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news.The US Food and Drug Administration (FDA) has accepted for filing Aprecia Pharmaceuticals' new drug application (NDA) for the first product using its ZipDose technology, a formulation platform that allows medicine to swiftly disperse in the patient’s mouth with a sip of water or other liquid.
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ZipDose products allow people to take their medications with greater ease, potentially increasing adherence and improving symptom management.
According to the company, these products achieve dosage strengths that are commercially unattainable using the existing fast-melt technologies, and they are more portable than liquid formulations and have greater dosing accuracy than liquids, which are susceptible to measurement errors.
Aprecia chief executive officer Don Wetherhold said: "The FDA’s acceptance of our filing is an important milestone for Aprecia as we seek FDA approval for our first product based on the ZipDose technology platform.
"This is the first in a line of products in the CNS therapeutic area that Aprecia plans to introduce over the next several years as part of our commitment to transform and improve the experience of taking potentially lifesaving medications."
The company develops its ZipDose formulations using a combination of expertise in formulation science and the layer-by-layer manufacturing capabilities of its Three-Dimensional Printing (3DP) system.
By using the 3DP technology as a catalyst, the company has developed a new 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.