Download Characterization of compaction behaviour of powders in solid

Characterization of Compaction Behaviour of
Powders in Solid-Dosage Manufacturing Using
Finite Element Analysis
A. Kumar1,2, J Dhondt2,3, J. Bertels3, D. Klingeleers3, K.V. Gernaey4, I. Nopens1, T. De
Beer2,
1. BIOMATH, Dept. of Mathematical Modelling, Statistics and Bioinformatics, Faculty of
Bioscience Engineering, Ghent University, Belgium
2. Laboratory of Pharmaceutical Process Analytical Technology, Dept. of Pharmaceutical
Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Belgium
3. Pharmaceutical Research and Development, Division of Janssen Pharmaceutica,
Johnson & Johnson, Belgium
4. CAPEC-PROCESS Research Center, Department of Chemical and Biochemical
Engineering, Technical University of Denmark, Denmark
Email for correspondence: [email protected]
Powder compaction is an essential step in pharmaceutical solid-dosage
manufacturing, irrespective of the chosen path for powder pre-processing. The
compaction changes the structure of material from a loose arrangement of particles
with various shapes and sizes to a condensed structure that behaves like a continuum.
An optimised compaction process is necessary to ensure production of high-quality
tablets. Experimentally determining the effects of involved parameters and
subsequent optimization of the compaction process is very difficult and expensive for
this process, as tablets contain the expensive drug substance. Therfore, numerical
simulation of the compaction process based on Finite Element Analysis (FEA) is
suggested. The FEA is used for calculating forces, deformations, stresses and strains
throughout a bonded structure, which is later used to ensure the formation of compact
material with uniform density, free from cracks or chips. Hence, these simulations
provide a detailed and cost-effective means of understanding and predicting the
compaction profiles of the formulation material based on the processing parameters,
such as imposed pressure, relative density of the powder and die shape.
In this study, the mechanical properties of a range of pharmaceutical formulations
were approximated using the modified Drucker-Prager Cap (DPC) plasticity model and
applied for FEA. The DPC model parameters were varied depending on the local
relative density using an external subroutine. Additionally, the effect of wall friction on
the mechanical behaviour of different formulation compacts during compaction is
explored. This numerically predicted density distribution is compared with
experimental measurements. The verification results are important for establishing a
predictive capability of this model. The results from this study contribute to a better
understanding of the impact of powder properties and process settings on the
tabletting process and final properties of the produced tablet.