Abstract
After three decades of foundational work, global interest remains ascendant for additive manufacturing (AM) of pharmaceuticals. At the forefront of this interest is binder jetting onto powder, which holds a unique position due to the early regulatory precedents established using this technology and also the diversity of materials it can process.
To date, binder jetting is the only type of additive manufacturing worldwide to be part of an approved drug application, first achieved with SPRITAM® in 2015. This milestone echoes the prior use of binder jetting in regulated life sciences via clearances for implantable medical devices in 2003 and 2004. These examples cement the early commercial implementation of binder jetting in centralized manufacturing configurations under the extant regulatory frameworks.
Conceptually, any pharmaceutical powder can be considered for binder jetting. A diverse body of research has prototyped a range of immediate and controlled release dosage forms, predominantly for oral use, along with a few implantable examples. As with other AM processes, strategies for decentralization and part customization are actively contemplated.
This chapter will provide a technical foundation for binder jet printing of pharmaceuticals, with particular emphasis on its application to novel pharmaceutical dosage forms and future perspectives on the field.
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Notes
- 1.
Authors note that a complete review of patents is beyond the scope of this chapter. Selected patents are cited only as needed to show specific advancements in binder jetting technology. This chapter should not be construed as legal advice, and the reader is directed to seek competent counsel for such purposes.
- 2.
Although the trademark is no longer active, the TheriForm name is only accurately used in reference to the machines made by Therics as the source of those machines. It is essentially a historical term now.
- 3.
Authors note that a complete review of regulatory pathways is beyond the scope of this chapter. Some basic information on certain regulatory pathways is provided in order to illustrate the use of binder jetting technology in certain marketed products. This chapter should not be construed as regulatory or legal advice.
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Acknowledgments
The authors wish to recognize collectively the teams from M.I.T., Therics, and Aprecia with the origination and foundational work in pharmaceutical binder jetting, and the broader group of researchers worldwide for increasing the study and awareness of this technology. This dynamic interest will continue to drive the opportunities for real-world deployment of binder jetting to help more patients today and in the years to come.
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West, T.G., Yoo, J. (2023). Inkjet and Binder Jet Printing in Pharmaceuticals. In: Banerjee, S. (eds) Additive Manufacturing in Pharmaceuticals. Springer, Singapore. https://doi.org/10.1007/978-981-99-2404-2_6
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