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Lamination of biconvex tablets: Numerical and experimental study
Vincent Mazel1, Harona Diarra1, Jérôme Malvestio1
1Université de Bordeaux, CNRS, I2M Bordeaux, 146 rue Léo Saignat, 33000 Bordeaux, France.
International Journal of Pharmaceutics
|March 13, 2018
Summary
This study investigates pharmaceutical tablet lamination, a common manufacturing defect. Central tensile stresses, influenced by residual die pressure and tablet shape, promote lamination, potentially leading to undetected internal cracks.
Area of Science:
- Pharmaceutical manufacturing
- Materials science
- Mechanical engineering
Background:
- Capping and lamination are prevalent industrial issues in pharmaceutical tablet production.
- These defects represent distinct failure modes with unique cracking mechanisms.
Purpose of the Study:
- To investigate a specific type of lamination in biconvex tablets.
- To understand the underlying mechanisms and contributing factors to this failure mode.
Main Methods:
- Finite element method (FEM) simulations were employed to model stress distribution.
- Experimental studies were conducted to validate simulation hypotheses.
- X-ray tomography was used for non-destructive internal crack observation.
Main Results:
- FEM simulations indicated tensile stresses at the tablet center promote lamination, exacerbated by residual die wall pressure and tablet geometry.
- Reduced band thickness and high compaction pressure were identified as favoring factors.
- X-ray tomography revealed internal cracks, often undetectable visually.
Conclusions:
- Tablet lamination in biconvex tablets is linked to central tensile stresses, residual die pressure, and tablet shape.
- Internal cracks may form without external signs, posing a risk for post-compaction failure.
- Consideration of these internal defects is crucial during pharmaceutical tablet development.
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