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By: Niklas Sandler and Akm Khairuzzaman

Curreniklas-sandler_photonakm-khairuzzaman_photot developments in technology allow manufacturing of dosage forms by printing. Printing technologies have also opened prospects for development and manufacturing scenarios for tailored and personalized drug delivery systems and can optimally meet the needs of individuals and different patient groups. The challenge is to deliver the foreseen benefits of this work to patients.

Recent research has demonstrated numerous examples of manufacturing of different types of dosage forms using computer aided design (CAD) and printing technologies. The activity in the research field is increasing and manufacturing of pharmaceutical products by printing has only recently emerged as a new viable option in drug manufacturing. As an example, in August 2015, the Food and Drug Administration approved the market authoriz
ation of Spritam—a 3D printed anti-epileptic product.

We believe printing technologies have immense potential to respond to many of the needs of personalized medication and tailored delivery systems. Optimally, the approach can be realized in an environmentally sustainable way, for example, through less waste generation, energy and solvent savings, and efficient containment. If individualized dosing becomes possible, it will create entirely new opportunities for dispensing medicines from pharmacies and dosing of substances at hospital pharmacies or wards, opening up totally new concepts for dosage forms for an individual patient when they can be produced on demand.3d-printer

Although this technology is new in pharmaceutical manufacturing, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has been dealing with 3D printing for more than 10 years and has cleared dozens of 3D printed device through the 510(k) process. On the other hand, unlike CDRH, FDA’s Center for Drug Evaluation and Research (CDER) has approved only one product (Spritam) that was submitted under the 505 (b)(2) pathway. To note, 3D printing technology does not require a unique regulatory pathway for pharmaceutical drug product manufacturing; it can use existing approval pathways that are flexible enough to address new technologies. The regulatory challenges could include defining a new dosage form and identifying labeling claims for the 3D printed product. CDER has also published guidance to advance emerging technology like this in order to modernize pharmaceutical manufacturing. Like any other pharmaceutical products, 3D printed drug products must also be manufactured in accordance with current chemistry, manufacturing, and control standards as set forth in the 21 CFR 200 s & 300 s and other relevant guidance.

Further progress and new developments will be needed for this technology to contribute to future treatments. Printing technologies will be able to become manufacturing tools of the future if the capabilities of the printers are continuously developed. This also means that a wider range of printable materials has to be developed to broaden the possibilities to create multifunctional drug delivery systems and medical devices.

Get more in-depth with this topic by joining us at the 2016 AAPS Annual Meeting and Exposition session A New Chapter in Pharmaceutical Technology: 3D Printing for Solid Oral Dosage Forms. Hope to see you there!

Akm Khairuzzaman, Ph.D., is an acting branch chief at the Food and Drug Administration’s Office of Pharmaceutical Quality, where he leads a group of review scientists responsible for the assessment of chemistry, manufacturing, and controls of investigational new drug applications, new drug applications, and abbreviated new drug applications seeking approval in the U.S. market.
Niklas Sandler has been professor in pharmaceutics at Åbo Akademi University (ÅAU), Finland since 2009 and heads the research group in drug-delivery and pharmaceutical technology. He has pioneered in research around printable drug-delivery systems.