Recent Advancements in Pharmaceutical 3D Printing Industry

Abstract

The pharmaceutical industry is progressing swiftly, driven by innovations that have led to the discovery of novel active pharmaceutical ingredients (APIs), along with new delivery platforms and technologies. Despite these advancements, traditional processing methods continue to encounter significant challenges in delivering new chemical entities. Many of these entities exhibit inherent issues such as poor solubility and permeability, which result in low bioavailability. Furthermore, there are constraints in customizing and delivering medications tailored to the pharmacokinetic variability of paediatric and geriatric patients, highlighting the need for advanced technological solutions in drug delivery. Additive manufacturing (AM), or 3D printing, represents one such technological breakthrough in the pharmaceutical sector. This review examines the latest advancements in 3D printing technology and its applications within the field. It focuses on the implementation of various 3D printing techniques to design and create dosage forms for multiple delivery routes, addressing the unique challenges posed by each route. In addition to exploring the research involved in developing novel formulations, the review also considers the regulatory hurdles that must be overcome to bring these dosage forms to market. It evaluates the market demand and financial considerations of this segment, assessing the feasibility of scaling up production to meet the requirements of the target patient population.

Introduction

The pharmaceutical field is advancing at a rapid pace with innovations leading to the development of novel active pharmaceutical ingredients (API), including small and large molecules and delivery platforms and technologies [1]. Conventional processing still faces a multitude of challenges concerning delivering new chemical entities, most of which are inherently associated with problems such as poor solubility and permeability leading to poor bioavailability [2]. Along with the limitation to modify and deliver medications specifically based on the pharmacokinetic variability for paediatric and geriatric patients, applications of newer technological innovations take precedence to improve the pharmaceutical drug delivery space [3]. One such advancement is the application of additive manufacturing (AM) or 3D printing in this sector.

Additive manufacturing, widely known as 3D printing is a process defined by the layer-by-layer addition of feed material to produce 3D objects from a digital model (according to the United States Government Accountability Office) [4]. 3DP is also known as a ‘rapid prototyping, ‘solid freeform fabrication, and ‘additive manufacturing process [5]. It is a standard and broadly used tool in automobile, aerospace, and consumer industries [6]. The swift increase in its application can be credited to the quick prototyping capabilities, adaptability and precision in design, and the multifaceted potential offered by 3D printing. In the medical sector, the application of 3DP mainly includes educational and training tools, bioprinting, and surgical instruments [7]. 3DP has gained a lot of attention in the pharmaceutical sector after the FDA approval of the first 3D printed product, Spritam® (Aprecia Pharmaceuticals) to deliver an anticonvulsant drug, levetiracetam in 2015. The approval of the orodispersible tablet Spritam was an important milestone for the pharmaceutical sector, as it established the applicability of 3D printing for commercial manufacturing for drug delivery [8]. The application of this technology has since then been demonstrated for manufacturing dosage forms for the delivery of both small and large molecules. Given the different 3D printing techniques, each carrying its advantages and limitations, the space opens opportunities to design and deliver dosage forms ranging from micro to macro scales with high precision and accuracy [9]. Although in the past two decades pharmaceutical and biopharmaceutical researchers across the world have depicted the applicability of AM platforms in manufacturing dosage forms for the delivery of both small and large molecules, with the increasing number of case studies and development in our understanding of AM parameters along with their impact on the dosage form performances, it is crucial to organize these findings moving forward [10].

This paper delivers an overview of the different printing techniques while focusing on the different applications in drug delivery. The review also focuses on highlighting the current market trends and regulatory challenges to further support the published research on 3D printing, which would help translate the technology from academia to consumer space.