(126g) Starting the Road to Commercialization: Pharmacy on Demand (POD) Ciprofloxacin

Unfortunately, both the cost and supply gaps of medicine are increasing. There are on average 200 active drug shortages nationally each year. Lengthy supply chains, limited numbers of manufacturers (commodity chemicals and drug product), and surges in demand are some of the more prominent causes of drug shortages. This lack of responsiveness, uncertainty, and diversity create pressure for drug suppliers, hospitals, and care givers to provide in time medication.

Through the lifetime of the Pharmacy on Demand (POD) initiative, researchers have worked toward addressing these chemical and economic inefficiencies associated with “typical” large-scale batch pharmaceutical manufacturing. Substantial advances in complex reaction telescoping, real time formulation, reaction engineering and pumping technologies have enabled the design, construction and implementation of a compact and reconfigurable platform. Tight control of process inputs and the implementation of in-line process analytical technologies enabled high volumes of APIs (Atropine, Diphenhydramine, Ciprofloxacin, Diazepam, Doxycycline, and Lidocaine to name but a few) to be manufactured over a four-week manufacturing campaign.

This production campaign served as a demonstration of these platforms ability to produce multiple API in one equipment train. However, to move towards the potential commercial realization of such platforms, it was thought prudent to select only one API, in this case Ciprofloxacin (a broad spectrum anti-biotic used to treat a wide spectrum of infections, most notably anthrax exposure) and target of filing an Abbreviated New Drug Application (ANDA) with the FDA.

The goal of this phase of the project was to create a platform/process capable of the end-to-end production of Ciprofloxacin HCl from commercially available starting materials to final oral solid dose. This platform/process had to be capable of meeting current Good Manufacturing Practices (cGMP) whilst producing material that would pass United States Pharmacopeia (USP) specifications for Ciprofloxacin HCl. Design of experiments, residence time distributions etc. were completed to aid in the process characterization, development, and optimization work required for the pharmaceutical development phase.