Electronic Theses and Dissertations

Date of Award


Document Type


Degree Name

Ph.D. in Pharmaceutical Sciences


Pharmaceutics and Drug Delivery

First Advisor

Michael Repka

Second Advisor

Seong Bong Jo

Third Advisor

Chalet Tan

Relational Format



Amorphous solid dispersion (ASD) has been well known as a potential strategy to improve the bioavailability and dissolution performance of poorly water-soluble drugs. The primary concern of this approach is the long-term stability of the amorphous drug in the solid dispersion. Accurate prediction and detection of the solubility and miscibility of drugs in polymeric binary systems will be a milestone in the development of ASDs. In Chapter Ⅰ, a method based on Flory-Huggins (F-H) theory was proposed to predict and calculate the solubility and miscibility of the drug in the polymeric matrix and construct the phase diagram to identify the relevance between drug loading and temperature for ASDs development. For further validation, formulations were developed using HME to verify the accuracy of the phase diagram and to get in the hot-melt extrusion (HME) process design space and optimization. Chapter Ⅱ aimed to investigate the impacts of HME processing parameters by the design of experiment (DoE) for the poorly water-soluble compound. This study presents a simple, novel, and three-level factorial design to evaluate each condition’s effect and explore the optimized formulation. Barrel temperature and screw speed were the most affected parameters in this research. The primary objective of Chapter Ⅲ was to combine fused deposition modeling (FDM) 3D printing with HME technology to explore the effect of manufacturing tablets with different densities and designs. These tablets are designed with an outer shell and inner core. HME technology causes some crystalline drugs to change form into an ASD during the processes used. Overall, this work illustrated the impacts of changing a printed tablet’s filling density as a strategy to control the drug release performance for 3-dimentional (3D) printed dosages and the possibility of HME coupling 3D printing technology to prepare ASDs.

Available for download on Thursday, August 15, 2024