The first prescription drug manufactured using 3D printing technology has been approved by the FDA.
Aprecia Pharmaceuticals‘ SPRITAM® (levetiracetam) tablets for oral suspension are now available as an adjunctive therapy for the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. With a sip of liquid, SPRITAM disintegrates in the mouth.
“As we explored potential applications for our 3D printing technology in prescription drug products, it was important that we identified disease areas with a real need for patient-friendly forms of medication,” said Don Wetherhold, CEO of Aprecia. “SPRITAM is designed to transform what it is like to take epilepsy medication, and is the first in a line of products we are developing to provide patients and their caregivers with additional treatment options.”
According to a press release on the approval:
SPRITAM is formulated with Aprecia’s proprietary ZipDose® Technology, which combines the precision of 3D printing and formulation science to produce rapidly disintegrating formulations of medications. Manufactured in a regulated commercial-scale facility, SPRITAM is available in four unit-dose strengths, including 250 mg, 500 mg, 750 mg, and 1,000 mg.
A proprietary platform that produces orodispersible formulations of highly prescribed medications that rapidly disintegrate within seconds, the ZipDose® Technology, according to the SPRITAM website, offers oral formulations of highly prescribed high-dose medications that are:
- Solid, yet easy to take
- Easy to administer
- Precisely dosed
It is the first and only drug-formulation platform that utilizes 3D printing, which doesn’t rely on compression forces, punches, or dies, but “binds layers of powdered medication together with an aqueous fluid to manufacture pharmaceutical products that are solid, yet highly porous. The porous design helps medication disintegrate rapidly in the mouth when taken with a sip of liquid.”
For more information, visit www.SPRITAM.com.