The Food and Drug Administration approved a 3D-printed drug for the first time, the manufacturer, Aprecia Pharmaceuticals, announced on August 3. It’s used to treat seizures in adults and children with epilepsy.
The tablet, called Spritam, is designed to give a high dose of anti-epileptic medication that dissolves in a sip of water, something that the company says should help patients that have trouble swallowing.
But the real news for the general public here is that this is the first time any medication made in a 3D printer has been given the FDA’s seal of approval.
Researchers have been excited about the possibilities of 3D-printed drugs for some time now, since the ability to specifically print an exact drug to order would allow custom versions of medications to be printed directly for an individual.
If researchers find something in your body, genetic or otherwise, that would make you respond to a tweaked formulation of a drug instead of a version designed for the general population, they could print that exact thing for you on-demand.
Other researchers have theorised that 3D printing could be a cheaper way to produce drugs for the developing world. It could also in theory make the production of illicit drugs simpler, provided a recipe could be downloaded and the base chemicals obtained.
In the case of Spritam, 3D printing “binds the powders [in the drug] without compression,” according to the prescription notes from the FDA. That’s a method of giving the medication a structure that allows a large dose to be easily absorbed, something the company says was made possible because of the technology.
This key development is clear in the video demonstration below:
Still, such absorption improvement does not represent the futuristic grail of customised, made-to-order drugs. This approval does show, however, that the FDA is willing to approve 3D-printed medication, something researchers considered a hurdle that would be difficult to overcome.
In a 2014 review of the medical applications for 3D printing, researchers wrote that the “demanding FDA regulatory requirements” could “impede the availability of 3D-printed medical products on a large scale.” While the FDA has approved 3D-printed medical devices in the past, this is the first time they have said a printed medication is appropriate for human consumption.
This approval could encourage future research and innovation in the field of 3D-printed medicine, potentially opening the door for that theoretical world where a drug designed to work perfectly with your biology could be printed to order at your pharmacy — or even in your basement.
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