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Scale-up methodology for pharmaceutical spray drying

MARCO GIL, JOÃO VICENTE, FILIPE GASPAR*
*Corresponding author
Hovione FarmaCiencia SA, Particle Design Discipline R&D, Sete Casas, Loures, 2674-506, Portugal

Abstract

The use of spray drying in the pharmaceuticalindustry is growing at a fast pace. The need for robustscale-up methods is essential in order to control criticalquality attributes and improve powder properties duringdrug development. Moreover, poor scale-up is likely tolead to considerable losses of expensive materials. Processunderstanding and simulation is a very powerful tool tosupport the scale-up of spray drying processes. A scale-upmethodology based on scientific principles is proposed in thisstudy. The method is divided in two steps: thermodynamicand atomization & particle formation. The method isrelatively straightforward to apply and has been tested innumerous spray-dried formulations across all productionscales. An illustrative example is also shown covering themain steps of the proposed methodology.


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