Table A4.
Properties of 12 mm ODTs during the stability studies.
| Parameter | T0 | 25 °C/60% RH | 40 °C/75% RH | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.5 mo | 1 mo | 2 mo | 3 mo | 6 mo | 0.5 mo | 1 mo | 2 mo | 3 mo | 6 mo | ||
| Hardness [N] | 30.08 ± 3.02 | 42.35 ± 4.78 | 36.79 ± 3.15 | 35.48 ± 1.90 | 23.54 ± 4.64 | 22.56 ± 1.07 | 37.61 ± 2.82 | 33.84 ± 3.15 | 31.23 ± 3.74 | 48.07 ± 6.99 | 26.16 ± 1.48 |
| Disintegration time–FP [s] | 54.2 ± 3.1 | 57.0 ± 5.8 | 54.7 ± 3.1 | 58.0 ± 5.8 | 116.5 ± 29.6 | 85.2 ± 19.3 | 57.0 ± 7.6 | 57.8 ± 4.5 | 62.5 ± 4.5 | 93.2 ± 27.6 | 39.3 ± 8.8 |
| Disintegration time–BJKSN [s] | >180 | - | >180 | >180 | >180 | >180 | - | >180 | >180 | 150.00 ± 4.73 | 89.03 ± 11.46 |
| Content [% of declared value] | 99.67 ± 0.78 | - | 98.36 ± 1.96 | - | 89.66 ± 10.40 | 84.79 ± 2.71 | - | 95.34 ± 2.66 | - | 81.55 ± 5.24 | 77.31 ± 1.91 |