We recently profiled Aprecia Pharmaceuticals (Langhorne, PA), an innovative company that is using 3D printing to manufacture prescription drugs. In that article, Aprecia said that it expects FDA approval for the first pharmaceutical product using its ZipDose technology some time this year. Well, we didn't have to wait long: Aprecia announced yesterday that FDA has approved its 3D-printed drug for the treatment of epilepsy. This reportedly marks the first time that a pharmaceutical product manufactured using this technology has been approved by FDA.
Spritam levetiracetam for oral use is designed for patients who have difficulty following a treatment regimen, either because they have a swallowing disorder or, as in the case of children, because they are forgetful or reluctant to take their medication. ZipDose technology produces a porous formulation that instantly disintegrates with a sip of liquid. Moreover, the technique enables delivery of a high drug load—up to 1,000 mg in a single dose—and no measuring is required, as each dose is individually packaged for on-the-go use.