US FDA approves first 3D printed pills

Posted on 6 Aug 2015 by Michael Cruickshank

The US Food and Drug Administration (FDA) has approved the first ever 3D printed pills to be sold in the country.

The pills in question are an anti-seizure drug for epilepsy patients called SPRITAM which is produced by Aprecia Pharmaceuticals Company.

To produce these pills the company makes use of a new, proprietary process which it calls ZipDose. This process involves the use of 3D printing to produce pills which dissolve at a faster rate than traditionally produced competitors.

“SPRITAM utilises […]a groundbreaking advance that uses three-dimensional printing to produce a porous formulation that rapidly disintegrates with a sip of liquid,” Aprecia states in a press release.

The company is confident that their new pills will provide a better experience for their patients. Previous anti-seizure pills were often very large and difficult to swallow, while with this new technology, the pills will rapidly dissolve in a patient’s mouth.

“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,” said Don Wetherhold, Chief Executive Officer of Aprecia.

The first of these 3D printed pills will hit the market in the first quarter of next year.

3D printing benefits

While 3D printed medical devices have seen significant proliferation within the industry, this is the first ever 3D printed pharmaceutical product designed for human consumption approved by the FDA.

The approval of SPRITAM is likely to set the stage for a boom in 3D printed medicines.

Unlike traditional pills, those manufactured through 3D printing allow for much more concentrated doses in a single pill

“ZipDose Technology enables the delivery of a high drug load, up to 1,000 mg in a single dose. As a result, SPRITAM enhances the patient experience – administration of even the largest strengths of levetiracetam with just a sip of liquid,” Aprecia claims.

In addition, further down the line, pills could theoretically be made to order, with completely personalised dosages and sizes following consultation with a doctor.