Research Project
8833554
DESCRIPTION (provided by applicant): A number of pharmaceutical reactions and wash processes involve interaction between immiscible phases within reactors or extraction equipment. Multi-phase synthesis processes have been traditionally been carried out through dispersion of one of the phases into the other in the form of droplets. Such arrangement increases the surface area of interaction, thereby increasing the rate of mass transfer between the phases. Dispersions are undesirable in large- scale processes due to the need for high energy mixing, the presence of dead volume leading to unreacted reagents, and the need for time and energy-intensive separation processes to coalesce the phases for further recovery or treatment. More recently, engineered microreactors have been introduced as alternatives that can provide high surface-to-volume ratios for interphase interaction. Unfortunately, microreactors are best suited for laboratory scale processes as they require highly complex designs to maintain design parameters upon scale up. This high complexity can translate into downtime and less-than-optimal results in industrial scale pharmaceutical processes. This Phase I Small Business Technology Transfer (STTR) project focuses on the development of non-dispersive reaction and separation platform processes for pharmaceutical syntheses that will provide significant benefits to the industry. The main objectives of the Phase I project will e to: (1) build a Phase I reactor system prototype, (2) develop methods for demonstration of pharmaceutical syntheses, (3) optimize process parameters to achieve high throughput, conversion, and product recovery, and (4) prepare for Phase II by identifying parameters where optimization will be required, performing thorough market analysis, and establishing partnership with commercial collaborators. To achieve these aims, the team will utilize the proposed fiber reactor platform system for the synthesis of pharmaceutical reagents through N-alkylations, which are representative of many reactions utilized in pharmaceutical processes. Product streams will be characterized for the identity and purity of the products with standard analytical equipment. Completion of Phase I aims will demonstrate the versatility and benefits of the proposed nondispersive reactor platform in terms of throughput, conversion, and process control compared to batch processes, while pointing out the main aspects of process optimization required for successful commercialization. Successful completion of this project would result in an inexpensive, robust, easily-scalable platform technology that could be easily adopted by the pharmaceutical industry for the synthesis of fine reagents through multi-phase processes.
