The FDA Approves the First 3D Printed Pill to Help Prevent Epileptic Seizures

Share this Article

3dp_3dpdrug_aprecia_logoOne of the largest hurdles that healthcare practitioners treating epilepsy need to overcome is often with their own patients. It turns out that an estimated 30 to 50 percent of epilepsy patients don’t adhere to the drug regimens prescribed to them. The reasons for noncompliance, however, are rarely due to patient’s being willfully defiant of their doctor’s orders, but often much more mundane. Forgetting to take pills regularly is common for all of us, and for some patients, specifically the elderly and children, taking larger pills is often quite difficult for medical reasons, as well as simply having aversions to swallowing large dose pills.

It was with these patients in mind that Aprecia Pharmaceuticals, which specializes in developing new ways to help patients maintain compliance with their prescribed medication regimen, developed a process to make large dose medication easier to swallow using 3D printing technology. Their new manufacturing process was designed to create large dose dissolvable versions of popular medications that would not need to be swallowed. The first medication made using this process was for a commonly prescribed anticonvulsant called levetiracetam that Aprecia says will dissolve in the mouth with a small sip of liquid.

The 3D printed dissolvable version of levetiracetam called Spritam.

The 3D printed dissolvable version of levetiracetam called Spritam.

Here is a video demonstration showing exactly how quickly the pill will dissolve:

Levetiracetam is typically sold using the brand name Keppra and has already been made available in several strengths as a tablet, a liquid, and an extended-release formulation. It is typically used to help treat a wide variety of seizures in both epileptic adults and children, including myoclonic seizures, partial-onset seizures and primary generalized tonic-clonic seizures. The largest dose available, 1,000 mg, will be a rather large pill measuring about the diameter of a nickel and a height of four nickels, however because of the pill’s porous nature it won’t actually need to be swallowed but the patient can simply allow it to dissolve.

The ZipDose manufacturing process.

The ZipDose manufacturing process.

Aprecia says that the 3D printing process that they developed, called ZipDose, will make it easier for patients who are required to take large dose medications or a large number of pills daily. The proprietary manufacturing technique developed by MIT is a familiar process to the 3D printing industry. The printer is mechanically quite similar to a sand 3D printer or the Selective Laser Sintering process sans the laser. The printer will lay down a very fine layer of the drug in powder form, a printing head runs over it, dropping a small amount of a binding agent into the power and the process repeats until the pill is fully formed.

In an interview with Neurology Today, the chief executive officer of Aprecia, Don Wetherhold, explained that the 3D printed pill was porous, which would allow it to dissolve in the patient’s mouth very quickly with just a sip of liquid. The pill can vary in dosage depending on the needs of the patient, and the process even allows extremely large doses, up to 1,000 mg, to be made into a relatively compact pill.

3dp_3dpdrug_spritam_logo“It has a unique capacity to dissolve at higher-dose loads. There clearly are some patients who would benefit — children, the elderly, people who have some other condition that may make it hard to swallow, such as cerebral palsy, stroke, or Alzheimer’s disease,” Wetherhold said.

The 3D printed levetiracetam pill was officially approved for use by the US Food and Drug Administration (FDA) this past August and is expected to be available sometime in 2016. Each pill will be individually packaged, and while Aprecia did not have any pricing information it is expected to be in-line with other formulations of the drug. This new version of levetiracetam will be marketed as Spritam. Aprecia is calling it the first drug manufactured using a 3D printing process, an assertion that is only partially true. Spritam will simply be the first 3D printed drug that has been approved for use, but the concept has been experimented with in the medical 3D printing market for several years now.

Let’s hear your thoughts on the use of 3D Printing within the drug industry.  Discuss in the Aprecia forum thread on 3DPB.com.

Facebook Comments

Share this Article


Related Articles

Bioprinting 101 Part 18 – Pharmaceutical Testing

Keimyung University: Researchers Explore FDM 3D Printing in Feasibility of Manufacturing 3D Printed Medications



Categories

3D Design

3D Printed Architecture

3D Printed Art

3D printed chicken


You May Also Like

DIY Drugs: Big Pharma and the FDA Most Likely To Steer the Outcome of 3D Printed Medications

Excitement has been building regarding patient-specific, 3D printable drugs over the past few years (especially with the advent of the 3D printed epilepsy drug, SPRITAM). But what if we could...

Medical 3D Printing Companies Gain FDA Certification Under Materialise Program

If you follow 3D printing or medical news at all, you’re likely familiar with the many ways that 3D printing is changing medicine for the better. 3D printed anatomical models...

Hebrew University and Yissum Developing Novel Technology Platform for 3D Printing Personalized Medicine

Yissum, which is the Hebrew University of Jerusalem‘s technology transfer company and handles the patenting and commercialization of any inventions produced there, has had a hand in many unique 3D printing...

Captiva Spine Receives FDA Clearance for 3D Printed Titanium Lumbar Cages

3D printing has been playing a big role in helping people with spinal conditions over the last few years, particularly in terms of implants and other medical devices. But none...


Training


Shop

View our broad assortment of in house and third party products.

Subscribe To Our Newsletter

Subscribe To Our Newsletter

Join our mailing list to receive the latest news and updates from our 3DPrint.com.

You have Successfully Subscribed!