The company has announced last week that SPRITAM (levetiracetam) tablets, for oral suspension, are now available for patient use. The administration initially approved the drug in August, 2015, marking the first time a drug product manufactured with 3D printing technology was been approved by the FDA.
Aprecia developed the ZipDose Technology platform using 3D printing technology that originated at the Massachusetts Institute of Technology (MIT). Jennifer Zieverink at Aprecia, told us, “The key to unlocking the potential for 3DP in pharmaceuticals was the proprietary technology needed for production at a commercial scale.”
According to the company, SPRITAM is designed to disintegrate in a patient’s mouth with “just a sip of liquid,” even at doses of up to 1,000 mg - in less than 20 seconds. This administration process is unique, and is only made possible through 3D printing.
“The [3D printing] process does not rely on compression forces, punches, or dies. Instead, [3D printing] binds layers of powdered medication together with an aqueous (water-based) fluid,” said Zieverink. “This forms medicine that is solid, yet very porous. The porous design helps medication disintegrate when taken with a sip of liquid.”
SPRITAM was approved under the FDA's 505(b)(2) regulatory pathway, “which means Aprecia leveraged safety and efficacy data already on file with the FDA,” explained Zieverink. “Aprecia conducted a pharmacokinetic (PK) bridging trial to show its dosage form is comparable to the rate and extent of the absorption as the reference listed drug, levetiracetam,” she added.
The company is working on several formulations that will be developed using 3D printing technology, and intends on manufacturing the drugs with Aprecia’s proprietary equipment, for which it holds an exclusive, worldwide license. Additionally, the company has the rights to more than 50 patents as they relate to pharmaceutical 3D printing, and has filed patent applications to protect its proprietary manufacturing system through 2033.
“Aprecia plans on focusing on manufacturing medicine that is easier to take, especially for those who may have trouble swallowing,” added Zieverink.
According to the company, Aprecia is the first and only company in the world to use 3D printing technology to develop and manufacture pharmaceutical products at the commercial scale.