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Modeling of Semicontinuous Fluid Bed Drying of Pharmaceutical Granules With Respect to Granule Size.

Abstract：

:In the transition of the pharmaceutical industry from batchwise to continuous drug product manufacturing, the drying process has proven challenging to control and understand. In a semicontinuous fluid bed dryer, part of the ConsiGma™ wet granulation line, the aforementioned production methods converge. Previous research has shown that the evolution of moisture content of the material in this system shows strong variation in function of the granule size, making the accurate prediction of this pharmaceutical critical quality attribute a complex case. In this work, the evolution of moisture content of the material in the system is modeled by a bottom-up approach. A single granule drying kinetics model is used to predict the moisture content evolution of a batch of material of a heterogeneous particle size, where it is the first time that the single granule drying mechanism is validated for different granule sizes. The batch approach was validated when the continuous material inflow rate and filling time of the dryer cell are constant. The original single granule drying kinetics model has been extended to capture the granules' equilibrium moisture content. Finally, the influence of drying air temperature is captured well with a droplet energy balance for the granules.

journal_name

J Pharm Sci

journal_title

Journal of pharmaceutical sciences

authors

Ghijs M,Schäfer E,Kumar A,Cappuyns P,Van Assche I,De Leersnyder F,Vanhoorne V,De Beer T,Nopens I

doi

10.1016/j.xphs.2019.01.013

subject

Has Abstract

pub_date

2019-06-01 00:00:00

pages

2094-2101

issue

6

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(19)30028-0

journal_volume

108

pub_type

杂志文章

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