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A novel approach to modelling
of tablet film-coating
Michael Lu, Joy Phophichitra
Dr Axel Zeitler
Motivation
Coated tablets are the dominant drug dosage form
Benefits: protect drug, mask taste, uniformity,
appearance, release profile
Batch process: Tablets are sprayed in a rotating drum
Complex multi-parameter system
Motivation
Many problems occur on a regular basis
Motivation
Better process understanding – basis for future process
improvement
Benefits of improved modelling:
Manufacturer - reduce expensive and time-consuming
trials
Regulator - compliance with FDA’s recent “quality by
design” initiative
Weaknesses of
Current approaches
Thermodynamic
models
Empirical
studies
Discrete element
model (DEM)
simulations
Limited
predictive power
No description of
film-forming
phenomena
Semi-empirical
Cannot translate
between coating
units
Many trials required
Most papers
concentrate on
isolated aspects
Large
computational
expense
Ray-tracing
spray coating
algorithm
Novel approach
“An all-encompassing model for film coating has not been
developed yet. In fact, one probably never will be.”
Ebey, 1987
Entire process had never been combined before:
Demonstrates holistic approach is possible
Links macroscale parameters to microstructural
processes
Large scope for further work and collaboration

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RP-Presentation-v1.5

  • 1. A novel approach to modelling of tablet film-coating Michael Lu, Joy Phophichitra Dr Axel Zeitler
  • 2. Motivation Coated tablets are the dominant drug dosage form Benefits: protect drug, mask taste, uniformity, appearance, release profile Batch process: Tablets are sprayed in a rotating drum Complex multi-parameter system
  • 3. Motivation Many problems occur on a regular basis
  • 4. Motivation Better process understanding – basis for future process improvement Benefits of improved modelling: Manufacturer - reduce expensive and time-consuming trials Regulator - compliance with FDA’s recent “quality by design” initiative
  • 5. Weaknesses of Current approaches Thermodynamic models Empirical studies Discrete element model (DEM) simulations Limited predictive power No description of film-forming phenomena Semi-empirical Cannot translate between coating units Many trials required Most papers concentrate on isolated aspects Large computational expense Ray-tracing spray coating algorithm
  • 6. Novel approach “An all-encompassing model for film coating has not been developed yet. In fact, one probably never will be.” Ebey, 1987
  • 7. Entire process had never been combined before: Demonstrates holistic approach is possible Links macroscale parameters to microstructural processes Large scope for further work and collaboration