In 2015, the US Food and Drug Administration (FDA) approved Aprecia Pharmaceuticals’ solid oral pill Spritam (levetiracetam) as the first 3-dimensional printed medicinal product, and has actively been encouraging the use of such ‘emerging’ technology since.
And in its latest effort, Ahmed Zidan, a visiting associate from the Office of Testing and Research (OTR), within the Center for Drug Evaluation and Research (CDER) at the agency wrote in a blog post: “3D printing can offer a tantalizing step toward changing the manufacturing processes to offer personalized medicines.”
Additive manufacturing “has the potential to produce unique dosage forms with characteristics that cannot be achieved in conventional dosage forms,” he argued, with the ability to tailor size, drug release profile and dosage form shape being particularly useful for treating special populations, such as children or the elderly.
However, Zidan noted there remain numerous questions as to how such technology can be integrated into the development and production of drug products which the OTR is looking to address. For example, how best to assess the critical parameters affecting the printability of various materials, assess the performance of 3D printed drug products, and whether using traditional in vitro testing methods for 3D printed drug products is possible.
“In OTR’s state-of-the-art 3D printing facility, we are studying the behavior of the traditionally available excipients of the conventional dosage forms during the 3D-printing processes, and discovering ways to best manage or control their behavior.”
He added the Agency is also looking at the regulatory challenges involved in controlling the quality of a 3D printed drug. “For example, the multiple components associated with 3D printing processes, namely 3D printers, printing materials, and intermediate products and processes, should be considered.”
The post comes a week after the FDA published its final guidance offering industry guidelines on incorporating 3D printing within medical device manufacturing processes.