Polyphenols and catechins in particular, have been shown to interact with proteins such as gelatin/collagen [ 23, 24] but also with cellulose derivatives Gefitinib chemical structure such as HPMC [ 25], resulting in insoluble complexes. Further experiments would be required to identify the specific catechin or potentially other compound(s) of the GTE causing the interaction. As mentioned earlier, the addition

of a dispersant might reduce this interaction and hence improve the dissolution of the formulation. This could be especially useful for DS, however, formulations used for clinical intervention trials are often kept as simple as possible to eliminate any potential physiological effect thereof, but as shown in this study this may limit complete release. Table 2 The dissolution in biorelevant media showed a delayed onset and rate of dissolution in the simulated fed state compared to the simulated fasted state. These results were in good agreement with previously reported in vitro and in vivo studies [ 16, 19]. The trend towards longer rupture times in the simulated fed state may be attributed to the slower hydration and softening rate of the tested capsule shell materials in the presence of food.

Whether this would also hold for other HPMC capsule types and gelling agents is still unclear. Data from dissolution in FaSSIF and FeSSIF are especially valuable to plan the time of administration, e.g. whether to dose with or Selleckchem LY294002 without a meal. In conclusion, in order to properly design and guide nutrition intervention trials and to enhance the success

rate of an investigational product or DS, a good understanding of the formulation’s in vitro performance is crucial, as the release profiles will GPX6 greatly affect the timings of clinical measurements. No- or negative-effect trials are often attributed to the active ingredient itself, rather than the formulation. Insufficient information on the quality and performance of the investigational product can lead to false negative and/or false-neutral interpretations of clinical data. GTE specifically, indicated variable disintegration and dissolution profiles depending on the capsule shell material employed. Therefore, it is recommended the performance of solid oral dosage forms intended for use as a DS or clinical trial investigational product be verified preferably with an in vitro dissolution test prior to the product being released. Natalie Glube: designed the study, supplied the materials, analysed the results and wrote the paper. Lea von Moos: conducted the experiments, analysed the results and contributed to the manuscript. Guus Duchateau: participated in the design, contributed to the manuscript and revised the paper. “
“A large amount of the novel pharmaceutically active substances can be characterized by a high hydrophobicity and a poor water solubility [1].