Defense Date

2021

Document Type

Dissertation

Degree Name

Doctor of Philosophy

Department

Pharmaceutical Sciences

First Advisor

Dr. Thomas D. Roper

Second Advisor

Dr. Sandro da Rocha

Third Advisor

Dr. James K. Ferri

Fourth Advisor

Dr. Qingguo Xu

Fifth Advisor

Dr. Guizhi Zhu

Abstract

Pharmaceuticals have been synonymously manufactured in a centralized, batch mode with less attention to process and formulation understanding. However, due to rising drug costs, shortages, and robustness issues, in addition to the alarming lack of flexibility and agility, regulatory agencies have pushed towards switching to continuous processes. They believed in continuous manufacturing, providing cleaner, flexible, and more efficient processes. Hence, it was foreseen to reduce development and manufacturing costs, time, and environmental impact and ensured drug product quality. Over the last two decades, continuous manufacturing quality, environmental, and economic advantages have been evident through many case studies and approved products reaching the market. However, up till now, all the developed platforms and approved products have implemented continuous processes partially in one or two steps in centralized-based manufacturing. Centralized manufacturing is based on active pharmaceutical ingredients and drug products manufactured at different sites, spanning continents. These world travelers are vulnerable to myriad disruptions and stability issues.

Therefore, this Ph.D. project was concentric on two main objectives: first, establish the formulation and manufacturing process for the first-ever end-to-end continuously manufactured ciprofloxacin tablets using the novel portable Pharmacy on Demand platform. The research was targeted towards tackling API-related challenges that hinder continuous pharmaceutical manufacturing. The developed formulation and entire drug product manufacturing process are part of an upcoming filing of an abbreviated new drug application with the FDA. Second, explore the advantages of continuous manufacturing compared to batch in a less studied area, hydrophilic drugs encapsulation in polymeric particles using a relatively novel platform, microfluidics, with metformin hydrochloride used as a model drug.

Rights

© The Author

Is Part Of

VCU University Archives

Is Part Of

VCU Theses and Dissertations

Date of Submission

8-12-2021

Available for download on Tuesday, August 11, 2026

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