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

De Leersnyder, F.; Vanhoorne, V.; Bekaert, H.; Vercruysse, J.; Ghijs, M.; Bostijn, N.; Verstraeten, M.; Cappuyns, P.; Van Assche, I.; Vander Heyden, Y.; Ziemons, Eric; Remon, J. P.; Nopens, I.; Vervaet, C.; De Beer, T.

doi:10.1016/j.ejps.2018.01.037

Article (Scientific journals)

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

De Leersnyder, F.; Vanhoorne, V.; Bekaert, H. et al.

2018 • In European Journal of Pharmaceutical Sciences, 115, p. 223-232

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/221235

DOI
10.1016/j.ejps.2018.01.037

PubMed
29374528

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Keywords :

Continuous manufacturing; Critical quality attributes; Fluid bed drying; Moisture content; Particle size distribution; Process understanding; Twin screw granulation

Abstract :

[en] 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. © 2018

Research Center/Unit :

CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège

Disciplines :

Pharmacy, pharmacology & toxicology

Author, co-author :

De Leersnyder, F.; Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium

Vanhoorne, V.; Laboratory of Pharmaceutical Technology, Ghent University, Belgium

Bekaert, H.; Laboratory of Pharmaceutical Technology, Ghent University, Belgium

Vercruysse, J.; Laboratory of Pharmaceutical Technology, Ghent University, Belgium

Ghijs, M.; BIOMATH, Department of Mathematical Modelling, Statistics and Bioinformatics, Ghent University, Belgium

Bostijn, N.; Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium

Verstraeten, M.; Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium

Cappuyns, P.; Department of Pharmaceutical Development, Johnson & Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium

Van Assche, I.; Department of Pharmaceutical Development, Johnson & Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium

Vander Heyden, Y.; Department of Analytical Chemistry and Pharmaceutical Technology, VUB, Belgium

More authors (5 more)

Language :

English

Title :

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

Publication date :

20 January 2018

Journal title :

European Journal of Pharmaceutical Sciences

ISSN :

0928-0987

eISSN :

1879-0720

Publisher :

Elsevier B.V.

Volume :

115

Pages :

223-232

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 12 March 2018

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