TY - JOUR

T1 - Mechanistic modelling of the drying behaviour of single pharmaceutical granules

AU - Thérèse F.C. Mortier,Séverine

AU - Beer,Thomas De

AU - Gernaey,Krist

AU - Vercruysse,Jurgen

AU - Fonteyne,Margot

AU - Remon,Jean Paul

AU - Vervaet,Chris

AU - Nopens,Ingmar

PY - 2012

Y1 - 2012

N2 - The trend to move towards continuous production processes in pharmaceutical applications enhancesthe necessity to develop mechanistic models to understand and control these processes. This workfocuses on the drying behaviour of a single wet granule before tabletting, using a six-segmented fluidisedbed drying system, which is part of a fully continuous from-powder-to-tablet manufacturing line. Thedrying model is based on a model described by Mezhericher et al. [1] and consists of two submodels.In the first drying phase (submodel 1), the surface water evaporates, while in the second drying phase(submodel 2), the water inside the granule evaporates. The second submodel contains an empirical powercoefficient, b. A sensitivity analysis was performed to study the influence of parameters on the moisturecontent of single pharmaceutical granules, which clearly points towards the importance of b on the dryingbehaviour. Experimental data with the six-segmented fluidised bed dryer were collected to calibrateb. An exponential dependence on the drying air temperature was found. Independent experiments weredone for the validation of the drying model.

AB - The trend to move towards continuous production processes in pharmaceutical applications enhancesthe necessity to develop mechanistic models to understand and control these processes. This workfocuses on the drying behaviour of a single wet granule before tabletting, using a six-segmented fluidisedbed drying system, which is part of a fully continuous from-powder-to-tablet manufacturing line. Thedrying model is based on a model described by Mezhericher et al. [1] and consists of two submodels.In the first drying phase (submodel 1), the surface water evaporates, while in the second drying phase(submodel 2), the water inside the granule evaporates. The second submodel contains an empirical powercoefficient, b. A sensitivity analysis was performed to study the influence of parameters on the moisturecontent of single pharmaceutical granules, which clearly points towards the importance of b on the dryingbehaviour. Experimental data with the six-segmented fluidised bed dryer were collected to calibrateb. An exponential dependence on the drying air temperature was found. Independent experiments weredone for the validation of the drying model.

KW - Mechanistic modelling

KW - Drying

KW - Porous material

KW - Pharmaceutical granules

KW - Model calibration

KW - Model validation

U2 - 10.1016/j.ejpb.2011.12.010

DO - 10.1016/j.ejpb.2011.12.010

M3 - Journal article

VL - 80

SP - 682

EP - 689

JO - European Journal of Pharmaceutics and Biopharmaceutics

T2 - European Journal of Pharmaceutics and Biopharmaceutics

JF - European Journal of Pharmaceutics and Biopharmaceutics

SN - 0939-6411

ER -