The Food and Drug Administration has approved the first prescription drug made through 3-D printing: a dissolvable tablet that treats seizures. That’s a notable achievement in itself but of keen interest as well to the Triangle where nanotechnology developed by Dr. Joseph DeSimone at UNC-Chapel Hill is a cornerstone of designer drug development technology being advanced at Triangle-based Liquidia and two related spin-out ventures.

Aprecia Pharmaceuticals said Monday the FDA approved its drug Spritam for adults and children who suffer from certain types of seizures caused by epilepsy. The tablet is manufactured through a layered process via 3-D printing and dissolves when taken with liquid.

The FDA has previously approved medical devices — including prosthetics — made with 3-D printing. An agency spokeswoman confirmed the new drug is the first prescription tablet approved that uses the process.

A new door for drug development has opened.

“By combining 3DP technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience,” said Don Wetherhold, Chief Executive Officer of Aprecia. “This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication.”

Liqudia is backed by drug giant GlaxoSmithKline and also has received a $10 million investment from the Bill and Melinda Gates Foundation. The firm’s “PRINT” technology is all about using nanotechnology to design drugs.

While not 3-D printing technology per se, Liquidia is seeking to demonstrate the effectiveness of assembling drugs.

Liquidia’s two spinout companies, Envisia and Lq3, use the PRINT micro- and nanoparticle system which is specialized printing presses to squeeze materials into microscopic molds that allow the companies to control the size, shape and chemistry of the resulting particles. That combination of size, shape and chemistry determines the therapeutic activity of the particle, NC Biotech Writer Jim Shamp reported last year.

The Ohio-based company says its printing system can package potent drug doses of up to 1,000 milligrams into individual tablets. It expects to launch Spritam in the first quarter of 2016.

ZipDose: “A revolution in formulations”

So how does Aprecia’s technology work? From its website:

ZipDose Technology is Aprecia’s unique delivery platform that serves as the foundation of our orodispersible formulations of highly prescribed high-dose medications. It creates premeasured, spill-proof unit-doses designed to disintegrate in the mouth with just a sip of liquid.1

ZipDose Technology utilizes our proprietary three-dimensional printing (3DP) platform. This process 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.1

Working to break barriers: Dose, taste, and speed

The 3DP-based ZipDose Technology platform does not rely on compression forces or molding techniques, which can sharply limit dose ranges for orodispersible medications. In fact, ZipDose Technology product candidates utilize the only delivery platform to date that can achieve high doses (up to 1,000 mg) while maintaining rapid medication disintegration.1

ZipDose Technology product candidates are intended to improve the patient experience and help increase adherence by being designed to:

  • Rapidly disintegrate in less than 10 seconds—a previously unachievable ratefor high-dose formulations (based on demonstrator development testing)
  • Offer a wider range of taste-masking capabilities than were previously possible

Potential benefits

Through ZipDose® Technology, Aprecia is working to enhance our customers’ experience with medication, so that:

  • Patients and caregivers can experience a rapidly disintegrating, taste-masked, and convenient way to take or administer medicine
  • Healthcare providers can be confident in prescribing high-dose formulations of highly prescribed medications that are precisely dosed and easy to take

Protecting our platform

Aprecia has taken the necessary steps to safeguard our intellectual property. Aprecia has the rights to more than 50 patents related to pharmaceutical applications of 3DP, and has filed patent applications to protect our proprietary manufacturing system through 2033. With several patent applications pending and plans to file additional applications, Aprecia is poised for growth through the protection of multiple competitive barriers, including our strong patent estate.

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Aprecia said in a statement it plans to develop other medications using its 3-D platform in coming years, including more neurological drugs. The company is privately owned.

Doctors are increasingly turning to 3-D printing to create customized implants for patients with rare conditions and injuries, including children who cannot be treated with adult-size devices. The FDA held a workshop last year for medical manufacturers interested in the technology.