As they become more varied and complex, new formulations optimization in early-stage development increasingly relies on modeling and other indirect techniques. In support of these, the need for actual reference data becomes an even more pressing challenge. With limited amounts of material available, tests such as dissolution at standard compendial volumes remain impractical. Fortunately, an array of non-compendial small volume dissolution testing solutions have become commercially available, and their popularity (along with a desire to harmonize with the Chinese Pharmacopeia, which explicitly defines such a setup) has led to the USP launching a program to begin reviewing some of these solutions for possible inclusion in the General Chapters. This Rapid Fire talk will summarize these needs, currently available solutions, and some questions for standardization, and paths one can utilize today that will probably remain valid approaches after the introduction of regulations.
Learning Objectives:
Understand available tools for early-stage formulation characterization using very limited amounts of available material for applications like development of predictive product performance models.
How do I make small volume dissolution comparable to compendial dissolution?