USFDA Approves first 3d printed drug

The term "designer drug" may soon refer less to the illicit kind and more to custom creations by the pharmaceutical industry. Aprecia Pharmaceuticals Company has just had its proprietary ZipDose Technology platform approved by the US Food and Drug Administration (FDA). This marks the very first instance that the FDA has given the green light for a 3D-printed drug product.

The use of 3D printing in the medical field is somewhat new, but growing rapidly. Bio-printing has proven to be an efficient way to create living tissues, and 3D-printed implants are able to deliver drugs more effectively. Now, with the FDA's approval, Aprecia can continue the creation of its 3D-printed drug, possibly paving the way for future drugs.

Spritam levetiracetam is an oral prescription for the treatment of seizures and those affected by epilepsy. Aprecia's ZipDose Technology enables the delivery of this drug, up to 1,000 mg per dose, with just a sip of water. This rapid disintegration method is achieved by 3D printing Spritam with a porous formulation. As a result, each dose is easy to take and does not require any measuring.

"In my experience, patients and caregivers often have difficulty following a treatment regimen. 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," says Dr. Marvin H. Rorick III, neurologist at Riverhills Neuroscience in Cincinnati, Ohio. "Especially for children and seniors, having an option for patients to take their medication as prescribed is important to managing this disease."

Spritam is the first 3D-printed drug of many that Aprecia plans to introduce as part of its plan to change how patients take prescribed medication. Spritam is expected to become available sometime in the first quarter of 2016.

Source: http://www.gizmag.com/fda-approves-first-3d-printed-drug/38770/