Non-Dispersive Reaction and Separation Processes for Pharmaceutical Synthesis

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 build a Phase I reactor system prototype develop methods for demonstration of pharmaceutical syntheses optimize process parameters to achieve high throughput conversion and product recovery and 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 PUBLIC HEALTH RELEVANCE The synthesis of pharmaceutical products is commonly carried out via highly complex procedures that many times require multi phase reactions washing and recovery processes to achieve the desired product with high yield and purity These multi phase processes bring about a number of difficulties from the standpoint of industrial scale production The proposed project aims to provide a versatile process that can be used for continuous manufacture of pharmaceutical precursors and drugs in a simple configuration that is compatible with industrial implementation Successful completion of this project would result in a low lost high throughput and commercially viable platform process for multi phase pharmaceutical syntheses that could be adopted in current or prospective Randamp D and large scale facilities