First FDA Approved 3D Printed Pharmaceutical

The first FDA approved 3D printed pharmaceutical is an epilepsy drug produced by Aprecia Pharmaceuticals Company (“Aprecia”). In its press release, Aprecia noted that the epilepsy drug, called Spritam® levetiracetam, has been approved for oral use to treat partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in both adults and children. Aprecia proclaims that the unique feature of the drug—other than that it is produced by 3D printing—is that it has a novel porous formulation that allows the drug to rapidly disintegrate in liquid.

The 3D printing system used by Aprecia—named the ZipDose® Technology platform—is based on innovations made at the Massachusetts Institute of Technology. Aprecia has an exclusive license on the 3D printing system for pharmaceutical applications and apparently already has one issued patent on the ZipDose® Technology. From a cursory review, the issued patent appears to be limited to a three-dimensional printing system for a powder layering method. So, those of you out there thinking that Aprecia has already cornered the market on every method of 3D printing pharmaceuticals can relax a bit. It appears, however, that Aprecia intends to continue to improve upon the technology—at least with respect to pharmaceuticals—as evidenced by another pending patent application claiming priority to US 8,888,480.

Aprecia has also evidently obtained a patent, US 8,828,411, claiming a three-dimensionally printed dosage form comprising

a.  a three-dimensionally printed solid matrix comprising a blend of at least one active ingredient and at least one inactive ingredient; and

b.  at least one or more chemical markers, wherein said one or more chemical markers define one or more internal three-dimensional patterns in said matrix that cannot be fully observed when the dosage form is intact and that may be used to authenticate dosage form, wherein said one or more chemical markers is [sic] comprises dye, pigment, color-shift substance, UV-active substance, fluorescent substance, or another inactive pharmaceutical ingredient, wherein said one or more internal patterns includes logo, batch code, lettering, numbering, a dot pattern, or a bar code, and wherein the internal pattern is non-concentric or asymmetric. [Emphasis added]

In addition to being able to provide a rapidly disintegrating drug at specific dosages, it also appears that one of the benefits of using 3D printing is that individual marks or symbols can be placed within the drug rather than on the drug, as evidenced by the above-recited claim.

Although the patent application specifically covering Spritam® levetiracetam has not issued yet, it’s fair to predict that Aprecia will be filing quite a few more patent applications for other drugs as Aprecia discerns additional active ingredients suitable for the fast disintegrating matrix produced by its ZipDose® Technology. 

As time goes on, it will be interesting to see the long term impact of 3D printing technology in the pharmaceutical industry—e.g., whether pharmaceutical-capable 3D printers will be regulated for use by only researchers and pharmaceutical companies or whether, as some people predict, 3D printers will eventually find their way into consumers’ homes so that each of us can be his or her own apothecary (highly unlikely!). Either way, John Cage’s outlook seems applicable here: “I can't understand why people are frightened of new ideas. I'm frightened of the old ones.”

Image from Figure 1 of US 8,888,480 issued to Aprecia Pharmaceuticals Company.

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