Determining The Pressure-Generating Capacity of The Classical and Alternative In Vitro Dissolution Methods Using a Wireless Motility Capsule

Purpose

In vitro dissolution tests are an important tool for prediction of in vivo behavior of pharmaceutical dosage forms. One of the main reasons behind poor in vitro-in vivo correlation is the lack of knowledge about the true in vivo conditions and the failure to replicate them adequately in vitro. The objective of this study was to investigate the conditions during the dissolution testing in terms of their capability to generate the biorelevant pressure values that orally administered dosage forms are exposed to in vivo.

Methods

Using the SmartPill®, three classical dissolution systems (USP 1–3) were subjected to the pressure measurements. With USP 3, the addition of plastic beads was also examined. Additionally, two novel in vitro dissolution models capable of simulating the peristaltic action were also investigated, namely, the advanced gastric simulator (AGS) and the intestine model for simulating the peristaltic action (IMSPA).

Results

The USP 1 and USP 2 systems showed no significant pressure readings, while the USP 3 (and especially its combination with plastic beads) showed measurable pressure peaks but still below the reported in vivo values. The AGS and the IMSPA, on the other hand, offered precise and repeatable controlled contractions of a silicone container resulting in the maximum pressure values very close to the reported in vivo measurements by the SmartPill® device.

Conclusions

The results therefore support the in vivo relevance of the newly developed AGS and IMSPA models and present their potential for further optimization of dissolution testing methods.