Table 1. In vitro dissolution data of 1 mg larazotide acetate of a delayed release formulation in 6 capsules.
Sampling time points (minutes) | Time in GIT (minutes) | Average (±SD) Dissolution (%) of 1 mg LA (n = 6) | |
---|---|---|---|
Simulated gastric media (Stomach) | 0 | 0 | 0 |
30 | 30 | 0 | |
60 | 60 | 0.1 ± 300 | |
120 | 120 | 0.7 ± 85.7 | |
Simulated intestinal media (Small intestine) | 15 | 135 | 1.4 ± 42.9 |
30 | 150 | 39.7 ± 11.4 | |
45 | 165 | 41.2 ± 14.4 | |
60 | 180 | 42.8 ± 12.6 | |
90 | 210 | 79.1 ± 18.3 | |
120 | 240 | 93.7 ± 2.4 | |
180 | 300 | 93.7 ± 2.5 |
Times (minutes) in small intestine were back calculated by adding 120 minutes to sampling time point respectively. LA: larazotide acetate, GIT: gastrointestinal tract, SD: standard deviation