(123b) Commercial Scale Manufacturing of a Pharmaceutical Product Using Powder-Liquid 3D Printing Technology

Three dimensional printing (3DP) opens the possibility to manufacture pharmaceuticals differently from today and provides the opportunity to create novel dosage forms for patients. Despite significant advances in the field, an obstacle to commercialization of 3DP pharmaceuticals has been the difficulty in being able to manufacture at commercial scale. Recently, utilizing powder-liquid 3DP technology a pharmaceutical (levetiracetam, Spritamâ„¢) has been developed through the 505(b)(2) regulatory pathway at commercial quantities and has received FDA approval for manufacture and sale. In addition, the product is a novel dosage form that utilizes fast-melt technology (ZipDoseâ„¢) that provides for rapid dispersion in the mouth (< 10 seconds) with only a sip of liquid, while containing doses of levetiracetam up to 1000mg. Products that rapidly disperse in the mouth are particularly useful for patients with dysphagia or difficulty swallowing, particularly of large tablets. This rapid dispersion at high doses was possible because of the selective porosity and hardness of the dosage form created by the 3DP layering process. To produce this unique dosage form, processes were developed to assure consistent and precise jetting of print fluid and careful control of powder deposition across up to 30 layers at commercial production speed to produce tablets that were highly accurate and reproducible with respect to dose of active drug. The regulatory approval and commercialization of this product demonstrated that unique pharmaceutical dosage forms could be created through 3DP technology that helped address unmet needs.