Three-dimensional (3D) printing in pharmaceutical manufacturing represents a significant advancement. This approach allows for the creation of medications with precise characteristics. The approval of the first 3D printed drug marked a historical moment, signaling a shift in how medicines can be designed and produced, setting the stage for new possibilities in drug delivery and patient care.
The Landmark Approval
The first 3D printed drug approved by the U.S. Food and Drug Administration (FDA) was Spritam (levetiracetam). Developed by Aprecia Pharmaceuticals, it received approval in August 2015. Spritam is prescribed as an adjunctive therapy for the treatment of seizures in individuals with epilepsy.
This approval was a notable event as it was the first drug product manufactured using 3D printing technology cleared by the FDA. Aprecia Pharmaceuticals secured an exclusive, worldwide license from the Massachusetts Institute of Technology (MIT) for the pharmaceutical applications of this 3D printing technology. Spritam became available for prescription in the first quarter of 2016.
How 3D Printing Transforms Drug Delivery
Aprecia’s proprietary ZipDose technology is central to how 3D printing transforms drug delivery. This platform utilizes 3D printing to create a highly porous formulation. The process involves spraying an aqueous solution to bind layers of powder, resulting in a tablet with an intricate internal structure.
This unique porous design allows the pill to disintegrate rapidly when it comes into contact with a small amount of liquid, like a sip of water. This quick dissolution makes it easier for patients who experience dysphagia, or difficulty swallowing, to take their medication. The technology also enables the incorporation of high drug loads, with single doses up to 1000 mg still dissolving quickly. While Spritam itself comes in fixed doses, the underlying technology holds potential for creating medications with precise, customized dosages and complex internal geometries for controlled drug release.
Implications for Patients and Healthcare
The advent of 3D printed drugs, exemplified by Spritam, offers significant implications for patient adherence and the broader healthcare system. The rapid disintegration of these tablets, requiring only a small amount of liquid, directly addresses swallowing difficulties. This feature is particularly beneficial for children, the elderly, and individuals with neurological disorders, potentially leading to improved medication adherence.
Beyond improved swallowing, this technology lays the groundwork for more personalized medicine. The ability to precisely control drug composition and structure through 3D printing opens doors for tailoring medications to an individual’s specific needs, including exact dosages or combinations of multiple active ingredients within a single pill. The potential for on-demand manufacturing could also streamline supply chains and enable more decentralized drug production in the future. The unique capabilities of 3D printing allow for new drug formulations that combine several active ingredients into a single, complex dosage form, simplifying treatment regimens for patients.