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As part of a drive to develop predictive in vitro models to forecast the in vivo performance of drugs and drug products, two biorelevant dissolution media simulating conditions in the proximal small intestine, Fasted-State Simulated Intestinal Fluid (FaSSIF) and Fed-State Simulated Intestinal Fluid (FeSSIF), were proposed in 1998 (1). Although these media have been proved useful in terms of in vivo predictions, there is room for improvement. One aspect that might lead to suboptimal predictions is that some parameters in FaSSIF and FeSSIF (e.g., buffer capacity) were chosen on the basis of canine, rather than human data (1). Additionally, since the first set of biorelevant media were developed, there have been several studies of the relevant parameters in humans (2, 3). Of particular note is that the bile salt concentrations reported in more recent studies tend to be lower than in older reports, most likely as a result of more specific analytical techniques. Moreover, the previous versions of the biorelevant media do not reflect the lipolysis products of meal digestion that are known to enhance the solubility and dissolution of poorly soluble lipophilic drugs (3). The biorelevant dissolution media have been updated recently to bring the composition and characteristics closer to those of aspirates collected from the human gastrointestinal (GI) tract (4). Together with the medium simulating the preprandial gastric conditions proposed by Vertzoni et al. in 2005 (5), a core group of four biorelevant media simulating both stomach and proximal small intestine of humans in the preand postprandial states has been established (4). These media can be used to investigate the release characteristics of drugs and drug products in the stomach and small intestine, particularly in terms of food effects. This article summarizes the media composition and their important characteristics. In addition, examples of applications of the in vivo predictiveness of these media are presented.

Biorelevant Dissolution Media Simulating the Proximal Human Gastrointestinal Tract: An Update