Abstract
The drying unit of a continuous from-powder-to-tablet manufacturing line based on twin-screw granulation (TSG) is a crucial intermediate process step to achieve the desired tablet quality. Understanding the size reduction of pharmaceutical granules before, during, and after the fluid bed drying process is, however, still lacking. A first major goal was to investigate the breakage and attrition phenomena during transport of wet and dry granules, the filling phase, and drying phase on a ConsiGma-25 system (C25). Pneumatic transport of the wet granules after TSG towards the dryer induced extensive breakage, whereas the turbulent filling and drying phase of the drying cells caused rather moderate breakage and attrition. Subsequently, the dry transfer line was responsible for additional extensive breakage and attrition. The second major goal was to compare the influence of drying air temperature and drying time on granule size and moisture content for granules processed with a commercial-scale ConsiGma-25 system and with the R&D-scale ConsiGma-1 (C1) system. Generally, the granule quality obtained after drying with C1 was not predictive for the C25, making it challenging during process development with the C1 to obtain representative granules for the C25.
Highlights
Among the different techniques for continuous pharmaceutical manufacturing of solid-dosage forms, continuous direct compression (CDC) is the most preferred technique if the involved material and formulation properties allow CDC [1,2,3]
This allowed us to evaluate the granule size distribution at each location throughout the process, whereby the degree of breakage and attrition could be attributed to each individual unit of a horizontal ConsiGma-25 line
The effect of different drying parameters on final granule size, moisture content per size fraction, and overall moisture content was investigated. This allowed us to evaluate whether the drying behavior and resulting granule quality obtained with ConsiGma-1 was predictive for the ConsiGma-25
Summary
Among the different techniques for continuous pharmaceutical manufacturing of solid-dosage forms, continuous direct compression (CDC) is the most preferred technique if the involved material and formulation properties allow CDC [1,2,3]. An extensive investigation on the influence of drying process parameters on granule quality attributes and breakage behavior was performed by De Leersnyder et al [29] Both a horizontal and vertical set-up of the ConsiGma-25 was used in this study. Granules were collected after the granulation module, after the wet transfer line connecting the granulator and dryer, in each off the drying cells (i.e., at different drying times) and after the dry transfer line connecting the dryer with the mill This allowed us to evaluate the granule size distribution at each location throughout the process, whereby the degree of breakage and attrition could be attributed to each individual unit of a horizontal ConsiGma-25 line. The effect of different drying parameters on final granule size, moisture content per size fraction, and overall moisture content was investigated This allowed us to evaluate whether the drying behavior and resulting granule quality obtained with ConsiGma-1 was predictive for the ConsiGma-25. 200, DFE Pharma, Goch, Germany), microcrystalline cellulose
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