FDA approval for 3D-printed drug

The first 3D-printed drug to receive approval from the US Food and Drug Administration (FDA) is now being shipped to pharmacies.

Pennsylvania-based Aprecia Pharmaceuticals says its 3D-printed Spritam (levetiracetam) tablets are used to treat epilepsy. The company is also working on at least three other 3D-printed drugs that it expects to eventually bring to market.

Aprecia says it used some off-the-shelf 3D printer parts but mostly developed its own technology to create the drugs, layer by layer at its East Windsor, N.J. manufacturing facility. The new process, which it calls ZipDose, stitches together multiple layers of powdered medication using an aqueous fluid to produce a porous, water-soluble matrix that rapidly disintegrates with a sip of liquid.

There is no increased efficiency in producing the pill with 3D printing; the technology simply allows the company to better manipulate the drug’s composition compared with traditional press and die pill-making technology, according to Aprecia Pharmaceuticals spokesperson Jennifer Zieverink.

Levetiracetam, the generic name for Spritam, has been available for the treatment of seizures for 15 years. But the new brand Spritam is the first to use the proprietary 3D-printing process to create a more dissolvable pill.

“It’s an option for some folks…looking for something easier to swallow than an intact tablet,” Zieverink says.

More than 10 years ago, MIT developed the basic technology for 3D-printed pharmaceuticals. That technology was later licensed by Therics, according to Terry Wohlers, president of Wohlers Associates, an independent consulting firm.

Therics “3D-printed many pills on an experimental basis, but it never took off commercially,” Wohlers says in an email reply to Computerworld. In 2008, Therics was acquired by Integra LifeSciences Holdings Corp.

“The MIT patents have since expired, but it’s possible that Therics developed additional IP. In some ways, Therics was many years ahead of its time,” Wohlers says.

3D printing could also someday enable custom drugs, Wohlers says, describing a scenario where a doctor sends a prescription to a pharmacy that uses a printer to create a custom formulation based on the special needs of a patient.

“The potential is large, in my opinion, but it will take many years for it to gain strong commercial traction, especially due to the requirements of the FDA,” Wohlers says.

By Lucas Mearian for www.computerworld.com

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