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Chapter 6 128 at these 14 time points. In between test periods and after the last test period, volunteers were telephoned to inquire after possible adverse events. Results In vitro GISS experiment In vitro analysis of the newly produced ileocolonic release peppermint oil capsules in the GISS showed that the actual release of the peppermint oil was postponed until the last phase (colon). Part of the coating remained intact and contained a small residual amount of peppermint oil ( Table 6.2 ). Table 6.2 Results of ileocolonic release peppermint oil capsules in in vitro dissolution test (GISS). Phase Gastrointestinal segment Capsule appearance Capsule location in dissolution vessel Oil observed on surface buffer solution I Stomach None II Jejunum Slight amount III Ileum (distal) Small amount IV Colon (proximal) Intact Intact, minor cracks in coating Intact, small cracks in coating Open - small residual amount of oil inside Bottom Bottom Bottom Floating on surface buffer solution Large amount GISS; gastro-intestinal simulation system, PO; peppermint oil. Phase I human trial Eight healthy volunteers were screened, included, and randomly assigned to a specific treatment order. All participants were between 20 and 65 years old (median 22.2, IQR 20.8-28.8). See Table 6.3 for baseline characteristics. All participants completed the study. Table 6.3 Summary of participant demographic and baseline characteristics. Total Small-intestinal release PO on first test day Ileocolonic release PO on first test day N =8 N =4 N =4 Female sex , N (%) 4 (50) 1 (25) 3 (75) * Age , years (median + IQR) 22.2 (20.8-28.8) 24.1 (21.2-55.0) 21.7 (20.6-27.9) BMI , kg/m 2 (median + IQR) 21.5 (20.2-23.0) 21.7 (18.5-23.8) 21.5 (20.6-22.2) Height , cm (median + IQR) 177 (171-183) 181 (177-192) 173 (168-177) Weight , kg (median + IQR) 65.5 (64.0-72.0) 71.0 (65.3-79.8) 64.0 (61.8-66.3) Differences were tested using Mann-Whitney U test for non-parametric data and chi-square or Fisher’s exact for parametric data. * Significant difference in gender between the group receiving small-intestinal peppermint oil (PO) on the first test day and the group receiving ileocolonic release PO on the first test day ( P <0.05). N =8 (total group).