Table II.
Mean ± SD (n = 6) Hardness, Disintegration Time, Weight Variation, Content Uniformity, Tablet Diameter, Tablet Thickness, and Friability for RDST Formulations
| Tablet characteristics | |||||||
|---|---|---|---|---|---|---|---|
| Formulations | H | DT | WV (AV) | CU (AV) | D | T | F |
| 10 mg Epi tablets | 1.7 ± 0.3 | 16.3 ± 0.3 | 100.0 ± 0.0 (0.0) | 100.6 ± 4.0 (9.6) | 7.9 ± 0.0 | 3.5 ± 0.0 | 0.4 |
| 20 mg Epi tablets | 1.6 ± 0.1 | 15.8 ± 0.4 | 99.9 ± 0.7 (1.68) | 97.7 ± 2.7 (6.48) | 7.9 ± 0.0 | 3.9 ± 0.0 | 0.5 |
| 40 mg Epi tablets | 1.7 ± 0.2 | 31.3 ± 0.4 | 100.0 ± 0.6 (1.44) | 95.6 ± 2.4 (5.76) | 7.9 ± 0.0 | 3.4 ± 0.0 | 0.6 |
| 10 mg Epi-MC tablets | 2.5 ± 0.0 | 5.5 ± 0.7 | 99.7 ± 1.2 (2.88) | 92.9 ± 0.3 (0.72) | 8.0 ± 0.1 | 3.7 ± 0.0 | NA |
| 20 mg Epi-MC tablets | 2.5 ± 0.1 | 8.7 ± 0.3 | 98.3 ± 1.7 (4.08) | 92.2 ± 4.2 (10.08) | 8.0 ± 0.1 | 3.7 ± 0.0 | NA |
H tablet hardness (kgf), DT disintegration time (values ≤60 s were considered acceptable for sublingual administration), WV weight variation (%), CU content uniformity (%), AV USP acceptance value (acceptance values ≤15.00 were considered acceptable according to the USP L1 limit), D tablet diameter (mm), T tablet thickness (mm), F friability (values ≤1% weight loss were considered acceptable according to the USP limit)