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In 2015, Aprecia Pharmaceuticals produced the first tablet manufactured through 3D printing to be approved by the FDA. Two years later, GlaxoSmithKline completed a study where inkjet 3D printing and ultraviolet (UV) curing were used to create tablets that treat Parkinson’s disease. With applications in controlled release, short-run medicines, and even the potential for on-site printing at pharmacies, 3D-printing technology has the ability to transform the pharmaceutical industry.
Not surprisingly, established players continue to invest in 3D-printing research, while newer manufacturers are also breaking into the pharmaceutical space. Such experiments can open the doors for personalized medicine and improvements in clinical trials, benefitting patients and manufacturers alike.1
Controlled Release
Demand for controlled-release pharmaceuticals, sometimes referred to as 4D pharmaceuticals because of their tendency to change shape during digestion or operate for extended times, is growing as patients’ desire for convenience expands. The reduced dosing frequencies extended-release products offer can increase patient compliance in those who take multiple doses of a drug per day—patients can take one pill in the morning instead of every few hours, or perhaps even one pill for a week or more. Pediatric care is a key application area for extended-release pharmaceuticals. Because children range in body mass, it can be difficult to manage proper dosing in youths. The solution is often to give children multiple low-dosage pills or a larger pill that must be manually cut. Extended-release tablets offer a more controlled method of delivery.
In the example of Aprecia Pharmaceuticals, 3D printing was used to reformulate the anti-epileptic medication levetiracetam. The new product, Spritam, has a highly porous structure that could not be achieved with traditional manufacturing.2 This structure causes the pill to dissolve in seconds upon contact with saliva, helping both elderly and young patients suffering from trouble swallowing pills, known as dysphagia.
This innovative development was achieved through a proprietary powder bed and inkjet 3D-printing technology known as ZipDose. In manufacturing, an initial powdered layer containing the drug itself is laid down. That first layer then passes under an inkjet printhead, and a binding liquid is printed at specified locations along the powdered sheet. Successive layers are then printed up to 40 times, depending on the size of the tablet. Printing the layers allows the drug to be packed more tightly. A single tablet that would normally hold 200 mg can be layered to hold 1,000 mg. The result is a high-dose medicine that is easy to swallow for epileptic patients and breaks down inside the body to administer a steady dose over time.