Regulatory challenges and myths in pharmaceutical 3D printing

Although three-dimensional (3D) printing has been around for some time, many people still underestimate its capabilities. This article addresses the regulatory challenges faced by the pharmaceutical sector and aims to correct some of the most common myths surrounding the technology.

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IMAGINE A FUTURE where patients with multiple disease conditions no longer have to take several tablets, numerous times per day. Instead, they can take one tablet containing all their required medications, once daily, thanks to 3D printing.

The process of 3D printing begins with a computer-aided format of a digital prototype of the product. The format is then sliced into horizontal layers that will form the shape of the digital file before being transfered into a 3D printer. Various excipients and drug combinations are then used to print the product with the aid of layering, transforming two-dimensional (2D) layers into a 3D product. Although the pharmaceutical industry is a laggard in this area, it is now waking up to the possibilities of 3D printing and we have witnessed various developments whereby specific tailor-made medicines can be manufactured according to a patient’s need.

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