Created by Aprecia Pharmaceuticals, the drug – called Spritam – is a dissolvable tablet used to treat certain types of seizures in adults and children with epilepsy. If we look at these Spritam tablets, they would appear like any other tablets but they are altogether different – they are manufactured through 3D printing technology.
The drug used far and wide by millions suffering from epilepsy has just been approved for consumer use by the US Food and Drug Administration (FDA). It is the first 3D printed drug approved by FDA in the history of medicine. This landmark event can change the course of how drugs are manufactured and have greater influence on the pharmaceutical industry world over.
“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 Don Wetherhold, CEO of Aprecia.
As a result of Aprecia’s proprietary 3D printing process known as the ZipDose Technology platform, the physical composition of the Spritam pill can be made more porous than typical pills, meaning that it dissolves almost instantaneously when added to a liquid. It literally melts in your mouth with just a sip of water or other liquid, making it easier to swallow. Aprecia refers to these new 3D-printed pills as “fast-melt,” to differentiate them from tablets and capsules. Furthermore, the new manufacturing technology opens new customization options for individual patient need and specific dosage. In other words, with 3D printing, each dosage can be individually measured and then printed.
The hope that patients will be able to print their own medicines at home is though a distant possibility today, may not be denied with the maturing and general acceptance of the technology.
Just imagine the doctor prescribing the process of manufacturing medicine to patients rather than certain number of pills certain number of times. It can be an amazing world.
Earlier FDA approved the first 3D printed prosthetic. Last year, the agency held a workshop on 3D printing for medical device makers, which shows the modern perspective of authorities on manufacture and consumption of drugs.
Aprecia Pharmaceuticals, the company that pioneered the concept of the 3D-printed pill, has already received more than 50 patents related to pharmaceutical applications for 3D printing.
Aprecia Pharmaceuticals makes the oral medication through a three-dimensional printing process, which builds the pill by spreading layers of the drug on top of one another until the right dosage is reached. This technique allows the pill to deliver a higher dosage of medicine – up to 1,000 milligrams – while being porous enough to dissolve quickly. These attributes can be particularly beneficial for patients who have a hard time swallowing their medication, and miss doses of treatment, the company says. In addition, with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on the go.
Aprecia says it expects the drug to be available early next year for adults and children.
Everything from toys to spare mechanical parts, and food and fashion have been made using a 3D printing process. It’s the first time that medicine for direct human consumption has been approved by FDA.