Electronic Theses and Dissertations

Date of Award

8-1-2022

Document Type

Dissertation

Degree Name

Ph.D. in Pharmaceutical Sciences

First Advisor

Michael A. Repka

Second Advisor

Soumyajit Majumdar

Third Advisor

Samir A. Ross

School

University of Mississippi

Relational Format

dissertation/thesis

Abstract

Coupling hot-melt extrusion (HME) with fused deposition modeling (FDM) three-dimensional printing (3DP) is a cutting-edge manufacturing technique that allows the exact deposition of materials in consecutive layers to create bespoke objects. HME technology has piqued academic research and the pharmaceutical industry's attention as a solvent-free continuous process for several pharmaceutical applications. It is possible to employ this technology alone/alongside other current technologies to produce new pharmaceuticals for various applications. The FDA has approved several HME commercial products for different pharmaceutical applications. HME and FDM 3D printing could open the door to a new era of pharmaceutical manufacturing. 3D printing has evolved into a novel and powerful tool for precisely fabricating specifically customized dosage forms and disease modeling. FDM is now the most popular, affordable, and frequently explored 3D printing technology in pharmaceutical research. It has the potential to be adopted in the near future in pharmacies for in-house production (patient-centered medicines) and by the pharmaceutical industry. The overall aim of these investigations is to fabricate different dosage forms for various routes of administration, such as fixed-dose combination (FDC) tablets for hypertension treatment and ocular inserts for topical ocular applications. A thorough investigation of the potential of merging HME with 3D printing technologies for patient-focused medication development has been conducted. The release kinetics and correlation of the drug release to the structure of 3D printed tablets have been investigated due to the highly tailored structure, providing a full understanding of the in vitro drug release mechanisms and kinetics from the 3D printed pharmaceutical dosage forms. Following a series of HME and 3D printing experiments, the oral fixed-dose combination and ocular inserts were optimized using a unique 3D structure design that is both rapidly effective and maintains a long therapeutic duration sequentially.

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