Additive manufacturing – colloquially known as 3-D printing – can generate complex objects like firearms and human organs, but its latest technical milestone revolves around something much more unassuming: a pill. Earlier this month, the FDA approved an anti-epileptic drug called Spritam that has the same active ingredient (levetiracetam) as a drug that was approved in 1999. So why is this noteworthy? It turns out that Spritam’s manufacturer (Aprecia Pharmaceuticals) uses 3-D printing to generate the fast-dissolving tablets that house the active pharmaceutical agent. With over two decades’ worth of research in the rear-view mirror, Spritam represents the first 3-D printed drug to be approved by the FDA.
In addition to being a technical marvel, Spritam’s unique formulation offers a bevy of advantages over traditional pills. Spritam is a porous tablet that rapidly dissolves with a single sip of liquid, which makes it easier for patients to swallow large doses and adhere to their prescribed regimen. On the manufacturing side, 3-D printing enables precise control of dose uniformity and density, allowing Aprecia to consistently fit a maximum-strength 1,000 milligram dose inside of a single, easy-to-ingest pill.
Looking beyond Spritam, 3-D printed drugs could advance personalized medicine by allowing doctors to “print” custom pills that address a patient’s specific needs. Daunting regulatory and economic hurdles will likely prevent 3-D printers from becoming fixtures at hospitals or pharmacies anytime soon, but there are plenty of other reasons to stay excited about this rapidly evolving field.
Acknowledgments: Many thanks to Nicholas Warren, a graduate student in the Experimental and Molecular Medicine program at Dartmouth College, for providing his expertise and commentary on the topic.
Managing Correspondent: Christopher Gerry
Media Coverage: First 3D-printed pill approved by US authorities – BBC News
Related SITN Article: 3D Printing – Why all the hype?
2 thoughts on “Printing Pills: FDA Approves First 3-D Printed Drug”
Amazing! Never thought to use 3D printing technology for pharmaceuticals. It seems 3D printing is being applied to new industries every day. Very exciting!
Very impressive now they can print pills and many other things. Incredible what 3d printer are accomplishing now and they just keep advancing.