3D Printing in Medicine? The FDA Says It’s Coming

3D printing is all the rage in the tech industry these days, and the trend’s popularity was just cranked up another notch by the U.S. Food and Drug Administration and its recent approval of 3D printing in medicine for the creation of drugs.

Used to treat epilepsy, Aprecia Pharmaceuticals’ Spritam is the first prescription medication that will use 3D printing along with the company’s trademarked ZipDose technology to produce a tablet that dissolves rapidly in less than 10 seconds. Young children, seniors, and anyone else who often finds it difficult to swallow epilepsy pills, which are often large and slow to dissolve, will benefit from the new drug.

From Aprecia’s press release:

“In my experience, patients and caregivers often have difficulty following a treatment regimen. Whether they are dealing with a swallowing disorder or the daily struggle of getting a child to take his or her medication, adherence can be a challenge,” said Marvin H. Rorick III, M.D., neurologist at Riverhills Neuroscience in Cincinnati, Ohio. “Especially for children and seniors, having an option for patients to take their medication as prescribed is important to managing this disease.”

Despite how skeptical some people might feel about putting something that came out of a 3D printer into their own bodies, the FDA’s approval of Spritam shows that 3D printed creations can be safe for humans to consume, and 3D printing could actually play a role in the future of prescribed medication. It offers patients the opportunity to receive custom-ordered dosages based on their specific needs making it more effective than the traditional one-size-fits-all dosage.

Aprecia explains that its 3DP platform “does not rely on compression forces or molding techniques, which can sharply limit dose ranges for orodispersible medications.” Instead, multiple layers of powder are carefully stitched together to produce a “porous, water-soluble matrix” that disintegrates extremely fast on contact with liquid.

According to the BBC, administrators of the drug would merely have to tweak the software to adjust the dose of the medication prior to printing. Before this was possible, creating such precise dosages for patients would have been very expensive.

Since 3D printing technology allows for the creation of a tablet structure that’s so tightly and precisely packaged together, even very high doses of up to 1,000mg can be delivered in an easy-to-swallow form. A patient would only need to take a sip of water or some other drink to very quickly and painlessly dissolve the tablet.

Although this is the first drug to use 3D printing, the technology has already been embraced worldwide across healthcare institutions. 3D printers are being used to produce dental implants, jaw replicas, hip replacements, and other types of prosthetics — with future plans to introduce 3D-printed tracheas and bones, ears, kidneys, and even skin.

Many benefits clearly stem from this technology, but the general 3D printing trend has its fair share of controversies too. MIT researchers discovered that the machines can be massive energy hogs, using anywhere from 50 to 100 times more energy than injection molding for an item of the same weight — especially if the objects produced come in big batches.

3D printers also don’t do us any favors in terms of air quality. A study from the Illinois Institute of Technology found that the emissions from a desktop 3D printer were comparable to a burning cigarette or use of a gas or electric stove.

There’s no telling exactly how the technological trend might expand or change in the future, or who might try to print or get access to drugs and what they’ll do if they succeed. There have been all sorts of problems related to 3D printed weapons already, so now that medication has come into the picture, a whole new set of issues could eventually emerge as well.

Spritam is scheduled to launch in the first quarter of 2016, but a prescription will be required to get access to it. For patients who aren’t able to swallow their regular epilepsy pills or decide to skip them all together out of frustration, the medication could help people stay on track and avoid any threatening lapses that might occur from infrequent dosages.

It’s been estimated that nearly three million people in the US have epilepsy, 460,000 of which are children, according to Aprecia. A survey also revealed that 15 percent of people aged 65 or older living in independent living facilities admit to experiencing difficulty with swallowing medication.

The company says that it plans to create additional types of medication using 3D printing technology in the future.

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Image of woman holding pill via Shutterstock