Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products.

摘要: Abstract Purpose The purpose of this study was to compare the dissolution behaviour etoricoxib in different media and establish vitro/in vivo correlation (IVIVC) using computer simulations. Methods Drug solubility measured media. studied USP Apparatus 2 A transfer model used investigate if drug stays solution when pH medium changes. permeability assessment performed caco-2 cell culture technique. vitro data were as input functions GastroPlus™ simulate profiles drug. Results Solubility highest at low pH, there no significant difference observed between blank buffers biorelevant similar pH. remained solubilised transferred into simulated intestinal fluids. Using function Gastro Plus, an IVIVC established. Further simulations confirmed that absorption occurs oral solution. Conclusions Due within physiological gradient gastrointestinal tract, can be classified intermediate class 1/2 rather than BCS 2. In results combined with silico GastroPlus support scientifically a biowaiver for immediate release solid dosage forms is justified.