Abstract
Three-dimensional (3D) printing technologies are continuously applied to novel fields, laying the foundations for a new industrial revolution. With regard to pharmaceutical sciences, 3D printed drug products are emerging as attractive and innovative tools in personalised medicine. For example, solid oral dosage forms (e.g. tablets) can be printed in a wide range of dosages, release profiles, geometries and sizes by simply modifying a digital model, thus providing patients with tailored therapies. Various 3D printing technologies have been applied to pharmaceutical manufacture in recent years, and different materials have been investigated to fabricate solid oral dosage forms in a broad range of properties. Therefore, the aim of this review is to describe the state of the art of 3D printing oral pharmaceuticals, with the view to provide formulation scientists with essential information to approach the development of 3D printed drug products, from digital design to final product quality control. Short- to long-term potential areas of application of 3D printed drug products and their relative regulatory pathway challenges are also presented.
Highlights
Automated production of solid oral dosage forms was introduced over two centuries ago [1]
Fused deposition modelling (FDM) is currently the most employed 3D printing technique in solid oral dosage form development; such a trend is due to the availability of inexpensive equipment that can even be coupled to conventional pharmaceutical processes such as hot melt extrusion (HME) and film coating [38]
Several formulation approaches to three-dimensional printing of solid oral dosage forms have been described and discussed
Summary
Automated production of solid oral dosage forms was introduced over two centuries ago [1]. The most relevant exponent of the class, have been improved in the last decades introducing techniques such as film coating, double compression and osmotic systems to achieve controlled and targeted release. Despite the technological advances, tablet production is still based on tableting machines whose design has not essentially changed for decades since the introduction of automated tablet presses [2]. Conventional tableting techniques still suffer from limitations, including challenges in direct compression of powders and the related need for granulation. Additive manufacturing (AM), a set of techniques including 3D printing, has recently aroused much interest in pharmaceutics due to its large flexibility (Fig. 1), which makes it a promising tool to produce the bespoke drug delivery devices, including solid oral dosage forms [6]
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