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
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