Analytical Quality Management for 3D-Printed Small Molecule Drugs

InfraTrac aims to demonstrate the viability of spectroscopy as an effective and practical mechanism for assessing the quality of in-pharmacy 3D drug printing, thereby enabling custom compounding by bringing necessary patient safety controls to this new realm. InfraTrac’s research strategy uses state-of-the-art 3D printing of solid dose forms to create test candidates, comparing the results of handheld spectroscopic analysis of those candidates with standard pharmaceutical quality techniques. We propose to: (1) Create a library of near-infrared (NIR) spectroscopic standards for 3D-printed (3DP) doses; (2) Test NIR modeling against standard pharmaceutical quality measures; and (3) Define a data framework for in-process NIR for 3D printers. We hypothesize that it is feasible to uphold 3DP standards via chemometric modeling with small, low-cost NIR instruments. We will create spectroscopic pass/fail match models that allow for variations in 3DP medications resulting from permissible customizations while identifying mistaken, substandard and impermissible formulations. Handheld NIR spectrometers or small benchtop units can, with good chemometric modeling, quickly determine the essential attributes of a dose, namely: Is this the right drug? Right dose? The spectrometer should also be able to confirm whether the target formulation has been matched, including customizations, e.g. for allergen avoidance or easier swallowing.