Master of Science in Pharmaceutical Science (MSP), University of Toledo, 2021, Pharmaceutical Sciences (Industrial Pharmacy)

Patient-specific medicine is a growing area of treatment in the healthcare sector and additive manufacturing, or 3D printing technology is a recent pharmaceutical approach to confront the challenge of this individualized drug delivery system. The focus of this study was to investigate the feasibility of formulating a 3D printed personalized dosage form using fused deposition modelling (FDM) in combination with hot-melt extrusion (HME) process. Acetaminophen was selected as a model drug and a commercial polyvinyl alcohol (PVA) filament was used to fabricate 3D printed tablets with two different drug loading percentages. After screening several polyvinyl alcohols (PVA), the commercial PVA filament was selected to enhance the extrusion process. 5% and 15% acetaminophen loaded filaments were successfully extruded through a filament extruder and tablets were printed using an FDM 3D printer. Thermal analysis using DSC and TGA confirmed the thermal stability of 3D printed tablets. No endothermic events corresponding to acetaminophen were observed in the DSC thermograms of drug-loaded filaments and tablets indicating that the drug was amorphously dispersed in PVA. With TGA, the drug-loaded filaments and tablets did not show any appreciable weight loss at the printing temperature of 240 ˚C suggesting that the polymer was stabilizing the drug. Molecular interactions of acetaminophen and PVA on drug-loaded tablets were verified through FTIR analysis. SEM micrographs of cross-sectioned drug-loaded filaments appeared to have a rough surface in compare to the commercial PVA filament due to the inclusion of acetaminophen, which was consistent with the drug-loaded tablets as well. Physical and mechanical characterization was performed according to mandated standards. The 3D printed tablets passed the weight variation, friability, thickness, dimensions, and breaking force tests with minimal outliers. Drug content loss was analyzed using a validated HPLC method. HPLC data demonstrat (open full item for complete abstract)

Committee: Jerry Nesamony (Committee Chair); Joseph Lawrence (Committee Member); Gabriella Baki (Committee Member) Subjects: Pharmaceuticals; Pharmacy Sciences