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Case study

Alternative fungal supplements for pancreatic insufficienty

Realistic replication of dynamic gastric and intestinal environments in fed state

 

About case

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The approach

Evaluation of drug release and absorption of over 20 drugs/formulations (neutral, acidic, basic, and salts) covering all BCS classes, using the upper GI model tiny-TIM to predict the effect of food and postprandial luminal changes, namely:

  • gastric pH and emptying (transit time)
  • (fresh) bile secretion and solubilization by bile micelles
  • (real) FDA-recommended High Fat Meal or Low Fat Meal components and viscosity

Services

Supplements IVIVC Fed State Food effect

TIM's

TIM-Upper GI tiny-TIM

The results

  • Correlation coefficient R2 of 0.78
  • Able to predict the direction of the food effect for 18/20 drugs and formulations, increased to 20/20 when combined with PBPK
  • tiny-TIM captured the food effect for compounds that in silico models incorrectly predicted
  • Level A IVIVC (R2 = 0.99) predicted food effect on cobimetinib exposure in healthy adults (see publication)
  • Using tiny-TIM data as a biopredictive dissolution input to Gastroplus PBPK model predicted in vivo metformin exposure (predicted to observed ratios of 0.93 and 1.03 for Cmax and 0.92 and 0.99 for tmax, for fasted and fed states respectively – see publication)

 tiny-TIM is a powerful tool to predict food effects for ionizable compounds and enabling formulations. Outputs can be used as biopredictive input to PBPK models 

Lui et al, 2024

Read full article

Liu et al., Evaluating Utilization of Tiny-TIM to Assess the Effect of Food on the Absorptions of Oral Drugs and Its Application on Biopharmaceutical Modeling. 2024. J. Pharm. Sci..

Lessons learned

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