Fasted state simulated intestinal fluid FaSSIF

Table 2. Composition of fasted state simulated intestinal fluid (FaSSIF) and fed state simulated intestinal fluid (FeSSIF) (Galia et al., 1998, Vertzoni et al., 2004).

FaSSIF Fasted state simulating intestinal fluid... 

The study was performed with a Class 1 member in the form of tablets. Changes in pH have no effects while changes in agitation intensity for USP apparatus II and IV have shown clear influences on the tablet erosion and subsequently on its release. Finally to simulate the fasted and fed state in vivo, fasted state stimulated intestinal fluid(Fassif) and fed state simulated intestinal fluid(Fessif) media were used. None of the USP traditional apparatus show a clear relationship with the in vivo results, especially in the fed conditions. In vitro data obtained by the ADS in the fasted state were consistent with those in vivo, as well as in the fed state after a slight time adjustment allowed in the FDA notes of guidance. A Level A of IVIVC was easily established with a good correlation coefficient in the fasted and fed states, respectively. The main results are presented in Fig. 13. 

FaSSIF.Fasted State Simulated Intestinal Fluid... 

After solvent evaporation, stirring elements and 200 tiL of dissolution medium (e.g., simulated fasted state intestinal fluid, FaSSIF, pH 6.5) are added to each well. The 96 microtiter plate is sealed with a cover plate and agitated by head-over-head... 

---