In August of 2015, the FDA approved the first-ever 3D-printed drug; in March of this year, it became available on the U.S. market. Manufactured by Aprecia Pharmaceuticals, SPRITAM is an epilepsy seizure medication that has been marketed under its formulary name levetiracetam in traditional tablet form for over a decade.
3D printing was developed in 1984 by inventor Charles Hull; in 1993, Massachusetts Institute of Technology patented “3-dimensional printing techniques” (3DP), which allowed liquids to be printed through an inkjet print head. This technology was subsequently licensed by Therics, a company that designed, developed, and manufactured synthetic bone substitute products (and was later acquired by Integra LifeSciences). Although Therics began to experiment with printing 3D drugs, it never went beyond the experimental stage. Aprecia has now designed and built its own proprietary large-format 3D printing machines that balance increased throughput with pharmaceutical regulatory requirements.
SPRITAM is produced through Aprecia’s ZipDose technology, which lays down a thin layer of powdered medication, applies a drop of liquid to bind the powder, and then repeats this process in as many layers as necessary. The result is that the very porous pills disintegrate immediately with just a small amount of liquid, making them much easier to swallow than a solid tablet. Termed “fast melt” by Aprecia, this type of pill is particularly beneficial for children, the elderly, or those with medical conditions that make swallowing difficult. The pills are equally dissolvable regardless of dosage, and can each hold a significant maximum dosage of 1,000 mg.
Aprecia believes that its process has the potential to decrease the cost of drug manufacturing, as it eliminates steps, improves throughput, and reduces the manufacturing footprint. It also allows the composition of drugs to be more meticulously controlled. In the future, this technology may be able to take some unique forms: made-to-order medications that can be customized to specific patients’ needs, as dosages can be individually measured and printed; print-at-home medications – with universal chemical ink sets, doctors would give out algorithms rather than written prescriptions, which would provide information about what is needed for each specific drug, including its molecular blueprint; 3D printing of tissues and organs to use for drug testing, making R&D more efficient and economical; and new types of medications created because 3D printing allows for more options in the minute shaping and structures of the medications.
Aprecia, which holds more than 50 patents in the area of 3D-printing pharmaceutical applications, is currently working on new drugs in the neurological realm that it hopes to bring to market soon.
Contributed by Holly Valovick -QLK