The First 3D-Printed Drug Has Been Approved in the US
The US Food and Drug Administration (FDA) has approved a drug made by 3D printing for the first time, according to American pharma company Aprecia.
The company announced on Monday that the FDA had approved its drug Spritam, a branded version of the generic levetiracetam, as an oral treatment to help treat seizures in patients with epilepsy.
Levetiracetam is an anticonvulsant that’s been available to treat epilepsy in the US and UK for years, but Aprecia claims that its proprietary 3D-printed formulation disintegrates rapidly (in less than 10 seconds for a high-dose drug) and could offer more taste-masking possibilities.
The company explains that its “ZipDose” technology works by printing together layers of powder with a fluid to make a “porous, water-soluble matrix that rapidly disintegrates with a sip of liquid.” Using this 3D printing method sets the product apart from conventional pills that are compressed or moulded into shape.
So while the medication itself has the same effect, it’s intended to improve the experience of taking it by literally making it easier to swallow: the company claims that even the strongest doses of the drug could be taken with just a sip of water.
In its announcement, Aprecia wrote that, “While 3DP [3D printing] has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.”
3D printing techniques have been put to use across medical research to create surgical guides, implants, and even human tissue. And while Aprecia is still delivered in its finished form as a prescription tablet, many hail the potential of 3D printing to allow for greater personalisation of medicines. Perhaps one day they’ll even come as print-at-home downloads.