The Food and Drug Administration yesterday approved the first drug made by a 3D printer. Called Spritam, it’s essentially a new formulation of an existing epilepsy drug. The 3D printing comes into play by making it easier to ingest – hopefully upping patient adherence rates for a difficult disease.
This is a particularly interesting move because thus far, 3D printing has demonstrated more applications in medical devices. But there may be some pretty wide-reaching promise for 3D printed drug.
Spritam was developed by Ohio biotech Aprecia Pharmaceuticals – using the 3D printing to create a porous formulation of levetiracetam that disintegrates rapidly with a sip of liquid. The drug has been around awhile, and a generic form has been approved orally and by injection since 2008.
“Spritam is designed to fill a need for patients who struggle with their current medication experience,” CEO Don Wetherhold said in a statement. He added that it plans to continue developing more reformulated, 3D-printed drugs for the central nervous system using the company’s current platform.
An FDA spokeswoman confirmed this is indeed the first approved 3D printed pharmaceutical. The underlying technology was actually developed in the late 1980s at the Massachusetts Institute of Technology.
It works by assembling a powdered form of a drug in thin layers, one on top of the other without compression or traditional molding techniques. Patterns of liquid droplets are printed onto portions of each powder layer, and bonded together at a microscopic level – creating highly porous, dissolvable structures despite high concentrations of the drug.
The so-called ZipDose technology used in Spritam delivers a high drug load of the epilepsy medication – up to 1,000 milligrams in a single dose – helping patients take larger doses orally, with a simple sip of liquid. This could be helpful in medication adherence – the current methods of taking levetiracetam are challenging, given the large size of the doses. It’s easier to take a sip of liquid than to swallow a large bolus of medication – hence the rationale for a new formulation. It’s expected to hit the market in the first quarter of 2016.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
A lot of the potential around 3D printed drugs stems from new applications in formulation – and in creating dosing systems better tailored for an individual. A recent Forbes article on the topic pointed out:
Since we know that some patients require medications that are faster acting, while others need medications to be released more gradually over a longer period of time, 3D printing offers one the ability to customize medications for individual patient needs.
There are also several applications in the work in developing 3D-printed therapeutics. Take the work being done by Swiss researchers at ETH Zurich – they’re developing microscopic robots that transport drugs within the body. Designed to operate like flagella, these 3D printed molecules are meant to be maneuvered to deliver drugs to preset locations around the body. They could be used to improve minimally invasive surgery, targeted drug delivery, remote sensing and single cell manipulation.
They can also be used to improve the development of prosthetics, create porous growth matrixes to build nerve cells for therapy, or, as the Forbes article discusses:
MakerBot Replicator, the innovator of technology that allows the 3D printing of pills into specific geometrical shapes and sizes–translating into solutions for more rapid or sustained release kinetics—is betting that pharmakinetics can become an important driver of medication production for the consumer. This lends itself to the ongoing trend for the evolution of precision medicine, ultimately leading to the customization of medications.
