What is COMPASS?
COMPASS is an innovative software solution that estimates if the differences in the dissolution of immediate-release formulations would lead to pharmacokinetically relevant differences under highly variable fasted gastric emptying kinetics. Thus, it enables rational comparison of the dosage form performance during the early stage of the formulation development.
Why is COMPASS unique?
COMPASS rapidly calculates plausible in vivo Cmax and AUC differences between two tested immediate-release formulations. The prediction method used in the proposed tool serves as a midway alternative to the f2 factor and elaborate systems based on full physiology-based pharmacokinetic models. An advantage over the f2 factor is the inclusion of gastric emptying kinetics and PK disposition parameters. Contrary to the sophisticated PBPK platforms, the use of COMPASS does not require in-depth knowledge of the physiologically-based systems. The estimated differences in Cmax and AUC are visualized as interactive 3D plots, and all the calculations can be downloaded in a comprehensive report to ensure data integrity.
How does it work?
COMPASS is a Python-based tool but all the calculations are made via a user-friendly graphical interface opened in any web browser. The analysis begins with uploading and fitting the dissolution data. To ensure the most accurate dissolution conditions, we recommend using biopredictive media. Then, the user may choose one of three simulation modules, depending on the focus of the analysis and knowledge of the drug’s pharmacokinetics in humans:
- a thorough investigation of the fasted gastric emptying kinetics’ influence,
- an evaluation of the population pharmacokinetic variability,
- or an exploration of the wide range of PK parameters’ combinations.
For pharmacokinetic simulations, the user should input parameters describing drug absorption (effective intestinal permeability), distribution (distribution volumes), and elimination (clearances).
