Problem
Innovations in 3D printing have caused a paradigm shift in the design and manufacture of pharmaceuticals. By allowing for on-demand production of custom dosages, 3D printing has the potential to transform the field of personalized medicine and the economics of pharmaceutical manufacturing.1 However, existing 3D printing techniques for drug manufacturing are compatible only with a narrow segment of active pharmaceutical ingredients. These techniques also require a mixture of ingredients and substantial downstream processing, both of which slow production. As such, there is a critical need for an efficient 3D printing system that is compatible with a variety of active ingredients.
Solution
The Maniruzzaman Lab has recently invented DosePlus, the first platform to combine continuous granulation with powder-based 3D printing for flexible production of precise dosages. The process uses hot melt extrusion to continuously transform drug and excipients into granules. Inside the granules are uniformly distributed amorphous drug particles. The stable amorphous structure enhances solubility and physical properties such as flow of the granules. The free-flowing granules do not bind to each other, making them suitable for 3D printing into tablets using selective laser sintering or for direct use in standard capsules.
In addition to the manufacturing benefits of 3D printing, DosePlus can make better performing tablets. Coupling enhanced drug solubility with the tablet architectures enabled by 3D printing allows for faster drug delivery with oral dosages. The researchers demonstrated that DosePlus manufactured 3D printed tablets improved the drug release of indomethacin from 60% in two hours to 80% within five minutes.2 Another benefit of the DosePlus platform is high-drug loading. By achieving drug loads of 90% w/w without compromising the product performance, DosePlus can reduce the number and size of pills. This new drug manufacturing platform produces dosages with excellent uniformity and stability, is scalable, and is compatible with BCS I-IV drugs. By enabling a wider design space and flexible production of precise dosages, DosePlus shows strong promise for advancing patient-centric care.
References
1. Park, B. J. et al., Pharmaceutical applications of 3D printing technology: current understanding and future perspectives. J. Pharm. Investig. 49, 575-585 (2019). https://doi.org/10.1007/s40005-018-00414-y
2. Thakkar, R., et al., Synergistic application of continuous granulation and selective laser sintering 3D printing for the development of pharmaceutical dosage forms with enhanced dissolution rates and physical properties. Preprint at bioRxiv (2021). https://doi.org/10.1101/2021.02.13.430988
