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By Suniket Fulzele and Michael Drues

Suniket Fulzele-finalMichael Drues-finalThe Food and Drug Administration (FDA) recently approved the first 3D printed drug, an anti-epilepsy drug called Spritam, made with Aprecia Pharmaceutical’s proprietary 3D printing technology, ZipDose. The technology creates pills that rapidly disintegrate with a sip of liquid and allow a high drug load—up to 1,000 mg—to be delivered in a single dose. 3D printing has already been embraced in other medical fields from printing new jawbones in facial reconstruction to dental implants to producing personalized prosthetics. This is the first time, however, that 3D printing has been applied to manufacture a pharmaceutical drug product, which marks a milestone.

A 3D printed pill is expected to offer the potential to create personalized drugs based on the specific patient needs, rather than having a one-product-fits-all approach. It raises some exciting possibilities on how medicines can be developed in the 21st century. The U.K. Medicines and Healthcare Regulatory Authority (MHRA) has stressed the importance of correct dose delivery by individualization of drug therapy in both choice and dose. 3D printing technology is also expected to reduce the incidence of adverse effects by tailored avoidance of over- or under-dosing individual patients as well as potentially increasing the ease of delivery. But it’s also expected to help in improving adherence to the therapy by providing a greater focus on one-to-one clinical management. The technology also offers some exciting possibilities to develop formulations with immediate release (as evidenced from the recent approval) to extended release profiles and from tablet dosage forms to films.

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The November 4 AAPS webinar 3D Printed Pill: Formulate, Download, and Print Your Own Medicine? will offer an overview and provide insights into the present and future of 3D printing in pharmaceuticals. For example, can we “print” drugs (i.e., new molecular entities)? Can we “print” combination products? Can we “print” different dosage forms (formulations)? What are the technical and regulatory challenges these new technologies pose? Using case studies, all of these and more will be discussed in this webinar. Finally, strategies for using regulation as a competitive advantage will also be discussed. Join the conversation and register today!

Suniket Fulzele, Ph.D., is an experienced drug delivery and formulation development scientist. He currently works as Group Leader, Formulation Development at CIMA Labs, Brooklyn Park, Minn.
Michael Drues, Ph.D., is president of Vascular Sciences, an education, training, and consulting company offering a broad range of services to medical device, pharmaceutical, and biotechnology companies. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa