Analytical Quality Management for 3D-Printed Small Molecule Drugs

The promise of personalized medicine can be realized in part via point-of-care 3D drug printing, but only if there are reliable quality measures available. Children and seniors may need custom or easy-to-swallow doses, a need now addressed only in a limited way by ad-hoc in-pharmacy compounding. Compliance-targeted enhancements such as flavor and shape choices are particularly important for children with chronic diseases. InfraTrac has shown feasibility for an integrated system, using non-destructive technology, that has the potential to enhance trust and safety for drugs printed in pharmacies. A miniature near-infrared spectrometer, coupled with appropriate chemometric modeling, will be deployed to enforce quality bounds on each drug print. Building on Phase I success in distinguishing high-dose from low-dose prints, this work aims to create enforceable quality parameters fast and easy enough to use for every dose. The modeling is designed to be spectrometer-independent and printer-independent, for maximal commercial viability. In contrast to existing spectral libraries, these models are specific to 3D printing, and, perhaps more importantly, create bounded ranges for permissible variation. A printed dose will be considered to remain in-bounds, for example, if its flavor varies or an allergen is removed, but not if the active ingredient is altered.