FDA approves first 3-D printed prescription drug
The drug, manufactured by privately owned Aprecia Pharmaceuticals Co, appeared to be accepted at pill call a medicine adjunctive procedures within the treatment for seizure disorders, the organization said on Monday.
SPRITAM’s 3D-printed designed makes it water soluble with a minimal amount of liquid, which absorbs into the blood stream in less than 10 seconds. An agency spokeswoman confirmed the new drug is the first prescription tablet approved that uses the process. The fascinating part is that each tablet is produced using a layering technique similar to now common 3D printing.
This product image provided by Aprecia Pharmaceuticals shows…
Companies have used 3D printers to build medical devices – surgeons have used the technology to create hip replacements custom-sized for specific patients, for example.
With the FDA approving such methods, it opens up the possibilities to other types of drugs and delivery systems in the future.
Nearly 3 million Americans have been diagnosed with epilepsy, as said by Aprecia, including 460,000 children. Originally developed by work at the Massachusetts Institute of Technology, the use of 3-D printing has enabled high dose loads that are more easily swallowed because they break down faster with a sip of liquid, according to the company’s description of the technology.
“In my experience, patients and caregivers often have difficulty following a treatment regimen”, he said. In the meantime Spritam is expected to be made available in the first quarter of 2016.