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Modeling the Formation of Debossed Features on a Pharmaceutical Tablet

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Abstract

Purpose

The objective of this work was to develop, validate, and implement a modeling methodology for predicting the shape and relative density fields in the vicinity of debossed features on a tablet surface. The resulting model was used to investigate the influence of debossed feature stroke angle and degree of pre-pick, which is expressed as a percentage of the stroke depth, as well as the influence of formulation lubricant on the aforementioned debossed feature parameters.

Methods

An experimental procedure for measuring formulation (modified) Drucker–Prager Cap parameters is described. These parameters are used in a finite element method simulation that models the formation of a debossed surface feature on a tablet. Techniques for validating the simulation and post-processing the results are also described.

Results

The stroke angle and degree of pre-pick significantly influence the debossed feature dimensions, with larger degrees of pre-pick and stroke angles giving debossed features that more closely match the target (embossment) values. Lubrication plays a much weaker role, but did improve the fidelity of the debossed feature slightly. The differences between the debossed and target feature dimensions are due to elastic spring back of the material. The tablet relative density is smallest at the shoulders of the debossed feature and largest at the base of the valley. Although the relative density fields show no obvious trends with stroke angle, the fields are clearly more uniform as the degree of pre-pick increases. The addition of lubricant to the formulation also improves the relative density field uniformity for larger degrees of pre-pick.

Conclusions

To improve feature fidelity and decrease the likelihood of damage, larger pre-picks, larger stroke angles, and the addition of a formulation lubricant should be used.

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Acknowledgments

The authors would like to thank Chuck Kettler and Bill Turner from Natoli Engineering for their helpful suggestions and for providing the tool used in the experimental studies. The authors would also like to thank Eli Lilly and Company for providing funding to support this work.

Author information

Authors and Affiliations

  1. School of Mechanical Engineering, Purdue University, West Lafayette, IN, 47907-2088, USA

    Shrikant Swaminathan & Carl Wassgren

  2. Eli Lilly & Company, Corporate Center, Indianapolis, IN, 46285, USA

    Jon Hilden & Brian Ramey

  3. Department of Industrial and Physical Pharmacy (by courtesy), Purdue University, West Lafayette, IN, 47907-2091, USA

    Carl Wassgren

Authors
  1. Shrikant Swaminathan
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  2. Jon Hilden
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  4. Carl Wassgren
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Corresponding author

Correspondence to Carl Wassgren.

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Swaminathan, S., Hilden, J., Ramey, B. et al. Modeling the Formation of Debossed Features on a Pharmaceutical Tablet. J Pharm Innov 11, 214–230 (2016). https://doi.org/10.1007/s12247-016-9257-6

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  • DOI: https://doi.org/10.1007/s12247-016-9257-6

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