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Pharmaceutical Manufacturing Handbook: Production and

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1140 TABLET COMPRESSION<br />

4. Estimation of the density distributions within a tablet that may infl uence dissolution<br />

or mechanical properties<br />

5. Estimation of the compaction force necessary to obtain tablets having given<br />

properties<br />

6. Taking into account the effect of the tablet material on the stress distribution<br />

on tooling to aid tool design<br />

7. Assessment of the origin of defect or crack formation<br />

8. Optimization of more complex compaction operations such as bilayer <strong>and</strong><br />

trilayer tablets or compression - coated tablets<br />

The demonstration of the validity of the continuum - based modelling approach<br />

to tablet compaction requires familiarity with fundamental concepts of applied<br />

mechanics. Under the theory of such a mechanism, powder compaction can be<br />

viewed as a forming event during which large irrecoverable deformation takes place<br />

as the state of the material changes from loose packing to near full density. Moreover,<br />

it is important to defi ne the three components of the elastoplastic constitutive<br />

models which arose from the growing theory of plasticity, that is the deformation<br />

of materials such as powder within a die:<br />

1. Yield criterion , which defi nes the transition of elastic to plastic deformation<br />

2. Plastic fl ow potential , which dictates the relative amounts of each component<br />

of plastic fl ow<br />

3. Evolution of microstructure , which in turn defi nes the resistance to further<br />

deformation<br />

It is also known that the compression process can be described using static <strong>and</strong><br />

dynamic models. In the case of static models, time is not considered, although it is<br />

a very important factor in the deformation process. The viscoelastic reactions are<br />

time dependent, especially for the plastic fl ow.<br />

Recently Picker [21] proposed a three - dimensional (3D) model to help explaining<br />

the densifi cation <strong>and</strong> deformation mechanism experienced by differently deforming<br />

materials during compression. According to the author, a single description of<br />

the processes during tableting is possible, <strong>and</strong> thus densifi cation <strong>and</strong> deformation<br />

properties can be clearly distinguished with a single model. This issue has been<br />

investigated over the last years, <strong>and</strong> a comprehensive approach has been developed<br />

for the analysis of compaction using continuum mechanics principles. This approach<br />

is based on the following components:<br />

1. Equilibrium equations (balance of forces transmitted through the material)<br />

2. Continuity equation (conservation of mass)<br />

3. Geometry of problem<br />

4. Constitutive behavior of powder (stress – strain behavior)<br />

5. Boundary conditions, including loading (e.g., displacement <strong>and</strong> velocity) <strong>and</strong><br />

friction between tooling <strong>and</strong> powder<br />

6. Initial conditions (e.g., initial relative density of powder)

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