Effect of Process and Formulation Variables on Quality, Stability, and Taste of Lamivudine Printlets Manufactured by Binder Jetting 3D Printing Method.

This study investigated effect of formulation and process variables on the quality attributes of lamivudine printlets manufactured by binder jetting 3D printing method. The variables studied through fractional design of experiment were number of solvent sprays, delay time, powder layer thickness, drying temperature and hydroxypropyl methyl percentage. The printlets were assessed for hardness, disintegration time (DT), and dissolution and chemical information by X-ray powder diffraction (XRPD) and Fourier transformed spectroscopy, near infrared hyperspectroscopy, and taste evaluation by electronic tongue. The printlet hardness and DT ranged from 2.5 to 21.1 N, and 2.3 to 317 s, respectively. The dissolution profile met USP specifications of > 85% drug dissolved in 30 min. XRPD indicated partial amorphization of the drug in the printlets and hyperspectroscopy indicated uniform distribution of the components in the formulation. Stability data indicated no significant change in quality of the printlets in terms of dissolution and assay. Excipients used in the formulation reduced the bitterness of the drug to some degree. In summary, binder jetting can be used to print personalized medication with quality control characteristics.