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 enhances<br/>the necessity to develop mechanistic models to understand and control these processes. This work<br/>focuses on the drying behaviour of a single wet granule before tabletting, using a six-segmented fluidised<br/>bed drying system, which is part of a fully continuous from-powder-to-tablet manufacturing line. The<br/>drying model is based on a model described by Mezhericher et al. [1] and consists of two submodels.<br/>In the first drying phase (submodel 1), the surface water evaporates, while in the second drying phase<br/>(submodel 2), the water inside the granule evaporates. The second submodel contains an empirical power<br/>coefficient, b. A sensitivity analysis was performed to study the influence of parameters on the moisture<br/>content of single pharmaceutical granules, which clearly points towards the importance of b on the drying<br/>behaviour. Experimental data with the six-segmented fluidised bed dryer were collected to calibrate<br/>b. An exponential dependence on the drying air temperature was found. Independent experiments were<br/>done for the validation of the drying model.

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