Controlled flow-through dissolution methodology: a high-performance system.

Measuring release rates using compendial systems, especially for sparingly soluble compounds, often produces complex results with less than desired precision and lacks relevance to key formulation or biological parameters. A flow-through approach was used by focusing on convective diffusion and controlling certain key physical-chemical factors. Results are presented for an automated multisample flow-through system that displays significant advantages over compendial (1) stirred and (2) flow-through systems. Advantages include precision, physicochemical, and in vivo relevance, along with analytical and formulation sensitivity. The convective diffusion/dissolution process was also simulated by using finite element modeling with predictions agreeing with measurements to within a few percent.