A new era was ushered in when the U.S. Food and Drug Administration (FDA) approved the first 3-D printed drug early this week.
The FDA approval of Aprecia Pharmaceuticals Company’s product came after decades of innovation in the 3-D printing world.
Aprecia’s Spritam (levetiracetam) is for oral use as a prescription therapy to treat certain types of seizures in epilepsy patients.
Spritam uses Aprecia’s proprietary ZipDose technology platform. That utilizes 3-D printing to make a porous product that dissolves with a sip of liquid.
That technology is based off one originated at the Massachusetts Institute of Technology (MIT).
The innovation lies in the fact that Spritam is bound with 3-D printing without compression, which allows for efficient delivery.
The Long Road to 3-D Pills
The road to an FDA-approved 3-D printed drug has been over two decades long. MIT reported using a 3-D printer “similar to a computer ink-jet printer” as far back as April 1997 that could successfully print pharmaceuticals into pills.
3-D drug printing works because the technology drops precise drug doses onto layers of powder as a pill is formed. A binder is then sprayed to seal the tablet.
In the MIT example, 30 to 50 layers of powder are sometimes used to build a tablet and thousands of pills can be printed at once.
The drugs can also be personalized by using different mixes of layers for effective release.
“Printed oral dosage forms offer several important advantages over conventionally prepared pharmaceutical products. Spritam exploits one of these,” said Michael J. Cima, Ph.D., the David H. Koch professor of engineering at MIT, in an email to Healthline.
Cima and another professor, Emanuel Sachs, co-developed 3-D printing in the late 1980s.
Aprecia’s newly approved drug utilizes a specific structure that rapidly dissolves.
“Specifically, it is a non-compression method for making tablets and, as such, these dosage forms can have sufficient porosity to rapidly dissolve when taken,” Cima said. “There are other non-compression methods, but few have been able to achieve the dose that printing methods can.”
Spritam utilizes the uniformity of dosage control provided by 3-D printing.
“The uniformity of dosage control with this type of manufacturing method is at least as good, if not far better, than conventional manufacturing. Thus, [the] only risk is really associated with the active ingredient,” Cima said.
Aprecia’s ZipDose technology can load up to 1,000 milligrams in a single dose. Spritam can therefore deliver the maximum strengths of levetiracetam with just a sip of a drink.
For patients that have trouble swallowing, like older adults or children, a one-sip drug could be beneficial.
Spritam is an oral medication approved for people 6 years or older.
Aprecia’s breakthrough may be just the first in a line of available printed drugs.
The Future of 3-D Drugs
Lee Cronin, a chemist at the University of Glasgow, gave a talk at TEDGlobal 2012 on his research for a 3-D pharmaceutical printer. The benefits of 3-D medical printing is that drugs could be used to print personalized doses cheaply and where they are needed.
“What Apple did for music, I’d like to do for the discovery and distribution of prescription drugs,” Cronin said in the talk.
Cronin describes a process where a patient will go to an online drug store, buy the blueprint and ink, and print their prescribed drug.
There are downsides to 3-D pharmaceutical printing, including illegal drug manufacturing and mislabeling.
Regulators and the pharmaceutical industry will have to work together to keep illicit activity at bay.
But today, researchers are working quickly to develop the latest in 3-D printed medicine.
“How are we doing this in the lab? It requires software. It requires hardware. And it requires ink,” Cronin said. “What could this mean? Ultimately it could mean that you could print your own medicine.”