A critical and often underappreciated step in the development of a new small-molecule drug is its manufacture into a pill for oral delivery. It is critical to maintain the biochemical potency that makes the drug a desirable therapeutic while simultaneously building in the physicochemical properties needed to meet the pharmacokinetic profile required for optimal clinical results. Methods and materials for engineering controlled-release drug products have been in development for some time, but their translation into pharmaceuticals has been slow given the exceedingly high bar placed by the U.S. Food and Drug Administration (FDA) for the acceptance of new pharmaceutical manufacturing methods and materials.
Aprecia Pharmaceuticals  has significantly shifted the playing field by its recent announcement of FDA approval to market its reformulation of the drug levetiracetam (Spritam), for the treatment of epilepsy, into a fast-action pill manufactured by three-dimensional (3-D) powder–liquid printing technology. The technology was originally developed in the late 1980s in the laboratory of Prof. Emanuel Sachs at the Massachusetts Institute of Technology and uses precise, localized deposition of an aqueous fluid to bind together multiple layers of the powdered drug to create a porous, water-soluble matrix that rapidly disintegrates in liquid. This allows uniform and predictable delivery of a high drug load in a quick-to-dissolve pill. The new drug Spritam rapidly disintegrates with a sip of liquid to deliver a high drug load of up to 1,000 mg in a single dose while, at the same time, conforming to the needs of patients who have trouble swallowing. The reliable and predictable dose of 3-D printed pills is especially important for a drug such as levetiracetam, which is intended to modulate central-nervous- system function.
Spritam is the first FDA-approved drug using 3-D printing as a crucial part of the manufacturing process. Aprecia Pharmaceuticals and the FDA have blazed a new path forward and opened a spectrum of new opportunities for optimized drug delivery. It is anticipated that other pharmaceutical and biotechnology companies will quickly follow this path to achieve improved clinical performance of their drugs delivered by pills manufactured by 3-D printing.
- Aprecia Pharmaceuticals. [Online].