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Aprecia Pharmaceuticals Set to Advance 3D Printed Drug Pipeline

Reporter: Irina Robu, PhD

 

UPDATED on @2/1/2016 by Stuart Cantor, PhD

 

Aprecia Pharmaceuticals has successfully developed the ZipDose® technology, which is a unique delivery platform for high-dose medications that utilizes three-dimensional printing (3DP) instead of a traditional tablet press. In fact, this is the first time that 3DP technology has been utilized to manufacture drug products. Tablets can be produced which can dissolve almost instantaneously (within 10 seconds) with just a sip of liquid. This is ideal for infants, the elderly, and those who have difficulty swallowing medicines (dysphagia) or who have symptoms of dry mouth.

Powder-liquid 3DP technology was first developed at the Massachusetts Institute of Technology (MIT) in the late 1980s. This patented technology uses an aqueous fluid to bind multiple layers of powder together to create orodispersible tablets. Aprecia Pharmaceuticals now owns the exclusive license to market the technology developed at MIT. The benefits of this technology are several: 1) highly porous structures can be developed even at high levels of drug loading (up to 1000 mg); 2) enhanced taste-masking techniques can be applied; and 3) the use of 3DP enables precise and uniform dosing, especially important for drugs intended for the central nervous system. Aprecia now has the rights to more than 50 patents related to various pharmaceutical applications of 3DP and has filed patent applications to protect this proprietary manufacturing system through 2033.

The company’s first New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) on October 1, 2014 and SPRITAM® (levetiracetam) was approved in July 2015 for four tablet dosage strengths of 250 mg, 500 mg, 750 mg, and 1000 mg for the treatment of epilepsy and seizure disorders (i.e., partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures) in children and adults. Each dose is individually packaged making it convenient for consumers.

 

Aprecia Pharmaceuticals Company specializes in three-dimensionally printed (3DP) prescription medicine it has completed a $35 million preferred stock financing. The financing was led by Deerfield Management Company LP and included participation by JW Asset Management.  The finances will support the commercialization of SPRITAM (levetiracetam) through an exclusive sales and marketing alliance with inVentiv Health will accelerate the development of additional 3D printed drug formulations utilizing Aprecia’s novel 3DP technology platform. SPRITAM, the world’s first 3D printed medicine approved by the US Food and Drug Administration, is expected to launch in the first half of 2016.

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