Streamlined selection of in vivo predictive dissolution media for in vitro testing of poorly water soluble drugs

Oral drug product administration is the most common delivery method in the pharmaceutical industry. Successful oral delivery requires dissolution of solid dosage forms in gastrointestinal (GI) fluids and permeation across the GI membrane. Therefore, efficient development of robust oral drug products requires the use of biopredictive in vitro dissolution methods to evaluate how the interplay between drug formulation and GI fluid properties impacts bioperformance. This presentation focuses on the design of dissolution media to support biopredictive dissolution testing, and highlights a method for selecting practical, yet physiologically relevant media based upon drug, formulation and GI fluid properties.