Not sure, but I think Aprecia Pharmaceuticals’ August 3, 2015, press release announcing FDA approval of its anti-seizure SPRITAM levetiracetam almost broke the Internet. Why? Unless you were trekking in the Himalayas the entire month of August, you likely know why. SPRITAM uses Aprecia’s proprietary ZipDose platform, a technology based on three-dimensional printing (a/k/a additive manufacturing) to print its formulation into a porous matrix that quickly dissolves with a sip of liquid. While the additive manufacturing (AM) technique has previously been approved to manufacture medical devices, says Aprecia, it’s the first time the FDA’s approved 3D printing to manufacture an orally ingested solid dose formulation. Who out there is not excited about this development?
Don Wetherhold, Aprecia’s CEO, explained that “By combining 3D printing technology with a highly prescribed epilepsy treatment,” SPRITAM is designed to fill a need for patients who struggle with their current medication experience.” According to Aprecia, SPRITAM is first in a line of central nervous system products it plans to introduce as part of a strategic initiative to transform “the way patients experience taking medication.”
The font of all human knowledge, Wikipedia, revealed that in 1981 Hideo Kodama of Nagoya Municipal Industrial Research Institute invented the first two AM fabricating methods. Thirty-plus years later we’re seeing what may prove to be the first truly commercial, 3D-printed consumer product.
Regardless, the news of Aprecia’s breakthrough spread across the Net like wildfire, with story after story touting the milestone and reviewing the potential and ability of this technology to supersede the invention of sliced bread while eliminating drug factories and pharmacies because everyone will soon be printing their own drugs at home! OK, that’s a bit of an exaggeration, but the bottom line is the technology has a high degree of potential to support patient-specific formulation and tailored release characteristics. First off, Aprecia’s ZipDose methodology enables the delivery of a high drug load, up to 1,000 mg in a single dose, with just a sip of liquid.
Engineering OSD release characteristics via 3D printing techniques have been attracting researchers interest and investor dollars in equal measure because the technique offers such a compelling a solution for manipulating release performance. For example, Professor Ricky Wildman of the EPSRC Center for Innovative Manufacturing, University of Nottingham, is recognized as one of the emerging authorities on the physics and engineering associated with biomedical-related 3D printing. Presenting at Medtec UK last March, Wildman noted 3D printing has a real role to play in personalized medicine. Noting that current forms of treatment require a systemic flooding of the system (ingesting of a tablet), printed drug delivery systems present the opportunity to tailor formulation, developing a release strategy at the design stage and enlisting geometry and material functionality to achieve specific release characteristics. Wildman asked the audience to imagine being assessed and then having the treatment manufactured specifically to treat their disease.
Of course, getting there is not without its challenges. Wildman maintains diagnostic capability needs to be matched to manufacturing. He notes that to design such specific platforms, drug makers will need a thorough understanding of its formulation’s material and structural characteristics including degradation and dissolution mechanics. Fortunately, advanced PAT technology has that covered. Freeman Technology’s FT4 Powder Rheometer delivers data that support process and product understanding and the optimization of powder processes. The system, says Freeman is currently being used to assess exactly how AM powders pack and flow to ensure process efficiency and consistent product quality.
Wildman says the current understanding of how drug developers can fine tune the “functionalization” of given molecules is relatively limited — one can’t “dial up” the needed molecule or material for an intended, specific purpose. Sure, we’re a ways away from when “bespoke” AM-printed drugs are commonplace, but thanks to Aprecia, and PAT vendors like Freeman, we’re all that much closer to this reality.