RESUMO
The drug loading efficiency was evaluated using a binder-jet 3D printing process by incorporating an active pharmaceutical ingredient (API) in ink, and quantifying the printability property of ink solutions. A dimensionless parameter Ohnesorge was calculated to understand the printability property of the ink solutions. A pre-formulation study was also carried out for the raw materials and printed tablets using thermal analysis and compendial tests. The compendial characterization of the printed tablets was evaluated with respect to weight variation, hardness, disintegration, and size; Amitriptyline Hydrochloride was considered as the model API in this study. Four concentrations of the API ink solutions (5, 10, 20, 40 mg/mL) were used to print four printed tablet batches using the same tablet design file. The excipient mixture used in the study was kept the same and consists of Lactose monohydrate, Polyvinyl pyrrolidone K30, and Di-Calcium phosphate Anhydrate. The minimum drug loading achieved was 30 µg with a minimal variation (RSD) of <0.26%. The distribution of the API on the tablet surface and throughout the printed tablets were observed using SEM-EDS. In contrast, the micro-CT images of the printed tablets indicated the porous surface structure of the tablets. The immediate release properties of the printed tablets were determined using a dissolution study in a modified USP apparatus II.