In August of last year, the FDA made history by approving the use of 3D printing technology to produce pills. A 3D printer can bind particles of a powdered form of a drug using miniscule quantities of liquid, resulting in a tablet that is highly porous and therefore dissolves quickly and easily in water. Aprecia Pharmaceuticals, which strives to improve the experience of prescription drug patients by reducing the discomfort and inconvenience often associated with oral medication1, is putting this technology to use in its production of Spritam, a medicine that treats epilepsy.
The benefits of such a pill are many. Small children and some physically disabled individuals who find swallowing a whole pill to be cumbersome can simply drop a 3D-printed pill in a glass of water and drink it down. The technology also opens the door to much more specific dosage customization. And while traditional production methods make it difficult to make a pill that both dissolves easily and carries a high dosage, 3D printing could allow companies to achieve this much more easily 1.
Use for researchers
This control over dosage could also have significant implications for clinical trials. Phase I cancer clinical trials, for instance, involve some variation in dosage, but that variation occurs on the group level: different doses of a medication are given to different groups of participants, but not individuals. 3D printing could make it much more practical to modify the dosage on an individual basis depending on the height, weight, etc., of each patient. This level of specificity could lead to great gains in accuracy and safety for a clinical trial2.
So what’s the holdup?
There are several factors preventing the widespread implementation of this innovation. One of these is doubts in the medical and academic communities about whether 3D printing technology is a viable replacement for traditional pill manufacturing. And such a high level of dosage customization can get expensive – the jury is still out on whether the average consumer will see the benefits of this technology to be worth the cost2. Also, the technology is, for now, exclusive to Aprecia, who has used it to create a proprietary platform called ZipDose Technology, with a patent that will be in place for the foreseeable future1.
There are also safety concerns. If anyone with a 3D printer and the correct chemicals can produce pills of any dosage, free from oversight, the idea begins to sound more than a little dangerous.
3D printing has the potential to usher in a breakthrough in healthcare. But will we be able to effectively mitigate the risks through regulation? The technology could improve patient experience in special cases and lead to advancements in clinical trials, but do these things add up to the economic potential necessary for it to really take off? When these questions are answered, it will be exciting to see the impact this new technology has on clinical research and the pharmaceutical industry as a whole.
1 Aprecia Pharmaceuticals;ZipDose® Technology; aprecia.com
2 Grunewald, Scott J.; 3D Printing Customized Pills May Lead to More Effective Medical Care; 3DPrint.com; 11/12/2015
3 Badgujar, Hitesh; Coming up Next in Personalized Medicine: 3D Printed Drugs; VentureBeat; 12/27/2015