Analysis of Dissolution Data Sets

In vitro dissolution data can be collected in closed systems (e.g., in compendial dissolution vessels) or by using open (flow-through) systems (1). 

A review of methods frequently used in the analysis of cumulative dissolution profiles has been recently published (21). 

In this chapter, the emphasis is on producing physiologically relevant dissolution data sets. Compared to dissolution profiles obtained according to relevant compendia requirements for quality control purposes, biorelevant dissolution data sets collected in closed systems often do not reach 100% dissolved and frequently are associated with higher variability (22). 

Various model-dependent methods for the comparison of two cumulative dissolution data sets have been proposed (21). Usually, these methods involve prior characterization of both profiles by one to three parameters per profile. In some models, these parameters can be interpreted in terms of the kinetics, the shape, and/or the plateau, but in other instances, they have no physical meaning. One issue that requires some attention is that, in cases where more than one parameter is estimated, a multi-variate procedure for the comparison of the parameters must be applied (9,21). 

In recent years, the comparison of two profiles with an index has become very popular mainly because it does 

---