printing or 3DP) might be the suitable option for pharmaceutical manufacturing.

Traditional galenic manufacturing and compounding comprise sequential manipulations to build a homogeneous mixture of powders, suspensions, or solutions from various amounts of starting materials. With 3D printing technology, additional potential is provided to production and preparation. 3DP is developing towards a mature and promising technology for coping with challenges arising from highly precise dosing, coating of surfaces, production of slowrelease galenic forms, formulation of gastric acid-resistant coating, complex release kinetics formulations, and easily dissolving hydrogels for dysphagia patients or for elderly patients who have difficulties swallowing. As printed layers are of minor thickness, 3D printing creates opportunities to design and produce medication with specific shapes, colours and flavours; even the "polypill" is possible.

3D printing can even be applied to the construction of medical devices to support surgery such as surgical models, planning guides or even prosthetics for plastic and reconstructive surgery. The technology can also produce wound dressings and prosthetic dentistry devices.

3DP related terminology such as inkjet printing, powder bed printing, Fused Deposition Modelling, hot-melt extrusion (the two 3D printing techniques with the greatest progress towards personalized pharmaceutical tablets), will be presented.

Although 3D printing suffers from several limitations, as it is still slow and printed layers have to dry before a next layer can be added, there is a huge potential to automate production, even in small-scale productions. Not to forget: Automation might provide further protections to technicians from exposure to toxic ingredients.

Learning objectives

After the session, participants should be able to:
• identify the different opportunities and evaluate the possible applications of 3DP in Hospital pharmacy production;
• assess the challenges of;
   1. tailoring individual pharmacotherapy with 3D-technology;
   2. identifying risks arising from 3D-printing;
   3. reproducibility;
• recognise limitations of the technology such as printing speed, spreading of contaminants in the working environment and line clearance;
• discuss the legislative and regulatory quality aspects of 3DP.

Educational need addressed

Since printing technology has opened the doors for wider use of 3D printers, several industrial branches have developed applications of this new option of manufacturing. Apart from the food industry, medical devices for implants or for plastic and reconstructive surgery were the first to profit from these developments. 

Hospital pharmacists now need to evaluate the options of 3D-printing aided production and compounding. 3D medicines printing might be considered as just a production technology and thus part of the hospital pharmacist's curriculum. However, the possible (disruptive) impact on the many stakeholders in the pharmaceutical care chain makes it clear, that 3DP earns a place in many more components of the curriculum.

Keywords: 3D printing, Three Dimensional Printing, 3DP, additive manufacturing, coating, slow release medicinal products, layer printing, moulages and wound dressings, personalised medicine, compounding, technology, safety.