Chapter 9 - Market Demands in 3D Printing Pharmaceuticals Products

Abstract

Interindividual variability is a widespread problem when treating patients with different needs. Since the past decade, dose adjustment was based on empirical methods leading to lack of efficacy and high risk of adverse effects. However, 3D printing technologies are revolutionizing the pharmaceutical manufacturing of medicines. Even though there are nine different types of 3D printing techniques, only three of these techniques have shown promising results in the pharmaceutical field, namely, printing-based inkjet systems, nozzle-based deposition systems, and laser-based writing systems. There is no single technique that can manufacture all types of medicines, as every drug has different physicochemical requirements that have to be met, such as degradation temperature, melt viscosity, and aqueous solubility. An additional issue is the lack of guidelines placed in order to understand which quality criteria the 3D printed medicines should meet to reach the patient. However, the perspective of the regulatory authorities is adapting fast to the changes of the research world and patient's needs. In 2017 the FDA developed a new guidance entitled Technical Considerations for Additive Manufactured Devices to provide an insight into technical considerations associated with 3D printing processes, including recommendations for testing and characterization of devices that include at least one additive manufacturing fabrication step. This chapter will focus on market demands in 3D printing of pharmaceutical products such as personalized polypills, patches, microneedles, and sustained-release hydrogels.