Date of Completion

1-31-2020

Embargo Period

1-30-2022

Keywords

Pharmaceutical Dosage, 3D prnting, Tablet dosage form, Inkjet-based, Binder-jet

Major Advisor

Bodhi Chaudhuri

Associate Advisor

Diane Burgess

Associate Advisor

Robin Bogner

Associate Advisor

Xiuling Lu

Associate Advisor

Anson Ma

Field of Study

Pharmaceutical Science

Degree

Doctor of Philosophy

Open Access

Campus Access

Abstract

Binder-jet 3D printing (BJ-3DP) process has been extensively used in rapid prototyping, mostly in the ceramic industry until 2015, when the first FDA approved 3D printed tablet Spritam® became commercially available. Since then, the interest in the pharmaceutical dosage development using BJ-3DP has amplified, which obliges to improve fundamental understanding of the printing process to optimize dosage development and manufacturing process. This study provides a basic understanding of the overall printing process along with the necessary considerations one needs to make while manufacturing a formulation dosage form using BJ-3DP printing process. This research implements a process to streamline the pre-formulation study phase of 3D printed dosage development. This study explores the critical effect of the raw materials onto the printed dosage form. This work also implements a screening step (drop test) to gain prior knowledge about the raw materials compatibility in the manufacturing process. This research investigates the critical aspects one needs to consider in the formulation development phase from a pharmaceutical stability perspective. Finally, the statistical model used in this study reveals the correlation between the screening step and raw materials attributes onto the printed dosage product. The result achieved from this work shows the governing factors responsible for the critical attributes of the printed tablet and the printing process, which will potentially be helpful in formulation development using BJ-3DP for future interested researchers/organizations.

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