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Formulation Optimization based on Modeling & Simulation for Transdermal Patch

In Silico trial to optimize formulation composition of transdermal patch for achieving bioequivalence


The Sponsor intended to modify the formulation composition based on the failed bioequivalence study. The Sponsor had performed a BA BE study and 90% CI was not within the range of 80% – 125%.  

Question of Interest

Could Modeling and Simulation propose a formulation composition (Q1 & Q2) which can be bioequivalent with the RLD? 


BA BE data of the test product and the reference were used in the analysis.

The in-silico BA BE prediction was performed by means of IVIVC modeling followed by virtual BE


Drug Record Cmax (ng/mL) AUC (ng/mL*h) Observed T/R Predicted T/R
Obs. Pred. % Pred. Error Obs. Pred. % Pred. Error Cmax AUC Cmax AUC
Lidoderm 38.06 41.2 -8.235 484.8 415 14.39
T2 22.79 27.09 -18.91 304.4 340.5 -11.86 0.60 0.63 0.66 0.82


  • The M&S methodology recommended the bioequivalent formulation composition.
  • The Sponsor reduced costs and timelines by decreasing the development timeline and number of clinical studies 

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