NDA Accepted for Filing for Investigational ZipDose Technology

Aprecia Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the first product using its proprietary ZipDose technology.

ZipDose technology is a formulation platform that enables medicine to swiftly disperse in the patient’s mouth with a sip of water or any other liquid. This technology satisfies an unmet patient need by achieving dosage strengths that cannot be made for commercial use via current fast-melt technologies (eg, orally disintegrating tablets and oral thin films). Additionally, ZipDose products have greater dosing accuracy than liquids, which are susceptible to measurement errors.

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Aprecia develops its ZipDose formulations using the layer-by-layer manufacturing capabilities of its proprietary Three-Dimensional Printing (3DP) system. The ZipDose platform was built using 3DP technology that originated at Massachusetts Institute of Technology (M.I.T.). Using the 3DP technology as a catalyst, Aprecia created a novel manufacturing system to produce fast-melt formulations of medicines that exceed the disintegration speed and dose-load capacity of products made by other fast-melt technologies.

For more information visit Aprecia.com.