Table 2.
Characteristics | Formulations | |
---|---|---|
Placebo | Epi 30 | |
Diameter (mm) | 9.98 ± 0.01 | 9.98 ± 0.01 |
WV (mg), (AV) a | 202 ± 2.58 (3.1) | 211 ± 2.85 (6.47) |
CU (%), (AV) a | N/A | 102 ± 4.77 (10.94) |
BF (kgf) | 2.53 ± 0.02 | 2.50 ± 0.01 |
F (%) | 0.1 | 0.7 |
DD (%) b | N/A | 102.97 ± 8.28 |
a AV, USP acceptance value (values ≤15.00 were considered acceptable according to USP L1 limit); b DD (%), Percentage of drug dissolved in the first 120 s.