When studying drug dissolution in the gastrointestinal (GI) tract, simulating realistic physiological conditions is crucial for accurate results. Enter Level I biorelevant media – a novel approach to create in vitro environments that closely mimic luminal pH and buffer capacity in different regions of the GI tract.
At Level I, they differentiate between fasted and fed states, considering the stomach and various locations in the small intestine and colon. The media compositions are based on human luminal data and previous proposals, ensuring a solid foundation.
For fasted state conditions, Level I FaSSGF, Level I FaSSIF, Level I FaSSIF-V2, and Level I FaSSCoF are designed to simulate different regions. However, in the midgut and ileum regions, buffer capacity data is not directly available, leading to interpolation based on existing data.
In the fed state, the focus shifts to different periods after meal ingestion and locations in the GI lumen. Level I FeSSGFearly, Level I FeSSGFmiddle, and Level I FeSSGFlate capture the stomach’s nuances during these periods. Similarly, Level I FeSSIF, Level I FeSSIF-V2, Level I FeSSIFmidgut, and Level I SIFileum represent various regions in the small intestine.
These media are valuable for evaluating drug performance and potential food interactions. For highly soluble drugs, they may not require bile salts and lipids to achieve accurate dissolution results. Moreover, they are useful for developing in vitro-in vivo correlation (IVIVC) models for extended-release products affected by luminal pH and buffer capacity.
However, further validation is needed, especially for the fed state, where buffer capacity data in the midgut and ileum are lacking. The choice of buffer materials also requires careful consideration to achieve the necessary pH and capacity, particularly in the fasted state.
Level I biorelevant media present an innovative tool for drug dissolution studies, enhancing our understanding of drug behavior in the GI tract. Nonetheless, continuous research and refinement are essential to optimize their effectiveness, particularly in the context of fed state conditions.
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Resource Person: Prakash Amate