Optimizing Surfactant Selection in Dissolution Studies

Surfactants play a key role in improving solubility and maintaining sink conditions, but using too much can artificially speed up drug release.

If you get similar dissolution results across different concentrations, it’s best to go with the lowest level that is still physiologically relevant.

Reproducibility matters – choose a concentration that gives consistent results across batches, strengths, and media.

Make sure your selection aligns with regulatory expectations, including FDA, EMA, ICH, and USP guidelines.

Consider factors like the critical micelle concentration, comparison with the reference product, biowaiver requirements, and multi-media dissolution across all strengths.

The surfactant should also preserve the method’s discriminatory power and avoid foaming or analytical interference.

In short, when multiple concentrations give the same results, the simplest, reproducible, and physiologically relevant option is the best choice.

Read also: Dissolution Requirements of IGDRP Participants

Resource Person: Vijay Agrawal