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The First FDA-Approved Drug Manufactured Using 3D Printing

The first prescription drug manufactured using 3D printing technology has been approved by the FDA. Aprecia Pharmaceuticals’ SPRITAM tablets for oral suspension are now available for the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. SPRITAM drug disintegrates in the mouth with liquid.

3d printing

Don Wetherhold, CEO of Aprecia stressed the importance of identifying disease areas with a real need for patient-friendly forms of medication when describing the choice of SPRITAM for 3D printing.

According to a press release on the approval:

“SPRITAM is formulated with Aprecia’s proprietary Zipdose Technology, which combines the precision of 3D printing and formulation science to produce rapidly disintegrating formulations of medications Manufactured in a regulated commercial-scale facility, SPRITAM is available in four unit-dose strengths, including 250 mg, 500 mg, 750 mg, and 1,000 mg.”

SPRITAM is the first and only drug-formation platform that utilizes 3D printing. The process “binds layers of powdered medication together with an aqueous fluid to manufacture pharmaceutical products that are solid, yet highly porous. The porous design helps medication disintegrate rapidly in the mouth when taken with a sip of liquid.”

Reference:
Snyder, M. (2016). The first FDA-approved drug manufactured using 3D printing. Pharmaceutical Processing.
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