Langhorne, Pennsylvania–based Aprecia Pharmaceuticals has become the first company to have a 3D-printed drug approved for use. The US Food and Drug Administration (FDA) approved the drug in August 2015, and the company will make the pill commercially available in early 2016. The drug helps people with epilepsy to control seizures. Aprecia developed the drug using its ZipDose Technology platform, which uses 3D printing's bottom-up approach to create pills that have a more porous structure than the norm. This porosity enables water to dissolve the pill quickly, facilitating the oral dispersion of high-dosage pills. The platform can create pills that contain up to 1,000-milligram doses and that disperse within 10 seconds.

Implications

The benefits of modern 3D printers include their precision at small scales and the programmable nature of the designs they can print. In medicine, these traits have already helped produce customizable implants and prostheses that the FDA has approved. The approval of this 3D-printed pill is perhaps a more significant step for the technology's use in medicine. Here, 3D printing enables the careful manipulation of the structure of the pill, directly affecting its delivery mechanism and efficacy. In Aprecia's case, the company has used 3D printing to accelerate the delivery of the drug. Developing this capability further, the precision of the technology could find use in controlling the exact timing of delivery of the dosage, potentially increasing the drug's effectiveness or reducing the side effects of a treatment. 3D printing could even find use in the tailoring of a drug to suit an individual's body.

Impacts/Disruptions

The pharmaceuticals industry is progressively moving toward developing drugs for diseases that affect relatively small numbers of people, partly because of the opportunities for creating high-value products. However, another driver behind more focused treatments is the increasing knowledge concerning the genetics behind some diseases and some reactions to medicines. This knowledge is enabling the potential for development of near-personalized drug treatments. With its need for small-scale production and high levels of customization, the opportunities for 3D printing in personalized medicine are enormous. In theory, 3D printing could enable the manipulation of a drug's structure and content to suit an individual patient. However, the drug chemistry and the patents system—which current pharmaceutical-industry practices enshrine—need to allow for this variability. Similarly, changes will need to occur if 3D printing is to move drug printing away from factories and into, for example, pharmacies and patients' homes. Ultimately, patients' printing their own medicines at home is a long way off because of the regulations that would need to be in place to ensure the availability of genuine base materials of the requisite quality, that only the correct people print the correct drugs, and to protect intellectual property.