Dissolution is a compendial method used to measure a drug’s rate of release from its dosage form. It is a complement to other analytical assays (potency and related substances) that characterize the dosage form. Dissolution is typically used:
- To optimize drug delivery rate during development studies
- For use in routine QC analysis for lot release and to measure lot-to-lot variability
- For use in stability studies to study the effects of time/temperature/humidity on the dosage form
- To compare one dosage form to another (different formulations, different processes, analysis of competitor's samples)
- To estimate release and absorption rates in humans after an in vitro - in vivo correlation is established
Dissolution is a sample preparation technique. Samples still need to be analyzed separately, usually by Microtest’s HPLC or UV Spectroscopy testing. Typical samples are oral dosage forms, although it can also be used on topicals and transdermal systems.