A pilot scale study on the fluidized bed binderless granulation of a humidified type C hygroscopic pharmaceutical material

The purpose of this research was to evaluate the technical feasibility of producing kilogramme batches using a previously reported lab-scale binderless fluidized bed granulation process for a hygroscopic and poor flowing type C powder. The process is scaled up in a pilot fluidized bed granulator with an internal diameter of 0.3 m using the same hygroscopic pharmaceutical material used for dry powder inhalers (DPIs). It was found that the moisture content in the powders can be controlled to within specifications by designing a drying step in the same equipment subsequent to fluidized bed granulation with wet air. The product quality in terms of improved flow properties, the desired particle morphology and size distribution were not affected with the additional drying step and were superior to the current commercial product. The aerosolization performance in terms of the fine particle fraction (FPF), which is critical for powder dispersion in DPIs, was also comparable to the current product.