Company builds plant for 3DP pill making as it nails first FDA approval

Aprecia Pharmaceuticals is building a small manufacturing facility in Blue Ash, OH, but instead of all of the usual accoutrements of drugmaking, the company will fill it with three-dimensional printing (3DP) technology, technology it is using to make quick-dissolve, easily ingested formulations of highly prescribed high-dose medications.

The Langhorne, PA-based company said Monday it has gotten FDA approval for the first of those, an epilepsy drug it is calling Spritam that it says is also the first FDA-approved drug to use three-dimensional printing technology. Spritam is a formulation of levetiracetam that uses the process so the pills rapidly disintegrate with a sip of liquid, making them easier to swallow.

Aprecia says the process "stitches together multiple layers of powdered medication using an aqueous fluid to produce a porous, water-soluble matrix that rapidly disintegrates with a sip of liquid." The powder-liquid 3DP technology was developed at the Massachusetts Institute of Technology (MIT) in the late 1980s as a rapid-prototyping technique. Aprecia says its technology allows for delivery of a high drug load, up to 1,000 mg, in a single dose.

The company, which already has a manufacturing facility in East Windsor, NJ, earlier this year said it would build a $25 million, 190,000-square-foot manufacturing facility in Blue Ash, OH, and has gotten an 8-year tax benefit for agreeing to hire 150. It says it expects the product to be available in Q1 2016.

"The facility has ample space to accommodate our proprietary manufacturing machines and equipment assemblies in the capacity necessary to achieve our projected commercial production volumes well into the future," CEO Don Wetherhold, said when the plant was announced.

- read the announcements here and here

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