FDA approved the first 3D printed drug product on August 3, 2015. The product, named Spritam (levetriacetam) is used to treat seizures. The product is listed in approved labeling as a “tablet for oral use.” Interesting terms for this new dosage form. After all, it is not a conventional tablet to be swallowed whole. Also, it is not an orally disintegrating tablet (ODT) because it is not designed to be dissolved on the tongue. The directions for use in the approved package insert are as follows: “Administer whole SPRITAM tablets with a sip of liquid; the tablet should be swallowed only after it disintegrates.” My guess is that FDA may be struggling as to what to officially call it and much of that struggle will come after approval (since the product is already approved).
This appears to represent a unique form of tablet, but one that must be distinguished from existing tablets as its dosage administration instruction is somewhat different. In these times when FDA and USP are trying to reduce the number of new dosage forms, i.e., trying to collapse new products into existing categories, the need to further define this product may make a big difference for any generic follow-on product.
The company’s web page (here) terms the product part of its new “ZipDose® Technology [which] is [a] unique delivery platform that serves as the foundation of our orodispersible formulations of highly prescribed high-dose medications. It creates premeasured, spill-proof unit-doses designed to disintegrate in the mouth with just a sip of liquid. ZipDose® Technology utilizes our proprietary three-dimensional printing (3DP) platform. This process stitches together multiple layers of powdered medication using an aqueous fluid to produce a porous, water-soluble matrix that rapidly disintegrates with a sip of liquid.”
So here we go, just load up the printer with “drug ink” and let ‘er rip. What will they think of next and how will FDA deal with this new technology in terms of its final nomenclature. In FDA’s approval letter for this 505(b)(2) application, the FDA called the product “SPRITAM (levetiracetam), 250 mg, 500 mg, 750 mg, and 1000 mg tablets, for oral use.” Will this name stick? Has the FDA already made its final decision? My guess is that the Office of Generic Drugs (OGD) was not consulted and it is often not until OGD has to face an application for a generic of the brand name product that the established name of the product and its dosage form comes into focus as a potential naming problem. Remember the Neoral case where the brand product has a unique physicochemical characteristic associated with its established name, “cyclosporine for microemulsion”, which was later changed to “cyclosporine modified” because a generic was found not to have to form a microemulsion to be found pharmaceutically equivalent and/or bioequivalent? Could this be another example of the right hand not knowing what the left hand is doing, or perhaps sleight of hand? We will have to wait to see how this plays out.