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Breakage and drying behaviour of granules in a continuous fluid bed dryer : influence of process parameters and wet granule transfer

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Abstract
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.
Keywords
BIOMATH, Continuous manufacturing, Fluid bed drying, Critical quality attributes, Twin screw granulation, Process understanding, Particle size distribution, Moisture content, TWIN-SCREW GRANULATION, PHARMACEUTICAL-INDUSTRY, MOISTURE, LINE, FLOWABILITY, PERFORMANCE, VALIDATION, EXCIPIENTS, MASS

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Citation

Please use this url to cite or link to this publication:

Chicago
De Leersnyder, Fien, Valérie Vanhoorne, H Bekaert, Jurgen Vercruysse, Michael Ghijs, Nils Bostijn, Maxim Verstraeten, et al. 2018. “Breakage and Drying Behaviour of Granules in a Continuous Fluid Bed Dryer : Influence of Process Parameters and Wet Granule Transfer.” European Journal of Pharmaceutical Sciences 115: 223–232.
APA
De Leersnyder, F., Vanhoorne, V., Bekaert, H., Vercruysse, J., Ghijs, M., Bostijn, N., Verstraeten, M., et al. (2018). Breakage and drying behaviour of granules in a continuous fluid bed dryer : influence of process parameters and wet granule transfer. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 115, 223–232.
Vancouver
1.
De Leersnyder F, Vanhoorne V, Bekaert H, Vercruysse J, Ghijs M, Bostijn N, et al. Breakage and drying behaviour of granules in a continuous fluid bed dryer : influence of process parameters and wet granule transfer. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES. 2018;115:223–32.
MLA
De Leersnyder, Fien, Valérie Vanhoorne, H Bekaert, et al. “Breakage and Drying Behaviour of Granules in a Continuous Fluid Bed Dryer : Influence of Process Parameters and Wet Granule Transfer.” EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES 115 (2018): 223–232. Print.
@article{8581879,
  abstract     = {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.},
  author       = {De Leersnyder, Fien and Vanhoorne, Val{\'e}rie and Bekaert, H and Vercruysse, Jurgen and Ghijs, Michael and Bostijn, Nils and Verstraeten, Maxim and Cappuyns, P and Van Assche, I and Vander Heyden, Y and Ziemons, E and Remon, Jean Paul and Nopens, Ingmar and Vervaet, Chris and De Beer, Thomas},
  issn         = {0928-0987},
  journal      = {EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES},
  keyword      = {BIOMATH,Continuous manufacturing,Fluid bed drying,Critical quality attributes,Twin screw granulation,Process understanding,Particle size distribution,Moisture content,TWIN-SCREW GRANULATION,PHARMACEUTICAL-INDUSTRY,MOISTURE,LINE,FLOWABILITY,PERFORMANCE,VALIDATION,EXCIPIENTS,MASS},
  language     = {eng},
  pages        = {223--232},
  title        = {Breakage and drying behaviour of granules in a continuous fluid bed dryer : influence of process parameters and wet granule transfer},
  url          = {http://dx.doi.org/10.1016/j.ejps.2018.01.037},
  volume       = {115},
  year         = {2018},
}

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