3-D printing has made headlines with the possibilities it offers for medical devices. The ability to manufacture a device on demand in particular size and shape offers the prospect of making components on demand. In the future, personalized medical devices could be made that fit the size and shape of an individual. But 3-D printing is also making inroads in pharmaceuticals. The Food and Drug Administration has approved a 3-D printed drug, the first of its kind for the biotechnology industry.
The drug, called Spritam, is from Aprecia Pharmaceuticals. While the FDA approval on Spritam is new, the active pharmaceutical ingredient in this drug for controlling epileptic seizures is not. What’s novel about the drug is Aprecia’s formulation. Aprecia says 3-D printing technology enables the company to make a pill formulation that is more porous and breaks down with just a sip of liquid. Making pills that are easier to administer is helpful for children and the elderly, two groups that can have difficulty swallowing pills, explains Marketplace.
The 3-D printing technology used to make Spritam came from the Massachusetts Institute of Technology. The patented technology uses an aqueous fluid to bind together powder for various applications. Aprecia was founded in 2003 to use that technology to make pharmaceuticals in different dosage forms. The company says that its 3-D printing technology can deliver a high load of active drug in a single, easy-to-take dose.
Aprecia plans to make Spritam available next year. The company says more 3-D versions of other drugs could also be on the way. But the approval also signals a significant development is on the regulatory side. Spritam’s approval as the first 3D-printed drug suggests a new openness from the FDA for drug formulations developed in new and different ways. Aprecia may be the first in 3D printing. But now that Aprecia has pushed the door open at the FDA, other novel formulations of drugs have a path to follow. This development could mean that some degree of drug customization for patients is on its way.
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