Chapter 3
3D Printing: A Case of ZipDose® Technology – World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product
Thomas G. West,
Thomas J. Bradbury,
Thomas G. West
Aprecia Pharmaceuticals, LLC, Intellectual Property, 89 Twin Rivers Drive, East Windsor, NJ, 08520 USA
Search for more papers by this authorThomas J. Bradbury
Aprecia Pharmaceuticals, LLC, Development Engineering, 89 Twin Rivers Drive, East Windsor, NJ, 08520 USA
Search for more papers by this authorThomas G. West,
Thomas J. Bradbury,
Thomas G. West
Aprecia Pharmaceuticals, LLC, Intellectual Property, 89 Twin Rivers Drive, East Windsor, NJ, 08520 USA
Search for more papers by this authorThomas J. Bradbury
Aprecia Pharmaceuticals, LLC, Development Engineering, 89 Twin Rivers Drive, East Windsor, NJ, 08520 USA
Search for more papers by this authorBook Editor(s):Mohammed Maniruzzaman,
Mohammed Maniruzzaman
School of Life Sciences, University of Sussex, Brighton, UK, BN1 9QG
Search for more papers by this authorSummary
This chapter provides substantial description of the technology development leading to SPRITAM's approval. Additive manufacturing effectively conveys the aspect of joining material during the process of forming parts, in contrast with techniques that remove material or reshape material from simpler standardized shapes. Three-dimensional (3D) printing under International Standards Organization/American Society for Testing and Materials is directed to fabrication via deposition of material using a printhead, nozzle, or other technology. ZipDose technology is the brand name of Aprecia's formulation technology related to orodispersible dosage forms. ZipDose technology is a platform in the sense that the formulation approach has applicability to a broad swathe of compounds, including pharmaceuticals and nutraceuticals. SPRITAM is the first example of a commercial product made using ZipDose technology. The use levels of each excipient are generally consistent with those outlined in US Food and Drug Administration's inactive ingredient database for approved products having the same route of administration.
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