It looks like the ability to 3D print drugs is coming about faster than many predicted, including me. SPRITAM (levetiracetam) tablets are the first prescription drug product approved by the U.S. Food and Drug Administration (FDA) manufactured using 3D printing technology. From Aprecia Pharmaceuticals, SPRITAM is for oral suspension and is now available as an adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures.
Nearly three million people in the United States were living with active epilepsy in 2013, and about 150,000 new cases are being diagnosed every year in the U.S.
Swallowing challenges can make taking medication difficult. In fact, two separate online surveys found that between 40 and 50% of surveyed U.S. adults – even those without epilepsy – have experienced difficulty swallowing tablets and capsules. Both surveys reported that 8% of those who reported swallowing difficulty also admitted to skipping doses of prescribed medication. In a separate survey conducted in epilepsy patients, adherence issues were shown to have the potential to undermine treatment outcomes, with results indicating that as many as 45% of epilepsy patients reported experiencing a seizure after missing a dose of their medication.
The benefit of SPIRITAM tablets is that they disintegrate in the mouth with a sip of liquid and offer a new option for patients, especially those who may struggle to take their medicine.
“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.”
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. The 3D printing (3DP) process does not rely on compression forces, punches, or dies. Instead, 3DP binds layers of powdered medication together with an aqueous (water-based) fluid. This forms medicine that is solid, yet porous. The porous design helps medication rapidly disintegrate when taken with a sip of liquid.
