TY - JOUR T1 - Breakage and drying behaviour of granules in a continuous fluid bed dryer: Influence of process parameters and wet granule transfer. AU - De Leersnyder,F, AU - Vanhoorne,V, AU - Bekaert,H, AU - Vercruysse,J, AU - Ghijs,M, AU - Bostijn,N, AU - Verstraeten,M, AU - Cappuyns,P, AU - Van Assche,I, AU - Vander Heyden,Y, AU - Ziemons,E, AU - Remon,J P, AU - Nopens,I, AU - Vervaet,C, AU - De Beer,T, PY - 2017/09/28/received PY - 2017/12/12/revised PY - 2018/01/20/accepted PY - 2018/1/29/pubmed PY - 2018/8/25/medline PY - 2018/1/29/entrez KW - Continuous manufacturing KW - Critical quality attributes KW - Fluid bed drying KW - Moisture content KW - Particle size distribution KW - Process understanding KW - Twin screw granulation SP - 223 EP - 232 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 115 N2 - Although twin screw granulation has already been widely studied in recent years, only few studies addressed the subsequent continuous drying which is required after wet granulation and still suffers from a lack of detailed understanding. The latter is important for optimisation and control and, hence, a cost-effective practical implementation. Therefore, the aim of the current study is to increase understanding of the drying kinetics and the breakage and attrition phenomena during fluid bed drying after continuous twin screw granulation. Experiments were performed on a continuous manufacturing line consisting of a twin-screw granulator, a six-segmented fluid bed dryer, a mill, a lubricant blender and a tablet press. Granulation parameters were fixed in order to only examine the effect of drying parameters (filling time, drying time, air flow, drying air temperature) on the size distribution and moisture content of granules (both of the entire granulate and of size fractions). The wet granules were transferred either gravimetrically or pneumatically from the granulator exit to the fluid bed dryer. After a certain drying time, the moisture content reached an equilibrium. This drying time was found to depend on the applied airflow, drying air temperature and filling time. The moisture content of the granules decreased with an increasing drying time, airflow and drying temperature. Although smaller granules dried faster, the multimodal particle size distribution of the granules did not compromise uniform drying of the granules when the target moisture content was achieved. Extensive breakage of granules was observed during drying. Especially wet granules were prone to breakage and attrition during pneumatic transport, either in the wet transfer line or in the dry transfer line. Breakage and attrition of granules during transport and drying should be anticipated early on during process and formulation development by performing integrated experiments on the granulator, dryer and mill. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/29374528/Breakage_and_drying_behaviour_of_granules_in_a_continuous_fluid_bed_dryer:_Influence_of_process_parameters_and_wet_granule_transfer_ DB - PRIME DP - Unbound Medicine ER -