Pharmaceutical manufacturing company Aprecia, has just made history with it’s new 3-D printed epilepsy drug, Spritam, achieving the first ever FDA approval.
The achievement was announced the beginning of August and makes the company the very first to ever have gained FDA approval on a pharmaceutical that was manufactured using 3-D printing technology.
The technology the company utilized to do this is called, ZipDose. According to Aprecia’s public filing statement the ZipDose technology enables medicine to swiftly disperse in the patient’s mouth with a sip of water or other liquid. ZipDose products enable people to take their medications with greater ease, potentially increasing adherence and improving symptom management.(2) The 3-D printing technology was originally developed by researchers at MIT.(1)
The companies goal is to provide patients with new, transformed ways to take their medications with more accuracy in the exact dosage amount than what is currently available. In addition, the creation of the new drug using this 3-D technology achieves an unmet patient need in medicine today; it achieves dosage strengths that are commercially unattainable using current fast-melt technologies. Fast-melt technologies are those medications in tablet form or oral thin films that orally disintegrate.
Additionally, the company goes on to describe the products manufactured with the ZipDose tech are more portable and have more accurate dosing than liquid formulations. Liquid dosing formulations have been known to be error-prone. (2)
The epilepsy drug Spritam is only the first product in a line of Central Nervous System pharmaceuticals that the company plans on manufacturing using the ZipDose technology.(1) The company states that they will continue release new products over the next several years that utilize ZipDose 3-D printing.