The US Food and Drug Administration (FDA) has granted its first-ever approval for a drug manufactured by 3D printing.
The FDA told Aprecia Pharmaceuticals it could move forward [PDF] with the introduction of Spritam, an anti-seizure medication for people with epilepsy. The pill is set to go on sale in the US early next year.
Aprecia said it uses a 3D printer to create a highly porous structure within the liquid-soluble pill. Each Spritam tablet carries 1,000mg of levetiracetam anti-seizure medication with one orally dissolving tablet, a dosage level not possible from traditional pill manufacturing techniques.
The printing technology, which Aprecia dubs "3DP," was licensed by the company from MIT. The process mixes a powdered medication with a fluid and prints multiple layers into a pill form. This results in a specially-designed structure capable of holding larger doses of medication in each tablet.
"In my experience, patients and caregivers often have difficulty following a treatment regimen," said Marvin H. Rorick III, M.D, a Cincinnati neurologist Aprecia trotted out to tout the drug.
"Whether they are dealing with a swallowing disorder or the daily struggle of getting a child to take his or her medication, adherence can be a challenge."
The pharmaceutical company hopes the pill will allow people with epilepsy to carry their medication in pill form without the need to measure out dosage every time they take the drug.
Additionally, the liquid soluble pills, which disintegrate in 10 seconds, will allow epileptics who have trouble swallowing tablets or dislike the taste of liquid medicines to receive their medications.
The approval marks the first time the FDA has allowed an orally-administered drug to be 3D printed, though the administration has previously approved other medical devices manufactured via printer.
While most of the 3D-printing focus in the medical field has been in areas such as implants and prosthetics, Aprecia said it will continue work on designing and printing pills for oral medications. The pharmaceutical company plans to use the 3D printing technology, which it has named "ZipDose," to manufacture additional drugs designed to treat central nervous system disorders. ®