Table 2. Characteristics of the Capsule PK Profiles and Corresponding In Vitro Dissolution Tests in PhysioCella.
in vivo PK profile |
in vitro dissolution test |
||||
---|---|---|---|---|---|
group | Tmax [h] | C0.5 h [mg/L] | intragastric stress | GET [min] | prevalence (%) |
1 | ≤0.5 | not applicable | none | 15 | 27 |
2 | 0.5–1.0 | 0.6–0.95 Cmax | 300 mbar at 10 and 13 min | 30 | 22 |
3 | 0.5–1.0 | 0.3–0.6 Cmax | 200 mbar at 5 min | 30 | 18 |
4 | 0.5–1.0 | <0.3 Cmax | none | 30 | 13 |
5 | 1.0–1.5 | not applicable | none | 60 | 13 |
6 | >1.5 | not applicable | none | 90 | 7 |
C0.5 h—drug concentration in plasma at 0.5 h; GET—complete gastric emptying time (“housekeeper wave” time).