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August 5, 2015

US FDA approves first 3D printed drug

The drug is designed to treat several types of epileptic seizures.

By CBR Staff Writer

The US Food and Drug Administration (FDA) has approved the first 3D printed drug product, dubbed Spritam.

Aprecia Pharmaceuticals developed the new product using its ZipDose technology formulation platform to treat epilepsy.

The company claims that the platform uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid even at a high dose of up to 1000 mg.

Aprecia said 3DP has been used earlier to manufacture medical devices, but the approval of Spritam marks the first time a drug product produced with this technology has been approved by the FDA.

Aprecia Pharmaceuticals chief executive officer Don Wetherhold said: "By combining 3DP technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience."

The company said even the largest strengths of the new drug will dissolve with a sip of liquid, no measuring is needed since each dose is individually packaged. Spritam is anticipated to be available in the first quarter of next year.

ZipDose Technology combines formulation science with the manufacturing capabilities of 3DP.

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Aprecia holds a worldwide licence for pharmaceutical applications of the 3DP technology.

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