A Model-Based Methodology for Spray Drying Process Development

A Model- Based Methodology for Spray Drying Process Development

Journal of Pharmaceutical Innovation September 2009 Volume 4 Issue 3

This paper describes a novel methodology based on fundamental engineering models as well as process characterization techniques 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 bioavailability of poorly soluble APIs. SDDs formulations include polymers that increase stability of the amorphous form so that the solubility of the drug can be increased. This novel methodology has the advantage of minimizing API usages during process development, reducing process development time and ensuring process robustness during technology transfer to clinical manufacturing. This method outlines specific steps based on flow rates, thermodynamics and drying kinetics to produce a more efficient process for spray drying. It is particularly efficient for process development and circumvents the iterative design of experiment (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 at the same time as hot drying gas. Spray solutions consist of API 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 two-fluid, ultrasonic, rotary, and pressure nozzles. The advantage of using a pressure nozzle is that it allows for scalability and the tuning of droplet size. When droplets from the spray no...

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...ge of physicochemical properties of drugs such as HPMCAS, thus making the first screening step more efficient. This method should also incorporate experiments that correlate the theoretical parameters given by computer models with the parameter actually seen during the process.

Work Cited:

Dobry, D. E., Settell, D. M., Baumann, J. M., Ray, R. J., Graham, L. J., & 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). Hydroxypropyl Methylcellulose Acetate Succinate-Based Spray-Dried Dispersions: An Overview. Molecular pharmaceutics, 5(6), 1003-1019.

Vehring, R. (2008). Pharmaceutical Particle Engineering via Spray Drying. Pharmaceutical Research, 25(5), 999-1022.