GOALI: Continuous Coating of Ultrafine Drug Particles by Heterogeneous Polymer Nucleation in a Hollow Fiber Membrane Module

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This Grant Opportunity for Academic Liaison with Industry (GOALI) Program award provides funding for developing a new method for continuous film coating of nano-sized drug particles to produce large amounts of individually coated particles having a desired layer of a biodegradable polymer coating. The coating method utilizes hollow fiber membrane devices employing either cooling crystallization and/or antisolvent crystallization. Both designs will enable controlled precipitation of a dissolved polymer from solution onto nanoparticles in suspension by heterogeneous polymer nucleation. A model system consisting of silica nanoparticles will be suspended in an organic solvent containing the dissolved polymer such as Eudragit or PLGA. Such a solution, with or without other additives such as surfactants to prevent agglomeration, will be subjected to polymer precipitation onto the nanoparticle surface to form an appropriate film coating. The hollow fiber devices should allow continuous processing of polymer coating of the model systems and will be tested with pharmaceutically relevant systems supplied by the industrial partner Bristol-Myers Squibb (BMS). The polymer coatings will be characterized by SEM, EDX and TEM-EELS electron microscopic techniques; mathematical models will be developed to predict the heterogeneous nucleation-driven coating processes. The polymer coating enables the drug release in a sustained/controlled manner, improves drug bioavailability and patient compliance by reducing the drug administration frequency, allows nano-sized drugs particles to overcome a mucus barrier and target specific body organs, and prevents immune cells (macrophages) from engulfing and eliminating nano-sized drug particles in the bloodstream.If successful, this research will develop a continuous, scalable, nanoparticle coating system that can produce large quantities of polymer-coated nanoparticles while operating at temperatures and pressures far closer to ambient than those relying on supercritical fluids. Such a process should find widespread application in the pharmaceutical and other industries. Working in partnership with BMS, these processes will be scaled-up and commercialization possibilities will be explored.