Table 2 Physicochemical testing of tenofovir and maraviroc bigel formulations
Bigel | Properties | Storage condition | |||
|---|---|---|---|---|---|
25° ± 2 °C/65 ± 5%RH | 40° ± 2 °C/75 ± 5%RH | ||||
0 month | 3 months | 0 month | 3 months | ||
A | Color | White | White | White | White |
Appearance | Homogenous | Homogenous | Homogenous | Homogenous | |
pH | 5.2 ± 0.18 | 5.2 ± 0.01 | 5.2 ± 0.18 | 5.2 ± 0.01 | |
Viscosity (cPas) 40 rpm | 14560 ± 10.8 | 14562 ± 11.1 | 14600 ± 9.32 | 14718 ± 4.78 | |
Spreadability (g.cm/s) | 63.11 | 62.0 ± 1.01 | 63.67 | 61.0 ± 3.59 | |
Osmolality (mOsm/kg) | 450.2 ± 4.4 | 451 ± 3.8 | 450.2 ± 4.4 | 456 ± 2.4 | |
B | Color | White | White | White | White |
Appearance | Homogenous | Homogenous | Homogenous | Homogenous | |
pH | 4.3 ± 0.03 | 4.9 ± 0.32 | 4.3 ± 0.03 | 4.9 ± 0.56 | |
Viscosity (cPas) 40 rpm | 14476 ± 9.1 | 14477 ± 12.3 | 14501 ± 10.2 | 14670 ± 9.9 | |
Spreadability (g.cm/s) | 56.57 | 58.31 ± 1.08 | 57.77 | 60.30 ± 2.01 | |
Osmolality (mOsm/kg) | 473 ± 2.7 | 473 ± 2.7 | 473 ± 2.7 | 478 ± 3.1 | |
C | Color | White | White | White | White |
Appearance | Homogenous | Homogenous | Homogenous | Homogenous | |
pH | 4.4 ± 0.29 | 4.6 ± 0.03 | 4.4 ± 0.29 | 4.6 ± 0.18 | |
Viscosity (cPas) 40 rpm | 14179 ± 10.1 | 14179 ± 14.6 | 14229 ± 7.3 | 14296 ± 11.5 | |
Spreadability (g.cm/s) | 45.14 | 48.7 ± 2.01 | 46.94 | 49.1 ± 1.99 | |
Osmolality (mOsm/kg) | 430 ± 4.9 | 431 ± 2.1 | 430 ± 4.9 | 439 ± 1.27 | |
D | Color | White | White | White | White |
Appearance | Homogenous | Homogenous | Homogenous | Homogenous | |
pH | 4.0 ± 0.34 | 4.9 ± 0.01 | 4.0 ± 0.34 | 4.9 ± 0.06 | |
Viscosity (cPas) 40 rpm | 14293 ± 7.9 | 14299 ± 9.2 | 14371 ± 8.1 | 14498 ± 12.8 | |
Spreadability (g.cm/s) | 47.44 | 45.33 ± 1.99 | 47.99 | 46.01 ± 1.29 | |
Osmolality (mOsm/kg) | 590 ± 7.4 | 599 ± 3.2 | 590 ± 7.4 | 603 ± 1.93 | |