A Model-Based Methodology for Spray-Drying Process DevelopmentJournal of Pharmaceutical Innovation September 2009 Volume 4 Number 3This article describes a new methodology based on fundamental engineering models as well as technical characterization processes to ensure that the spray drying process is efficient and requires minimal time and API. Spray drying methods use rapid drying kinetics to produce solid amorphous dispersions, excipients and encapsulation. Spray drying dispersions are used to increase the bioavailability of poorly soluble APIs. SDD formulations include polymers that increase the stability of the amorphous form so that the solubility of the drug can be increased. This new methodology has the advantage of minimizing API usage during process development, reducing process development time, and ensuring process robustness during technology transfer to clinical manufacturing. This method describes specific steps based on flow rates, thermodynamics and drying kinetics to produce a more efficient spray drying process. It is particularly effective for process development and bypasses the iterative design of experiments (DOE) method for spray drying process development. The typical spray drying process begins when a spray solution is delivered to an atomizer in a spray drying chamber along with hot water. drying gas. Spray solutions consist of APIs and polymers dissolved in a solvent. This solution is atomized into droplets using a spray nozzle. There are an assortment of nozzles that can be used in this process, including dual-fluid, ultrasonic, rotary, and pressure nozzles. The advantage of using a pressure nozzle is that it allows for scalability and droplet size adjustment. When the droplets from the spray do...... middle of paper ...... ge of the physicochemical properties of drugs such as HPMCAS, thus making the first stage of screening more effective. This method must also integrate experiments that correlate the theoretical parameters given by the computer models with the parameter actually observed during the process. Work cited: Dobry, DE, Settell, DM, Baumann, JM, Ray, RJ, Graham, LJ and Beyerinck, R.A. (2009). A model-based methodology for spray drying process development. Journal of Pharmaceutical Innovation, 4(3), 133-142. Friesen, D.T., Shanker, R., Crew, M., Smithey, D.T., Curatolo, W.J., & Nightingale, J.A. (2008). Spray-dried dispersions based on hydroxypropyl methylcellulose acetate succinate: an overview. Molecular Pharmaceuticals, 5(6), 1003-1019.Vehring, R. (2008). Pharmaceutical particle engineering via spray drying. Pharmaceutical research, 25(5), 999-1022.