DIAMOD^®

The DIAMOD^® system is a cutting-edge technology for biorelevant in vitro analysis of the bioavailability and pharmacokinetics of small molecule drugs, especially to measure dissolution and permeation of poorly soluble but permeable (BCS-class II) compounds.

By design, the DIAMOD^® recreates the physical interconnection of the dissolution and permeation processes by fully reproducing the dynamic environment of the stomach and the small intestinal compartments. Unlike other models, in the DIAMOD^® all factors influencing dissolution and permeation are dynamically simulated in function of time, including pH, flux rates, secretions of enzymes, and the concentration of the drug. This reflects the biological complexity of the in vivo gastrointestinal tract. The permeation component of the DIAMOD^® discriminates between apparent versus molecular solubility.

Correlation between published clinical PK data and in vitro DIAMOD^® data (in vivo-in vitro correlation) is superior to other in vitro simulators, reaching sometimes values > 90%, making the DIAMOD^® an excellent technology to speed up biopharmaceutical risk assessment, formulation prototype development, study of food effects or for solving PK and manufacturing challenges. An additional advantage is that the DIAMOD^® can be modified to simulate disease conditions, as such simulating pharmacokinetic data for specific disease populations.

“With DIAMOD ^® we get better insights than with in vivo studies, because we can monitor the behavior of our drug not only in plasma, but also in the GIT lumen”

[T.F.]

“When we perform a clinical study, we dose healthy volunteers. But we have no idea of how our drug will perform in the target patient population. With DIAMOD ^® we can tweak parameters and simulate, for instance, hypochlorhydria”

[P.B.]

“With DIAMOD ^® cycles of development have significantly improved. We get results in a couple of weeks, instead of a couple of months. And costs are so much lower…”

[J.S.]

Kinetics of solute and total test product in the lumen of the compartments of he gastrointestinal tract and of the total permeated fraction.

PK values: C_max, T_max, AUC, level of supersaturation.

• UHPLC
• LC-MS