Continuous single-step wet granulation with integrated in-barrel-drying

Aug. 1, 2018, midnight - by Adrian Schmidt , Hans de Waard , Peter Kleinebudde , Markus Krumme

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Objective: This study aimed to explore the feasibility of integrating continuous wet granulation and drying into a twin-screw granulator, with the objective of producing (pre-)dried granules in a single-step process known as in-barrel-drying. Methods: To establish a consistent and reliable material propulsion mechanism, the twin-screw granulator was divided into two compartments. One compartment operated at a lower temperature for granulation and material pre-heating, while the other operated at a very high temperature to expedite the evaporation of the granulation liquid. Design of experiments was employed for a detailed investigation of the in-barrel-drying process. The study also compared the process with traditional fluidized-bed drying in the context of twin-screw wet granulation with API suspension feed. The impact of the process on granule and compact properties was assessed to understand its effects on product quality. Results: The study demonstrated the feasibility of in-barrel-drying, producing thoroughly dried and granulated material under specific settings. Key parameters identified for balancing the process's evaporation capacity and material throughput included the evaporation zone temperature and the processed mass of water. Granules and compacts exhibited acceptable product quality. Conclusions: In-barrel-drying provides an opportunity to consolidate the wet granulation and drying process steps into a single piece of equipment, potentially reducing or eliminating the need for downstream drying processes.

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Continuous single-step wet granulation with integrated in-barrel-drying

fluid bed api suspension feed fluidised-bed drying telescoped process twin-screw wet granulation stylone active pharmaceutical ingredients styl'one evo design of experiments